chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 45 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: Covid-19 vaccine (Prev dose Product: COVID 19, Prev dose Dose number: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Prev dose Product: COVID 19, Prev dose Dose number: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 51 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 51 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: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 48 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 48 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: Covid 19 vaccine (Dose 1, Single, Manufacturer Unknown, Lot number- UNKNOWN), for COVID-19 Immunization; Covid 19 vaccine (Dose 2, Single, Manufacturer Unknown, Lot number- UNKNOWN), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nausea". Additional information: Device Date was reported as 14Jan2022.   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 47 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 47 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=1), for Covid-19 immunization; Bnt162b2 (dose_number=2), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Illness
Clinical narrative: temperature was higher yesterday; he was very sick also; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY), administration date 13Jan2022 (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 (First Dose), for Covid-19 Immunization; Bnt162b2 (Second Dose), for Covid-19 Immunization. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 13Jan2022, outcome "unknown", described as "temperature was higher yesterday"; ILLNESS (non-serious) with onset 13Jan2022, outcome "unknown", described as "he was very sick also". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller reported that she and her husband had the first two Pfizer Covid vaccines and they were fine. They got the Pfizer booster dose yesterday and they had severe reactions that were terrible and they still had some residual left today. She was shocked after receiving it because the first two were fine. She stated her husband's temperature was higher yesterday and he was very sick also.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). A 40-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 40 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: Covid-19 vaccine (Dose Number: 1, manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose Number: 2, manufacturer unknown), for Covid-19 Immunization.  The following information was reported: PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nausea".  Additional information: The report was assessed as non-serious. The events did not result into death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: This is a spontaneous report received from a noncontactable other healthcare professional. A 25-year-old female patient (unknown if pregnant) received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FD7218), at the age of 25, on Jan 12, 2022, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown/not available/not provided to  at the time of report), for COVID-19 immunization. The patient had pyrexia/fever and nausea, onset Jan 2022, with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 57 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 57 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: Covid19 vaccine (Prev dose product: COVID-19, Prev dose lot unknown: True, prev dose brand name unknown: COVID19 Vaccine, Prev dose dose number: 1), for COVID-19 Immunization; Covid19 vaccine (Prev dose product: COVID-19, Prev dose lot unknown: True, prev dose brand name unknown: COVID19 Vaccine, Prev dose dose number: 2), for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Decreased appetite, Nausea, Platelet count
Clinical narrative: fever; chills; loss of taste; lack of appetite; weight loss; occasional nausea at times; low platelet count; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a sponsored program (060820).  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTUERER UNKNOWN (where X=1, 2, or number unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; AGEUSIA (non-serious), outcome "unknown", described as "loss of taste"; DECREASED APPETITE (non-serious), outcome "recovering", described as "lack of appetite"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "weight loss"; NAUSEA (non-serious), outcome "unknown", described as "occasional nausea at times"; PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "low platelet count". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reports she missed therapy for 3 week. Two weeks (21Dec2021 to 04Jan2022) therapy was on hold due to low platelet count. Third week (05Jan2022 to 10Jan2022) patient had insurance issues and was unable to start therapy. During this 3 weeks of no therapy patient took covid booster (unknown date) and reports fever, chills, loss of taste, lack of appetite and weight loss. Patient restarted therapy on 11Jan2022 and also reports md asked her to take 75 mg every other day. unknown if md still wants her to have a week off. Advised to ask md on 18Jan2022 visit. Patient reports since last few days her appetite has improved a little but, she has occasional nausea at times. prescription: 75 mg daily for 21 days on and 7 days off. md aware.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased, Pyrexia, Weight, Weight decreased
Clinical narrative: fever; chills; loss of taste; lack of appetite; weight loss; occasional nausea at times; low platelet count; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a sponsored program (060820).  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTUERER UNKNOWN (where X=1, 2, or number unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; AGEUSIA (non-serious), outcome "unknown", described as "loss of taste"; DECREASED APPETITE (non-serious), outcome "recovering", described as "lack of appetite"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "weight loss"; NAUSEA (non-serious), outcome "unknown", described as "occasional nausea at times"; PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "low platelet count". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reports she missed therapy for 3 week. Two weeks (21Dec2021 to 04Jan2022) therapy was on hold due to low platelet count. Third week (05Jan2022 to 10Jan2022) patient had insurance issues and was unable to start therapy. During this 3 weeks of no therapy patient took covid booster (unknown date) and reports fever, chills, loss of taste, lack of appetite and weight loss. Patient restarted therapy on 11Jan2022 and also reports md asked her to take 75 mg every other day. unknown if md still wants her to have a week off. Advised to ask md on 18Jan2022 visit. Patient reports since last few days her appetite has improved a little but, she has occasional nausea at times. prescription: 75 mg daily for 21 days on and 7 days off. md aware.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Fluid retention, Immunisation, Lymphadenopathy, Swelling
Clinical narrative: Swollen lymph node underarm area; Fluid build up under skin; general swelling on whole left side of torso; Discomfort; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 13 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 (Lot number: ew0161) at the age of 13 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Bee" (unspecified if ongoing); "wasp" (unspecified if ongoing); "vespid allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ewo178, Location of injection: Arm Left), administration date: 24Jun2021, when the patient was 12 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: 3313OBA, Location of injection: Arm Left), administration date: 14May2021, when the patient was 12 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Jan2022, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset 11Jan2022, outcome "recovered" (2022), described as "Swollen lymph node underarm area"; FLUID RETENTION (non-serious) with onset 11Jan2022, outcome "recovered" (2022), described as "Fluid build up under skin"; SWELLING (non-serious) with onset 11Jan2022, outcome "recovered" (2022), described as "general swelling on whole left side of torso"; DISCOMFORT (non-serious) with onset 11Jan2022, outcome "recovered" (2022), described as "Discomfort". Therapeutic measures were not taken as a result of lymphadenopathy, fluid retention, swelling, discomfort.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis contact, Discomfort, Immunisation, Rash
Clinical narrative: Rash (red spots) on stomach after 24 hours.; Over next 48 hours the rash spread to front and back of torso; mild discomfort; dose received 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2022 (Lot number: FL3198) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171), administration date: 25Apr2021, when the patient was 35 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737), administration date: 03Apr2021, when the patient was 35 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Jan2022, outcome "unknown", described as "dose received 3"; DERMATITIS CONTACT (non-serious) with onset 12Jan2022, outcome "not recovered", described as "Rash (red spots) on stomach after 24 hours."; RASH (non-serious) with onset 12Jan2022, outcome "not recovered", described as "Over next 48 hours the rash spread to front and back of torso"; DISCOMFORT (non-serious) with onset 12Jan2022, outcome "not recovered", described as "mild discomfort".  Additional information: The patient prior to vaccination, was not diagnosed with COVID-19 and since the vaccination, was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A 54 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 54 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: Covid-19 vaccine (dose number=2, Prev dose product=COVID 19, Prev dose brand unknown= true, Prev dose brand name unknown = Covid 19 vaccine, Prev dose lot unknown= true, Prev dose lot unknown reason = not available/provided to reporter at the time of report completion.), for COVID-19 immunization; Covid-19 vaccine (dose number= 1, Prev dose product=COVID 19, Prev dose brand unknown= True, Prev dose lot number unknown, prev dose brand name unknown= Covid 19 vaccine, Prev dose lot unknown= true, Prev dose lot unknown reason = not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Tremor
Clinical narrative: headache; fever; shakes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. Relevant medical history included: "allergy to nuts" (unspecified if ongoing), notes: Just as a note, (name-withheld) has an allergy to nuts, including peanut and coconuts.; "including peanut" (unspecified if ongoing), notes: Just as a note, (name-withheld) has an allergy to nuts, including peanut and coconuts.; "coconuts" (unspecified if ongoing), notes: Just as a note, (name-withheld) has an allergy to nuts, including peanut and coconuts. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; PYREXIA (non-serious), outcome "unknown", described as "fever"; TREMOR (non-serious), outcome "unknown", described as "shakes".  Additional Information: It was unknown whether patient had any other medical history or known allergies. It was unknown whether patient tested for COVID-19 prior and post the vaccination. It was unknown if the patient had received any other vaccines within 4 weeks prior to the COVID vaccine and also unknown if patient had received any other medications in two weeks. It was unknown whether patient tested for COVID-19 prior and post the vaccination. Patient believe was getting their booster shot today. There was a discussion regarding vaccine side effects, and they said that they agreed that they had a similar experience to (Name withheld) reported in (not sure for which dose(s)). Specifically, the headache, fever, shakes (or scenario described for the 1st dose or 3rd dose, whichever was the one actually described. Not sure which vaccine has gotten or timeframe. Believe today was getting booster, so believe has had the first two shots.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Pain, Pyrexia
Clinical narrative: Chills; fever; body ache; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Jan2022 16:00 (Lot number: 33036BD) at the age of 15 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0217, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 05Jun2021, when the patient was 15 years old, for Covid-19 Immunization, reaction(s): "Body aches", "Fever", "Dizziness", "pain(arm)", "soreness at site of injection"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0182, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 13Jan2022 16:00, outcome "unknown", described as "booster dose"; CHILLS (non-serious) with onset 14Jan2022 02:00, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 14Jan2022 02:00, outcome "recovering", described as "fever"; PAIN (non-serious) with onset 14Jan2022 02:00, outcome "recovering", described as "body ache". Therapeutic measures were taken as a result of chills, pyrexia, pain.  Follow-Up (21Jan2022): Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Poor quality product administered
Clinical narrative: The patient did not receive the Pfizer Covid Vaccine as his first doses. The patient received the Janssen Vaccine on 03May2021; The patient did not receive the Pfizer Covid Vaccine as his first doses. The patient received the Janssen Vaccine on 03May2021; booster; The vaccine should have been discarded on 15Jan2022.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 67 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Jan2022 (Lot number: FE3594, Expiration Date: Feb2022) at the age of 67 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen vaccine (First Dose, Lot Number: 204A21A), administration date: 03May2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "The patient did not receive the Pfizer Covid Vaccine as his first doses. The patient received the Janssen Vaccine on 03May2021"; IMMUNISATION (non-serious) with onset 17Jan2022, outcome "unknown", described as "booster"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 17Jan2022, outcome "unknown", described as "The vaccine should have been discarded on 15Jan2022.".  Additional information: Clinical course: It was reported that patient who was administered a booster dose of the Pfizer-BioNTech COVID 19-vaccine (purple cap) on 17Jan2022. The vaccine should have been discarded on 14Jan2022. They pulled up their vaccines for today and administered one of them. They then realized it was supposed to have been discarded after the 14Jan2022. States they need to know what to do. Reporter asks if any additional stability information. The patient did not receive the Pfizer Covid Vaccine as his first doses. The patient received the Janssen Vaccine on 03May2021.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Purpura
Clinical narrative: experiencing purple small dot around her neck; she received booster dose for Pfizer vaccine yesterday; 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 57-year-old female patient received bnt162b2 (BNT162B2), administration date 14Jan2022 (Lot number: FL3198) at the age of 56 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN (E.C.); LISINOPRIL taken for hypertension. Vaccination history included: Covid-19 vaccine (manufacturer unknown, dose number unknown), for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 14Jan2022, outcome "unknown", described as "she received booster dose for Pfizer vaccine yesterday"; PURPURA (non-serious), outcome "unknown", described as "experiencing purple small dot around her neck".  Additional information: It was reported that, the patient used Aspirin everyday, but she have high blood pressure about 1 week she went to doctor, 1 week the doctor gave her medication for blood pressure, Lisinopril HS. About 1 week, she was in ER. Her blood pressure was high. The doctor gave her 'hydrocholocalci' and he told her to follow up with her doctor. She went to doctor office last week, he gave her this medication about 1 week. She took them (medical condition and other medicines; further not clarified hence not captured in tab hence tab left unchecked). Site of administration: Consumer stated, Left arm. Further help: It was reported that, the patient do not do anything, only she followed this. She not gonna take aspirin tonight and not going to take it.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia areata, Anti-thyroid antibody, COVID-19, Drug ineffective
Clinical narrative: drug ineffective; SARS-CoV-2 infection; Alopecia areata; This is a literature report.   A 29 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Aug2021, outcome "unknown", described as "drug ineffective"; COVID-19 (medically significant) with onset Aug2021, outcome "unknown", described as "SARS-CoV-2 infection"; ALOPECIA AREATA (non-serious) with onset Apr2021, outcome "unknown", described as "Alopecia areata". The patient underwent the following laboratory tests and procedures: anti-thyroid antibody: (2021) elevated; (2021) elevated. Therapeutic measures were taken as a result of alopecia areata with ILTAC.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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/COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202200081166 same article, drug, different patient, event;US-PFIZER INC-202200081167 same article, drug, different patient, event;US-PFIZER INC-202200081168 same article, drug, different patient, event;US-PFIZER INC-202200081169 same article, drug, different patient, event;US-PFIZER INC-202200081170 same article, drug, different patient, event;US-PFIZER INC-202200081171 same article, different patient, drug, event;US-PFIZER INC-202200081172 same article, different patient, drug, event;US-PFIZER INC-202200081173 same article, different patient, drug, event;US-PFIZER INC-202200081174 same article, different patient, drug, event;US-PFIZER INC-202200081175 same article, different patient, drug, event;US-PFIZER INC-202200081176 same article, different patient, drug, event;US-PFIZER INC-202200081177 same article, different patient, drug, event
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site mass
Clinical narrative: She has a lump on the injection site; I have a lump in my arm where I receive the injection; I didn't feel well; 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 female patient received bnt162b2 (BNT162B2), administration date 16Jul2021 (Batch/Lot number: unknown) as dose 2, single and administration date 25Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cough", start date: 2020 (unspecified if ongoing), notes: I have 'annual' issue with the bad cough last, not last, in 2020 (Intent: history). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION SITE MASS (non-serious), outcome "unknown", described as "She has a lump on the injection site; I have a lump in my arm where I receive the injection"; MALAISE (non-serious), outcome "unknown", described as "I didn't feel well". Therapeutic measures were taken as a result of vaccination site mass, malaise.  Additional information: Dates for She has a lump on the injection site: Patient had a lump in her arm where she received the injection: (From: Unspecified To: Unspecified). Dates for she has cancelled her booster shot (COVID 19 Vaccine) schedule for tomorrow because of cough: She already cancelled the booster dose because she had been coughing: (From: Unspecified To: Unspecified) Dates for I didn't feel well: (From: Unspecified To: Unspecified) Patient stated that 'she had to cancel her appointment for tomorrow because she had her 2 vaccines, one was on 25Jun of past year and the other one was 16Jul past year and tomorrow would be her booster but she was concerned that she didn't knew what are the symptoms are for the virus, She had 'annual' issue with the bad cough last, not last, in 2020 (Intent: history), she spent in ICU because she drank too much water trying to stop the cough and had (voice not clear) anyway. So what right now, the reason she cancelled it was she had lump in her arm where she received the injection, they gave them both in the same place, anyway so she did not feel well and she needed to use nebulizers (Intent: Treatment). So she cancelled the appointment and she said when you are doing better, but she gave me the number to call and report this and that's what I am trying to do.'  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye discharge, Eye infection, Eye pruritus
Clinical narrative: Pick eye/Pink eye; her eyes itched; The green goo was in her eye; eye infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 55-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 28Nov2021 15:00 (Lot number: EH8027) at the age of 55 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Hypothyroidism" (ongoing), notes: Diagnosed 2-3 years ago; "Covid" (unspecified if ongoing), notes: She has had covid twice.; "Fuchs eye disease" (unspecified if ongoing), notes: her mother and grandmother. Family history included: "bad eyes" (unspecified if ongoing), notes: mother; "corneal transplants" (unspecified if ongoing), notes: mother. Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing). The following information was reported: CONJUNCTIVITIS (non-serious) with onset 30Nov2021, outcome "recovering", described as "Pick eye/Pink eye"; EYE PRURITUS (non-serious) with onset 30Nov2021, outcome "recovering", described as "her eyes itched"; EYE DISCHARGE (non-serious) with onset 30Nov2021, outcome "recovering", described as "The green goo was in her eye"; EYE INFECTION (non-serious) with onset 30Nov2021, outcome "recovering", described as "eye infection". The events "pick eye/pink eye", "her eyes itched", "the green goo was in her eye" and "eye infection" were evaluated at the physician office visit. Therapeutic measures were taken as a result of conjunctivitis, eye pruritus, eye discharge, eye infection.  Additional information: The patient did not receive any other vaccines on same date with the Pfizer vaccine. No Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. The patient had first dose on 28Nov2021, and she developed the pick eye/Pink eye 2 days later on 30Nov2021. The green goo was in her eye and her eyes itched. She was prescribed with drops for her pink eye. She took them for a week and her eyes got worse. The patient called the eye doctor, and her eyes were really bad. She was given 2 different eye drops by the eye doctor and her symptoms got better within a week. The eye doctor said that she had an eye infection and said that it was worse than pick eye. She does not know if it is bacterial or viral. The patient stated that it was definitely from the vaccine. The patient was treated with Ofloxacin 1 drop every 2 hours and Prednisolone acetate 1 drops in each eye every 4 hours. The patient did not undergo any lab tests.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: DOSE 1: 23Nov2021; DOSE 2: 04Jan2022; Blisters in mouth and throat; feeling unlike myself consistently since vaccination; rash; Feeling disoriented; Inability to sleep; stomach pain; Excess bruising at injection site; vomiting; extreme fatigue; headaches; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2022 14:00 (Lot number: FF2593) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Remission from cervical cancer" (unspecified if ongoing), notes: Remission from cervical cancer; "known allergies: Cinnamon" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single; 02:30 PM; Batch/Lot No: FH8028; Location of injection: Arm Left) administration date: 23Nov2021, when the patient was 36 years old, for COVID-19 Immunization.  The following information was reported: (non-serious), outcome "unknown", described as "DOSE 1: 23Nov2021; DOSE 2: 04Jan2022"; BLISTER (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "Blisters in mouth and throat"; FEELING ABNORMAL (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "feeling unlike myself consistently since vaccination"; RASH (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "rash"; DISORIENTATION (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "Feeling disoriented"; INSOMNIA (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "Inability to sleep"; ABDOMINAL PAIN UPPER (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "stomach pain"; VACCINATION SITE BRUISING (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "Excess bruising at injection site"; VOMITING (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "vomiting"; FATIGUE (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "extreme fatigue"; HEADACHE (non-serious) with onset 04Jan2022 22:00, outcome "not recovered", described as "headaches". Therapeutic measures were taken as a result of blister, feeling abnormal, rash, disorientation, insomnia, abdominal pain upper, vaccination site bruising, vomiting, fatigue, headache.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, Prior to vaccination. patient been tested for COVID-19 since the vaccination.  Serious: No Seriousness criteria-Results in death: No Seriousness criteria-Life threatening: No Seriousness criteria-Caused/prolonged hospitalization: No Seriousness criteria-Disabling/Incapacitating: No Seriousness criteria-Congenital anomaly/birth defect: No  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Immunisation, Pain, Pruritus
Clinical narrative: dose number: 3; achy; fatigued; red itchy spots on the top of my right thigh and left side of my chest/ many more red itchy spots on my lower back and  bottom; red itchy spots on the top of my right thigh and left side of my chest/ many more red itchy spots on my lower back and  bottom; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Dec2021 12:00 (Lot number: FD7218) at the age of 56 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "tree nuts" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; TOPROL XL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 23Mar2021, when the patient was 55 years old, for COVID-19 immunization, reaction(s): "low grade fever", "body aches", "Chills", "Fatigue", "tiny red itchy spots on my abdomen", "tiny red itchy spots on my abdomen"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Right), administration date: 02Mar2021, when the patient was 55 years old, for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 12:00, outcome "unknown", described as "dose number: 3"; PAIN (non-serious) with onset Dec2021, outcome "not recovered", described as "achy"; FATIGUE (non-serious) with onset Dec2021, outcome "not recovered", described as "fatigued"; ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "red itchy spots on the top of my right thigh and left side of my chest/ many more red itchy spots on my lower back and bottom". Therapeutic measures were taken as a result of pain, fatigue, erythema, pruritus.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 1 week later developed a few tiny red itchy spots on my abdomen. These spots continued to develop and cause discomfort for 4 months all over my body. My primary care physician prescribed steroid creams. Did not help much, but spots kept appearing on my body. Finally saw my dermatologist who prescribed a stronger cream. Not sure if the cream did the trick or not but the spots finally turned brown and stopped itching. Third shot booster felt achy, fatigued and that same evening developed some red itchy spots on the top of my right thigh and left side of my chest. These spots are slightly bigger than last time. A month later 15Jan developed many more red itchy spots on my lower back and bottom. They are currently active and again everyday new ones appear, causing discomfort and concern.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Fall, Immunisation, Interchange of vaccine products
Clinical narrative: off label use; Had J&J and your booster; Had J&J and your booster; Fainted; Dizzy; Falling; Bruising my wrist and hand; 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 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant), outcome "unknown" and all described as "Had J&J and your booster"; SYNCOPE (medically significant), outcome "unknown", described as "Fainted"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; FALL (non-serious), outcome "unknown", described as "Falling"; CONTUSION (non-serious), CONTUSION (non-serious), outcome "unknown" and all described as "Bruising my wrist and hand".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Syncope
Clinical narrative: off label use; Had J&J and your booster; Had J&J and your booster; Fainted; Dizzy; Falling; Bruising my wrist and hand; 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 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant), outcome "unknown" and all described as "Had J&J and your booster"; SYNCOPE (medically significant), outcome "unknown", described as "Fainted"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; FALL (non-serious), outcome "unknown", described as "Falling"; CONTUSION (non-serious), CONTUSION (non-serious), outcome "unknown" and all described as "Bruising my wrist and hand".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: Very large and hot lump at injection site; It was hot and painful and red; It was hot and painful and red; It was hot and painful and red; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 23:30 (Lot number: FL3199) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "kidney stones" (unspecified if ongoing); "hypothyroidsim" (unspecified if ongoing); "plantars warts" (unspecified if ongoing); "known allergies: almost all antibiotics" (unspecified if ongoing), notes: known allergies: almost all antibiotics. Concomitant medication(s) included: ELTROXIN; IBUPROFAN; SERTRALINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Left), administration date: 11May2021, when the patient was 47 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0164, Location of injection: Arm Left), administration date: 20Apr2021, when the patient was 47 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE MASS (non-serious) with onset 24Dec2021 12:00, outcome "recovered with sequelae" (Jan2022), described as "Very large and hot lump at injection site"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 24Dec2021 12:00, outcome "recovered" (Dec2021) and all described as "It was hot and painful and red". Therapeutic measures were taken as a result of vaccination site mass, vaccination site warmth, vaccination site pain, vaccination site erythema.  Additional information: No other vaccine was taken in four weeks. The lump ran crosswise across her upper left arm, centered on injection site. It was approx 4x2 inches. It was hot and painful and red for about 3 days. Now over three weeks later, she still had a mark on her my arm in the same size and shape as that lump, although it was not swollen, painful, or hot.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Neuralgia, Pudendal canal syndrome, SARS-CoV-2 test
Clinical narrative: burning pelvic Nerve pain; burning pelvic Nerve pain; diagnosed with pudendal neuralgia; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: Er8732) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MIRENA. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose 1,, Product: COVID 19,, Brand: Pfizer,, Dose brand unknown: False,, Dose lot number: En6198,, Dose lot unknown: False,, Dose vaccine location: Left arm), administration date: 05Mar2021, when the patient was 33 years old, for Covid-19 immunization. The following information was reported: BURNING SENSATION (disability), NEURALGIA (disability) all with onset 27Mar2021, outcome "not recovered" and all described as "burning pelvic Nerve pain"; PUDENDAL CANAL SYNDROME (disability) with onset 27Mar2021, outcome "not recovered", described as "diagnosed with pudendal neuralgia". The events "burning pelvic nerve pain", "burning pelvic nerve pain" and "diagnosed with pudendal neuralgia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of burning sensation, neuralgia, pudendal canal syndrome.  Clinical course was reported as: The patient had not received other vaccine in 4 weeks. Within 24 hours of patient vaccinated dose 2 and started having burning pelvic Nerve pain. It has gone on since then and not gone away. Patient have been diagnosed with pudendal neuralgia and it has not subsided since it began. Patient had received AE treatment with antibiotics, steroids, pain meds, nerve blocks. The patient had received covid prior vaccination and covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relation, the association between the events of burning sensation, neuralgia and pudendal canal syndrome and the suspect product of BNT162B2 cannot be completely ruled out. 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.