chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dry mouth, Fatigue
Clinical narrative: Chills for 8 hrs; Extreme fatigue; extreme mouth dryness; loose bowels; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "RA" (unspecified if ongoing); "OA" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro", notes: Known allergies: Cipro. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 21Apr2022 at 16:00, outcome "recovered", described as "Chills for 8 hrs"; FATIGUE (non-serious) with onset 21Apr2022 at 16:00, outcome "not recovered", described as "Extreme fatigue"; DRY MOUTH (non-serious) with onset 21Apr2022 at 16:00, outcome "not recovered", described as "extreme mouth dryness"; DIARRHOEA (non-serious) with onset 21Apr2022 at 16:00, outcome "not recovered", described as "loose bowels". Therapeutic measures were not taken as a result of chills, fatigue, dry mouth, diarrhoea.  Additional information: Patient did not have COVID prior vaccination. Patient has not been COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Rash
Clinical narrative: chills; arm pain; rash all over body; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 at 10:00 as dose 3 (booster), single (Lot number: FK9894) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EW0185, Location of injection: Left arm, Route of Administration: Intramuscular), administration date: 29Jul2021, when the patient was 34-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: FD8448, Location of injection: Left arm, Route of Administration: Intramuscular), administration date: 19Aug2021, when the patient was 34-year-old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19Apr2022, outcome "recovered" (Apr2022), described as "arm pain"; CHILLS (non-serious) with onset 19Apr2022, outcome "recovered" (Apr2022); RASH (non-serious) with onset 19Apr2022, outcome "recovered" (Apr2022), described as "rash all over body". The events "chills", "arm pain" and "rash all over body" required emergency room visit. Therapeutic measures were taken as a result of chills, pain in extremity, rash.  Additional information: The Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received within 2 weeks of vaccination any other medications was not applicable. treatment received for the adverse event was Benadryl. Seriousness criteria did not leads to death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect . Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes under left arm/ Day five right arm lymph nodes starting to hurt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: moderna (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 21Mar2022, when the patient was 64-year-old, for Covid-19 Immunization; Moderna (Dose Number: 2, Batch/Lot No: Unknown. , Location of injection: Arm Left), when the patient was 64 years old, for Covid-19 Immunization; Moderna (Dose Number: 3, Batch/Lot No: 065F21A,, Location of injection: Arm Left), when the patient was 64 years old, for Covid-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 18Apr2022 at 23:00, outcome "not recovered", described as "Swollen lymph nodes under left arm/ Day five right arm lymph nodes starting to hurt". It was unknown if therapeutic measures were taken as a result of lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: her first Pfizer covid vaccine dose on 01Apr2022, then on 15Apr2022 she had symptoms of covid and was diagnosed of covid infection on 17Apr2022.; her first Pfizer covid vaccine dose on 01Apr2022, then on 15Apr2022 she had symptoms of covid and was diagnosed of covid infection on 17Apr2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Apr2022, outcome "unknown" and all described as "her first Pfizer covid vaccine dose on 01Apr2022, then on 15Apr2022 she had symptoms of covid and was diagnosed of covid infection on 17Apr2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Positive, notes: was diagnosed of covid infection on 17Apr2022.  Clinical information included as Reporter said patient had her first Pfizer covid vaccine dose on 01Apr2022, then on 15Apr2022 patient had symptoms of covid and was diagnosed of covid infection on 17Apr2022. Reporter had a schedule for her second dose on 26Apr2022 and patient wanted to know if we have guidelines for this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Ulcer, Weight, Weight decreased
Clinical narrative: she lost some weight; ulcer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) 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; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: WEIGHT DECREASED (non-serious), outcome "unknown", described as "she lost some weight"; ULCER (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that caller was a consumer on behalf of his 65-year-old wife. He stated that she lost some weight because of an ulcer and now she weighs around 80 pounds. He wanted to know if, based on her weight, she could receive the second booster dose of Pfizer-BioNTech Covid-19 Vaccine. System e-transmitting potential AE. They were not sure if this would count as an AE. A 65-years-old female patient wants to get vaccinated with the second booster shot of Pfizer-BioNTech Covid-19 Vaccine. Her husband (the caller) stated that she had recently had an ulcer and lost some weight. Now she weighs about 80 pounds and wanted to know if there was a weight requirement for getting the vaccine. No specific information was found for the wife's age group, but they explained the caller, based on the attached document, that vaccine dosing in studies are routinely based on age, not weight since vaccines are typically administered based on age, not weight. Referred to HCPs.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Paraesthesia
Clinical narrative: herpes like symptoms on her lips, similar to cold sores/severe fever blisters all across the bottom lip, one bellow her lips, some across the upper lip and one between her lips and nose; tingles; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.   A 70-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for Covid-19 immunization; Herpes simplex (she hasn't had an outbreak since10 years ago), for herpes zoster.  The following information was reported: PARAESTHESIA (non-serious) with onset 19Apr2022, outcome "unknown", described as "tingles"; ORAL HERPES (non-serious) with onset 20Apr2022, outcome "unknown", described as "herpes like symptoms on her lips, similar to cold sores/severe fever blisters all across the bottom lip, one bellow her lips, some across the upper lip and one between her lips and nose".   Additional information: Caller on the line had her second booster on 08Apr2022 and started having tingles on 19Apr2022. On 20Apr2022, she started having signs of herpes like symptoms on her lips, similar to cold sores. She wanted to know if this has been reported as a possible side effect for the vaccine. Caller described her symptoms like severe fever blisters all across the bottom lip, one bellow her lips, some across the upper lip and one between her lips and nose. When mentioning to caller about attached report regarding reports of herpes zoster, caller mentioned having herpes simplex but that she hasn't had an outbreak since 10 years ago.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error, Pyrexia
Clinical narrative: Fever; past the beyond-use-date (BUD) Confirmed 7 Patients involved; past the beyond-use-date (BUD) Confirmed 7 Patients involved; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 6-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2022 as dose 2, single (Lot number: FL8094, Expiration Date: 31May2022) at the age of 6 years for covid-19 immunisation. The patient's relevant medical history included: "Congenital heart disease" (unspecified if ongoing); "Patent ductus arteriosus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1), administration date: 25Mar2022, when the patient was 6-year-old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 15Apr2022, outcome "unknown" and all described as "past the beyond-use-date (BUD) Confirmed 7 Patients involved"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  Additional information: Reporter mentioned that they gave a few doses of the Pediatric Pfizer-BioNTech COVID-19 Vaccine past the beyond-use-date (BUD). Lot Number: FL8094, Expiry Date: 31May2022, Stored in Refrigerator: 36-46°F, BUD: 11Apr2022. Nurse stated, I have given actually, we have given seven doses, seven doses beyond the use date. When probed for Ethnicity and medical condition of patient: Nurse stated these are all healthy children, so there is no medical conditions on here, these are pediatric Pfizer vaccine so there is no medical. Nurse stated the patient does have some Congenital heart disease. Any prior vaccinations (within 4 weeks): Nurse stated: I will have to look at each one. Many of them were the boosters. I can look up each one individually. And it turns out actually the women I spoke to before, she didn't ask the date of birth or gender of these patients, just the other details. Other medical conditions, concomitant medications and Lab tests: Nurse stated nothing there and this does have a Patent Ductus Arteriosus. Treatment for the medical condition: Nurse stated Not really, just Tylenol for fever so nothing on meds.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200617791 same reporter/drug/event, different patient;US-PFIZER INC-202200617790 same reporter/drug/event, different patient;US-PFIZER INC-202200617789 same reporter/drug/event, different patient;US-PFIZER INC-202200617794 same reporter/drug/event, different patient;US-PFIZER INC-202200617792 same reporter/drug/event, different patient;US-PFIZER INC-202200617793 same reporter/drug/event, different patient
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site pain
Clinical narrative: Left arm pain injestion location after still  4 months and numbness in arm and hand.; Left arm pain injestion location after still  4 months and numbness in arm and hand.; Left arm pain injestion location after still  4 months and numbness in arm and hand.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2022 at 09:15 as dose 3 (booster), single (Lot number: FL3209) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Codine, reaction(s): "known allergies: Codine", notes: known allergies: Codine. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Left, Vaccine Administration Time: 07:30 AM), administration date: 25Mar2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left, Vaccine Administration Time: 07:30 AM), administration date: 04Mar2021, when the patient was 58-year-old, for COVID-19 immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious), HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 28Jan2022 at 10:00, outcome "not recovered" and all described as "Left arm pain injestion location after still  4 months and numbness in arm and hand.". Therapeutic measures were not taken as a result of vaccination site pain, hypoaesthesia, hypoaesthesia.  Additional Information: The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Any other medications the patient received within 2 weeks of vaccination was Multi-vitamin. Prior to vaccination, the patient was not  diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Neuralgia, Prostatic specific antigen
Clinical narrative: Reoccurrence of nerve pain in my left arm from an incident that occurred 6 months prior/nerve pain resurfaced; Reoccurrence of nerve pain in my left arm from an incident that occurred 6 months prior/nerve pain resurfaced; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 12Jun2021 as dose 2, single (Lot number: EW0180) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "nerve pain in my left arm", start date: Jan2021 (unspecified if ongoing), notes: Reoccurrence of nerve pain in my left arm from an incident that occurred 6 months prior. Concomitant medication(s) included: CLARITINE; ACIPHEX; SINGULAIR; LIPITOR; VITAMIN D2. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol", notes: Known allergies: Demerol. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW-0187, Location of injection: Arm Left, Manufacturer: Pfizer), administration date: 22May2021, when the patient was 56-year-old, for Covid-19 Immunization. The following information was reported: NEURALGIA (non-serious), DISEASE RECURRENCE (non-serious) all with onset 14Jun2021, outcome "recovered" and all described as "Reoccurrence of nerve pain in my left arm from an incident that occurred 6 months prior/nerve pain resurfaced". The event "reoccurrence of nerve pain in my left arm from an incident that occurred 6 months prior/nerve pain resurfaced" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of neuralgia, disease recurrence.  Additional information: Reoccurrence of nerve pain in his left arm from an incident that occurred 6 months prior. The prior issue was resolved via physical Therapy. He had no issues for several months. After the second dose of the COVID 19 vaccine the nerve pain resurfaced. He had the injection in his left arm. He had to go through PT to resolve the pain. No other vaccine in four weeks. No covid prior vaccination.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: HIV test, Therapeutic response unexpected
Clinical narrative: I am an HIV+ patient that has had an undetectable viral load for over 20 years - in bloodwork that was 4/14 they are showing my HIV status as detectable; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 at 13:00 as dose 1, single (Lot number: EN6198), in left arm, on 30Mar2021 at 13:00 as dose 2, single (Lot number: ER2613), in left arm and on 22Aug2021 at 13:00 as dose 3 (booster), single (Lot number: FD8448) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillan Allergy" (unspecified if ongoing), notes: known allergies: Penicillan Allergy. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR]; BIKTARVY; TRAZODONE; SERTRALINE. Past drug history included: Z-pack, reaction(s): "known allergies: Z-Pack", notes: known allergies: Z-Pack. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 14Apr2022 at 13:00, outcome "unknown", described as "I am an HIV+ patient that has had an undetectable viral load for over 20 years - in bloodwork that was 4/14 they are showing my HIV status as detectable". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional information: Did the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: A break-through covid inflection. Tested positive on 21Apr2022; A break-through covid inflection. Tested positive on 21Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 13Dec2021 as dose number unknown (booster), single (Lot number: FD7218, Expiration Date: Feb2022) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Apr2022, outcome "unknown" and all described as "A break-through covid inflection. Tested positive on 21Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Apr2022) Positive, notes: Tested positive on 21Apr2022.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Left Leg Hurting Badly; Has a little redness on the back of her leg and when she gets up it hurts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 79 years, in left arm for covid-19 immunisation, autoimmune disorder. The patient's relevant medical history included: "AFib" (ongoing); "High blood pressure" (unspecified if ongoing), notes: High blood pressure medication; "Heart medication" (unspecified if ongoing), notes: Heart medication. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Lot: EN6202), administration date: 27Feb2021, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2 (Dose: 02, Lot: EN8730), administration date: 27Mar2021, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2 (Dose: 03, Lot: FC3182), administration date: 20Aug2021, when the patient was 79-year-old, for Covid-19 immunization. The following information was reported: ERYTHEMA (non-serious) with onset 21Apr2022, outcome "not recovered", described as "Has a little redness on the back of her leg and when she gets up it hurts"; PAIN IN EXTREMITY (non-serious) with onset 21Apr2022, outcome "not recovered", described as "Left Leg Hurting Badly". Therapeutic measures were not taken as a result of pain in extremity, erythema.  Additional information: Caller states she had her Second Booster Shot on 09Apr2022, Caller states she is 79-Year-Old and all together she has gotten 4 shots and the last one was Booster 2. Caller states she is wondering has anyone reported any leg problems, Caller states she has never had any leg problems before. Caller states her Left leg is hurting badly. Caller states she was reading the paper she received about the Booster, and she was just wondering if it could be from that. Caller states she said if it is still hurting, she will go to the ER. Caller asks, has anyone reported any leg pain from the booster, Caller states she has a little redness on the back of her leg and when she gets up it hurts. Caller states she is wondering if she has a blood clot no treatment was taken, and she was just trying to walk around. No Additional Vaccines Administered on Same Date of the Pfizer Suspect, no prior vaccinations, no AE (s) following prior to vaccinations.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Diabetes mellitus, Hypertension
Clinical narrative: DM; HF; HTN; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US093754_OS (Company).  A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 01, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "DM"; CARDIAC FAILURE (medically significant), outcome "unknown", described as "HF"; HYPERTENSION (non-serious), outcome "unknown", described as "HTN". Clinical course was reported as, Patient believes he had HF/HTN/DM from 2nd COVID-19 Vaccine. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Swelling
Clinical narrative: He also has the same swelling.; Achiness and the tired feeling.; Achiness and the tired feeling.; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2022 as dose 3 (booster), single (Lot number: FM9992, Expiration Date: 22Jun2022) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing), notes: Glaucoma; "Cervicis' and had 'motely' removed/ neck surgery" (unspecified if ongoing), notes: 'cervicis' and had 'motely' removed,. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization; Bnt162b2 (Dose: 02), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), FATIGUE (non-serious) all with onset Apr2022, outcome "unknown" and all described as "Achiness and the tired feeling."; SWELLING (non-serious) with onset Apr2022, outcome "unknown", described as "He also has the same swelling."; NAUSEA (non-serious) with onset Apr2022, outcome "unknown". Therapeutic measures were not taken as a result of swelling, pain, fatigue, nausea.  Additional information: A neuro surgeon 'get to' neck surgery on him. The patient was on some pain medication.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200621154 Same product and event, different patient
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jun2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and in Aug2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Avocados" (unspecified if ongoing). There were no concomitant medications, reported as no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19 started on 22Apr2022 and stopped on unspecified date in Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menstruation after menopause; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2022 at 12:00 as dose 3 (booster), single (Lot number: EN4207) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN4207, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 20Mar2021, when the patient was 57-year-old, for Covid-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 30Apr2022 at 12:00, outcome "not recovered", described as "Menstruation after menopause". The event "menstruation after menopause" required physician office visit. Therapeutic measures were not taken as a result of menstruation irregular  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Low grade fever and headache noted around 24 hours after vaccination. Resolved within around 24 hours of onset.; Low grade fever and headache noted around 24 hours after vaccination. Resolved within around 24 hours of onset.; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 at 18:00 as dose 4 (booster), single (Lot number: FJ 4989) at the age of 58 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 03, Unknown manufacturer), for COVID-19 Immunization.  The following information was reported: HEADACHE (non-serious), PYREXIA (non-serious) all with onset 22Apr2022 at 23:45, outcome "recovered" (Apr2022) and all described as "Low grade fever and headache noted around 24 hours after vaccination. Resolved within around 24 hours of onset.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pyrexia.  Additional Information: It was reported that other vaccine did not take within four weeks. Low grade fever and headache noted around 24 hours after vaccination. Resolved within around 24 hours of onset. Therapeutic measures were taken as a result of events include Tylenol. Patient was not reported with covid prior vaccination and was not tested with covid post vaccination.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9809), in right arm, on 26Feb2021 as dose 2, single (Lot number: EM9809), in left arm and on 13Sep2021 as dose 3 (booster), single (Lot number: Ba30130) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Inflammation severe allergies" (unspecified if ongoing), notes: Type 2 Inflammation severe allergies and asthma; "Asthma" (unspecified if ongoing), notes: Type 2 Inflammation severe allergies and asthma. Concomitant medication(s) included: DUPIXENT, start date: 19Apr2022. Past drug history included: Vicodin, reaction(s): "Known allergies: Vicodin"; Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "Covid 19"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: The patient had received other medication in 2 weeks. Anti-viral details product COVID 19 Treatment, brand Pfizer, the treatment start date was 21Apr2022, lot number: Fx4466 sn998227446683, indication was treatment of COVID-19. On 22Apr2022 09:00 PM, patient had Loose stool, a Bitter Metallic taste in back of mouth, General feeling of weakness and off balance (but that could be attributed to COVID).  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site discomfort
Clinical narrative: Redness and it's hot to touch at the injection site. Still there 24 hours after receiving injection; Redness and it's hot to touch at the injection site. Still there 24 hours after receiving injection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 at 11:30 as dose 1, single (Batch/Lot number: unknown) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "migraines" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Known allergies:Seafood" (unspecified if ongoing); "Known allergies:trees" (unspecified if ongoing); "Known allergies:animals" (unspecified if ongoing); "Known allergies:insects" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; MICROZIDE [GLICLAZIDE]; BREO ELLIPTA; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; MICRONOR. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), ERYTHEMA (non-serious) all with onset 22Apr2022 at 15:00, outcome "not recovered" and all described as "Redness and it's hot to touch at the injection site. Still there 24 hours after receiving injection". Therapeutic measures were not taken as a result of vaccination site discomfort, erythema.  Additional information:The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnosed with COVID-19, Prior to vaccination. The patient had not been tested for COVID-19, Since the vaccination   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Immunisation, Musculoskeletal discomfort
Clinical narrative: Booster dose 4 adminstered; Booster dose 4 adminstered; Flat on his back; sleepy; tiredness; woozy; he has pain in his shoulder around the site of injection/ pain in arm and shoulder around site of injection; he has pain in his shoulder around the site of injection/ pain in arm and shoulder around site of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in arm 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, on the 2nd and both boosters he is flat on his back and sleepy with no pain), for COVID-19 immunization, reaction(s): "on the 2nd and both boosters he is flat on his back and sleepy with no pain", "on the 2nd and both boosters he is flat on his back and sleepy with no pain"; Bnt162b2 (DOSE: 3, on the 2nd and both boosters he is flat on his back and sleepy with no pain), for COVID-19 immunization, reaction(s): "on the 2nd and both boosters he is flat on his back and sleepy with no pain"; Bnt162b2 (DOSE:3, on the 2nd and both boosters he is flat on his back and sleepy with no pain), for COVID-19 immunization, reaction(s): "on the 2nd and both boosters he is flat on his back and sleepy with no pain". The following information was reported: IMMUNISATION (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "Booster dose 4 adminstered"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "not recovered", described as "Flat on his back"; SOMNOLENCE (non-serious), outcome "not recovered", described as "sleepy"; FATIGUE (non-serious), outcome "not recovered", described as "tiredness"; DIZZINESS (non-serious), outcome "not recovered", described as "woozy"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "he has pain in his shoulder around the site of injection/ pain in arm and shoulder around site of injection".  Additional information: The patient received the 2nd booster last night at 5 pm.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Somnolence
Clinical narrative: Booster dose 4 adminstered; Booster dose 4 adminstered; Flat on his back; sleepy; tiredness; woozy; he has pain in his shoulder around the site of injection/ pain in arm and shoulder around site of injection; he has pain in his shoulder around the site of injection/ pain in arm and shoulder around site of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in arm 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, on the 2nd and both boosters he is flat on his back and sleepy with no pain), for COVID-19 immunization, reaction(s): "on the 2nd and both boosters he is flat on his back and sleepy with no pain", "on the 2nd and both boosters he is flat on his back and sleepy with no pain"; Bnt162b2 (DOSE: 3, on the 2nd and both boosters he is flat on his back and sleepy with no pain), for COVID-19 immunization, reaction(s): "on the 2nd and both boosters he is flat on his back and sleepy with no pain"; Bnt162b2 (DOSE:3, on the 2nd and both boosters he is flat on his back and sleepy with no pain), for COVID-19 immunization, reaction(s): "on the 2nd and both boosters he is flat on his back and sleepy with no pain". The following information was reported: IMMUNISATION (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "Booster dose 4 adminstered"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "not recovered", described as "Flat on his back"; SOMNOLENCE (non-serious), outcome "not recovered", described as "sleepy"; FATIGUE (non-serious), outcome "not recovered", described as "tiredness"; DIZZINESS (non-serious), outcome "not recovered", described as "woozy"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "he has pain in his shoulder around the site of injection/ pain in arm and shoulder around site of injection".  Additional information: The patient received the 2nd booster last night at 5 pm.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Lip blister, Lip pain
Clinical narrative: Cold sores on lower lip.  Painful blisters and cracking; Cold sores on lower lip.  Painful blisters and cracking; Cold sores on lower lip. Painful blisters and cracking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 at 14:45 as dose 4 (booster), single (Lot number: 9943) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "High BP, Cholesteral" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN; LOVASTATIN. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Booster, unknown manufacturer), for Covid-19 Immunization. The following information was reported: CHAPPED LIPS (non-serious), LIP PAIN (non-serious) all with onset 20Apr2022 at 13:00, outcome "not recovered" and all described as "Cold sores on lower lip. Painful blisters and cracking"; LIP BLISTER (non-serious) with onset 20Apr2022 at 13:00, outcome "not recovered", described as "Cold sores on lower lip. Painful blisters and cracking". Therapeutic measures were not taken as a result of chapped lips, lip pain, lip blister.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine received in four weeks. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Olmesartin, lovastatin. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. COVID was not prior vaccination. COVID was not tested post vaccination. No Known allergies. Other medical history included High BP and Cholesterol.
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: her arm really bothered her/it hurt for a long time; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm really bothered her/it hurt for a long time".  Additional information: Caller states she had her Second Booster Dose on 5Apr2022 and that day it was a small dime size, red area with no pain, it just felt prickly. She states the following day it got larger and larger and it was red and hot and inflamed and that continued for about a week and then it didn't get any larger and the swelling started to go down but it was never sore, it was just achy, hot and inflamed. She states about a week later, the swelling started to subside and it was red until a couple of days ago. She states now it is just a dark bruised looking area and it is peeling and still achy and it is kind of hot and prickly feeling and really itchy. She states her symptoms are still present but much better She states she doesn't know what is going on and it was warm this morning but it is no longer warm now, but it is pricking and itching like crazy and peeling. She states she went to her Pharmacist today and he said he thought she should call Pfizer and notify of the reaction. She states the Pharmacist said she could put some steroid cream on it, but she hasn't. She states she had a Sore Arm after all of the first 3 Covid Vaccines. She had no fever, no ache, no headache. Call handler asked caller for dates and she responded with each of those vaccines.  She states she is just concerned if it is recommended she gets another booster, should she get it in the same arm if it is still bothering her this long after? She states it is not serious, she is just going to manage it as long as her arm doesn't start to slough off. Caller states she will go to the doctor if it gets worse.  There was no additional vaccines administered on same date of the Pfizer suspect. Adverse events did not require a visit to emergency room or physician office. No vaccinations were taken within 4 weeks prior to COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site warmth, Pain in extremity, Paraesthesia, Skin exfoliation
Clinical narrative: her arm really bothered her/it hurt for a long time; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm really bothered her/it hurt for a long time".  Additional information: Caller states she had her Second Booster Dose on 5Apr2022 and that day it was a small dime size, red area with no pain, it just felt prickly. She states the following day it got larger and larger and it was red and hot and inflamed and that continued for about a week and then it didn't get any larger and the swelling started to go down but it was never sore, it was just achy, hot and inflamed. She states about a week later, the swelling started to subside and it was red until a couple of days ago. She states now it is just a dark bruised looking area and it is peeling and still achy and it is kind of hot and prickly feeling and really itchy. She states her symptoms are still present but much better She states she doesn't know what is going on and it was warm this morning but it is no longer warm now, but it is pricking and itching like crazy and peeling. She states she went to her Pharmacist today and he said he thought she should call Pfizer and notify of the reaction. She states the Pharmacist said she could put some steroid cream on it, but she hasn't. She states she had a Sore Arm after all of the first 3 Covid Vaccines. She had no fever, no ache, no headache. Call handler asked caller for dates and she responded with each of those vaccines.  She states she is just concerned if it is recommended she gets another booster, should she get it in the same arm if it is still bothering her this long after? She states it is not serious, she is just going to manage it as long as her arm doesn't start to slough off. Caller states she will go to the doctor if it gets worse.  There was no additional vaccines administered on same date of the Pfizer suspect. Adverse events did not require a visit to emergency room or physician office. No vaccinations were taken within 4 weeks prior to COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.