chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: my arm was sore and swollen; my vision is really blurry; Itchy; feel like that I got the flu; Headache; my arm was sore and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 21Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 22Jan2022, outcome "unknown" and all described as "my arm was sore and swollen"; VISION BLURRED (non-serious) with onset 22Jan2022, outcome "unknown", described as "my vision is really blurry"; PRURITUS (non-serious) with onset 22Jan2022, outcome "unknown", described as "Itchy"; FEELING ABNORMAL (non-serious) with onset 22Jan2022, outcome "unknown", described as "feel like that I got the flu"; HEADACHE (non-serious) with onset 22Jan2022, outcome "unknown", described as "Headache".  Additional information: report was not related to study programme, Consumer stated that well patient do not want to give all the information, just ant to see if the patient do not know if calling to right number, patient want to know some thing about side effects because on Friday got the shot in the evening and then when patient woke up arm was sore and swollen and king of felt, feel itchy all over, it kind of feel like that got the flu and have a bad headache and vision was really blurry. so the patient know if should go to get check or wait and see if kind of stop or what. Consumer was informed about Pfizer Medical information department, As, consumer hung up the call abruptly. Further probing could not be done. Hence, limited information available over the call.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: given the shot in my upper left arm / experiencing soreness and sharp pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Dec2021 13:00 (Lot number: FJ1620) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPRIN; LISINOPRIL; PRAVASTATIN; CLOPIDOGREL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9269, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 05Feb2021, when the patient was 65 years old, for COVID-19 immunization, reaction(s): "inappropriate schedule of vaccine administered"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Vaccine Administration Time: 04:00 PM), administration date: 04Feb2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "given the shot in my upper left arm / experiencing soreness and sharp pain". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: facility at pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. The patient had no known allergies. Patient in good health  follow-up attempts are completed. no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: contracted COVID in September 2021; contracted COVID in September 2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Sep2021, outcome "unknown", COVID-19 (medically significant) with onset Sep2021, outcome "recovering" and all described as "contracted COVID in September 2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Sep2021) contracted covid. Therapeutic measures were not taken as a result of covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid infection; Covid infection; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "RA" (Rheumatoid arthritis) (unspecified if ongoing). The patient took concomitant medications. She takes medications for RA. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid infection". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient received primary series of vaccinations and is now recovering from COVID infection, received PAXLOVID for treatment. The report was considered by reporter as not serious.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have been sick now for over 13 days and I was vaxed.; I have been sick now for over 13 days and I was vaxed.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "I have been sick now for over 13 days and I was vaxed.". The patient's parents were both sick with the first wave of COVID and they are now sick again and needed Paxlovid. Tests are scarce and although, they all know why, it is not as important as getting his parents on the medication to save their lives. The patient have been sick now for over 13 days and he was "vaxed" but his concern is for them.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: PNC13
Symptoms: Death
Clinical narrative: patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) as dose 2; The patient has passed away; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team and a Pfizer sponsored program. The reporter is reporting on behalf of her husband.   A 76 year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose 2, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Dose 1, single), for immunization. The patient had passed away on 13Oct2021. The reporter stated that her husband got a second dose of pneumococcal 13-val conj vac (dipht crm197 protein) when he was in the hospital. He was deceased. The patient's  passing away did not have anything to do with receiving the second dose of the pneumococcal 13-val conj vac (dipht crm197 protein) vaccine as it happened so long after. The patient date of death was 13Oct2021. The reported cause of death was unknown. It was not reported if an autopsy was performed.   The lot number for pneumococcal 13-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified and assessed as unrelated.  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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: passed away
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Reaction to excipient
Clinical narrative: anaphylaxis reaction; they think it was due to the polyethylene glycol in the vaccine; This is a spontaneous report received from a contactable reporter Physician from medical information team.  A 17 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: lamictal, reactions: "reacted", notes: in the past that contained polyethylene glycol. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis reaction"; REACTION TO EXCIPIENT (medically significant), outcome "unknown", described as "they think it was due to the polyethylene glycol in the vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: again experiencing swelling in his armpits, however "not as bad" and glands are not currently painful this time; again experiencing swelling in his armpits, however "not as bad" and glands are not currently painful this time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2022 (Lot number: FJ6369) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetic", start date: 1994 (ongoing), notes: Verbatim: Diabetic; "immune deficient" (unspecified if ongoing), notes: Caller states he is diabetic, immune deficient. There were no concomitant medications. Vaccination history included: Bnt162b2 (First shot was on 17Mar2021. He didn't experience the swelling so much. Lot number: ER2613.), administration date: 17Mar2021, for COVID-19 Immunization, reaction(s): "First shot was on 17Mar2021. He didn't experience the swelling so much"; Bnt162b2 (He got the second one on 07Apr2021. Lot number looks like EB8729), administration date: 07Apr2021, for COVID-19 Immunization, reaction(s): "experienced painful swollen glands in his neck and armpits that resolved after 3-4 months", "swollen glands in arm and neck".  The following information was reported: LYMPHADENOPATHY (non-serious) with onset Jan2022, outcome "unknown", AXILLARY PAIN (non-serious), outcome "unknown" and all described as "again experiencing swelling in his armpits, however "not as bad" and glands are not currently painful this time".
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: still feel sore and still experiencing muscle weakness/she cannot lift anything with her hand and her arm is still store; she cannot lift anything with her hand and her arm is still store; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for Covid-19 immunization; Bnt162b2 (Dose: 02), for Covid-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset Jan2022, outcome "not recovered", described as "still feel sore and still experiencing muscle weakness/she cannot lift anything with her hand and her arm is still store"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "not recovered", described as "she cannot lift anything with her hand and her arm is still store".  Additional information: Caller received her booster shot on 10Jan2022. Caller mentioned that "it has been two weeks ago today" since she received her booster shot but still feel sore and still experiencing muscle weakness. Caller also mentioned that she didn't experienced this after receiving the primary series of Pfizer COVID 19 Vaccine. Caller mentioned that she cannot lift anything with her hand and her arm was still store. "she didn't like this. This was crazy, she have no strength in her arm anymore. Caller was asking, was this how it supposed to feel and if it was, how long will this take effect. Response received as If You Received a Booster Shot, "So far, reactions reported after getting a booster shot were similar to those after the two-dose or single-dose primary series. Fever, headache, fatigue and pain at the injection site were the most commonly reported side effects and other response included as of the moment, there was no specific information yet with regards to the duration of the Pfizer COVID-19 Vaccine booster shot's side effects. How long the side effect will last was still unknown, but since you've mentioned you were experiencing reported side effects for about 2 weeks now, please consult your HCP for treatment recommendations. We here at Pfizer was unable to make any treatment recommendations for individuals who received the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Fatigue, Headache, Hypersomnia, Immunisation
Clinical narrative: Seizure/eyes went back in head/convulsions; weepy; headache; runny nose; tired; slept a lot; prev dose brand: Johnson & Johnson; prev dose brand: Johnson & Johnson; prev dose brand: Johnson & Johnson; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Jan2022 (Lot number: 331308A) at the age of 46 years as dose 3, (booster) single for covid-19 immunisation. Relevant medical history included: "depression" (unspecified if ongoing); "personality disorder NOS" (unspecified if ongoing); "obesity" (unspecified if ongoing); "nerve pain in foot" (unspecified if ongoing); "congenital deafness" (unspecified if ongoing); "seizures" (not ongoing). Concomitant medication(s) included: VITAMIN D3; IODINE; METAMUCIL [PLANTAGO OVATA]; SAPHRIS; FISH OIL; DEXILANT; IBUPROFEN; VIIBRYD; PROBIOTICS; SELENIUM; LACTAID. Vaccination history included: Johnson & johnson (Dose Number: 1, Batch/Lot No: 201A21A), administration date: 07Apr2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 17Jan2022, outcome "unknown" and all described as "prev dose brand: Johnson & Johnson"; SEIZURE (medically significant) with onset 21Jan2022 12:30, outcome "recovered" (21Jan2022), described as "Seizure/eyes went back in head/convulsions"; FATIGUE (non-serious) with onset 17Jan2022 12:30, outcome "recovered" (Jan2022), described as "tired"; HYPERSOMNIA (non-serious) with onset 17Jan2022 12:30, outcome "recovered" (Jan2022), described as "slept a lot"; CRYING (non-serious) with onset 21Jan2022 12:30, outcome "recovered" (Jan2022), described as "weepy"; HEADACHE (non-serious) with onset 21Jan2022 12:30, outcome "recovered" (Jan2022), described as "headache"; RHINORRHOEA (non-serious) with onset 21Jan2022 12:30, outcome "recovered" (Jan2022), described as "runny nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) negative. Therapeutic measures were taken as a result of seizure, fatigue, hypersomnia, crying, headache, rhinorrhoea. Clinical course: After booster on Monday (17Jan2022), the patient was tired and slept a lot. On Friday (21Jan2022), the patient was tired, weepy, slept a lot, had headache, runny nose, and then a seizure. Seizure further described as eyes went back in head. She had convulsions for less than a minute. The patient has history of seizures but hasn't had one in several years. No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Off label use, Rhinorrhoea, SARS-CoV-2 test, Seizure
Clinical narrative: Seizure/eyes went back in head/convulsions; weepy; headache; runny nose; tired; slept a lot; prev dose brand: Johnson & Johnson; prev dose brand: Johnson & Johnson; prev dose brand: Johnson & Johnson; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Jan2022 (Lot number: 331308A) at the age of 46 years as dose 3, (booster) single for covid-19 immunisation. Relevant medical history included: "depression" (unspecified if ongoing); "personality disorder NOS" (unspecified if ongoing); "obesity" (unspecified if ongoing); "nerve pain in foot" (unspecified if ongoing); "congenital deafness" (unspecified if ongoing); "seizures" (not ongoing). Concomitant medication(s) included: VITAMIN D3; IODINE; METAMUCIL [PLANTAGO OVATA]; SAPHRIS; FISH OIL; DEXILANT; IBUPROFEN; VIIBRYD; PROBIOTICS; SELENIUM; LACTAID. Vaccination history included: Johnson & johnson (Dose Number: 1, Batch/Lot No: 201A21A), administration date: 07Apr2021, when the patient was 45 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 17Jan2022, outcome "unknown" and all described as "prev dose brand: Johnson & Johnson"; SEIZURE (medically significant) with onset 21Jan2022 12:30, outcome "recovered" (21Jan2022), described as "Seizure/eyes went back in head/convulsions"; FATIGUE (non-serious) with onset 17Jan2022 12:30, outcome "recovered" (Jan2022), described as "tired"; HYPERSOMNIA (non-serious) with onset 17Jan2022 12:30, outcome "recovered" (Jan2022), described as "slept a lot"; CRYING (non-serious) with onset 21Jan2022 12:30, outcome "recovered" (Jan2022), described as "weepy"; HEADACHE (non-serious) with onset 21Jan2022 12:30, outcome "recovered" (Jan2022), described as "headache"; RHINORRHOEA (non-serious) with onset 21Jan2022 12:30, outcome "recovered" (Jan2022), described as "runny nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) negative. Therapeutic measures were taken as a result of seizure, fatigue, hypersomnia, crying, headache, rhinorrhoea. Clinical course: After booster on Monday (17Jan2022), the patient was tired and slept a lot. On Friday (21Jan2022), the patient was tired, weepy, slept a lot, had headache, runny nose, and then a seizure. Seizure further described as eyes went back in head. She had convulsions for less than a minute. The patient has history of seizures but hasn't had one in several years. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Paraesthesia, Rash, Sensitive skin, Urticaria
Clinical narrative: poking needle sensation; I had the booster Pfizer vaccine and developed a rash all over my face; It is unusually red with small 'hives."; It is unusually red with small 'hives."; my skin is very sensitive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 21Dec2021 (Lot number: FL3198, Expiration Date: Jun2022) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "poking needle sensation"; RASH (non-serious), outcome "unknown", described as "I had the booster Pfizer vaccine and developed a rash all over my face"; ERYTHEMA (non-serious), URTICARIA (non-serious), outcome "unknown" and all described as "It is unusually red with small 'hives.""; SENSITIVE SKIN (non-serious), outcome "unknown", described as "my skin is very sensitive".  Additional Information: Customer Verbatim: After a Booster shoot (Pfizer/BioNTech, Lot: FL3198, Exp: Jun2022) On 21Dec2021, I had the booster Pfizer vaccine and developed a rash all over my face. It is unusually red with small 'hives." The rash is not itchy, but my skin is very sensitive. If I scratch, it feels like I am being poked with a small needle. It has been over one month, and the rash and the poking needle sensation has not disappeared. How long is this going to last, should I be concerned, and do I need to see my doctor?  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives; lot of itching on his body specially inside thighs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570).  A 75 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "hives"; PRURITUS (non-serious), outcome "unknown", described as "lot of itching on his body specially inside thighs".  Additional information: The patient (age more than 75) was hospitalized due to COVID in March2020. He had taken Pfizer vaccines and booster shot. He was having hives and lot of itching on his body specially inside thighs.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter (pharmacist). A 44-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient experienced an ineffective drug (medically significant); COVID-19/she received the Pfizer primary series, then she contracted COVID-19 (medically significant), with outcome of unknown. The patient underwent the following laboratory tests and procedures: COVID-19 test: positive. The batch/lot number for BNT162B2 not provided and will be requested during follow-up. Sender's comments: Lack of effect is defined as absence of the intended clinical or pharmacological effect of a drug. For vaccine, the lack of effect, reported as COVID-19, is considered a listed event.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Bilateral COVID-induced pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A 69-year-old female patient received BNT162B2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Tested positive for COVID-19"; COVID-19 PNEUMONIA (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Bilateral COVID-induced pneumonia". The patient was hospitalized for drug ineffective, COVID-19 pneumonia (start date: 16Oct2021). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2021) positive. Clinical course: The consumer (patient's child) reported that the patient received 2 doses of the Pfizer COVID-19 vaccine. Unfortunately, she tested positive for COVID-19 and was admitted to the hospital on 16Oct2021. She was diagnosed with bilateral COVID-induced pneumonia. Doctors speculated that the patient did not have a response to the Pfizer vaccine since she was the worst case in a vaccinated adult they have seen. She had scheduled her booster. The consumer mentioned that the patient has "6-12 months left".  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 (C19); tested positive for COVID-19 (C19); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Jan2022, outcome "unknown" and all described as "tested positive for COVID-19 (C19)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Jan2022) positive. Clinical course: The patient received initial 2 doses of COVID-19 vaccine last year (in 2021) and this fall was boosted. On Monday of this week, the patient tested positive for COVID-19 (C19). And today, 5 days later, the patient is not dead and was not hospitalized. The patient did not need a ventilator. The case could easily be described as mild.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nail avulsion
Clinical narrative: My feet and toes feel numb; My feet and toes feel numb; One nail is like almost off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 15Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number 1, Manufacturer- Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose number 2, Manufacturer- Unknown), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "My feet and toes feel numb"; NAIL AVULSION (non-serious) with onset Jan2022, outcome "unknown", described as "One nail is like almost off".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: little tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 14 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 24Jan2022, outcome "unknown", described as "little tired".  Additional information: Reporter's neighbor told them yesterday and her son (14) and daughter (13) were a little tired after receiving their booster shot (Comirnaty) the day before.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200132763 same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: little tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 13 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "little tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200132748 same reporter/product/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter consumer or other non HCP for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Oct2021 (batch/lot number: unknown) as dose 3 (booster), single, administration date Feb2021 (batch/lot number: unknown) as dose 1, single and administration date Feb2021 (batch/lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jan2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: COVID-19 test: (21Jan2022) positive for covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Circulatory collapse, Drug ineffective, Vomiting
Clinical narrative: had COVID; had COVID; collapsed on 14Jan2022; vomited; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 89 year-old male patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hard of hearing" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: Mar2021, for Covid-19 immunization; Bnt162b2 (Dose: 02), administration date: Apr2021, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "recovering" and all described as "had COVID"; CIRCULATORY COLLAPSE (medically significant) with onset 14Jan2022, outcome "recovering", described as "collapsed on 14Jan2022"; VOMITING (non-serious) with onset 14Jan2022, outcome "recovering", described as "vomited". Therapeutic measures were taken as a result of drug ineffective, covid-19, circulatory collapse, vomiting.The caller's dad got COVID first, he goes out of the house more than her mother dose. He didn't wear his N95, only a cloth mask. He had a sore throat that started on 13Jan2022 and collapsed on 14Jan2022 and couldn't get up, he also vomited, and then 15Jan2022 he was was diagnosed with COVID. The doctor also ordered Paxlovid for him which he started on 17Jan2022 and has been stellar on it, his symptoms have revolved pretty quick and he is much better. He did great on it. Her dad had the COVID vaccines at the same time as her mother, they went as soon as they were able to for their age group. She thinks maybe around Mar2021. Caller knows that his Paxlovid was also 4 mg PO BID and it was issued on 15Jan2022 but he didn't start it then because it took 2 days to get it. He had no side effects to that, it was going good and she has no concern with that. He started on 17Jan2022 and did the whole course and he says that he feels 90 percent better than when he was really bad, which was a week prior. He seems to be fine so she doesn't want to do a report for him.  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 association between reported events Drug ineffective, Covid-19, circulatory collapse, vomitting and the suspect BNT162B2 cannot be excluded/assessed.  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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Investigation, Premature menopause
Clinical narrative: Having hot flashes; Early menopause; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 40 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: HOT FLUSH (non-serious) with onset Jan2022, outcome "unknown", described as "Having hot flashes"; PREMATURE MENOPAUSE (non-serious) with onset Jan2022, outcome "unknown", described as "Early menopause". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received the Pfizer Covid booster in Dec2021 and started having hot flashes in early Jan2022. She had hormones tested the week of 17Jan2022 and will have to start hormone therapy for early menopause.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on her arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent.  A 42 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "hives on her arms".  Additional information: Reporter stated that, daughter (the patient) had all COVID vaccines and booster. She has been getting hives on her arms, and it goes away after some time and hives appear on the other arm. Reporter queried if there was a co-relationship for the COVID vaccines?  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hives; horrendous full body rashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "hives"; RASH (non-serious), outcome "unknown", described as "horrendous full body rashes".  Additional information: My wife and dozens of other people in the area are suffering horrendous full body rashes and hives following the Covid booster dose of your vaccine. Her dermatologist is advising her patients with this adverse reaction that they must suffer with debilitating rash for 6-8 weeks. Why is Pfizer not warning people about this major side effect from the booster dose? My wife Ts condition had been reported to VAERS and we are seeking legal help for action against Pfizer.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200133100 same reporter/drug/event, different patients
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A 26-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administration date 2021 (Batch/Lot number: unknown) at an unspecified age as dose 2, single and via an unspecified route of administration, administration date 2021 (Batch/Lot number: unknown) at an unspecified age as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", COVID-19 (medically significant) with onset Dec2021, outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test (COVID-19 home test): (Dec2021) positive. Additional information: The reporter was asking how long they have to wait after testing positive for COVID-19 to get the booster shot. Someone told the reporter 3 weeks and someone else told the reporter 90 days, so just wanted to het the right answer.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Causality cannot be excluded for the serious event tested positive for Covid-19 and the suspect vaccine BNT162B2.,Linked Report(s) : US-PFIZER INC-202200131930 same reporter/drug, different patient, similar event.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive for COVID-19; Positive for COVID-19; This is a spontaneous report received from a contactable reporter (consumer) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Additional information: patient was asking about how long to wait before taking the booster after recently being positive for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Pyrexia, Sinus congestion, Sinusitis, Suspected COVID-19
Clinical narrative: she had both Pfizer Covid vaccines and booster shot and she still got Covid; she had both Pfizer Covid vaccines and booster shot and she still got Covid; sinus congestion; sinus infection; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XANAX. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she had both Pfizer Covid vaccines and booster shot and she still got Covid"; PYREXIA (non-serious), outcome "recovered", described as "fever"; SINUS CONGESTION (non-serious), outcome "unknown", described as "sinus congestion"; SINUSITIS (non-serious), outcome "unknown", described as "sinus infection". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient had both Pfizer Covid vaccines and booster shot and she still got Covid. She had Covid and her doctor prescribed Paxlovid. Patient stated she had a fever for a week and thought she just had a sinus infection. It was reported that there was fever and sinus congestion with Covid.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: First shot was on 17Mar2021. He didn't experience the swelling so much; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: ER2613) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic", start date: 1994 (ongoing). There were no concomitant medications. The following information was reported: SWELLING (non-serious) with onset 2021, outcome "unknown", described as "First shot was on 17Mar2021. He didn't experience the swelling so much".  Additional information: First shot was on 17Mar2021. He didn't experience the swelling so much. Lot number: ER2613.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Presyncope, SARS-CoV-2 test
Clinical narrative: She had the COVID; She had the COVID; Almost passed out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had the COVID"; PRESYNCOPE (non-serious), outcome "unknown", described as "Almost passed out". The event "almost passed out" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Clinical course: The consumer (patient's mother) reported that her daughter (patient) was one of the first one that came down with it, she almost passed out and she was taken to the emergency room. She had the COVID on an unspecified date.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 75 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 02Mar2021 (Lot number: En6203) at the age of 74 years as dose 2, single and intramuscular, administered in arm, administration date 09Feb2021 (Lot number: En6201) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies to Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Allergy". The following information was reported: PNEUMONIA (hospitalization, medically significant) with onset 03Nov2021, outcome "recovered" (13Nov2021), described as "Pneumonia". Therapeutic measures taken as a result of pneumonia included IV antibiotics during hospital stay.   No follow-up attempts are possible. No further information is expected.