chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Muscular weakness, Myalgia, Neuropathy peripheral
Clinical narrative: numbness; tingling; pain; neuropathy in both hands and both feet; Joint pain; muscle soreness; mild weakness in hands and feet; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration, administered into left arm on 07Sep2021 11:15 (at the age of 43-year-old) as dose 2, single for COVID-19 immunisation. Medical history included L4-5 spinal hernia, removal of L4-5 spinal hernia on Dec2019, sciatica and neuropathy on L leg due to spinal hernia. Patient was not pregnant. Concomitant medications included acetylsalicylic acid (ASPIRIN 81); ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10), dhea (DHEA) and unspecified prenatal vitamins. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) administered into left arm on 17Aug2021 11:45 AM (at the age of 43-year-old) for COVID-19 immunisation. On 08Sep2021 03:00 patient experienced neuropathy in both hands and both feet, joint pain, muscle soreness and mild weakness in hands and feet. On 08Sep2021 15:00 patient experienced numbness, tingling and pain. Patient did not receive treatment for the events reported. Outcome of events was recovered with sequelae.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information, the causal association between the event neuropathy peripheral and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: numbness; tingling; pain; neuropathy in both hands and both feet; Joint pain; muscle soreness; mild weakness in hands and feet; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration, administered into left arm on 07Sep2021 11:15 (at the age of 43-year-old) as dose 2, single for COVID-19 immunisation. Medical history included L4-5 spinal hernia, removal of L4-5 spinal hernia on Dec2019, sciatica and neuropathy on L leg due to spinal hernia. Patient was not pregnant. Concomitant medications included acetylsalicylic acid (ASPIRIN 81); ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10), dhea (DHEA) and unspecified prenatal vitamins. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) administered into left arm on 17Aug2021 11:45 AM (at the age of 43-year-old) for COVID-19 immunisation. On 08Sep2021 03:00 patient experienced neuropathy in both hands and both feet, joint pain, muscle soreness and mild weakness in hands and feet. On 08Sep2021 15:00 patient experienced numbness, tingling and pain. Patient did not receive treatment for the events reported. Outcome of events was recovered with sequelae.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information, the causal association between the event neuropathy peripheral and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: CSF test, Electromyogram, Guillain-Barre syndrome, Neuropathy peripheral, SARS-CoV-2 test
Clinical narrative: Diagnosed with guillain Barre based on CSF and EMG findings.; signs/symptoms of acute ascending neuropathy in stocking glove distribution that began on 29Aug2021; This is a spontaneous report from a contactable physician. A non-pregnant 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jul2021 (Batch/Lot number was not reported) as dose number unknown, single at the age of 54 years old for COVID-19 immunisation.  Medical history included hypertension (HTN). No known allergies. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced signs/symptoms of acute ascending neuropathy in stocking glove distribution that began on 29Aug2021. The patient was diagnosed with Guillain Barre based on CSF and EMG findings. The events resulted in emergency room/department or urgent care visit. The patient received IVIG as treatment for the events. No history of COVID prior to vaccination and has been tested for COVID post vaccination via nasal swab/rapid PCR on 02Sep2021 and via nasal swab/rapid dry swab on 06Sep2021 with negative results. The patient is recovering from the events. The events were assessed as serious (hospitalization).   Information on the lot/batch number has been requested.; Sender's Comments: A contributory role of BNT162B2 to events Guillain Barre and signs/symptoms of acute ascending neuropathy in stocking glove cannot be excluded based on temporal association and available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Cerebrovascular accident, Paraesthesia
Clinical narrative: stroke like symptoms; stated that her voice has not come back from the day that she took the shot; has pins and needles in right leg; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: SC3182), via an unspecified route of administration, administered in right arm on 03Aug2021 (at the age of 42-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had a very bad reaction to the vaccine. On 03Sep2021, the patient experienced stroke-like symptoms and her voice has not came back from day that she took the first shot. She also had lasting effects of pins and needles in her right leg. She was hospitalized for 24 hours from 04Sep2021 to 05Sep2021. The patient also stated that she went to the emergency room for treatment of all symptoms. Outcome of the event stroke-like symptoms was recovered with sequel on 07Sep2021, voice has not come back was recovering, and pins and needles in leg was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Palpitations
Clinical narrative: heart palpitations, faster and fluttering after the first vaccination; heart palpitations, faster and fluttering after the first vaccination; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 01Apr2021 at 10:00 (Lot Number: EP6955) as dose 1, single for COVID-19 immunization. Medical history included allergies to penicillin and sulfa on unknown dates. The patient's concomitant medications were not reported. The patient experienced heart palpitations, faster and fluttering on an unknown date in 2021, after the first vaccination. The heart related reaction lasted 4 weeks. The outcome of the events was recovered on an unknown date in 2021.    No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Bradykinesia, Dizziness, Fall, Feeling abnormal, Injury
Clinical narrative: passed out/hit the ground; felt weird/loopy; injured himself in the fall; injured himself in the fall; feeling lightheaded; walking really slow; didn't look like he felt well.; This is a spontaneous report received from a contactable pharmacist via a Pfizer-sponsored program. A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 08Sep2021 11:45 (Batch/lot number: FF2588; Expiration date: Dec2021; NDC number: 59267-1000-1), at age 21 years old, as dose 2, 0.3 ml single, for COVID-19 immunisation. Relevant medical history was reported as none. Concomitant medications were not reported. On 08Sep2021 at 11:50, 5 minutes after the second vaccination, the patient felt weird, stood up to get attention and then passed out and hit the ground. The patient was alert and fine but injured himself in the fall, the pharmacist stated that it had nothing to do with the vaccine itself. The patient was feeling lightheaded, looked a little loopy and was walking really slow. The patient did not look like he felt well. The patient had to be rushed to the hospital. The events resulted to hospitalization. It was reported that the patient fainted or passed out before and nothing like this, this was new to him. The outcome of the events was unknown. The reporting pharmacist stated that the events were serious.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise
Clinical narrative: passed out/hit the ground; felt weird/loopy; injured himself in the fall; injured himself in the fall; feeling lightheaded; walking really slow; didn't look like he felt well.; This is a spontaneous report received from a contactable pharmacist via a Pfizer-sponsored program. A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 08Sep2021 11:45 (Batch/lot number: FF2588; Expiration date: Dec2021; NDC number: 59267-1000-1), at age 21 years old, as dose 2, 0.3 ml single, for COVID-19 immunisation. Relevant medical history was reported as none. Concomitant medications were not reported. On 08Sep2021 at 11:50, 5 minutes after the second vaccination, the patient felt weird, stood up to get attention and then passed out and hit the ground. The patient was alert and fine but injured himself in the fall, the pharmacist stated that it had nothing to do with the vaccine itself. The patient was feeling lightheaded, looked a little loopy and was walking really slow. The patient did not look like he felt well. The patient had to be rushed to the hospital. The events resulted to hospitalization. It was reported that the patient fainted or passed out before and nothing like this, this was new to him. The outcome of the events was unknown. The reporting pharmacist stated that the events were serious.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: patient received the 2nd dose of vaccine and when waiting after administration, patient experienced a seizure; This is a spontaneous report from a contactable pharmacist. A 20-year-old female patient received bnt162b2, intramuscular on 02Jun2021 14:00 (Lot Number: ER8730), at the age of 20-years-old, as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 28Apr2021 (lot number: EW0153), at the age of 20 years-old, for COVID-19 immunisation. The patient received the 2nd dose of vaccine and when waiting after administration, patient experienced a seizure on 02Jun2021 14:00. Ae resulted in Emergency room/department or urgent care. The patient was not pregnant at the time of vaccination. No treatment received for the event. Unknown if covid prior vaccination and unknown if covid tested post vaccination. It was unknown if the patient received other vaccines within four weeks prior to the vaccination. The patient received other medications in two weeks. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on current available information, a possible contributory role of BNT162B2 cannot be completely excluded for event Seizure due to temporal relationship.  However, current information is limited and does not allow a full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Painful respiration, Pulmonary cavitation, X-ray
Clinical narrative: suspected cavitary lesion on lung; Chest pain while breathing; cough; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 29Jun2021 11:30 (at the age of 27-years-old) (Batch/Lot Number: EWO167) as DOSE 2, SINGLE for covid-19 immunisation. The patient received first dose of BNT162B2 on 08Jun2021 (at the age of 27 years-old) for COVID-19 immunisation (Product=COVID 19, Brand= Pfizer, Lot number= EWO167, Lot unknown=False, Administration date=08Jun2021, Administration time=11:30 AM, Vaccine location=Left arm, Dose number=1). The patient's medical history and concomitant medications were not reported. On 04Jul2021 06:00, it was reported that the patient experienced Chest pain while breathing, cough, and shortness of breath. Did two separate rounds of antibiotics after doctors visit. No change in condition so the patient received chest X-ray, image showed a suspected cavitary lesion on lung. The patient underwent lab tests and procedures which included x-ray: a suspected cavitary lesion on lung on 04Jul2021.  Therapeutic measures were taken as a result of the events. The patient did not have COVID prior vaccination, and the patient was not covid tested post vaccination. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Hypoaesthesia, Inappropriate schedule of product administration, Palpitations
Clinical narrative: Heart palpitations, faster and fluttering; Heart palpitations; dose 1 on 01Apr2021/dose 2 on 07Sep2021; left hand felt somewhat numb; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 07Sep2021 at 08:45 am (Lot Number: EW0177, unknown expiration) as dose 2, single at the age of 62 years old for COVID-19 immunisation. Medical history included penicillin allergy and sulfa allergy. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP6955) on 01Apr2021 at 10:00 am in the left arm at the age of 61 years old for COVID-19 immunization and experienced heart palpitations, faster and fluttering/pounding heart rate (1st vaccine heart related reaction lasted 4 weeks). No history of COVID prior to vaccination and has not been tested for COVID post vaccination. No other vaccine in four weeks. On 07Sep2021 at 17:30, the patient experienced heart palpitations, faster and fluttering after the second vaccine. Events still present this morning. Pounding heart rate is not as bad as first vaccine but concerning. While waiting at the hospital after receiving the vaccine on 07Sep2021, the patient's left hand felt somewhat numb, but subsided. The patient did not receive treatment for the events. The patient recovered from left hand numb on 07Sep2021, while the patient has not yet recovered from the remaining events.  No follow-up attempts are possible; information about batch number was already obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: Sharp heart pain/sharp pain in the heart; chest pain; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 01Jul2021 (Batch/Lot Number: ER8731) (at the age of 37-years-old) as dose 1, single for COVID-19 immunisation. Medical history included lower back pain, testicular pain, left knee pain and scabs on his head. Family medical history: father had esophageal cancer and stomach cancer. The patient's concomitant medications were not reported. The patient has no COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. On 08Jul2021, the patient experienced sharp heart pains, chest pains and shortness of breath. At first it was short sharp pain in the heart but now the pains are lasting longer. The patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jul2021. The patient had an EKG and chest x-ray in the emergency room (ER) on 14Aug2021 and they said everything was fine. The patient was told to follow up with a heart doctor. No treatment was given to patient for the events. The events resulted in ER visit. The patient had not recovered from the events.
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Atrial fibrillation, Feeling abnormal, Heart rate, Skin oedema
Clinical narrative: heart went to a-fib; It's like I got a flesh eating something in my hand creeping up to my wrist; retain fluid like when I get a bug bite/ a gooey-like substance on my skin; retain fluid like when I get a bug bite/ bugs are really attacking me this year; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 12Mar2021 at dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 19Feb2021 at dose 1, single for COVID-19 immunization. The patient reported that she had rather get the flu and pneumonia shot because BNT162B2 caused her to retain fluid like when she gets a bug bite. The bugs were really attacking her this year and it caused a gooey-like substance on her skin. The mosquitoes have bothered her before, but not to this extreme. It was like she had a flesh eating something in her hand creeping up to her wrist. She reported that she also went to the hospital overnight from an unspecified date in 2021 to an unspecified date in 2021 because her heart went to A-fib, she had a fast heart rate. The events occurred on Jun2021. She asked if anyone else reported late side effects like hers. Initially, the patient was concerned about getting her flu and pneumonia shot. She asked if she could get the flu shot since she already received both COVID shots. She then reported that there is a possible third dose in Nov2021, but she thought about not getting the booster or to wait until next spring. She added that she had a flu shot and pneumonia shot and wanted to know if getting the vaccine will still be effective on her. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Lymph node pain, Lymphadenopathy, Neck pain
Clinical narrative: Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0191), via an unspecified route of administration, administered in right deltoid on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. There were no other relevant medical history, no known allergies. Prior to vaccination, the patient was not pregnant, did not have COVID, and did not receive any other vaccines within 4 weeks. The patient's concomitant medications were not reported. On 13Aug2021 23:45, the patient experienced right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment included Kenalog intramuscularly. The patient underwent lab tests and procedures which included a COVID-19 nasal swab test on 16Aug2021 which was negative. Outcome of the events was not recovered.; Sender's Comments: Based on the plausible temporal relation, the association between the events of lymph node pain and lymphadenopathy and the suspect product of BNT162B2 cannot be completely ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; Right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EW0191), via an unspecified route of administration, administered in right deltoid on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. There were no other relevant medical history, no known allergies. Prior to vaccination, the patient was not pregnant, did not have COVID, and did not receive any other vaccines within 4 weeks. The patient's concomitant medications were not reported. On 13Aug2021 23:45, the patient experienced right side lymph node extreme swelling and pain - neck, axillary to breast through bicep to forearm. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment included Kenalog intramuscularly. The patient underwent lab tests and procedures which included a COVID-19 nasal swab test on 16Aug2021 which was negative. Outcome of the events was not recovered.; Sender's Comments: Based on the plausible temporal relation, the association between the events of lymph node pain and lymphadenopathy and the suspect product of BNT162B2 cannot be completely ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Urticaria
Clinical narrative: developed hives twice that lasted for 3 weeks each; lymphadenopathy in her left axilla; This is a spontaneous report from a non-contactable health care professional (patient). A 26-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 18Feb2021 (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11Mar2021, the patient developed hives twice that lasted for 3 weeks each and also keeps getting lymphadenopathy in her left axilla. The events resulted in a visit to the emergency room/department or urgent care and a healthcare professional office/clinic visit. The patient was given steroids, allergy meds and other unspecified treatments for the event. The events recovered/resolved with sequel on an unknown date in 2021. The events were reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event Urticaria and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Rash morbilliform, Rash pruritic
Clinical narrative: breastfeeding her son (patient); rash/started to look like chicken pox/dots everywhere/itching and it had not itched until that day and it has developed on his face; then it transitioned into a measles looking rash; This is a spontaneous report from a contactable consumer (patient's mother) who reported for herself and her son (patient). This is the report for the baby. A 16-month-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), transmammary on 24Aug2021 (Lot Number: FD8448) as dose 1, single for COVID-19 immunization. Medical history included roseola which was diagnosed by the pediatrician on Jan2021 along with fever and cough also on Jan2021. The patient went to the pediatrician 3 times and never was tested for COVID. There were no concomitant medications. The patient previously received the Hep A vaccine on 04Aug2021 at 15 months old in the leg and the first dose of the MMR vaccine on an unknown date in 2021 at 12 months both for immunization. The patient's mother (reporter) received her first dose of BNT162B2 on 24Aug2021 and was breastfeeding her son (patient). After a week on an unknown date in 2021 (reported as either 31Aug2021 or 01Sep2021) the patient started developing a rash. It started to look like chicken pox. There were dots everywhere and then it transitioned into a measles looking rash, but it was not on his face. It continuously got worse. 07Sep2021 was probably the worst day. The patient's mother called her pharmacist and her son's pediatrician. He has no symptoms of being sick. The doctor said it could be related. The pharmacist said it sounds like COVID rash and that she should call and report it because there is not much research on how it reacts in breast fed patients. The rash was ongoing and has continuously worsened. It is kind of strange. He will wake up and she will think it is all better. Then it gets worse. On the day of the report, it is itching and it had not itched until that day and it has developed on his face, which is the first time the rash has been on his face. The patient's mother wanted to know if she could give him Benadryl and wanted to know if that will have an effect on the vaccine. She thinks that the patient is getting the antibodies if he is getting a rash. She was okay with the rash but wanted to know if giving the patient Benadryl would affect his antibodies. The outcome of the events was unknown. The events were reported as non-serious.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101176675 mother case
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Haemorrhage
Clinical narrative: Bleeding flare; Diarrhea flare; This is a solicited report received from marketing program based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-4066686-00). A contactable consumer (patient) reported that a 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, TOZINAMERAN, Solution for injection), via intramuscular on 14Aug2021 (at age of 45 years old, Batch/Lot number was not reported) as a single dose for covid-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at Daily dose: CF (as reported) for Moderate to Severe Ulcerative Colitis. No relevant medical history. No known allergies. No concomitant drugs taken. The patient experienced bleeding flare and diarrhea flare on an unspecified date.  The action taken in response to the event for adalimumab was permanently withdrawn on an unspecified date. The outcome of events was recovering. The causality as per reporter (Drug/Vaccine) for events and PFIZER BIONTECH COVID-19 VACCINE was Possible, for events and HUMIRA was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, A possible causal relationship between reported events and suspect product BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Migraine, SARS-CoV-2 test
Clinical narrative: COVID breakthrough; COVID breakthrough; migraine; This is a solicited report received from a contactable consumer (patient) based on the information received by Pfizer from. (Mfr. Control No. :21K-163-4064367-00).   A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), intramuscular on an unspecified date (at an unspecified age) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported), at citrate free for moderate to severe pediatric Crohn's. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced COVID breakthrough on 2021, migraine on 2021. The patient underwent lab tests and procedures which included Covid-19: positive on 2021. The action taken in response to the events for adalimumab was unknown. The outcome of event COVID breakthrough was recovering, outcome of event migraine was recovered in 2021.  Causality for BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE): The reporter's causality for the event of migraines and COVID breakthrough with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was possible. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event of migraines and COVID breakthrough with HUMIRA (adalimumab) was no reasonable possibility.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be completely excluded.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Retinal tear
Clinical narrative: torn retina; sore arm; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (Mfr. Control No. :21K-163-4064125-00) from a contactable male consumer (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 vaccination; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. On unknown dates, the patient experienced torn retina and sore arm. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The action taken in response to the events for adalimumab was unknown. The outcome of events was recovering.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the events of torn retina and sore arm with HUMIRA (ADALIMUMAB) was no reasonable possibility.  Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN): The reporter's causality for the events of torn retina and sore arm with vaccine was not reported.  No follow-up attempts are needed; information about lot/batch no. can not be obtained. No further information is expected.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Retinal tear and pain in extremity cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: positive PCR test; positive PCR test; This is a spontaneous report from a contactable Nurse. This nurse reported for a 39-year-old patient that:  A 39-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in arm left on 24Mar2021 (Batch/Lot Number: EP6955; Expiration Date: 30Jun2021) as single dose, dose 2 intramuscular, administered in arm left on 15Apr2021 (at the age of 39-year-old) (Batch/Lot Number: EP6955; Expiration Date: 30Jun2021) as single dose, for COVID-19 immunisation, administered at workplace clinic.  The patient medical history and concomitant medications were not reported. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced vaccination failure (medically significant) on 03Sep2021 with outcome of unknown, positive PCR test (medically significant) on 03Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included: Sars-cov-2 test (Nasal Swab): positive on 03Sep2021  Investigational results were received from a Pfizer product quality complaint group for Lot: EP6955. Product-Description: COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. Lot: EP6955. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EP6955 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Loss of consciousness, Vomiting
Clinical narrative: headache; abnormally amout of bleeding; vomiting; almost passing out; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received 2nd single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: ew0158, expiration date unknown) via an unspecified route of administration in the arm left on 17Jun2021 at age of 33-year-old for COVID-19 immunization. Patient was not pregnant at time of vaccination and events onset. Medical history included anxiety. Patient had no known allergy. There was no COVID-19 prior vaccination. COVID was not tested post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications received within 2 weeks of vaccination included sertraline. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received 1st single dose of BNT162B2 (Batch/lot number: EW0153) via an unspecified route of administration in the arm left on 27May2021 at age of 33-year-old for COVID-19 immunisation and the first menstrual cycle following the vaccine was much heavier than previous ones. It was reported that the first menstrual cycle following the vaccine was much heavier than previous ones. Each month since, the amount of bleeding during patient's cycles has increased from the previous month. Patient had also been getting really bad headaches during her cycles since the second dose. She had brought it up to her doctor and he said he hadn't heard of the vaccines affecting cycles nor amount of bleeding and brushed her off. Not until recently did she start finding others who were experiencing similar symptoms since the vaccine and decided to report it as her doctor would not. Her most recent cycle had an abnormally amout of bleeding specifically one day 24Aug2021, vomiting, and almost passing out. Patient reported she should have probably went to the ER but she was not thinking right nor did she knew this be from the vaccine and could be a sign of something more serious. Patient has dr appointments set up and if she experience this again, she will be going to the hospital as she cannot see how it can get worse than it did last cycle and she still live. The events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. No treatment received for the events.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Dizziness, Malaise, Tinnitus, Vertigo
Clinical narrative: severe tinnitus; severe tinnitus/history of tinnitus; Dizzy; Vertigo; Malaise; This is a spontaneous report from a contactable pharmacist. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in left deltoid on 05Apr2021 AM (Batch/Lot Number: ep7533) as DOSE 2, SINGLE for covid-19 immunisation at Pharmacy or drug store. Family medical history relevant to events included tinnitus-No issues prior to vaccine, not had problems with it for a couple of years prior. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Mar2021 (Batch/Lot number: eL9629) administered in left deltoid via intramuscular for covid-19 immunisation and experienced tinnitus, vertigo and dizziness. No prior Vaccinations (within 4 weeks). Patient complained of severe tinnitus, dizzy, vertigo and malaise on 19Apr2021. The events required visit to Emergency Room and Physician office. Treatment included meclizine. Symptoms started in two weeks after the second vaccine PCP suggested meclizine 75 mg-QID. Patient still has serious symptoms, 2-3 times/monthly. Seriousness Criteria: Important medical event. No relevant tests. The outcome of events was not recovered. The reporter consider Pfizer product had a casual effect to the adverse events.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events severe tinnitus, disease recurrence, dizziness, vertigo, malaise and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: pericarditis; This is a spontaneous report from a non-contactable consumer reported for another male patient (reporter's boss's husband). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient developed pericarditis months after his second dose. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a solicited report based on the information received by Pfizer (Manufacturer Control No: 21K-163-4066039-00). A contactable consumer (patient) reported a 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, intramuscularly on 04Mar2021 at the age of 63 years old, as single dose, second dose, intramuscularly on 25Mar2021 at the age of 63 years old as single dose for covid-19 vaccination; adalimumab (HUMIRA), subcutaneously from an unspecified date to an unspecified date, at unspecified dose for rheumatoid arthritis. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced covid-19 in Aug2021. The patient underwent lab tests and procedures which included Covid Test: positive in 2021.  The action taken in response to the events for adalimumab was unknown. The outcome of the event was unknown. Causality as per reporter for BNT162 was possible.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and vaccination failure due to temporal relationship.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Gait disturbance, Loss of personal independence in daily activities, Malaise
Clinical narrative: my heart is racing; Cannot function with every day things that normal people do; Will take 10 steps before losing control of her legs and can't walk anymore; I am so exhausted from this vaccine; I am getting nervous; I feel like shit; this is not normal I do not feel good; feel horrible; Joint pain; my hand shake; shaking everything; This is a spontaneous report from a Pfizer sponsored program received from a Consumer (the patient).    A 42-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 01Sep2021 (Batch/Lot Number: F-3184) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced my heart is racing  (medically significant) on 2021 with outcome of unknown , cannot function with every day things that normal people do (medically significant) on 2021 with outcome of unknown , will take 10 steps before losing control of her legs and can't walk anymore  (medically significant) on 2021 with outcome of unknown , I am so exhausted from this vaccine  (non-serious) on 2021 with outcome of unknown , I am getting nervous  (non-serious) on 2021 with outcome of unknown , I feel like shit; this is not normal i do not feel good; feel horrible  (non-serious) on 2021 with outcome of unknown , joint pain (non-serious) on 2021 with outcome of unknown , my hand shake; shaking everything  (non-serious) on 2021 with outcome of unknown.  Follow-Up (13Sep2021): Follow-up attempts are completed. No further information is expected.