HERE are our points of note from the latest MHRA Yellow Card reporting up to August 24 (published September 1 2022). These notes are followed by our full Yellow Card summary.
(Elsewhere in these pages I will be reporting specifically on pregnancy, breastfeeding, foetal deaths, stillbirths and related reproductive health reactions in light of renewed concerns, and new awareness across social media about the absence of vaccine safety data for this category of women.)
Fatal – 820 (Pfizer) + 1,301 (AZ) + 70 (Moderna) + 49 (Unknown) = 2,240 (up from 2,226 in four weeks)
(19 new deaths minus 5 deaths removed from total)
In the 28 days since the previous summary for 27 July 2022 we have received a further:
· 425 Yellow Cards for Pfizer/BioNTech (seven fatal minus two removed fatalities = five fatalities)
· 187 for AstraZeneca (five fatal minus one removed fatality = four fatalities)
· 306 for Moderna (six fatalities minus one removed fatality = five fatalities)
· 28 where the brand was not specified (one fatality, minus one removed fatality = zero fatalities)
Pfizer – seven extra deaths minus two fatalities removed
· Cardiac Disorders x 3
o one myocardial infarction
o one cardiomegaly
o one cardiac arrest
· General Disorders category x 1
o one death
· Infections x 1
o one sepsis
· Neoplasms x 1
o one throat cancer
· Respiratory Disorders x 1
o one chronic obstructive pulmonary disorder
Removed Fatalities
· Immune Disorders x 1
o one anaphylaxis
· Pregnancy Conditions x 1
o one spontaneous abortion (miscarriage)
Note: One brain death and one cardiac death noted under ‘death and sudden death’ sub-category but not recorded as fatal
AstraZeneca – five extra deaths minus one fatality removed
· General Disorders Category x 1
o one adverse drug reaction
· Infections x 1
o one COVID-19 pneumonia
· Neoplasms x 1
o one pancreatic carcinoma
· Nervous System Disorders x 2
o one cerebral infarction
o one cerebral venous sinus thrombosis
Removed Fatalities
· Infections x 1
o one pneumonia
Note: Three brain deaths, one cardiac death, one death, one drowning and one hanging noted under ‘death and sudden death’ sub-category but not recorded as fatal
Moderna – six extra deaths minus one fatality removed
· Cardiac Disorders x 2
o one pericardial haemorrhage
o one cardiac arrest
· General Disorders category x 1
o one death
· Infections x 1
o one pneumonia aspiration
· Nervous System Disorders x 2
o one Guillain Barré syndrome
o one haemorrhagic stroke
Removed Fatalities
· Nervous System Disorders x 1
o One cerebral haemorrhage
Brand unspecified – (one fatality, minus one removed = zero fatalities recorded)
· Muscle & Tissue Disorders x 1
o One costochondritis
Removed Fatality
· Pregnancy Conditions
o one abortion spontaneous (miscarriage)
Other changes this month:
First doses
· Adults
o Minimal increase
· Children
o Increase of 100,000 (Pfizer) – rounded total
o Decrease of 100 (AZ)
Second doses
· Adults
o Increase of 300,000 (Pfizer) – rounded total
o Increase of 100,000 (AZ) – rounded total
· Children
o Increase of 100,000 (Pfizer) – rounded total
o Increase of 100 (Moderna) – rounded total
Booster uptake
· Adults
o Overall, 118,321 boosters administered including 400 (AZ) – other brands rounded totals
o Adverse event yellow card reporting rate for adult AZ boosters – 1-in-97
· Children
o Zero increase
Overall increases in a month (28 days)
· First doses administered – 64,596 (all brands)
· Second doses administered – 176,765 (all brands)
· Adult Yellow Card reports filed – 946 (people impacted from all brands)
· Child Yellow Card reports filed – 69 (children impacted from all brands)
· Total doses (1st, 2nd & booster) administered to under 18s – 7,226,800 (up 200,000 doses)
General Disorders Category – Vaccination/Injection Site Reactions incl.bruising, cyst, eczema, discolouration, haematoma, haemorrhage, inflammation, injury, irritation, joint pain, lymphadenopathy, movement impairment, mass, muscle weakness, necrosis, nerve damage, nodule, oedema, pain, rash, pruritus, scab, scar, paraesthesia, swelling, vesicles, discharge, hypersensitivity, phlebitis, ulcer
Vaccination/Injection Site Reactions – 11,401 (Pfizer) = 14,037 (AZ) + 3,767 (Moderna) = 29,205
Injuries Category
· Falls – 230 (Pfizer) + 319 (AZ) + 65 (Moderna) = 614
· Medication Error – 213 (Pfizer) + 255 (AZ) + 76 (Moderna) = 544
· Off-Label Use – 532 (Pfizer) + 130 (AZ) + 34 (Moderna) = 696
· Inappropriate Schedule of Product Administration – 751 (Pfizer) + 155 (AZ) + 105 (Moderna) = 1,011
MHRA YELLOW CARD REPORTING SUMMARY UP TO 24th AUGUST 2022 (Data published 1st Sept 2022)
Adult – Primary & Booster/Third Dose, Child Administration
Primary doses
· Pfizer – 27.1million people – Yellow Card reporting rate – 1-in-157 people impacted
· Astrazeneca – 24.9m people – reporting rate – 1-in-101 people impacted
· Moderna – 1.7m people – reporting rate – 1-in-42 people impacted
Overall 1-in-116 people injected experiences a Yellow Card Adverse Event, which may be less than 10% of actual figures according to MHRA.
Total doses including boosters administered – 83m (Pfizer) + 49.16m (AZ) + 12.7m (Moderna)
1st doses = 53,769,032 (all brands)
2nd doses = 50,646,995
Boosters = 40,304,702 (30.9m Pfizer, 58,700 AZ & 9.4m Moderna)
TOTAL = 144,720,729 doses
Booster Yellow Card Reports – 32,128 (Pfizer) + 605 (AZ) + 18,512 (Moderna) + 218 (Unknown) = 51,463
Reactions – 498,473 (Pfizer) + 872,333 (AZ) + 134,340 (Moderna) + 5,548 (Unknown) = 1,510,694
Reports – 172,901 (Pfizer) + 246,183 (AZ) + 40,576 (Moderna) + 1,819 (Unknown) = 461,479 people impacted
Fatal – 820 (Pfizer) + 1301 (AZ) + 70 (Moderna) + 49 (Unknown) = 2,240
(19 new deaths minus 5 deaths removed from total = increase by 14 deaths in 4 weeks)
Blood Disorders – 17,229 (Pfizer) + 7,897 (AZ) + 2,602 (Moderna) + 65 (Unknown) = 27,793
Anaphylaxis – 667 (Pfizer) + 887 (AZ) + 95 (Moderna) + 4 (Unknown) = 1,653
Acute Cardiac – 13,733 (Pfizer) + 11,655 (AZ) + 3,573 (Moderna) + 119 (Unknown) = 29,080
Eye Disorders – 8,248 (Pfizer) + 15,056 (AZ) + 1,684 (Moderna) + 99 (Unknown) = 25,087
Blindness – 172 (Pfizer) + 330 (AZ) + 44 (Moderna) + 4 (Unknown) = 550
Deafness – 311 (Pfizer) + 440 (AZ) + 54 (Moderna) + 6 (Unknown) = 811
Infections – 13,045 (Pfizer) + 20,735 (AZ) + 2,648 (Moderna) + 215 (Unknown) = 36,643
Herpes – 2,277 (Pfizer) + 2,720 (AZ) + 280 (Moderna) + 27 (Unknown) = 5304
Spontaneous Abortions – 500 + 16 stillbirths/foetal deaths (Pfizer) + 239 + 5 stillbirths (AZ) + 71 + 1 stillbirth (Moderna) + 8 (Unknown) = 818 miscarriages
Nausea & Vomiting – 21,079 (Pfizer) + 45,635 (AZ) + 7,104 (Moderna) + 216 (Unknown) = 74,034
Nervous System Disorders – 82,654 (Pfizer) + 183,800 (AZ) + 21,889 (Moderna) + 953 (Unknown) = 289,296
Paralysis – 536 (Pfizer) + 911 (AZ) + 128 (Moderna) + 11 (Unknown) = 1,586
Seizures – 1,166 (Pfizer) + 2,107 (AZ) + 305 (Moderna) + 27 (Unknown) = 3,605
Tremor – 2,251 (Pfizer) + 9,995 (AZ) + 781 (Moderna) + 51 (Unknown) = 13,078
Vertigo & Tinnitus – 4,391 (Pfizer) + 7,082 (AZ) + 814 (Moderna) + 49 (Unknown) = 12,336
Strokes and CNS haemorrhages – 843 (Pfizer) + 2,401 (AZ) + 76 (Moderna) + 21 (Unknown) = 3,341
Respiratory Disorders – 22,366 (Pfizer) + 30,099 (AZ) + 4706 (Moderna) + 238 (Unknown) = 57,409
Epistaxis (nosebleeds) – 1,126 (Pfizer) + 2,303 (AZ) + 213 (Moderna) + 12 (Unknown) = 3,654
Psychiatric Disorders – 10,484 (Pfizer) + 18,606 (AZ) + 2,706 (Moderna) + 131 (Unknown) = 31,927
