chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, COVID-19, Fall, Vaccination failure
Clinical narrative: He had a vaccine but he subsequently had COVID/was diagnosed with COVID; He had a vaccine but he subsequently had COVID/was diagnosed with COVID; he slipped out of bed, he said that he had balance problems and he couldn't get off or something; he slipped out of bed, he said that he had balance problems and he couldn't get off or something; This is a spontaneous report from a contactable consumer who reported for a patient. A 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203, Expiry Date: unknown), dose 1 via an unspecified route of administration on 11Mar2021 as dose 1, single and dose 2 via an unspecified route of administration on 01Apr2021 (Batch/Lot Number: EN6198, Expiry Date: Unknown) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Aug2021, the patient experienced "he had a vaccine but he subsequently had covid/was diagnosed with covid", he slipped out of bed, he said that he had balance problems and he couldn't get off or something in 2021. Reporter (Pfizer Employee) stated that a cousin who had the Pfizer vaccine, he is in his 80s and it was the Pfizer COVID 19 Vaccine, and he had a breakthrough case. So, he had a vaccine, but he subsequently had COVID. Reporter was informed about role of Pfizer Drug Safety. Reporter stated patient was diagnosed with COVID on 24Aug2021. His wife was not vaccinated but he said that he meets with another individual who was vaccinated. He gave that person's name but that was the only information that he has about the other person. So, he went to breakfast with someone else who was vaccinated. That person got COVID. So, in other words he got it from someone else who had COVID, but that person was also vaccinated (further details unknown). Reporter stated it was after he was diagnosed, it was around the time of diagnosis. So, it was around on 24Aug2021, but exact date was unknown. He said that he (patient) slipped out of bed, he had balance problems and he could not get off or something. So, he had balance problem. He was discharged and he was ok now, was at home. When confirmed reason of hospitalization as diagnosis of COVID, the reporter stated Yes. Reporter stated the patient got COVID he has the Regeneron, he was actually hospitalized after he got COVID, and he had to receive the Regeneron treatment.  He may be on other medication, not known. The patient underwent lab test and procedure which included COVID-19: Positive on 24Aug2021. The outcome of events was recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Immunisation, Off label use, Pain in extremity, Pyrexia
Clinical narrative: she also had has similar side effects: Fever; she also had has similar side effects: diarrhea; she also had has similar side effects: arm pain; she also had has similar side effects: sluggish; she also had has similar side effects: sleepy; Her side effects were a lot more intense than the second vaccine dose 3 (booster); Her side effects were a lot more intense than the second vaccine dose 3 (booster); This is a spontaneous report from a contactable consumer. This consumer (patient's daughter) reported for a 84-year-old female patient (reporter's Mother) that:  An 84-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/lot number: Not provided, Expiry Date: Not Provided) via an unspecified route of administration on an unspecified date in 2021 as dose 3 (booster), single for COVID-19 immunization. Patient medical history included Horton's disease. The concomitant medications were not reported. Patient took BNT162b2 (COMIRNATY, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 1, single and received dose 2 of BNT162b2 (COMIRNATY, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient experienced similar side effects: fever, diarrhea, arm pain, she was sluggish and sleepy on an unspecified date in 2021. The report was not related to a study or programme. Investigation assessment was not provided. Reporter stated that patient will be fine, but she noticed her side effects were a lot more intense than the second vaccine, at the same time it's probably going to work just fine, and she is not worried. Reporter states that she doesn't want her information being shared with 3rd parties, and she does not want it shared with other people on the internet. Reporter states that she had to remove herself from 82 different things for that she would stop being contacted. The clinical outcome of all events was unknown.   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-202101312073 Same reporter/product, different patient, similar side effects
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Somnolence
Clinical narrative: she also had has similar side effects: Fever; she also had has similar side effects: diarrhea; she also had has similar side effects: arm pain; she also had has similar side effects: sluggish; she also had has similar side effects: sleepy; Her side effects were a lot more intense than the second vaccine dose 3 (booster); Her side effects were a lot more intense than the second vaccine dose 3 (booster); This is a spontaneous report from a contactable consumer. This consumer (patient's daughter) reported for a 84-year-old female patient (reporter's Mother) that:  An 84-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/lot number: Not provided, Expiry Date: Not Provided) via an unspecified route of administration on an unspecified date in 2021 as dose 3 (booster), single for COVID-19 immunization. Patient medical history included Horton's disease. The concomitant medications were not reported. Patient took BNT162b2 (COMIRNATY, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 1, single and received dose 2 of BNT162b2 (COMIRNATY, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient experienced similar side effects: fever, diarrhea, arm pain, she was sluggish and sleepy on an unspecified date in 2021. The report was not related to a study or programme. Investigation assessment was not provided. Reporter stated that patient will be fine, but she noticed her side effects were a lot more intense than the second vaccine, at the same time it's probably going to work just fine, and she is not worried. Reporter states that she doesn't want her information being shared with 3rd parties, and she does not want it shared with other people on the internet. Reporter states that she had to remove herself from 82 different things for that she would stop being contacted. The clinical outcome of all events was unknown.   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-202101312073 Same reporter/product, different patient, similar side effects
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Headache, Limb injury
Clinical narrative: Very tired all of the time; Headache; Fingers Shaking; brain fog and can''t concentrate; problems with both arms hurting; sleeps a lot; brain fog and can''t concentrate; feeling of swelling; This is a spontaneous report from a contactable consumer or other non-health care professional.   A 73-year-old male patient (reporter's husband) received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FC3183) via an unspecified route of administration, administered in left arm on 02Oct2021 (at the age of 73-year-old) as dose 3 (booster), single for covid-19 immunization. Medical history included bone cancer 10 years ago and they took out his pubic bone on the left side and his pelvis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (solution for injection, Lot Number: EL9264) via an unspecified route of administration administered on 03Feb2021 (at the age of 73-year-old), as dose 1 single and BNT162B2 (solution for injection, Lot Number: EN6200) via an unspecified route of administration administered on 24Feb2021 (at the age of 73-year-old) as dose 2, single for COVID-19 immunization. On 02Oct2021 the patient was very tired all of the time, headache, fingers shaking, brain fog and can't concentrate, problems with both arms hurting, sleeps a lot, booster has been really rough on them, really hard on the body. On an unknown date in 2021, the patient had feeling of swelling. Treatment received with Ibuprofen to get rid of that. Outcome of the events were not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Swelling, Tremor
Clinical narrative: Very tired all of the time; Headache; Fingers Shaking; brain fog and can''t concentrate; problems with both arms hurting; sleeps a lot; brain fog and can''t concentrate; feeling of swelling; This is a spontaneous report from a contactable consumer or other non-health care professional.   A 73-year-old male patient (reporter's husband) received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FC3183) via an unspecified route of administration, administered in left arm on 02Oct2021 (at the age of 73-year-old) as dose 3 (booster), single for covid-19 immunization. Medical history included bone cancer 10 years ago and they took out his pubic bone on the left side and his pelvis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (solution for injection, Lot Number: EL9264) via an unspecified route of administration administered on 03Feb2021 (at the age of 73-year-old), as dose 1 single and BNT162B2 (solution for injection, Lot Number: EN6200) via an unspecified route of administration administered on 24Feb2021 (at the age of 73-year-old) as dose 2, single for COVID-19 immunization. On 02Oct2021 the patient was very tired all of the time, headache, fingers shaking, brain fog and can't concentrate, problems with both arms hurting, sleeps a lot, booster has been really rough on them, really hard on the body. On an unknown date in 2021, the patient had feeling of swelling. Treatment received with Ibuprofen to get rid of that. Outcome of the events were not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Rheumatoid arthritis
Clinical narrative: like a flare of her rheumatoid arthritis; soreness in her legs; fatigue; HA; This is a spontaneous report from a Pfizer-sponsored program. A contactable other healthcare professional and consumer reported that a 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation; tofacitinib citrate (XELJANZ), oral from 07May2021 and ongoing, at 10 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient was fine the day of the injection, but the following day she had what seems like a flare of her rheumatoid arthritis. She notes soreness/fatigue, particularly in her legs ever since she received the COVID vaccine. She also reports having a headache (HA). An organization recommends holding a dose of tofacitinib citrate for one week after receiving the vaccine but patient was not aware of that so she did not do that. The action taken in response to the events for bnt162b2 was not applicable while for tofacitinib citrate was unknown. Outcome of the events was unknown.  The lot number for bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for event rheumatoid arthritis flare up.  The disease nature should also be considered, which may flare up as natural disease course. 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, UNK, COVID19
Symptoms: Pain, Renal impairment
Clinical narrative: like a flare of her rheumatoid arthritis; soreness in her legs; fatigue; HA; This is a spontaneous report from a Pfizer-sponsored program. A contactable other healthcare professional and consumer reported that a 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation; tofacitinib citrate (XELJANZ), oral from 07May2021 and ongoing, at 10 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient was fine the day of the injection, but the following day she had what seems like a flare of her rheumatoid arthritis. She notes soreness/fatigue, particularly in her legs ever since she received the COVID vaccine. She also reports having a headache (HA). An organization recommends holding a dose of tofacitinib citrate for one week after receiving the vaccine but patient was not aware of that so she did not do that. The action taken in response to the events for bnt162b2 was not applicable while for tofacitinib citrate was unknown. Outcome of the events was unknown.  The lot number for bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for event rheumatoid arthritis flare up.  The disease nature should also be considered, which may flare up as natural disease course. 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: Blindness, Breast cancer, Hepatic cancer, Immunisation, Off label use
Clinical narrative: serious cancers, like breast and liver cancer; serious cancers, like breast and liver cancer; blindness; booster shot; booster shot; This is a spontaneous report from a contactable consumer.  A female patient (reporter's girlfriend) of an unspecified age received the third dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown) via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: unknown) and the second dose of BNT162B2 (lot number: unknown), both on an unspecified date at single dose for COVID-19 immunisation. The reporter stated that, the patient got that booster shot. On an unknown date, the reporter stated that the patient was in the hospital right now. The reporter mentioned that the patient health was terrible. The reporter did not want to talk about patient because it was depressing. The reporter mentioned that the patient had blindness and serious cancers, like breast and liver cancer. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Immunisation, Off label use, Pain in extremity
Clinical narrative: patient received Comirnaty booster (dose 3); patient received Comirnaty booster (dose 3); Fever; Diarrhea; arm pain; sluggish and sleepy; sluggish and sleepy; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received third dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient Previously received dose 1 and dose 2 of BNT162B2 (COMIRNATY, solution for injection, Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date for COVID-19 immunization.  The patient received Comirnaty booster (dose 3) (off label use) and experienced fever, diarrhea, arm pain, she was sluggish and sleepy on an unspecified date. The patient stated that she experienced fever, diarrhea, arm pain, she was sluggish and sleepy, and she knew that she will be fine, but she noticed her side effects were a lot more intense than the second vaccine, at the same time it was probably going to work just fine, and she was not worried. She also told that her mom got her booster as well and she had Horton's Disease and she was an 84-year-old, she also had had similar side effects. The patient underwent lab tests and procedures which included body temperature: unknown on an unspecified date. The outcome for the events fever, diarrhea, arm pain, sluggish and sleepy was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101311877 Same reporter/product, different patient, similar side effects
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sluggishness, Somnolence
Clinical narrative: patient received Comirnaty booster (dose 3); patient received Comirnaty booster (dose 3); Fever; Diarrhea; arm pain; sluggish and sleepy; sluggish and sleepy; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received third dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient Previously received dose 1 and dose 2 of BNT162B2 (COMIRNATY, solution for injection, Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date for COVID-19 immunization.  The patient received Comirnaty booster (dose 3) (off label use) and experienced fever, diarrhea, arm pain, she was sluggish and sleepy on an unspecified date. The patient stated that she experienced fever, diarrhea, arm pain, she was sluggish and sleepy, and she knew that she will be fine, but she noticed her side effects were a lot more intense than the second vaccine, at the same time it was probably going to work just fine, and she was not worried. She also told that her mom got her booster as well and she had Horton's Disease and she was an 84-year-old, she also had had similar side effects. The patient underwent lab tests and procedures which included body temperature: unknown on an unspecified date. The outcome for the events fever, diarrhea, arm pain, sluggish and sleepy was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101311877 Same reporter/product, different patient, similar side effects
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dermatitis allergic, Feeling abnormal, Rash
Clinical narrative: Allergic skin reaction; rash; memory loss; brain fog; This is a spontaneous report from a contactable other hcp (patient) via database. A 33-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 14:00 (at 33 years old) (Batch/Lot Number: EL9261) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Known allergies: nuts, penicillin, from an unknown date. There were no concomitant medications. Historical vaccine included 1st dose BNT162B2 on 22Jan2021 at 33 years old (Batch/Lot No: EL9261,Location of injection: Arm Left,Vaccine Administration Time: 02:00 PM) for Covid-19 immunization. The patient experienced Allergic skin reaction, rash, brain fog, memory loss, all on 13Feb2021 with outcome of not recovered. Facility type vaccine: Hospital.No other vaccine in four weeks. No Covid prior vaccination.Not Covid tested post vaccination. AE resulted in visit to doctor. No treatment for the events.  No follow-up attempts are required. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported Allergic skin reaction, rash, brain fog, memory loss, and the administration of the suspect vaccine, BNT162B2, based on the reasonable temporal association.   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 RA, IEC, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: she had her first dose; she tested positive with COVID-19; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority Support. This is a report from a contactable female consumer (patient herself). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: FC3182, Expiry Date: Unknown), via an unspecified route of administration on 08Sep2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 56 years). The patient medical history included depression, blood cholesterol, thyroid. Concomitant medications included Levothyroxine, 75mg taken for thyroid, Lamotrigine, 200mg taken for depression, Atorvastatin, 20mg taken for cholesterol.  The patient prior vaccination (within 4 weeks) information was not available. On 08Sep2021, the patient experienced she had her first dose, she tested positive with COVID-19. The patient underwent lab tests and procedures which included SARS-COV-2 test: COVID-19 positive on 08Sep2021. Therapeutic measures were taken as a result of the event include Steroids and Remdesivir. The seriousness of the event was serious and medically significant. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: contracted Covid after getting the vaccine; contracted Covid after getting the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports.   A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter mentioned that she knew someone who a contracted COVID on an unspecified date after getting the vaccine. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101310883 same reporter and drug, similar event, different patients
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Disease recurrence, Gangrene, Memory impairment, Raynaud's phenomenon
Clinical narrative: limited scleroderma and it made it worse because the skin hardens and she can hardly make a fist; limited scleroderma and it made it worse because the skin hardens and she can hardly make a fist; got gangrene on her finger, it was dark purple but not black which gangrene is the next step; then getting the booster it triggered her Reynaud's' phenomenon and made it worse; Each time the vaccines effected her memory; Each time the vaccines effected her memory; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included Raynaud's phenomenon and scleroderma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously had BNT162B2 dose 1 and dose 2 on unspecified dates for COVID-19 immunisation and experienced COVID-19 and it effected her memory. The patient had her booster it triggered her Reynaud's phenomenon and made it worse. The patient also has limited scleroderma and it made it worse because the skin hardens and she can hardly make a fist. The patient almost got gangrene on her finger, it was dark purple but not black which gangrene is the next step. The patient's fingers were painful and hurt to the touch because her finger tips are also very cold because of the Raynaud's. The caller is having to wear gloves 24/7 because of this. The patient's finger turned purple almost black, gangrenous, had Raynaud's and limited scleroderma worsened. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Scleroderma
Clinical narrative: limited scleroderma and it made it worse because the skin hardens and she can hardly make a fist; limited scleroderma and it made it worse because the skin hardens and she can hardly make a fist; got gangrene on her finger, it was dark purple but not black which gangrene is the next step; then getting the booster it triggered her Reynaud's' phenomenon and made it worse; Each time the vaccines effected her memory; Each time the vaccines effected her memory; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included Raynaud's phenomenon and scleroderma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously had BNT162B2 dose 1 and dose 2 on unspecified dates for COVID-19 immunisation and experienced COVID-19 and it effected her memory. The patient had her booster it triggered her Reynaud's phenomenon and made it worse. The patient also has limited scleroderma and it made it worse because the skin hardens and she can hardly make a fist. The patient almost got gangrene on her finger, it was dark purple but not black which gangrene is the next step. The patient's fingers were painful and hurt to the touch because her finger tips are also very cold because of the Raynaud's. The caller is having to wear gloves 24/7 because of this. The patient's finger turned purple almost black, gangrenous, had Raynaud's and limited scleroderma worsened. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure diastolic decreased, Blood pressure measurement, Body temperature, COVID-19, Heart rate
Clinical narrative: my positive COVID-19 Test on 02Sep2021; my positive COVID-19 Test on 02Sep2021; Blood pressure: 100/52; I was very ill for more than two weeks; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) at the age of 62 years old, on 16Mar2021 (Lot Number: EP6955) as dose 1, single and on 06Apr2021 (Lot Number: EP7533) as dose 2, single; both doses were received via an unspecified route of administration for COVID-19 immunization. Medical history included allergies to adhesive (specific reaction was rash which was red and itchy, unknown what type of tape). The patient's concomitant medications were not reported. The patient previously took cefdinir and experienced diarrhoea, metoclopramide and experienced shaky, naproxen and experienced itching, and sulfamethoxazole and trimethoprim and experienced rash. The patient also previously took methylprednisolone acetate 80 Mg/mL on 01Oct2019 and 23Jul2019, and dexamethasone sodium phosphate "4_Mg/mV" injection on 25Nov2009, 01Oct2019, 01Nov2013. Historical vaccine, all received for immunization, included the following: Zoster on 15Mar2012; ZOSTER RECOMB ADJUV on 01Oct2019 and 23Jul2019; and INFLUENZA on 22Oct2018 and 04Sep2009. It was reported that the patient had their first vaccine on 16Mar2021 and second on 06Apr2021 at a pharmacy. The patient provided their positive COVID-19 Test on 02Sep2021. They were surprised at the test result since they had been "fully vaccinated". They were very ill for more than two weeks on an unspecified date in 2021. The patient's oxygen saturation level was still only 95 % (2021). The patient wanted to inform that the vaccine did not work for them. The patient was seen on Thursday, 02Sep2021. The following issue was addressed: COVD-19 virus infection, and the following results were obtained: Blood pressure: 100/52, Pulse: 81, Temperature: 97.9 F, Oxygen Saturation: 98 %. POC RAPID STREP A for COVID-19 virus infection (Negative) and POC COVID-19 PCR DETECTION COVID-19 virus infection (Positive); both done on 02Sep2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Illness, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: my positive COVID-19 Test on 02Sep2021; my positive COVID-19 Test on 02Sep2021; Blood pressure: 100/52; I was very ill for more than two weeks; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) at the age of 62 years old, on 16Mar2021 (Lot Number: EP6955) as dose 1, single and on 06Apr2021 (Lot Number: EP7533) as dose 2, single; both doses were received via an unspecified route of administration for COVID-19 immunization. Medical history included allergies to adhesive (specific reaction was rash which was red and itchy, unknown what type of tape). The patient's concomitant medications were not reported. The patient previously took cefdinir and experienced diarrhoea, metoclopramide and experienced shaky, naproxen and experienced itching, and sulfamethoxazole and trimethoprim and experienced rash. The patient also previously took methylprednisolone acetate 80 Mg/mL on 01Oct2019 and 23Jul2019, and dexamethasone sodium phosphate "4_Mg/mV" injection on 25Nov2009, 01Oct2019, 01Nov2013. Historical vaccine, all received for immunization, included the following: Zoster on 15Mar2012; ZOSTER RECOMB ADJUV on 01Oct2019 and 23Jul2019; and INFLUENZA on 22Oct2018 and 04Sep2009. It was reported that the patient had their first vaccine on 16Mar2021 and second on 06Apr2021 at a pharmacy. The patient provided their positive COVID-19 Test on 02Sep2021. They were surprised at the test result since they had been "fully vaccinated". They were very ill for more than two weeks on an unspecified date in 2021. The patient's oxygen saturation level was still only 95 % (2021). The patient wanted to inform that the vaccine did not work for them. The patient was seen on Thursday, 02Sep2021. The following issue was addressed: COVD-19 virus infection, and the following results were obtained: Blood pressure: 100/52, Pulse: 81, Temperature: 97.9 F, Oxygen Saturation: 98 %. POC RAPID STREP A for COVID-19 virus infection (Negative) and POC COVID-19 PCR DETECTION COVID-19 virus infection (Positive); both done on 02Sep2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid 19 after first dose of Pfizer Covid 19 Vaccine; Covid 19 after first dose of Pfizer Covid 19 Vaccine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included heart patient (heart disorder), has high blood pressure, has had 13 surgeries on her legs for blood clots; and she had no problems with her vaccines, quadruple bypass surgery, Diabetic. There were no concomitant medications. Patient caught Covid 19 herself when was taking her husband to the hospital.She had already had one of her Pfizer Covid 19 Vaccines.Now, States she has taken both doses and her booster dose with no problems. She got COVID, but the doctor caught it and gave her some special medicine and she is fine. The outcome of the events was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse, Paraplegia
Clinical narrative: diagnosed with transverse myelitis; paralyzed from her waist down; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age (family friend) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated that he has a really close family friend that is a female and she was diagnosed with transverse myelitis in T2 and was paralyzed from her waist down and she received the Pfizer Vaccine as well and it came on out of the blue that morning and she felt tingling in her legs like he did and within an hour she could not move her legs and they did diagnose her as well with transverse myelitis (hospitalization). Outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101314920 same reporter/drug, similar event, different patients
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to arthropod bite, Blood test, Chills, Electrocardiogram, Rash
Clinical narrative: She believes she was bit by a spider, fainted twice; Crazy reaction to a spider bite/believes she was bit by a spider; Chills; Hives on the face; Rash on arms/full body rash; The swelling has gone down around the bite and I can see two holes looking like a bite.; This is a spontaneous report from a contactable consumer (patient) through a Pfizer-sponsored program, COVAX US SUPPORT. A 74-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 301308A; Expiration date was not reported) on the left arm on 27Sep2021 (11:30) as dose 3, single, with route of administration unspecified, for COVID-19 immunization. Medical history included eczema (diagnosed since she was a child). There were no concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249; Expiration date was not reported) on 13Jan2021 (when the patient was 73 years old) for COVID-19 immunization, and had rash on her torso; and the second dose (Lot number: EL9265; Expiration date was not reported) on 03Feb2021 (when the patient was 73 years old) for COVID-19 immunization, and had hives on her face and arms. On 28Sep2021, the patient had hives on the face, and rash on arms/full body rash. On 01Oct2021, the patient had believed she was bitten by a spider, and fainted twice; had a crazy reaction to a spider bite; and had chills. On an unspecified date in 2021, the patient had swelling that has gone down around the bite and could see two holes looking like a bite. The events, "believed she was bitten by a spider, and fainted twice" and "crazy reaction to a spider bite", had resulted in to an emergency room visit and physician's office visit. The patient's EKG was okay; bloodwork was okay; and still had to sit in the waiting room for 10 hours. The patient took cetirizine HCl (ZYRTEC) as treatment for hives and rash. The outcome of the events was recovered on an unspecified date in 2021 for hives and rash; and was unknown for all the other events.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Syncope, Urine analysis, Urticaria
Clinical narrative: She believes she was bit by a spider, fainted twice; Crazy reaction to a spider bite/believes she was bit by a spider; Chills; Hives on the face; Rash on arms/full body rash; The swelling has gone down around the bite and I can see two holes looking like a bite.; This is a spontaneous report from a contactable consumer (patient) through a Pfizer-sponsored program, COVAX US SUPPORT. A 74-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 301308A; Expiration date was not reported) on the left arm on 27Sep2021 (11:30) as dose 3, single, with route of administration unspecified, for COVID-19 immunization. Medical history included eczema (diagnosed since she was a child). There were no concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249; Expiration date was not reported) on 13Jan2021 (when the patient was 73 years old) for COVID-19 immunization, and had rash on her torso; and the second dose (Lot number: EL9265; Expiration date was not reported) on 03Feb2021 (when the patient was 73 years old) for COVID-19 immunization, and had hives on her face and arms. On 28Sep2021, the patient had hives on the face, and rash on arms/full body rash. On 01Oct2021, the patient had believed she was bitten by a spider, and fainted twice; had a crazy reaction to a spider bite; and had chills. On an unspecified date in 2021, the patient had swelling that has gone down around the bite and could see two holes looking like a bite. The events, "believed she was bitten by a spider, and fainted twice" and "crazy reaction to a spider bite", had resulted in to an emergency room visit and physician's office visit. The patient's EKG was okay; bloodwork was okay; and still had to sit in the waiting room for 10 hours. The patient took cetirizine HCl (ZYRTEC) as treatment for hives and rash. The outcome of the events was recovered on an unspecified date in 2021 for hives and rash; and was unknown for all the other events.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Frustration tolerance decreased
Clinical narrative: lost some vision; very frustrated; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 25May2021 at 13:00 (Batch/Lot number was not reported) as dose 2, single (at the age of 46-years-old) for Covid-19 immunisation. Medical history included Covid-19, and Neuropathy . The patient had no known allergies and no other medical history. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 04May2021 at 13:00 (Batch/Lot number was not reported) as dose 1, single (at the age of 46-years-old) for Covid-19 immunisation and experienced left eye felt blurry, floater and some distortion. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient was not tested for Covid post vaccination. The patient started to feel some problems with her left eye on 10May2021 at 08:00. Her left eye felt blurry, had floater and some distortion. She did not take it seriously because she thought her eye contact lenses needs to change or clean by then. Then it was getting worse after the second dose of Covid-19 vaccine on 25May. She started to see an eye doctor and was told she lost some vision on her left eye. She was referred to doctors in hospitals and none of them could not firmly diagnosed what was causing her vision loss even when they completed all kinds of possible tests and procedures. She does not have any ocular disease history before as well as in her family. First, the doctor suspected she have LHON, and the genetic test were negative. She has been very frustrated since it happened in May. The time of each vaccination is definitely correlated to the problem on set. Therapeutic measures taken as a result of the events included infusion and medication. The outcome of the events was not resolved. The events required doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care, with disability or permanent damage.   The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dysphagia, Rash erythematous, Swelling face
Clinical narrative: Swelling of face; difficulty swallowing; chest hurt to breathe; rash head to toe - pinprick rash; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A 15-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: FF3389) via an unspecified route of administration at left arm on 01Oct2021 at 14:15 (at the age of 15-year-old) as dose 2, single for COVID-19 immunisation. Medical history included irritable bowel syndrome, known allergies Peanuts, cashews, augmenting, covid-19 on an unspecified date. There were no concomitant medications. Patient did not receive any other medications within 2 weeks of vaccination. The patient previously took augmentin [amoxicillin sodium; clavulanic acid] and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was diagnosed with COVID-19 Prior to vaccination and since the vaccination patient has not been tested for COVID-19. Patient was not done with covid test post vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: FC3182) via an unspecified route of administration at left arm on 03Sep2021 15:30 (at the age of 15-year-old) as dose 1, single for COVID-19 immunisation. The patient experienced swelling of face, difficulty swallowing, chest hurt to breathe, rash head to toe - pinprick rash on 02Oct2021 at 15:30. Case was reported as non-serious. Patient received treatment with Ibuprofen and Benadryl for the events. Outcome of all events was recovered on Oct2021.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Lumbar puncture, Magnetic resonance imaging, Myelitis transverse, Neuropathy peripheral
Clinical narrative: transverse myelitis; neuropathy from his waist down; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients. This is the first of two reports.  A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 41 years old) via an unspecified route of administration, administered in Arm Right on 24May2021 (Batch/Lot Number: EW0186) as dose 2, single for covid-19 immunisation. The patient has no medical history and concomitant medications. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EW0176) via an unspecified route of administration in the left arm on 03May2021 10:00 (at the age of 41 years old) for COVID-19 immunization and experienced brain fog, a lot of digestive issues and still has a huge knot on his left arm and it has remained the same and is as hard as a rock (the patient had the 2nd dose administered in his right arm and it has no knot on that arm). No additional vaccines administered on same date of the Pfizer suspect and no prior vaccinations within 4 weeks. The patient was diagnosed with transverse myelitis on 09Sep2021 per his 'MyChart'. The patient that stated they have been doings tests and treatment running over the last few months. The patient had four MRIs, a spinal tap and blood tests. The results of the MRI showed white matter on his spine at T2 and the neurologist diagnosed him with transverse myelitis. For the first symptoms of transverse myelitis, he lost all feeling in his legs and had numbness and tingling and now neuropathy from his waist down and that happened on 16Aug2021 and the hospital emergency room visit was on 19Aug2021 in the hospital outpatient and saw his doctor on 16Aug2021. On 17Aug2021, they did the MRI and thought this was Guillian Barre syndrome as it has the same side effects but ruled out Guillian Barre syndrome. He went on 19Aug2021 for admission to the emergency room and had tingling up to his chest and down to his feet including all his extremities and spent two nights in the hospital admitted on 19Aug2021 and discharged on 21Aug2021. The only other thing was that until he took the vaccine, he had not been to the HCP in two years for anything and since he took the vaccine not counting all the follow up visits to the doctor five times for different ongoing symptoms and since then he has been doing research. The patient stated that in hospitals and with doctors, his neurologist said they had a spike in cases of transverse myelitis since people have been taking the vaccine; his chiropractor said there has been a spike in his patients coming to him for relief as well in the last 8-10 months. The outcome of the event transverse myelitis was not recovered while the other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101312448 same reporter/drug, similar event, different patients