chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Ear discomfort, Head discomfort, Hypoacusis, Pain
Clinical narrative: pins & needle feeling in my limbs especially my finger tips to the point I couldn't open a fruit snack; Extreme pain & pressure in my head, ears, & jaw; Extreme pain & pressure in my head, ears, & jaw; Extreme pain & pressure in my head, ears, & jaw; Extreme pain & pressure in my head, ears, & jaw; Blurry vision; muffled sounds; balance was off; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 09:30 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma, Arthritis; "Arthritis" (unspecified if ongoing), notes: Other medical history: Asthma, Arthritis. The patient had no known allergies. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks and not received other medications in two weeks. Covid prior vaccination and covid tested post vaccination was reported as no. The following information was reported: PARAESTHESIA (disability) with onset 15Jan2022 08:00, outcome "not recovered", described as "pins & needle feeling in my limbs especially my finger tips to the point I couldn't open a fruit snack"; PAIN (disability), HEAD DISCOMFORT (disability), EAR DISCOMFORT (disability), PAIN IN JAW (disability) all with onset 15Jan2022 08:00, outcome "not recovered" and all described as "Extreme pain & pressure in my head, ears, & jaw"; VISION BLURRED (disability) with onset 15Jan2022 08:00, outcome "not recovered", described as "Blurry vision"; HYPOACUSIS (disability) with onset 15Jan2022 08:00, outcome "not recovered", described as "muffled sounds"; BALANCE DISORDER (disability) with onset 15Jan2022 08:00, outcome "not recovered", described as "balance was off"; VOMITING (disability) with onset 15Jan2022 08:00, outcome "not recovered", described as "vomiting". Therapeutic measures were not taken as a result of paraesthesia, pain, head discomfort, ear discomfort, pain in jaw, vision blurred, hypoacusis, balance disorder, vomiting. It was reported that extreme pain & pressure in her head, ears, & jaw! It effected all of her senses! Blurry vision, muffled sounds, balance was off, pins & needle feeling in her limbs especially her finger tips to the point she couldn't open a fruit snack & vomiting.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Paraesthesia, Vision blurred, Vomiting
Clinical narrative: pins & needle feeling in my limbs especially my finger tips to the point I couldn't open a fruit snack; Extreme pain & pressure in my head, ears, & jaw; Extreme pain & pressure in my head, ears, & jaw; Extreme pain & pressure in my head, ears, & jaw; Extreme pain & pressure in my head, ears, & jaw; Blurry vision; muffled sounds; balance was off; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 09:30 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma, Arthritis; "Arthritis" (unspecified if ongoing), notes: Other medical history: Asthma, Arthritis. The patient had no known allergies. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks and not received other medications in two weeks. Covid prior vaccination and covid tested post vaccination was reported as no. The following information was reported: PARAESTHESIA (disability) with onset 15Jan2022 08:00, outcome "not recovered", described as "pins & needle feeling in my limbs especially my finger tips to the point I couldn't open a fruit snack"; PAIN (disability), HEAD DISCOMFORT (disability), EAR DISCOMFORT (disability), PAIN IN JAW (disability) all with onset 15Jan2022 08:00, outcome "not recovered" and all described as "Extreme pain & pressure in my head, ears, & jaw"; VISION BLURRED (disability) with onset 15Jan2022 08:00, outcome "not recovered", described as "Blurry vision"; HYPOACUSIS (disability) with onset 15Jan2022 08:00, outcome "not recovered", described as "muffled sounds"; BALANCE DISORDER (disability) with onset 15Jan2022 08:00, outcome "not recovered", described as "balance was off"; VOMITING (disability) with onset 15Jan2022 08:00, outcome "not recovered", described as "vomiting". Therapeutic measures were not taken as a result of paraesthesia, pain, head discomfort, ear discomfort, pain in jaw, vision blurred, hypoacusis, balance disorder, vomiting. It was reported that extreme pain & pressure in her head, ears, & jaw! It effected all of her senses! Blurry vision, muffled sounds, balance was off, pins & needle feeling in her limbs especially her finger tips to the point she couldn't open a fruit snack & vomiting.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Herpes simplex, Immunisation
Clinical narrative: my booster; bad outbreak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "shingles" (unspecified if ongoing), notes: I also had shingles 32 years ago; "HSV2" (ongoing), notes: I have had HSV2 for about 25 years, mainly suppressed. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number:1, I did not have any outbreak after the first vaccine. I felt Pfizer should have this info.), for COVID-19 immunization; Bnt162b2 (Dose number:2, When I got my 2nd vaccine and my booster, each caused a pretty bad outbreak.), for COVID-19 immunization, reaction(s): "bad outbreak".  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "my booster"; HERPES SIMPLEX (non-serious), outcome "unknown", described as "bad outbreak".  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Headache, Oropharyngeal pain, Pain
Clinical narrative: Fever 104/103.9; sore throat; cough; headache; body aches; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Jan2022 14:30 (Lot number: FJ1611) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart attack ", start date: 31Jan2022, stop date: 31Jan2022. Concomitant medication(s) included: PLAVIX; BABY ASPIRIN; ROSUVASTATIN. Past drug history included: Versed, reaction(s): "Known allergies: Versed". Vaccination history included: Bnt162b2 (EN9581, Intramuscular, Previous dose number: 2, Vaccine location: Left arm), administration date: 04Feb2021, when the patient was 52 years old, for Covid-19 immunization, reaction(s): "Heart attack 13Jul2021"; Bnt162b2 (EK9231, Intramuscular, Previous dose number: 1, Vaccine location: Left arm), administration date: 13Jan2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: PYREXIA (medically significant) with onset 15Jan2022 11:00, outcome "recovering", described as "Fever 104/103.9"; OROPHARYNGEAL PAIN (non-serious) with onset 15Jan2022 11:00, outcome "recovering", described as "sore throat"; COUGH (non-serious) with onset 15Jan2022 11:00, outcome "recovering", described as "cough"; HEADACHE (non-serious) with onset 15Jan2022 11:00, outcome "recovering", described as "headache"; PAIN (non-serious) with onset 15Jan2022 11:00, outcome "recovering", described as "body aches". The patient underwent the following laboratory tests and procedures: body temperature: (15Jan2022) 104/103.9; sars-cov-2 test: (15Jan2022) negative, notes: Nasal Swab; (17Jan2022) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pyrexia, oropharyngeal pain, cough, headache, pain. Additional Information:  It was also reported that patient did not received any other vaccine in four weeks. Patient was not detected with Covid prior to vaccination. Patient was tested with covid post vaccination. Facility type vaccine was Workplace clinic.; Sender's Comments: Based on limited information in the case , a possible causal association between all the reported  events headache , pain, oropharyngeal pain ,pyrexia , cough and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever 104/103.9; sore throat; cough; headache; body aches; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Jan2022 14:30 (Lot number: FJ1611) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart attack ", start date: 31Jan2022, stop date: 31Jan2022. Concomitant medication(s) included: PLAVIX; BABY ASPIRIN; ROSUVASTATIN. Past drug history included: Versed, reaction(s): "Known allergies: Versed". Vaccination history included: Bnt162b2 (EN9581, Intramuscular, Previous dose number: 2, Vaccine location: Left arm), administration date: 04Feb2021, when the patient was 52 years old, for Covid-19 immunization, reaction(s): "Heart attack 13Jul2021"; Bnt162b2 (EK9231, Intramuscular, Previous dose number: 1, Vaccine location: Left arm), administration date: 13Jan2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: PYREXIA (medically significant) with onset 15Jan2022 11:00, outcome "recovering", described as "Fever 104/103.9"; OROPHARYNGEAL PAIN (non-serious) with onset 15Jan2022 11:00, outcome "recovering", described as "sore throat"; COUGH (non-serious) with onset 15Jan2022 11:00, outcome "recovering", described as "cough"; HEADACHE (non-serious) with onset 15Jan2022 11:00, outcome "recovering", described as "headache"; PAIN (non-serious) with onset 15Jan2022 11:00, outcome "recovering", described as "body aches". The patient underwent the following laboratory tests and procedures: body temperature: (15Jan2022) 104/103.9; sars-cov-2 test: (15Jan2022) negative, notes: Nasal Swab; (17Jan2022) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pyrexia, oropharyngeal pain, cough, headache, pain. Additional Information:  It was also reported that patient did not received any other vaccine in four weeks. Patient was not detected with Covid prior to vaccination. Patient was tested with covid post vaccination. Facility type vaccine was Workplace clinic.; Sender's Comments: Based on limited information in the case , a possible causal association between all the reported  events headache , pain, oropharyngeal pain ,pyrexia , cough and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: developed Covid-19 infection; developed Covid-19 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 26Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "developed Covid-19 infection".  Clinical Course: Patient received first dose of Pfizer Covid vaccine on 26Dec2021, subsequently developed Covid-19 infection. Caller is seeking information as to whether or not she can receive her second dose today.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: contracted covid19; contracted covid19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 29Sep2021 (Lot number: 301858A, Batch number: EN5318) at the age of 61 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 27Jan2021 (Lot number: EN5318) as dose 2, single and intramuscular, administered in arm left, administration date 06Jan2021 (Lot number: EL0742) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing); "never smoked" (unspecified if ongoing); "blood pressure" (ongoing), notes: diagnosed over 20 years ago. Concomitant medication(s) included: RAMIPRIL taken for blood pressure abnormal (ongoing); FLU VACCINE VII, administration date Nov2021. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 18Jan2022, outcome "not recovered" and all described as "contracted covid19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive. Clinical course: It was stated that, dry cough and chills began yesterday 17Jan2022 and are ongoing and the same as when they began. Patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. Patient did not receive any additional therapies for COVID-19. Did not require the initiation of new medication or other treatment or procedure. Patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination; Sender's Comments: Based on the information in the case report, a causal association between reported events vaccination failure, Covid-19 and suspect BNT162B2 is possible.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, SARS-CoV-2 test negative
Clinical narrative: Heart attack; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 04Feb2021 (Lot number: EN9581) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PLAVIX; BABY ASPIRIN; ROSUVASTATIN. Past drug history included: Versed, reaction(s): "Known allergies: Versed". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, lot number: EK9231, administrator route: Intramuscular on 13Jan2021, on left arm), administration date: 13Jan2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 13Jul2021, outcome "unknown", described as "Heart attack". The patient underwent the following laboratory tests and procedures: sars-cov-2 test negative: (15Jan2022) negative, notes: Covid test type post vaccination: Nasal Swab and Covid test name post vaccination was unknown; (17Jan2022) negative, notes: Covid test type post vaccination: Nasal Swab and Covid test name post vaccination was unknown. Patient received vaccine at Workplace clinic. Patient did not receive other vaccine in four weeks. Patient had covid prior vaccination.  No follow-up attempts needed. No further information expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events Myocardial Infarction and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Patient recently had COVID; Patient recently had COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Patient recently had COVID". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE) (Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose number unknown, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with COVID". Clinical course: Caller mentioned to have received COVID-19 vaccine and booster dose (no brand name), but reported being diagnosed with COVID prior to starting Paxlovid treatment. Caller was in current treatment with Paxlovid, stating she's "almost finished" and only one day left for treatment. Caller reported an "overwhelming bitter taste that didn't go away", then described it as "toilet water and metal taste, it was so incredibly bitter that I can only describe it as bile taste". Reporter's seriousness criteria was non-serious. She wanted to know if this had been reported, if she can take any medication to get rid of the bad taste and if it will be "residual" or for how long will it last after treatment. Caller wanted to know if Paxlovid was "made" for treatment of "COVID-19 Omicron variant" or for "COVID-19 in general". Caller wanted to know if Paxlovid was already approved or if it was still under EUA.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Coagulopathy
Clinical narrative: Clotting issues; he had stroke on Jul2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1), administration date: Mar2021, for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Jul2021, outcome "unknown", described as "he had stroke on Jul2021"; COAGULOPATHY (non-serious), outcome "unknown", described as "Clotting issues". Clinical course: patient got the first dose of the Pfizer BioNtech COVID-19 Vaccine in late Mar2021 and the second dose in early Apr2021. Patient stated that he had stroke on Jul2021. He was considering to take the protease inhibitor pill. Patient experienced a mild stroke after the second dose. He had a question, he was clotting issues and asking about getting the booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positively for COVID; Tested positively for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Dec2021 13:30 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 22Jul2021 16:45 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administered in arm left, administration date 01Jul2021 11:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation.The patient's relevant medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Jan2022 12:30, outcome "recovering" and all described as "Tested positively for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure during pregnancy
Clinical narrative: had Covid over New Years holiday; had Covid over New Years holiday; she had a lady who was pregnant/ looked like she was 7 months pregnant; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A female patient (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient was 7 months pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had Covid over New Years holiday"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "she had a lady who was pregnant/ looked like she was 7 months pregnant". Clinical course: The pharmacist was calling about the Covid-19 vaccine Purple Cap for Adults. She reported that she had a lady who was pregnant and just had covid over New years holiday. The patient's doctor told her to wait 90 days to get a booster, but the caller said that she was there now wanting a booster. The patient looked like she was 7 months pregnant or so. She wanted to know if it was ok that she got the booster.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out in this 7 months pregnant female patient.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Patient has Covid-19 currently although patient had 3 doses of Covid-19 vaccine; Patient has Covid-19 currently although patient had 3 doses of Covid-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient has Covid-19 currently although patient had 3 doses of Covid-19 vaccine". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based pm the limited available information, the events vaccination failure and COVID-19 are considered possibly related to BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: the patients tested positive with Covid.; the patients tested positive with Covid.; pregnant patient; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A female patient (pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the patients tested positive with Covid."; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "pregnant patient". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Clinical course: Pregnant patient is in the office asking for a booster dose. The caller mentioned that the patients tested positive with Covid.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: A contributory role of BNT162B2 to event the patients tested positive with Covid cannot be excluded based on temporal association and available information.
Sex: U
Vaccine: COVID19
Symptoms: Multisystem inflammatory syndrome in adults
Clinical narrative: MIS in an adult patient; This is a literature report. An adult patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (medically significant), outcome "unknown", described as "MIS in an adult patient". There are no prior reports of MIS-C among patients who have been fully vaccinated, and only a single case of MIS in an adult patient who had received his second shot just 4 days prior to symptom onset.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the event of MIS 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Musculoskeletal stiffness, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; Stiffness; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4233732-00.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single and intramuscular, administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (cf) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "recovering" and all described as "COVID-19 virus test positive"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Mar2021, outcome "unknown", described as "Stiffness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive. The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and  DRUG INEFFECTIVE , COVID-19 , MUSCULOSKELETAL STIFFNESS   cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Hypersensitivity, Nasal congestion, Pruritus
Clinical narrative: His nose is also cold; having itching on his head and it spread all over his body during the day/Yesterday he had itches in his head now he has itches in his backside; Nasal congestion; Allergy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2) (Lot number: FL0007) as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "ALLERGY" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING COLD (non-serious), outcome "unknown", described as "His nose is also cold"; PRURITUS (non-serious), outcome "unknown", described as "having itching on his head and it spread all over his body during the day/Yesterday he had itches in his head now he has itches in his backside"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Nasal congestion"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergy".  Additional information: he is a healthy kid. He is taking Cetirizine because he has allergies and the 'hcp' gave me for 3 months (Further clarification unknown) and when I went there and I asked if it is okay to put the shot because he is taking Cetirizine because he has allergies. He has a 3 months 'pill' and this month is the last one but after that I am not giving him.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Feeling abnormal, Hypoaesthesia, Malaise
Clinical narrative: I still had feeling burning sensations in my chest and you know it still felt like needle pain in my chest.; I was getting chest discomfort and then an hour later it felt like somebody has stabbed needle in my chest; I was not feeling well.; My left arm went numb; my fingers were tingling, my left leg also had the same reaction.; I was still having chest pain and it''s like my body just did not feel normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 23 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 (Batch/Lot number: unknown) at the age of 23 years as dose 1 , single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE 50 mg, Frequency, every day in the morning taken for hypothyroidism. The following information was reported: CHEST PAIN (hospitalization), outcome "unknown", described as "I still had feeling burning sensations in my chest and you know it still felt like needle pain in my chest."; CHEST DISCOMFORT (hospitalization), outcome "unknown", described as "I was getting chest discomfort and then an hour later it felt like somebody has stabbed needle in my chest"; MALAISE (non-serious), outcome "unknown", described as "I was not feeling well."; HYPOAESTHESIA (non-serious), outcome "unknown", described as "My left arm went numb"; PARAESTHESIA (non-serious), outcome "unknown", described as "my fingers were tingling, my left leg also had the same reaction."; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I was still having chest pain and it''s like my body just did not feel normal". The events "i still had feeling burning sensations in my chest and you know it still felt like needle pain in my chest.", "i was getting chest discomfort and then an hour later it felt like somebody has stabbed needle in my chest", "i was not feeling well.", "my left arm went numb", "my fingers were tingling, my left leg also had the same reaction." and "i was still having chest pain and it''s like my body just did not feel normal" were evaluated at the emergency room visit. Therapeutic measures baby aspirin, Sulpha Codeine were taken as a result of chest pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: I still had feeling burning sensations in my chest and you know it still felt like needle pain in my chest.; I was getting chest discomfort and then an hour later it felt like somebody has stabbed needle in my chest; I was not feeling well.; My left arm went numb; my fingers were tingling, my left leg also had the same reaction.; I was still having chest pain and it''s like my body just did not feel normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 23 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 (Batch/Lot number: unknown) at the age of 23 years as dose 1 , single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE 50 mg, Frequency, every day in the morning taken for hypothyroidism. The following information was reported: CHEST PAIN (hospitalization), outcome "unknown", described as "I still had feeling burning sensations in my chest and you know it still felt like needle pain in my chest."; CHEST DISCOMFORT (hospitalization), outcome "unknown", described as "I was getting chest discomfort and then an hour later it felt like somebody has stabbed needle in my chest"; MALAISE (non-serious), outcome "unknown", described as "I was not feeling well."; HYPOAESTHESIA (non-serious), outcome "unknown", described as "My left arm went numb"; PARAESTHESIA (non-serious), outcome "unknown", described as "my fingers were tingling, my left leg also had the same reaction."; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I was still having chest pain and it''s like my body just did not feel normal". The events "i still had feeling burning sensations in my chest and you know it still felt like needle pain in my chest.", "i was getting chest discomfort and then an hour later it felt like somebody has stabbed needle in my chest", "i was not feeling well.", "my left arm went numb", "my fingers were tingling, my left leg also had the same reaction." and "i was still having chest pain and it''s like my body just did not feel normal" were evaluated at the emergency room visit. Therapeutic measures baby aspirin, Sulpha Codeine were taken as a result of chest pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test
Clinical narrative: after the first vaccine is when I had my side effects; I had A-fib and is very controllable its minor caser of A-fib but after the first dose I was in A-fib for a total 48, little over 48 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 24Aug2021 (Lot number: FC3182) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing), notes: have A-fib but it's controlled A-fib but it's controlled by a medication. The patient took concomitant medications included 'water pill (unspecified)'. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "after the first vaccine is when I had my side effects; I had A-fib and is very controllable its minor caser of A-fib but after the first dose I was in A-fib for a total 48, little over 48 hours". The patient underwent the following laboratory tests and procedures: blood test: unknown results, notes: it was after I got the vaccination. It was about a month or so that I got blood work then (Not clarified). What's then? No. The patient received treatment with Metoprolol and Propafenone.  Clinical course: Consumer stated, "Someone told she that, she should report a side effects that she had when she received the Covid vaccine, the Pfizer Covid vaccine. "Paraphrased for Covid19 vaccine: Consumer stated, "That's correct. "After the first vaccine was when she had her side effects. Yes with the first dose was when she had her side effects. She didn't have any side effects with the second dose." Consumer stated, "she went into, she had A-fib and was very controllable its minor caser of A-fib but after the first dose she was in A-fib for a total 48, a little over 48 hours and medication (Further not clarified hence suspect captured as Unspecified medication) wasn't controlling it." Further probing: Consumer stated, "Yes, as it helps somebody, yes." Medical condition: Consumer stated, "No, she didn't have anything like that. She had, she did have A-fib but it's controlled A-fib but it's controlled by a medication. A-fib, it stands for atrial fibrillation which mean her heart flutters." Treatment: Consumer stated, "Yes she took all the medication that she was supposed to take.". Consumer stated, "It would help for may be better an hour and then it would come back (Further clarification unknown hence suspect not made). Sure, hold on, she took 2. She took Metoprolol 25mg, she took it twice and another medication Propafenone she took 300 mg and she took that twice for 2 days, twice a day for 2 days." Consumer further stated, " The second medication the Propafenone, she only took that once one day and once another day. She didn't take it twice in 1 day. She only took it once. The other 1, she took it twice."  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Drug ineffective, Gastrointestinal disorder, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Crohns Disease flare ups; Gastrointestinal issues; COVID; COVID; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4234680-00.  A 31 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single, intramuscular, administration date 23Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 23Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27Dec2021, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 27Dec2021, outcome "not recovered" and all described as "COVID"; CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Crohns Disease flare ups"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "Gastrointestinal issues". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) negative. The action taken for adalimumab was unknown. Concomitant drugs and dates of administration (Exclude those used to treat event): Concomitant Drugs Not Reported Other Relevant History: Not reported.   The reporter's causality for the event(s) of GASTROINTESTINAL ISSUES, COVID and CROHNS DISEASE FLARE UPS was not provided with HUMIRA(ADALIMUMAB).   The reporter causality for Gastrointestinal disorder, COVID-19, Crohns disease aggravated is possible with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN).  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events Crohn's disease flare up, drug ineffective, suspected covid19, gastrointestinal disorder cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient experienced COVID; patient experienced COVID; Joint pain; MARKETING PROGRAM NAME WAS NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4233077-00.  A 70 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single and intramuscular, administration date 03Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for colitis ulcerative. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "recovering" and all described as "patient experienced COVID"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovered", described as "Joint pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive, notes: In 2021, the patient experienced COVID. The action taken for adalimumab was unknown. In 2021, the patient experienced COVID and JOINT PAIN. On an unknown date, Joint pain resolved. Pfizer BioNTech COVID-19 vaccine (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 03Feb2021, he received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 01Mar2021, he received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech.   The reporter's causality for the event of COVID with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event of joint pain was not provided.  The reporter's causality for the events of COVID and joint pain with BNT162B2 was Possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events drug ineffective, covid19, arthralgia cannot be totally excluded.
Sex: M
Vaccine: COVID19
Symptoms: Dementia, Feeling abnormal, Mucous stools, Productive cough, Weight
Clinical narrative: dementia; there a lot of mucus whenever he's coughing up and when he defecates, there's more mucus than feces; there a lot of mucus whenever he's coughing up and when he defecates, there's more mucus than feces; experienced some "goofy things"; dropped 30lbs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.  A 77 year-old male patient received bnt162b2 (BNT162B2), administration date 13May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Deaf" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization. The following information was reported: DEMENTIA (medically significant), outcome "unknown", described as "dementia"; PRODUCTIVE COUGH (non-serious), MUCOUS STOOLS (non-serious), outcome "unknown" and all described as "there a lot of mucus whenever he's coughing up and when he defecates, there's more mucus than feces"; WEIGHT DECREASED (non-serious) with onset May2021, outcome "unknown", described as "dropped 30lbs"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "experienced some "goofy things"". The patient underwent the following laboratory tests and procedures: weight: (May2021) 30 lbs, notes: dropped 30lbs. Clinical course: The patient got second shot of the Pfizer-BioNTech Covid19 vaccine on 13May2021, and after the second shot started having problems it affected his body in a way, patient dropped 30 lbs since May2021 and experienced some "goofy things", there a lot of mucus whenever patient was coughing up and when defecates, there was more mucus than faeces. Per caller, the doctor's think that patient was having dementia and does not believe the patient and the hospital said to call Pfizer for information on how to counter whatever patient was experiencing.  The lot number for bnt162b2 was not provided and will be requested during follow up.