chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: Had TIA 27Aug; This is a spontaneous report from a non-contactable consumer (patient). A 74-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in right arm in Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included asthma and blood cholesterol increased, both from an unknown date. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in left arm in Feb2021 09:00 AM (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient had a Transient ischemic attack (TIA) on 27Aug2021 18:00, which required Emergency room/department urgent care and then hospitalization for 2 days. The patient underwent lab tests and procedures on 27Aug2021 which included SARS-CoV-2 (nasal swab) test: negative. At the time of the report the reported event was resolving without any treatment.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Cough, Pain, Productive cough, Pyrexia
Clinical narrative: like a bronchitis; cough; wheezing; coughing up phlegm; Fever; body aches; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received secondo dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181), via an unspecified route of administration, administered in left arm on 26Aug2021 at 16:30 (at the age of 34-years-old) as dose 2, single for COVID-19 immunisation. Previously the patient received the first dose of bnt162b2 (lot number: EW0180) on 04Aug2021 for COVID-19 immunisation. The patient did not receive any other vaccination in 4 weeks. The patient's medical history and concomitant medications were not reported.  The patient experienced like a bronchitis on 27Aug2021. The onset time was reported as 00:30-01:00. The patient was at a urgent care for like a bronchitis she thought, and they told her that she needed to call and report her symptoms since her symptoms started after her second dose of the Covid-19 Vaccine. She said that she had a little bit of a cough on 27Aug2021 and it has progressively gotten worse. She said that she had a fever, and body aches for a couple of days and at the time of reporting she felt like she has intermittent wheezing and she was coughing up phlegm. The events resulted in Urgent care and Physician Office visit. The reporter assessed the event bronchitis as related to suspect product. Bronchitis and coughing up phlegm were not resolved, pyrexia and body aches were resolved and the outcome of the other events was unknown.; Sender's Comments: .As per temporal association , causal association of events(pyrexia , Bronchitis, cough, wheezing, pain, Productive cough  ) cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: like a bronchitis; cough; wheezing; coughing up phlegm; Fever; body aches; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received secondo dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181), via an unspecified route of administration, administered in left arm on 26Aug2021 at 16:30 (at the age of 34-years-old) as dose 2, single for COVID-19 immunisation. Previously the patient received the first dose of bnt162b2 (lot number: EW0180) on 04Aug2021 for COVID-19 immunisation. The patient did not receive any other vaccination in 4 weeks. The patient's medical history and concomitant medications were not reported.  The patient experienced like a bronchitis on 27Aug2021. The onset time was reported as 00:30-01:00. The patient was at a urgent care for like a bronchitis she thought, and they told her that she needed to call and report her symptoms since her symptoms started after her second dose of the Covid-19 Vaccine. She said that she had a little bit of a cough on 27Aug2021 and it has progressively gotten worse. She said that she had a fever, and body aches for a couple of days and at the time of reporting she felt like she has intermittent wheezing and she was coughing up phlegm. The events resulted in Urgent care and Physician Office visit. The reporter assessed the event bronchitis as related to suspect product. Bronchitis and coughing up phlegm were not resolved, pyrexia and body aches were resolved and the outcome of the other events was unknown.; Sender's Comments: .As per temporal association , causal association of events(pyrexia , Bronchitis, cough, wheezing, pain, Productive cough  ) cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Erythema, Feeling hot, Headache, Hot flush
Clinical narrative: Arm got really swollen red and hot all the way down to her fingertips; Arm got really swollen red and hot all the way down to her fingertips; Arm got really swollen red and hot all the way down to her fingertips; Injection site soreness; Metal taste in her mouth; had a weird feeling to her fingertips; arm was really sore; Injection site swelling; wave of heat go through her and it was like a hot flash; Headache/mild headache; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 20Jul2021 at 12:00 (at the age of 56-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 20Jul2021, the patient experienced arm got really swollen, red, and hot all the way down to her fingertips, and injection site soreness. Later than night the patient had a heat wave go through her, metal taste, and then a headache. The clinical course was the patient had the first dose at like 12:00 and the red arm started happening at 16:30 or 17:00. Her arm was really sore, hot, red and swollen, and had a weird feeling to her fingertips. This eventually went away but the injection site swelling was still there for a week. The injection site was still sore when she put the injection in for the second dose (on 11Aug2021). After the first dose, the patient had a wave of heat go through her and it was like a hot flash and then she got the metal taste in her mouth. The metal taste lasted about 30 minutes. Her mild headache lasted for a day and a half or two days. The sore arm at the injection site was sore for about a week, like it hurt. The heat wave went away and then the patient was more focused on her arm. The outcomes of arm sore, hot, red, and swollen, weird feeling to her fingertips, heat wave, metal taste, headache, and injection site swelling were recovered. The outcome of injection site pain 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) : -PFIZER INC-202101128576 same patient, different vaccine dose/AE
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm got really swollen red and hot all the way down to her fingertips; Arm got really swollen red and hot all the way down to her fingertips; Arm got really swollen red and hot all the way down to her fingertips; Injection site soreness; Metal taste in her mouth; had a weird feeling to her fingertips; arm was really sore; Injection site swelling; wave of heat go through her and it was like a hot flash; Headache/mild headache; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 20Jul2021 at 12:00 (at the age of 56-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 20Jul2021, the patient experienced arm got really swollen, red, and hot all the way down to her fingertips, and injection site soreness. Later than night the patient had a heat wave go through her, metal taste, and then a headache. The clinical course was the patient had the first dose at like 12:00 and the red arm started happening at 16:30 or 17:00. Her arm was really sore, hot, red and swollen, and had a weird feeling to her fingertips. This eventually went away but the injection site swelling was still there for a week. The injection site was still sore when she put the injection in for the second dose (on 11Aug2021). After the first dose, the patient had a wave of heat go through her and it was like a hot flash and then she got the metal taste in her mouth. The metal taste lasted about 30 minutes. Her mild headache lasted for a day and a half or two days. The sore arm at the injection site was sore for about a week, like it hurt. The heat wave went away and then the patient was more focused on her arm. The outcomes of arm sore, hot, red, and swollen, weird feeling to her fingertips, heat wave, metal taste, headache, and injection site swelling were recovered. The outcome of injection site pain 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) : -PFIZER INC-202101128576 same patient, different vaccine dose/AE
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Gait disturbance
Clinical narrative: I am terrible, I feel horrible; I can hardly walk; Do not feel good; I am as weak as I can be, I have no strength; This is a spontaneous report from a contactable consumer or other non hcp.   A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced do not feel good (feeling abnormal) (non-serious) on 26Aug2021 with outcome of not recovered , i am as weak as i can be, i have no strength (asthenia) (non-serious) on 26Aug2021 with outcome of not recovered , i am terrible, i feel horrible (feeling abnormal) (non-serious) on 27Aug2021 with outcome of not recovered , i can hardly walk (gait disturbance) (non-serious) on 27Aug2021 with outcome of not recovered.  The action taken in response to the event(s) for bnt162b2 was not applicable.  Therapeutic measures were taken as a result of do not feel good (feeling abnormal), i am as weak as i can be, i have no strength (asthenia).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This is a spontaneous report from a contactable consumer reporting for her mother.     A 84-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm in Jul2021 (Batch/Lot number was not reported) as single dose  for covid-19 immunisation (age at vaccination 84 years)  .  Medical history included ongoing dementia. Concomitant medications included donepezil (DONEPEZIL) taken for dementia from 2016 and ongoing; memantine (MEMANTINE) taken for dementia from 2016 and ongoing.   In 2021 the patient received the first dose of BNT162B2 vaccine) The patient experienced pulmonary embolism (medically significant) on 29Aug2021 with outcome of unknown.  The patient was hospitalized for pulmonary embolism  from 29Aug2021 to an unknown date. Therapeutic measures were taken as a result of pulmonary embolism including heparin.  Course of the Event: Yesterday morning her mother had a pulmonary embolism to the right lung. She went to the Emergency Room at local hospital. She was treated there and then transferred to the main hospital.  The lot number for the vaccine, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Eating disorder, Feeling abnormal, Gait disturbance, Pain, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (Patient). A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported, Expiry Date of COVID-19 Vaccine: Unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, consumer stated, they got COVID the 1st shot and was feeling awful, whole body everything was hurting, could not walk, could not eat and was throwing up. Patient asked should they go to the hospital. When informed about Pfizer Medical Information Department and offered the number, consumer stated, Should they go to the hospital that was what they were asking. And asked for transfer. In response to further probing, consumer stated, they were hurting too bad, and need to get an ambulance or need help. Consumer was unwilling to share further information, hence, product details (LOT, expiration date, NDC, UPC) and other details were unknown. Limited information was available over the call. QR comment: Reporter type was not available over the call, hence reporter type was captured as consumer or non-healthcare professional by default. Event seriousness was not specified. Outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Colitis ulcerative
Clinical narrative: ulcerative colitis; This is a spontaneous report. A contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient had ulcerative colitis and currently received infusions of Remicade. The patient just got a booster vaccine and wanted to know if there would be a test for antibodies before infusion on 06Sep2021 and after to see how Remicade affected the antibodies. The outcome of the event was unknown.  Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She is experiencing soreness around her injecting area; This is a spontaneous report from a contactable consumer. This consumer (patient's father) reported for a female patient (reporter's daughter). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FC3181), dose 1 via an unspecified route of administration on 28Aug2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced she was experiencing soreness around her injecting area on Aug2021. It has the date that was given which was yesterday the next appointment is 21 days from yesterday which is 18Sep. Outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: sick with COVID-19 after getting fully vaccinated with the Pfizer COVID-19 vaccine; sick with COVID-19 after getting fully vaccinated with the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. The consumer reported same events for 2 patients. This is the 2nd of 2 reports. A 67-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number: Unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single; dose 1 via an unspecified route of administration on an unspecified date as dose 1, single  for covid-19 immunization. The patient's medical history and concomitant medications were not reported. According to the reporter the patient was sick with covid-19 after getting fully vaccinated with the Pfizer covid-19 vaccine on an unspecified date. 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-202101127923 Same reporter/ drug/ event for different patients
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Extra dose administered, Off label use, Pain
Clinical narrative: severe diarrhea; Had the third dose on 26 Aug 2021; Had the third dose on 26 Aug 2021; body aches as though he has the virus, which he doesn't; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received the third dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route left arm on 26Aug2021 13:00, at 69 years of age, (Batch/Lot Number: 47823300) as single dose for COVID-19 immunization. Medical history included kidney damage and lung problems from medication and he spent 65 days in the hospital when he had Methicillin resistant Staphylococcal infection (MRSA) about 5 years before this report, all from an unknown date. Family Medical History was none. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot/ Batch number: FVP63021, administered via an unspecified route in left arm on 05Mar2021, at 68 years of age, as single dose for COVID-19 immunization and the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot/ Batch number: EN6202, administered via an unspecified route on 26Mar2021, at 69 years of age, as single dose for COVID-19 immunization. The patient had no problems with vaccines in the past. He stated he felt fine until he got the third shot. The patient didn't receive any other vaccine in the 4 weeks prior to the COVID-19 vaccine. The patient's concomitant medications were not reported. On 26Aug2021 an extra dose was administered, the patient received the third vaccine shot because his immune system was compromised because of MRSA and "they were putting in a funeral for him". His sister sent him a text message about the third shot and told him where he could go to get it. He has to be really careful since he has kidney damage and lung problems from medication and spent 65 days in the hospital then when he had MRSA. He was in 3 hospitals and in a rehabilitation center. Moreover, on 28Aug2021, he experienced severe diarrhea, body aches as though he had the virus, which he didn't. On 29Aug2021 he felt a little better "but really feeling good overall". He went to the emergency room/hospital on 30Aug2021 and just got home at the time of the report: he specified he stayed there from noon to 2pm and he was feeling a little better, but not 100%. The outcome of the extra dose administered was unknown at the time of the report, all the other events had not resolved yet at the time of the report.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Herpes zoster, Poor quality sleep, Rash
Clinical narrative: severe headache; fatigue; foggy thinking; poor sleep; within 6 days developed a rash on her left lower leg that was painful, burning, and itchy; within 6 days developed a rash on her left lower leg that was painful, burning, and itchy; For the next 4-5 multiple lesions erupted on her leg and then scanned over and was told she had shingles; For the next 4-5 multiple lesions erupted on her leg and then scanned over and was told she had shingles; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 08Aug2021 at 14:00 (at the age of 47-years-old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 and asthma both from an unknown date. The patient previously took aspirin and experienced allergy. The patient has no concomitant medications in two weeks. The patient experienced within 24 hours of the vaccine severe headache, fatigue, foggy thinking, and poor sleep all on 09Aug2021; On an unspecified date (within 6 days, as reported) developed a rash on her left lower leg that was painful, burning, and itchy. For the next 4-5 multiple lesions erupted on her leg and then scanned over and was told she had shingles. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Skin lesion, Thinking abnormal
Clinical narrative: severe headache; fatigue; foggy thinking; poor sleep; within 6 days developed a rash on her left lower leg that was painful, burning, and itchy; within 6 days developed a rash on her left lower leg that was painful, burning, and itchy; For the next 4-5 multiple lesions erupted on her leg and then scanned over and was told she had shingles; For the next 4-5 multiple lesions erupted on her leg and then scanned over and was told she had shingles; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 08Aug2021 at 14:00 (at the age of 47-years-old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 and asthma both from an unknown date. The patient previously took aspirin and experienced allergy. The patient has no concomitant medications in two weeks. The patient experienced within 24 hours of the vaccine severe headache, fatigue, foggy thinking, and poor sleep all on 09Aug2021; On an unspecified date (within 6 days, as reported) developed a rash on her left lower leg that was painful, burning, and itchy. For the next 4-5 multiple lesions erupted on her leg and then scanned over and was told she had shingles. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: received both scheduled doses of Pfizer's COVID vaccine (Feb/Mar 2021). Recently I was infected with the virus; received both scheduled doses of Pfizer's COVID vaccine (Feb/Mar 2021). Recently I was infected with the virus; I am now healthier than I have felt in months and months prior to my infection and no longer need to take daily doses of allergy or cough variant asthma meds; This is a spontaneous report from a contactable consumer. This 66-year old female consumer patient reported that:  A 66-year old female patient received both scheduled doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) in Feb2021/ Mar2021 a single dose for COVID-19 immunization. Medical history included penicillin allergy. Concomitant medications were unknown.  The patient reported that recently was infected with the virus (2 times tested positive) and subsequently recovered from the infection (tested negative). She was now healthier than she has felt in months and months prior to her infection and no longer need to take daily doses of allergy or cough variant asthma meds. Perhaps this is an area of research to pursue.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bell's palsy; This is a spontaneous report. A contactable consumer(patient) reported that a patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on Jun2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced bell's palsy and was told by urgent care to go to the emergency room. Outcome of event was unknown.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3246; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 13Jan2021 13:00 (at age of 60-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient's historical vaccine included shingles and flu vaccine for immunization; for that patient experienced minor aches, pain and a sore arm. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm on an unspecified date in 2021. Adverse event did not require a visit to emergency Room but visited to physician office. The outcome of event was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: after the first dose she "was sick for about a week, like with the flu"; after the first dose she "was sick for about a week, like with the flu"; This is a spontaneous report from a contactable consumer (patient herself). A 68-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date (at age of 68-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included COVID-19 and drug hypersensitivity; she was sensitive to medications from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced after the first dose she "was sick for about a week, like with the flu on an unspecified date. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: Near death experience; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter is (Name) who said he just got off a phone call with a person who was no longer on the other line and disconnected, they were no longer there. He said he wanted to report an adverse event mentioned on the call for which reporter provided no name or no phone number but said they had a friend who received a COVID-19 vaccine and after that had a near death experience, that afterwards the vaccine nearly killed them. Agent reported the COVID-19 vaccine was not clarified as either Pfizer or Moderna. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency, Neoplasm malignant
Clinical narrative: Developed cancer; Immunocompromised; This is a spontaneous report from a Pfizer sponsored program from a physician (the patient).     A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and  dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) both as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient stated he became  immunocompromised (medically significant) on 2021 with outcome of unknown , and developed cancer  (medically significant) on an unspecified date with outcome of unknown.   Events description. He is done with the first and second dose of the Pfizer covid vaccine. He is now immunocompromised today and for the past few days. He has also developed cancer.   The lot number for the vaccine  was not provided and will be requested during follow up.; Sender's Comments: There is no reasonable possibility of causal association between the event of Immunodeficiency ,Neoplasm malignant and the drug BNT162b2.The case will be reassessed further upon receipt of additional information. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: U
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Fatigue, Myalgia
Clinical narrative: COVID infection diagnosed; COVID infection diagnosed; fatigue; low grade temp; muscle aches; nasal congestion; sneezing; dry cough; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Feb2021 as dose 2, single for covid-19 immunisation. There is no relevant medical history, No underlying immune conditions or medications. There were no concomitant medications. The patient experienced covid infection diagnosed on 29Aug2021, fatigue, low grade temp, muscle aches, nasal congestion, sneezing, and dry cough on an unspecified date in Aug2021. The patient underwent lab tests and procedures which included body temperature low grade temp on 29Aug2021, sars-cov-2 test breakthrough covid infection. Breakthrough COVID infection diagnosed on 29Aug quick test on 29Aug2021. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Pyrexia, SARS-CoV-2 test, Sneezing, Vaccination failure
Clinical narrative: COVID infection diagnosed; COVID infection diagnosed; fatigue; low grade temp; muscle aches; nasal congestion; sneezing; dry cough; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Feb2021 as dose 2, single for covid-19 immunisation. There is no relevant medical history, No underlying immune conditions or medications. There were no concomitant medications. The patient experienced covid infection diagnosed on 29Aug2021, fatigue, low grade temp, muscle aches, nasal congestion, sneezing, and dry cough on an unspecified date in Aug2021. The patient underwent lab tests and procedures which included body temperature low grade temp on 29Aug2021, sars-cov-2 test breakthrough covid infection. Breakthrough COVID infection diagnosed on 29Aug quick test on 29Aug2021. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Insomnia, Neuropathy peripheral
Clinical narrative: suffering from Neuropathy; Have not been able to sleep; First dose on 19Jan2021, second dose on 19Aug2021; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2), second single dose via an unspecified route of administration, administered in Arm Left on 19Aug2021 12:00 (Batch/Lot number was not reported) for covid-19 immunisation at age of 60-year-old. The patient previously received first dose of bnt162b2 on 19Jan2021 at 13:00 at age of 59-year-old for Covid-19 Immunisation in left arm. Medical history included multiple myeloma. Concomitant medication included bortezomib (VELCADE). There were no known allergies. The patient had no COVID prior vaccination. No COVID tested post vaccination. The patient had Pfizer Booster vaccine administered on 19Aug2021 than on same day had a bortezomib Infusion within 24 hours, patient had been suffering from neuropathy on 19Aug2021 at 16:00. Patient went to emergency room with pain and currently taking gabapentin and unable to control pain. Patient had not been able to sleep in days due to pain in feet and hands. The event neuropathy resulted in emergency room/department or urgent care and hospitalization. Outcome of the event neuropathy was not recovered, of the other event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Dysphagia, Seizure, Weight, Weight decreased
Clinical narrative: Ever since received Vaccine admitted in Hospital at least 4 times because she was having seizures, heart problem; Ever since received Vaccine admitted in Hospital at least 4 times because she was having heart problem; She lost 100 Pounds; she can't swallow; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program.  A female patient of an unknown age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on May2021 at single dose for COVID-19 immunization. The patient was unsure of the day as she when received the first vaccine. Medical history and concomitant drugs were unknown.  Since received Vaccine the patient was admitted in Hospital at least 4 times because she was having seizures, heart problem. Dates when patient was in hospital were unspecified. She lost 100 Pounds on "charade food" (further not clarified) and she could not swallow. The outcome of the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive for Covid-19; Patient tested positive for Covid-19; This is a spontaneous report from a contactable consumer. A  non-pregnant 40-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, and then dose 2 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE,  for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient did not have COVID prior vaccination. Patient tested positive for COVID-19 via nasal swab on 30Aug2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment for the adverse event was unknown. Facility type vaccine was at a hospital. The outcome of the event was recovering at the time of reporting.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Covid positive on 29Aug2021. Test results (PCR) received 31Aug2021. Mild to-Moderate symptoms.; Covid positive on 29Aug2021. Test results (PCR) received 31Aug2021. Mild to-Moderate symptoms.; This is a spontaneous report from a contactable consumer.   A 43-year-old female patient received Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3248), via intramuscular route of administration, administered in left arm, on 25Mar2021, as dose 2, single and 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6203), via intramuscular route of administration, administered in left arm, on 02Mar2021 as dose 1, single for covid-19 immunization at the age of 43-year-old. The patient was not a pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient had no known allergies. No other vaccines received within 4 weeks. The patient did not receive any treatment. The patient did not have covid prior vaccination and the patient had tested positive post vaccination. On 29Aug2021, the patient underwent nasal swab PCR test and resulted with covid positive. On 31Aug2021, the polymerase chain reaction test results were received. Mild-to-Moderate symptoms were noticed. The outcome of the event was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis, Neck pain
Clinical narrative: I have developed Bell's Palsy; paralysis of the left side of my face on 27Aug2021. Preceded by left ear, head; neck pain; This is a spontaneous report from a contactable consumer (patient).    A 36-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in the right arm on 21Jun2021 17:45 (Lot Number: EW0178) as single dose (at the age of 36 years old) for COVID-19 immunisation  .  The patient medical history was not reported. here were no concomitant medications. Previously the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE on 28May2021 (at the age of 36 years old) in the right arm for COVID-19 immunisation. The vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.  On 27Aug2021 10:00, the patient experienced: I have developed bell's palsy (medically significant), paralysis of the left side of my face on 27aug2021. Preceded by left ear, head (medically significant), neck pain. No other infection, trauma or virus is found to be to blame. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events (Medications are underway). The events required a visit to the emergency room and a visit to the physician's office.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic shock, Cough, Dyspnoea
Clinical narrative: anaphylactic shock; difficulty breathing; coughing; This is a spontaneous report from a non-contactable consumer (parent). A 4-decade-year old female patient received Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylactic shock, difficulty breathing, coughing all on an unspecified date. Caller is a father. He states that he has a mid 30s year old daughter that he describes as morbidly obese. He states that she declines to receive the COVID 19 vaccine because she says there is PEG in the vaccine and that she is allergic to it. He relays that they would really like her to get it because she could get really sick or pass it to someone else, he states that she has kids or that she could pass it to them (referencing himself). He states that she was coughing and having some symptoms 7-8 years ago and so she received a pneumonia vaccine. She had a reaction that resulted in difficulty breathing and he describes as anaphylactic shock. He states that the doctors at the time said that it may have been to the PEG in the pneumonia vaccine but that they were not sure. 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: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product preparation issue
Clinical narrative: states 3 patients received doses of Comirnaty that were diluted with sterile water instead of 0.9% Sodium Chloride.; states 3 patients received doses of Comirnaty that were diluted with sterile water instead of 0.9% Sodium Chloride.; This is a spontaneous report from a contactable other HCP. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated that, she was a nurse calling from a hospital clinic. Reporter was reporting 3 doses of Comirnaty vaccine administered to patients after reconstituting with incorrect diluent. Reporter stated 3 patients received doses of Comirnaty that were diluted with sterile water instead of 0.9% Sodium Chloride. Reporter asking if Pfizer has stability information to support these doses as valid doses.  Pfizer has not tested the effects of using sterile water for injection as the diluent for the current formulation of the Pfizer-BioNTech COVID-19 Vaccine. If the vaccine that was diluted with sterile water for injection was inadvertently administered to individuals, a definitive statement on the quality and usability of the vaccine diluted in water cannot be made. The Pfizer-BioNTech COVID-19 Vaccine has not been tested with sterile water for injection as the diluent. Based on this lack of information, Pfizer is unable to definitively state if the vaccine dose is valid or invalid. Therefore, we kindly refer you to the CDC to discuss revaccination need or timing. It is not within Pfizer's remit to recommend revaccination. The clinical outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Insomnia, Pruritus, Rash, Urticaria
Clinical narrative: itchiness on her whole neck, head, both arms and both legs; rash and welts on both her arms, legs, and stomach.; rash and welts on both her arms, legs, and stomach.; having an allergic reaction; she couldn't go back to sleep; This is a spontaneous report from a contactable consumer.   A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Aug2021 (Batch/Lot Number: FD8448) as DOSE 1, SINGLE for covid-19 immunisation  .  Medical history included depression and trouble swallowing.  Concomitant medication included pantoprazole (PANTOPRAZOLE) 20 mg for at least 10 years for trouble swallowing, start and stop date were not reported; fluoxetine hydrochloride (FLUOXETIN) 40mg 1x/day oral taken for depression, start and stop date were not reported.  Caller received the first dose of the Pfizer Covid-19 vaccine on 28Aug2021 and on the first night afterwards (29Aug2021), started having complaints of itchiness on her whole neck, head, both arms, and both legs as well as rash and welts on both her arms, legs, and stomach.  Caller stated that the complaints are clearing up and is better but she is still itchy.  Caller is taking Claritin for the above complaints.Caller stated that she did refer to her vaccination provider about her side effects but the HCP there did not know what to do about her side effects.  Caller stated that she doesn't know if she wants to get the second dose of the Pfizer Covid-19 vaccine if vaccination providers don't  know what to do with side effects.  Caller says she was fine after she got the shot that morning, then overnight she started itching, it woke her up. She says her head, arms, legs, everything was itching. She says she couldn't go back to sleep and it was 03:00AM so there was no pharmacy open and nobody to contact so she had to wait until that morning to get something. She says she called and asked them what they suggest to do for it and they basically said she can try to take Benadryl and Claritin, they didn't ask to see her or anything, and she has welts. She says her major concern is once you have got the shot there is no one that checks on you after. Caller says she did take Claritin and it helped some, she is still itching, and she still has some rash. She says it has cured up some, but she still has rash and itching, so she was hoping they could recommended something to take, to see if something else might help. She says she took Claritin on the 29th  and yesterday, so for the two days day after. The outcome of the insomnia was unknown for the remining events was not recovered.   Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.