chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Migraine, Product dose omission issue
Clinical narrative: 1 day after ran out of medication , Migraine crisis; ran out of medication; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 75 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; atogepant (ATOGEPANT), oral (Batch/Lot number: unknown) at 60 mg 1x/day (60mg, daily) for migraine. Relevant medical history included: "Yes" (unspecified if ongoing), notes: relevant Medical History: Yes. The patient's concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "1 day after ran out of medication , Migraine crisis"; PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "not recovered", described as "ran out of medication".  Additional information-It was unknown if patient was breastfeeding mother at the time of vaccination. Patient was not hospitalized for the event. It was reported that patient did not stop atogepant because of event. The patient was still ran out of medication and waiting on a shipment of Qulipta (atogepant) tablets.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Immunisation
Clinical narrative: pain at the injection site; tired; Headache; Muscle ache; Chills; Joint pain; Fever; Nausea; Feeling unwell; Covid vaccine booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 12:00 (Lot number: FG3527) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, 04Mar2021, Lot: EN6204), administration date: 04Mar2021, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "tiredness", "fever"; Bnt162b2 (Dose 2, Second: Given on 25Mar2021 Lot: ER2613), administration date: 25Mar2021, for Covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "Covid vaccine booster shot"; VACCINATION SITE PAIN (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "pain at the injection site"; FATIGUE (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "tired"; HEADACHE (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Headache"; MYALGIA (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Muscle ache"; CHILLS (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Chills"; ARTHRALGIA (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Joint pain"; PYREXIA (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Fever"; NAUSEA (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Nausea"; MALAISE (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Feeling unwell".  Additional information: Report is  related to a study or programme. No investigation Assessment.Primary Healthcare: declines as he is ok now. The caller clarifies this all lasted 2 days, all of Sunday and all of Monday and then he was ok. AE did not requires to visit to emergency room and physician office. No prior vaccination within 4 weeks. No AE's following prior vaccination. No relevant test's.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: pain at the injection site; tired; Headache; Muscle ache; Chills; Joint pain; Fever; Nausea; Feeling unwell; Covid vaccine booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 12:00 (Lot number: FG3527) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, 04Mar2021, Lot: EN6204), administration date: 04Mar2021, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "tiredness", "fever"; Bnt162b2 (Dose 2, Second: Given on 25Mar2021 Lot: ER2613), administration date: 25Mar2021, for Covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "Covid vaccine booster shot"; VACCINATION SITE PAIN (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "pain at the injection site"; FATIGUE (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "tired"; HEADACHE (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Headache"; MYALGIA (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Muscle ache"; CHILLS (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Chills"; ARTHRALGIA (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Joint pain"; PYREXIA (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Fever"; NAUSEA (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Nausea"; MALAISE (non-serious) with onset 21Nov2021, outcome "recovered" (Nov2021), described as "Feeling unwell".  Additional information: Report is  related to a study or programme. No investigation Assessment.Primary Healthcare: declines as he is ok now. The caller clarifies this all lasted 2 days, all of Sunday and all of Monday and then he was ok. AE did not requires to visit to emergency room and physician office. No prior vaccination within 4 weeks. No AE's following prior vaccination. No relevant test's.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Immunisation, Poor quality product administered, Product temperature excursion issue
Clinical narrative: booster; temperature range of 41-43 degrees Fahrenheit.; stored in refrigerator state and intact with a  temperature range of 41-43 degrees Fahrenheit.; expired on the 14Nov2021 but 4 doses were administered on 19Nov2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2, solution for injection), administration date 19Nov2021 (Batch/Lot number: unknown, Expiration Date: 14Nov2021) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 1.), for Covid-19 immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 2.), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "booster"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 19Nov2021, outcome "unknown", described as "temperature range of 41-43 degrees Fahrenheit."; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 19Nov2021, outcome "unknown", described as "stored in refrigerator state and intact with a  temperature range of 41-43 degrees Fahrenheit."; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 19Nov2021, outcome "unknown", described as "expired on the 14Nov2021 but 4 doses were administered on 19Nov2021".  Additional information: Reporter said that the vaccines should be discarded on 14Nov (30th day) but 4 doses were given to patients on 19Nov. I am a nurse for a medical office, and we received Pfizer vaccines for our patients and of course when they come out of deep freeze, they are good for 30 days after and we had patients that received the dose of the booster doses five days past the date that they should have been discarded.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101656254 same reporter/drug/event, different pt;US-PFIZER INC-202101656255 same reporter/drug/event, different pt;US-PFIZER INC-202101656256 same reporter/drug/event, different pt
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity
Clinical narrative: booster; sore arm for 4 days; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01), for Covid-19 immunization; Bnt162b2 (Dose 02), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm for 4 days".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Product administered to patient of inappropriate age, Underdose
Clinical narrative: middle son got the pediatric Pfizer covid 19 vaccine; middle son got the pediatric Pfizer covid 19 vaccine; Joint pain/ knees and ankles; back pain like charley horses in the lower back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 04Nov2021 (Batch/Lot number: unknown) at the age of 13 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), UNDERDOSE (non-serious), outcome "unknown" and all described as "middle son got the pediatric Pfizer covid 19 vaccine"; BACK PAIN (non-serious) with onset 04Nov2021, outcome "unknown", described as "back pain like charley horses in the lower back"; ARTHRALGIA (non-serious) with onset 05Nov2021, outcome "not recovered", described as "Joint pain/ knees and ankles".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Aches and pains all over; Fever; hands and feet keep locking up; sweated it out; Headache; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 10:30 (Lot number: FJ1620) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII. Vaccination history included: Bnt162b2 (1st dose, Lot: EP7533, Expiry: Unknown, didn't have any issue with the 1st 2 doses, just a sore arm and was a little bit tired.), administration date: 23Apr2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (1st dose, Lot: EP7533, Expiry: Unknown, didn't have any issue with the 1st 2 doses, just a sore arm and was a little bit tired.), administration date: 23Apr2021, for COVID-19 immunization, reaction(s): "was a little bit tired."; Bnt162b2 (2nd dose, Lot: EW0158, Expiry: Unknown, didn't have any issue with the 1st 2 doses, just a sore arm and was a little bit tired.), administration date: 14May2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "was a little bit tired.", "sore arm". The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021, outcome "unknown", described as "booster"; PAIN (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Aches and pains all over"; HEADACHE (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 24Nov2021, outcome "recovering", described as "Fever"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 24Nov2021, outcome "unknown", described as "hands and feet keep locking up"; HYPERHIDROSIS (non-serious) with onset 24Nov2021, outcome "unknown", described as "sweated it out". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, headache, pyrexia, loss of personal independence in daily activities, hyperhidrosis. Additional information: Caller states that patient was calling her best friend who went to the hospital yesterday and got the Pfizer booster for Covid 19 vaccine, the adult dose. Ever since this morning her friend has just been laying around in bed, and experienced aches and pains all over, a headache, a fever of 100.8 which just broke and is now 98.1, and her hands and feet keep locking up, Caller states that patient has been giving her friend 2 Tylenol 500mg every 4 hours because she is not supposed to take Ibuprofen, but the patient already called her pharmacy and they told her that it was a side effect so she just wants to report it. She didn't have any issue with the 1st 2 doses, just a sore arm and was a little bit tired.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Ear pain, Headache, Immunisation
Clinical narrative: Terrible headache; I got body aches; Chills; I have absolutely no energy; At one point today my ears hurt as well; Very lethargic no energy; Low grade fever; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 16:45 (Lot number: FH8030) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Family history included: "diabetes" (unspecified if ongoing); "heart disease" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN (ongoing); AMLODIPINE BESILATE; LIPITOR; FAMOTIDINE; NORETHINDRONE ACETATE. Vaccination history included: Bnt162b2 (Dose:1, Date: 01Mar2021, Time: 11:00, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: EL3247), administration date: 01Mar2021, when the patient was 52 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Date: 01Apr2021, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: EP6955), administration date: 01Apr2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021 16:45, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 24Nov2021, outcome "unknown", described as "Terrible headache"; PAIN (non-serious) with onset 24Nov2021, outcome "unknown", described as "I got body aches"; CHILLS (non-serious) with onset 24Nov2021, outcome "unknown", described as "Chills"; ASTHENIA (non-serious) with onset 24Nov2021, outcome "unknown", described as "I have absolutely no energy"; EAR PAIN (non-serious) with onset 24Nov2021, outcome "unknown", described as "At one point today my ears hurt as well"; LETHARGY (non-serious) with onset 24Nov2021, outcome "unknown", described as "Very lethargic no energy"; PYREXIA (non-serious) with onset 24Nov2021, outcome "unknown", described as "Low grade fever". Therapeutic measures were taken as a result of headache, pain, chills, asthenia, ear pain, lethargy.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: Terrible headache; I got body aches; Chills; I have absolutely no energy; At one point today my ears hurt as well; Very lethargic no energy; Low grade fever; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 16:45 (Lot number: FH8030) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Family history included: "diabetes" (unspecified if ongoing); "heart disease" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN (ongoing); AMLODIPINE BESILATE; LIPITOR; FAMOTIDINE; NORETHINDRONE ACETATE. Vaccination history included: Bnt162b2 (Dose:1, Date: 01Mar2021, Time: 11:00, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: EL3247), administration date: 01Mar2021, when the patient was 52 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Date: 01Apr2021, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: EP6955), administration date: 01Apr2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021 16:45, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 24Nov2021, outcome "unknown", described as "Terrible headache"; PAIN (non-serious) with onset 24Nov2021, outcome "unknown", described as "I got body aches"; CHILLS (non-serious) with onset 24Nov2021, outcome "unknown", described as "Chills"; ASTHENIA (non-serious) with onset 24Nov2021, outcome "unknown", described as "I have absolutely no energy"; EAR PAIN (non-serious) with onset 24Nov2021, outcome "unknown", described as "At one point today my ears hurt as well"; LETHARGY (non-serious) with onset 24Nov2021, outcome "unknown", described as "Very lethargic no energy"; PYREXIA (non-serious) with onset 24Nov2021, outcome "unknown", described as "Low grade fever". Therapeutic measures were taken as a result of headache, pain, chills, asthenia, ear pain, lethargy.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, C-reactive protein, Colitis microscopic, Colonoscopy, Diarrhoea
Clinical narrative: 2-3 loose to watery stools per day); nausea; abdominal cramping; incontinence; Lymphocytic colitis; This is a literature report.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. A 69 years woman with a history of GERD, hyperlipidemia, paroxysmal SVT, and hypertension. The patient's concomitant medications were not reported. The patient was presented for evaluation of severe abdominal pain, nausea, and diarrhea. She reported no significant GI issues prior to her second Pfizer COVID vaccination on 2/17/21. Within 24-hrs of vaccination, she reported onset of diarrhea (2-3 loose to watery stools per day). Symptoms intensified over the next several days to 3-5 watery stools per day with incontinence, abdominal cramping, and nausea. After consultation with her primary care provider, GI PCR and COVID testing were negative. Ondansetron and loperamide were started with minimal benefit. Two months later, a GI consultation was obtained due to persistent symptoms. Work up demonstrated no anemia with normal CRP, celiac serologies, and GI PCR. Colonoscopy on day 98 post-onset revealed patchy erythema in the descending colon and rectosigmoid. Histologic evaluation of mucosal biopsies revealed lymphocytic colitis characterized by numerous lymphocytes infiltrating the epithelium and abundant plasma cells in the lamina propria. A previous colonoscopy performed in 2012 was unremarkable. At her most recent follow-up on day 113 post-onset, the patient reported gradual improvement of abdominal symptoms and diarrhea.  No follow-up attempts were possible. No further information was expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Colitis microscopic and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Histology, Incontinence, Mucosal biopsy, Nausea, Polymerase chain reaction
Clinical narrative: 2-3 loose to watery stools per day); nausea; abdominal cramping; incontinence; Lymphocytic colitis; This is a literature report.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. A 69 years woman with a history of GERD, hyperlipidemia, paroxysmal SVT, and hypertension. The patient's concomitant medications were not reported. The patient was presented for evaluation of severe abdominal pain, nausea, and diarrhea. She reported no significant GI issues prior to her second Pfizer COVID vaccination on 2/17/21. Within 24-hrs of vaccination, she reported onset of diarrhea (2-3 loose to watery stools per day). Symptoms intensified over the next several days to 3-5 watery stools per day with incontinence, abdominal cramping, and nausea. After consultation with her primary care provider, GI PCR and COVID testing were negative. Ondansetron and loperamide were started with minimal benefit. Two months later, a GI consultation was obtained due to persistent symptoms. Work up demonstrated no anemia with normal CRP, celiac serologies, and GI PCR. Colonoscopy on day 98 post-onset revealed patchy erythema in the descending colon and rectosigmoid. Histologic evaluation of mucosal biopsies revealed lymphocytic colitis characterized by numerous lymphocytes infiltrating the epithelium and abundant plasma cells in the lamina propria. A previous colonoscopy performed in 2012 was unremarkable. At her most recent follow-up on day 113 post-onset, the patient reported gradual improvement of abdominal symptoms and diarrhea.  No follow-up attempts were possible. No further information was expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Colitis microscopic and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Serology test
Clinical narrative: 2-3 loose to watery stools per day); nausea; abdominal cramping; incontinence; Lymphocytic colitis; This is a literature report.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. A 69 years woman with a history of GERD, hyperlipidemia, paroxysmal SVT, and hypertension. The patient's concomitant medications were not reported. The patient was presented for evaluation of severe abdominal pain, nausea, and diarrhea. She reported no significant GI issues prior to her second Pfizer COVID vaccination on 2/17/21. Within 24-hrs of vaccination, she reported onset of diarrhea (2-3 loose to watery stools per day). Symptoms intensified over the next several days to 3-5 watery stools per day with incontinence, abdominal cramping, and nausea. After consultation with her primary care provider, GI PCR and COVID testing were negative. Ondansetron and loperamide were started with minimal benefit. Two months later, a GI consultation was obtained due to persistent symptoms. Work up demonstrated no anemia with normal CRP, celiac serologies, and GI PCR. Colonoscopy on day 98 post-onset revealed patchy erythema in the descending colon and rectosigmoid. Histologic evaluation of mucosal biopsies revealed lymphocytic colitis characterized by numerous lymphocytes infiltrating the epithelium and abundant plasma cells in the lamina propria. A previous colonoscopy performed in 2012 was unremarkable. At her most recent follow-up on day 113 post-onset, the patient reported gradual improvement of abdominal symptoms and diarrhea.  No follow-up attempts were possible. No further information was expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Colitis microscopic and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation
Clinical narrative: Fatigue on the following day, which lasted only about ~15 hours.; Dose Number : 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Nov2021 01:00 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VALSARTAN; HYDROCHLOROTHIAZIDE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown., Location of injection: Arm Left, Vaccine Administration Time: 01:00 AM, Route of Administration: Intramuscular), administration date: 18Feb2021, when the patient was 57 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM, Route of Administration: Intramuscular), administration date: 28Jan2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 01:00, outcome "unknown", described as "Dose Number : 3"; FATIGUE (non-serious) with onset 25Nov2021 06:00, outcome "recovered" (25Nov2021), described as "Fatigue on the following day, which lasted only about ~15 hours.". Therapeutic measures were not taken as a result of fatigue.  Additional information: Prior to the vaccination, patient not had COVID-19. The patient was not tested positive for COVID-19 post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Malaise
Clinical narrative: Diarrhea; stomach was upset; did not feel good; She and her husband both got their booster; Coughing; Extreme Fatigue; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 77 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 16:00 (Lot number: FF2588) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot En6201, expiration unknown; Route, Anatomical Location: Right arm in the muscle., Verbatim: They were fine with them), administration date: 28Jan2021, when the patient was 76 years old, for COVID-19 Immunisation, reaction(s): "They were fine with them"; Bnt162b2 (Dose: 2, Lot EL1284, expiration unknown; Route, Anatomical Location: Right arm in the muscle., Verbatim: They were fine with them), administration date: 19Feb2021, when the patient was 76 years old, for COVID-19 Immunisation, reaction(s): "They were fine with them". The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "She and her husband both got their booster"; COUGH (non-serious) with onset 15Nov2021, outcome "not recovered", described as "Coughing"; FATIGUE (non-serious) with onset 15Nov2021, outcome "recovering", described as "Extreme Fatigue"; HEADACHE (non-serious) with onset 15Nov2021, outcome "recovering", described as "Headache"; DIARRHOEA (non-serious) with onset 16Nov2021, outcome "recovering", described as "Diarrhea"; ABDOMINAL DISCOMFORT (non-serious) with onset 15Nov2021, outcome "unknown", described as "stomach was upset"; MALAISE (non-serious) with onset 15Nov2021, outcome "unknown", described as "did not feel good".  Additional information: Vaccination Facility Name was PRIVACY. Patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient had no AE(s) following prior vaccinations. Patient's Medical History was none. Patient was not diagnosed with allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Family Medical History Relevant was none. She did not have an address, phone or email for his primary care provider. Her husband has the same primary care provider. It was reported that patient and her wife both got their booster on 15 Nov2021. This was 6 months after first one and they decided to get the booster. Most of their symptoms started within 2 hours of getting it. After receiving the booster, they stopped and got dinner and took care of their animals.  By 7pm, neither one felt like eating and their stomach was upset and did not feel good. Coughing started in Evening, Headache started Late in the evening and Diarrhea in the middle of the night. AE(s) did not require a visit to Emergency Room.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Immunisation, Vaccination site pain
Clinical narrative: headache; Fatigue; injection site pain; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 10:30 (Lot number: 33026bd) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing); "latex" (unspecified if ongoing); "pcn" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; OMEPRAZOLE; MELATONIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Neomyocin, reaction(s): "known allergies: neomyocin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ep6955, Location of injection: Arm Left), administration date: 02Apr2021, when the patient was 52 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 12Mar2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Nov2021 10:30, outcome "unknown", described as "Dose Number: 3"; HEADACHE (non-serious) with onset 25Nov2021 17:00, outcome "recovered" (2021), described as "headache"; FATIGUE (non-serious) with onset 25Nov2021 17:00, outcome "recovered" (2021), described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 25Nov2021 17:00, outcome "recovered" (2021), described as "injection site pain". Therapeutic measures were taken as a result of headache, fatigue, vaccination site pain. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenitis, Lymphadenopathy
Clinical narrative: I just had booster meaning third dose for the Pfizer vaccine; Lymph nodes inflammation under your armpit and chest they are swollen; Lymph nodes inflammation under your armpit and chest they are swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "I just had booster meaning third dose for the Pfizer vaccine"; LYMPHADENITIS (non-serious), LYMPHADENOPATHY (non-serious) all with onset 2021, outcome "unknown" and all described as "Lymph nodes inflammation under your armpit and chest they are swollen".  Additional information: It was reported that the patient had a concern about that the patient just had booster meaning third dose for the Pfizer vaccine, patient wanted to see how normal or not normal was to have lymph nodes inflammation under the armpit and chest, they are swollen.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: lymph node under armpit is swollen; Booster; 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. Other Case identifier(s): US-PFIZER INC-202101689622 (Pfizer).  A male patient received bnt162b2 (BNT162B2), administration date 27Nov2021 19:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 19:00, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset 29Nov2021, outcome "unknown", described as "lymph node under armpit is swollen".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Vaccination site swelling
Clinical narrative: Swelling has moved to under arm area. noticed underarm swelling on 28Nov2021; Booster; Severe swelling at injection site.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administered in arm left, administration date 26Nov2021 (Lot number: FG3527) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0179, Location of injection: Arm Left), when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Er8737), when the patient was 49 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021, outcome "unknown", described as "Booster "; VACCINATION SITE SWELLING (non-serious) with onset 26Nov2021, outcome "unknown", described as "Severe swelling at injection site."; LYMPHADENOPATHY (non-serious) with onset 28Nov2021, outcome "unknown", described as "Swelling has moved to under arm area. noticed underarm swelling on 28Nov2021". Therapeutic measures were not taken as a result of immunisation, vaccination site swelling, lymphadenopathy  Additional information: Events were non-serious as per the reporter. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, patient had not been tested for COVID-19. Device Date : 29Nov2021 . No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunisation, Loss of personal independence in daily activities, Nausea
Clinical narrative: this year was her booster shot; Could not get out of bed after taking it; Was very nauseous; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): AGN279331 (Allergan).  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation; atogepant (ATOGEPANT), since Nov2021 (Lot number: W05826, Expiration Date: Nov2023) for 2 weeks. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), administration date: Mar2021, when the patient was 58 years old, for COVID-19 immunization; Bnt162b2 (dose 2), administration date: Apr2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Oct2021, outcome "unknown", described as "this year was her booster shot"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Could not get out of bed after taking it"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Was very nauseous". The action taken for atogepant was unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Immunisation, Lymph node pain, SARS-CoV-2 test
Clinical narrative: pain in my lymph nodes under my left arm pit.; Slight numbness in face and arm on side where shot was given; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 16:00 (Lot number: FH8027) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 01Apr2021, when the patient was 33 years old, for COVID-19 immunization, reaction(s): "common side effects"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 11Mar2021, when the patient was 33 years old, for COVID-19 immunization, reaction(s): "common side effects". The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 16:00, outcome "unknown", described as "Booster"; LYMPH NODE PAIN (non-serious) with onset 27Nov2021 18:00, outcome "not recovered", described as "pain in my lymph nodes under my left arm pit."; HYPOAESTHESIA (non-serious) with onset 27Nov2021 18:00, outcome "not recovered", described as "Slight numbness in face and arm on side where shot was given". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymph node pain, hypoaesthesia.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient had no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.Device Date :29Nov2021.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Immunisation
Clinical narrative: She got the booster dose; Hair is falling out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Lot number: FG3527) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LOVASTATIN (ongoing); MEDROXYPROGESTERONE; AMITRIPTYLINE taken for fibromyalgia, depression; METFORMIN taken for diabetes mellitus (ongoing); LISINOPRIL taken for blood pressure measurement (ongoing); ESTRADIOL (ongoing); METOPROLOL SUCCINATE ER (ongoing); CYCLOBENZAPRINE taken for muscle spasms (ongoing); L-THYROXINE [LEVOTHYROXINE] taken for blood pressure measurement (ongoing); AMLODIPINE BESYLATE taken for blood pressure measurement (ongoing); SYNTHROID (ongoing). V accination history included: Bnt162b2 (Dose Number : 2, Lot- EL9266, Administered in left upper arm), administration date: 19Feb2021, when the patient was 72 years old, for COVID-19 immunization; Bnt162b2 (Dose Number : 1, Time the Vaccination Was Given: 1:10PM, Lot- EN6199 , Administered in upper left arm), administration date: 12Mar2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "Hair is falling out". The following information was reported: IMMUNISATION (non-serious) with onset 09Nov2021, outcome "unknown", described as "She got the booster dose"; ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "Hair is falling out". The event "hair is falling out" was evaluated at the physician office visit. Therapeutic measures were taken as a result of alopecia.  Follow-up (06Dec2021): Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Pain, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Pins and needles through whole body including eyes, lips, tongue, and throat within five minutes of vaccination; Swollen lymph nodes; throbbing pain throughout whole body; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Nov2021 09:45 (Batch/Lot number: unknown) at the age of 18 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Iron deficiency anaemia" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: VITRON C; IRON. Past drug history included: Pseudoephedrine, reaction(s): "Known allergies: pseudoephedrine"; Phenylephrine, reaction(s): "Known allergies: phenylephrine"; Cefalexin, reaction(s): "Known allergies: cefalexin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not with me , Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 13May2021, when the patient was 18 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Vaccine card not with me , Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 22Apr2021, when the patient was 18 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 09:45, outcome "unknown", described as "booster"; PARAESTHESIA (non-serious) with onset 28Nov2021 10:00, outcome "recovering", described as "Pins and needles through whole body including eyes, lips, tongue, and throat within five minutes of vaccination"; LYMPHADENOPATHY (non-serious) with onset 28Nov2021 10:00, outcome "recovering", described as "Swollen lymph nodes"; PAIN (non-serious) with onset 28Nov2021 10:00, outcome "recovering", described as "throbbing pain throughout whole body". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia, lymphadenopathy, pain.  Additional information: Patient didn't had any other vaccine in four weeks. Patient had Covid test post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.