chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Arthralgia, Chills, Headache
Clinical narrative: Chills; another arm headache; another arm headache; neck ache; body aches; upset stomach; teeth aching; leg aching; foot aching; stomach hurting; wrist pain; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Nov2021 09:45 (Lot number: F63527) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose:1, Left upper arm, Intramuscular, time:09:00, Batch/Lot Number: EN6204), administration date: 06Mar2021, when the patient was 67 years old, for Covid-19 Immunization; Bnt162b2 (dose:2, Left upper arm, Intramuscular, time:09:15, Batch/Lot Number: ER8737), administration date: 06Apr2021, when the patient was 67 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 11Nov2021, outcome "unknown" and all described as "another arm headache"; NECK PAIN (non-serious) with onset 11Nov2021, outcome "unknown", described as "neck ache"; PAIN (non-serious) with onset 11Nov2021, outcome "unknown", described as "body aches"; ABDOMINAL DISCOMFORT (non-serious) with onset 11Nov2021, outcome "unknown", described as "upset stomach"; TOOTHACHE (non-serious) with onset 11Nov2021, outcome "unknown", described as "teeth aching"; PAIN IN EXTREMITY (non-serious) with onset 11Nov2021, outcome "unknown", described as "leg aching"; PAIN IN EXTREMITY (non-serious) with onset 11Nov2021, outcome "unknown", described as "foot aching"; ABDOMINAL PAIN UPPER (non-serious) with onset 11Nov2021, outcome "unknown", described as "stomach hurting"; ARTHRALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "wrist pain"; CHILLS (non-serious) with onset 12Nov2021, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "body ache". Additional information: User reported the Adverse Event as well another arm headache, neck ache, body aches, wrist pain, upset stomach, teeth aching, leg aching, foot aching, stomach hurting, Chills, headache and Body Ache. Relevant Tests were None.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Toothache
Clinical narrative: Chills; another arm headache; another arm headache; neck ache; body aches; upset stomach; teeth aching; leg aching; foot aching; stomach hurting; wrist pain; body ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Nov2021 09:45 (Lot number: F63527) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose:1, Left upper arm, Intramuscular, time:09:00, Batch/Lot Number: EN6204), administration date: 06Mar2021, when the patient was 67 years old, for Covid-19 Immunization; Bnt162b2 (dose:2, Left upper arm, Intramuscular, time:09:15, Batch/Lot Number: ER8737), administration date: 06Apr2021, when the patient was 67 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 11Nov2021, outcome "unknown" and all described as "another arm headache"; NECK PAIN (non-serious) with onset 11Nov2021, outcome "unknown", described as "neck ache"; PAIN (non-serious) with onset 11Nov2021, outcome "unknown", described as "body aches"; ABDOMINAL DISCOMFORT (non-serious) with onset 11Nov2021, outcome "unknown", described as "upset stomach"; TOOTHACHE (non-serious) with onset 11Nov2021, outcome "unknown", described as "teeth aching"; PAIN IN EXTREMITY (non-serious) with onset 11Nov2021, outcome "unknown", described as "leg aching"; PAIN IN EXTREMITY (non-serious) with onset 11Nov2021, outcome "unknown", described as "foot aching"; ABDOMINAL PAIN UPPER (non-serious) with onset 11Nov2021, outcome "unknown", described as "stomach hurting"; ARTHRALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "wrist pain"; CHILLS (non-serious) with onset 12Nov2021, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "body ache". Additional information: User reported the Adverse Event as well another arm headache, neck ache, body aches, wrist pain, upset stomach, teeth aching, leg aching, foot aching, stomach hurting, Chills, headache and Body Ache. Relevant Tests were None.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Swollen right ankle and pain - pain has mitigated, but still present 3 days post-injection; Swollen right ankle and pain - pain has mitigated, but still present 3 days post-injection/R ankle pain; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient reporting for himself.  A 44 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Nov2021 (Lot number: EW0217) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Anatomical site of injection: L shoulder, Route of administration: Intramuscular, Time: 09:00), administration date: 27Jan2021, when the patient was 43 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN5318, Anatomical site of injection: L shoulder, Route of administration: Intramuscular, Time: 09:00), administration date: 16Feb2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 12Nov2021 16:00, outcome "recovered" (2021), described as "Swollen right ankle and pain - pain has mitigated, but still present 3 days post-injection/R ankle pain"; JOINT SWELLING (non-serious) with onset 13Nov2021, outcome "recovering", described as "Swollen right ankle and pain - pain has mitigated, but still present 3 days post-injection". Therapeutic measures were not taken as a result of arthralgia, joint swelling.  Additional information: known allergies were None. other medical history was None. Patient's medical history was None. Family medical history relevant to AE(s) was None. Facility type vaccine was Workplace clinic. Prior vaccinations were None. Other vaccine in four weeks was None. Other medications in two weeks were None. Concomitant drugs were None. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. Relevant tests were None. Specific relevant test for Thromboembolic events with Thrombocytopenia was None. Adverse events resulted in None of the above. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Seriousness criteria for event, R ankle pain was reported as Not serious.  Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash, Urticaria, Vaccination site erythema, Vaccination site warmth
Clinical narrative: At 430 pm, broke out in hives and itchy rash all over body, primarily stomach chest back buttocks upper thighs and arms.; At 430 pm, broke out in hives and itchy rash all over body, primarily stomach chest back buttocks upper thighs and arms.; Redness on both upper arms.; Skin warm at injection site and red; Skin warm at injection site and red; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 09:30 (Lot number: FK5618) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Slight peanut allergy" (unspecified if ongoing); "Flu" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for influenza. The following information was reported: URTICARIA (non-serious), RASH (non-serious) all with onset 12Nov2021 16:30, outcome "unknown" and all described as "At 430 pm, broke out in hives and itchy rash all over body, primarily stomach chest back buttocks upper thighs and arms."; ERYTHEMA (non-serious) with onset 12Nov2021 16:30, outcome "unknown", described as "Redness on both upper arms."; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 12Nov2021 16:30, outcome "unknown" and all described as "Skin warm at injection site and red". Therapeutic measures were taken as a result of urticaria, rash, erythema, vaccination site warmth, vaccination site erythema.  Additional information included: The patient received other vaccine in 4weeks details [{other vaccine 4weeks product=Flu shot}]. Adverse event: on 12Nov2021, at 4:30 pm, broke out in hives and itchy rash all over body, primarily stomach chest back buttocks upper thighs and arms. Redness on both upper arms. Skin warm at injection site and red. The patient received the treatment Benadryl for adverse events. The patient was not diagnosed with covid1-19 prior to vaccination. The patient was not tested for covid-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Only some pain in the shoulder for 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Oct2021 18:00 (Lot number: 301558A) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. The following information was reported: ARTHRALGIA (non-serious) with onset 25Oct2021 20:00, outcome "recovered" (2021), described as "Only some pain in the shoulder for 2 days". Therapeutic measures were taken as a result of arthralgia. 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. Facility type Vaccine was Pharmacy or perfume shop. Other medications in two weeks included Humira 15 days before. The patient did not have Known allergies. The patient received Tylenol as treatment for the event.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Pyrexia, Vaccination site swelling
Clinical narrative: moderate dizziness; low-grade fever; arm aches; mild swelling at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: 30145BA) as dose 1, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Cholecystectomy" (unspecified if ongoing). Concomitant medication(s) included: BENTYL; FERROUS SULPHATE [FERROUS SULFATE]. The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "moderate dizziness"; PYREXIA (non-serious), outcome "recovered", described as "low-grade fever"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm aches"; VACCINATION SITE SWELLING (non-serious), outcome "recovered", described as "mild swelling at the injection site". Therapeutic measures were not taken as a result of dizziness, pyrexia, pain in extremity, vaccination site swelling.  Additional Information: If other vaccine in four weeks was reported as no. If covid prior vaccination reported as no. If covid tested post vaccination was reported as no. Known allergies was reported as no. patient first dose Administration time 10. on an unspecified date. Adverse event: After receiving my first shot I experienced moderate dizziness, low grade fever, arm aches and mild swelling at the injection site.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: Headache; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 6 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 14Nov2021 17:00, outcome "recovering", described as "Headache"; PYREXIA (non-serious) with onset 14Nov2021 17:00, outcome "recovering", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pyrexia.  Additional Information: The patient was a child. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Antibiotics medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient has been tested for COVID-19. The patient underwent nasal swab test on 15Nov2021, results were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vomiting
Clinical narrative: Fever up to 102; vomiting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection" (unspecified if ongoing), notes: Structured information (Patient episode name): PANDAS. Concomitant medication(s) included: FLU taken for immunisation, administration date 23Oct2021; NALTREXONE. The following information was reported: PYREXIA (non-serious) with onset 15Nov2021 00:30, outcome "recovering", described as "Fever up to 102"; VOMITING (non-serious) with onset 15Nov2021 00:30, outcome "recovering", described as "vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vomiting.  Additional Information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. List of any other medications the patient received within 2 weeks of vaccination: Low dose naltrexone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. If other vaccine in four weeks= Yes. Other vaccine 4weeks details other vaccine 4weeks product=Flu (unknown) other vaccine 4weeks vaccine= date =23Oct2021. Other medications in two weeks= Low dose naltrexone. If covid prior vaccination= No. If covid tested post vaccination= No. known allergies= No. Other medical history= PANDAS. 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. Relevant medical history and concurrent conditions. Structured information (Patient episode name): PANDAS. Reaction/event as reported by primary source Fever up to 102 and vomiting. Date of start of reaction/event: 15Nov2021 00:30. Outcome of reaction/event at the time of last observation: Recovering/Resolving. Hospitalization Prolonged: No. Treatment Received: No.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Vaccine virus shedding
Clinical narrative: shedding; got shingles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINE VIRUS SHEDDING (non-serious), outcome "unknown", described as "shedding"; HERPES ZOSTER (non-serious), outcome "unknown", described as "got shingles".  Additional information: Caller refused to share additional demographic or contact information. Caller states he heard of others having heart attacks from all the Covid 19 vaccines. The CDC website Is up to 18,000 deaths due to myocarditis and heart attack. He also stated he got shingles from the shedding of the vaccine being around vaccinated people. Caller was not willing to share patient information and refused transfer to DSU. Further queried were they considered a vaccine or was it something that we were just passing off as a vaccine. The definition of a vaccine by the CDC changed from immunization to treatment. He was confused on what this vaccine does. Response provided as spoke from the attached CONS Document. Spoke from the attached VR: The Fact Sheet mentions that the vaccines are legally distinct with certain differences What does that mean? Also queried If he was injured by a vaccine under an EUA, does he had the same legal standing for injury as if something that is fully FDA approved? If he had a heart attack like others that he had heard of or myocarditis and several other issues as well, will Pfizer be liable? Responded as spoke from the attached VR: If asked: Are there any differences in the liability protections of the products (Pfizer-BioNTech COVID-19 Vaccine or comirnaty)?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Pyrexia, Restless legs syndrome, SARS-CoV-2 test
Clinical narrative: pain in glutes; restless muscles; fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-healthcare professional). This female consumer reported for herself.   An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 25Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion.), for Covid-19 Immunization, reaction(s): "No reactions after 1st dose".  The following information was reported: MUSCULOSKELETAL PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "pain in glutes"; RESTLESS LEGS SYNDROME (non-serious) with onset 2021, outcome "recovered" (2021), described as "restless muscles"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of musculoskeletal pain, restless legs syndrome, pyrexia.   Additional information: Dose Number: 2, Batch/Lot No: Not available/provided to reporter at the time of report completion. Reaction/event as reported by primary source: No reactions after first dose, after second dose: pain in glutes, restless muscles, fever, after third dose: pain in both elbow joints. Hospitalization Prolonged: (NO), Treatment Received: (YES). On 17Nov2021, the patient received third dose of BNT162B2 (Solution for injection, Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. Proprietary medicinal product name: Pfizer. Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received treatment with Tylenol for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Results of tests and procedures for investigation of the patient: Test: Nasal Swab. Result: Negative.   No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Erythema, Rash
Clinical narrative: Rash on jaw line of face; dermatitis; Bumpy, red but not itchy or sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 16:00 (Lot number: FK6127) at the age of 8 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, administration date 22Oct2021. Past drug history included: Augmentin, reaction(s): "Allergy_Augmentin".  The following information was reported: RASH (non-serious) with onset 15Nov2021 20:00, outcome "unknown", described as "Rash on jaw line of face"; DERMATITIS (non-serious) with onset 15Nov2021 20:00, outcome "unknown", described as "dermatitis"; ERYTHEMA (non-serious) with onset 15Nov2021 20:00, outcome "unknown", described as "Bumpy, red but not itchy or sore". Therapeutic measures were not taken as a result of rash, dermatitis, erythema.  Additional information: Seriousness criteria-Results in death. Seriousness criteria-Life threatening. Seriousness criteria-Caused/prolonged hospitalization. Seriousness criteria-Disabling/Incapacitating. Seriousness criteria-Congenital anomaly/birth defect were not reported. Other vaccine 4 weeks product Flu vaccine. List of any other medications the patient received within 2 weeks of vaccination No. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, has the patient not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: flow seems to be getting heavier/around 04Nov and have been bleeding ever since; bloating; very painful cramping; abbreviated 2 day period in mid Sep/In mid Oct, I had a phantom period/around 04Nov and have been bleeding ever since; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 (Lot number: FC3182) at the age of 42 years as dose 1, single and administered in arm left, administration date 16Sep2021 (Lot number: FF2588) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MIRENA, start date: 2017. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Sep2021, outcome "not recovered", described as "abbreviated 2 day period in mid Sep/In mid Oct, I had a phantom period/around 04Nov and have been bleeding ever since"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset Nov2021, outcome "not recovered", described as "flow seems to be getting heavier/around 04Nov and have been bleeding ever since"; ABDOMINAL DISTENSION (non-serious) with onset Oct2021, outcome "not recovered", described as "bloating"; DYSMENORRHOEA (non-serious) with onset Oct2021, outcome "not recovered", described as "very painful cramping". Therapeutic measures were not taken as a result of menstrual disorder, heavy menstrual bleeding, abdominal distension, dysmenorrhoea.  Additional information: The most recent COVID-19 vaccine was administered in facility at Pharmacy or Drug Store. The patient had no allergies. 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. The other medications the patient received took within 2 weeks of vaccination was Mirena which was implanted in 2017. Clinical course: The adverse event start date was provided as 15Sep2021. Patient stated that she had regular 28-day cycles even on Mirena (5-7 days). She had an abbreviated 2-day period in mid sept. In mid Oct, she had a phantom period, with all the signs bloating, very painful cramping but no bleeding (She never had cramps with Mirena). After 2 weeks of this uncomfortable phantom period, she started a spotty period, around 04Nov and have been bleeding ever since. As this month progresses, flow seems to be getting heavier. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: Left back and shoulder soreness; Left back and shoulder soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  A 9-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 9 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: QUILLIVANT XR. The following information was reported: BACK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 17Nov2021, outcome "unknown" and all described as "Left back and shoulder soreness". Therapeutic measures were not taken as a result of back pain, arthralgia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The other medication, patient received within 2 weeks of vaccination included, Quillivant XR. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no known allergies reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Rash maculo-papular
Clinical narrative: Strange raised rash bilateral axillae raised maculopapular with dusky centers, depressed in center/target-like (EM? Juicier than pityriasis) slightly itchy; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Nov2021 (Lot number: FK5127) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acanthosis" (unspecified if ongoing); "BMI >95th percentile" (unspecified if ongoing), notes: BMI >95th percentile. There were no concomitant medications. The following information was reported: RASH MACULO-PAPULAR (non-serious) with onset 14Nov2021, outcome "unknown", described as "Strange raised rash bilateral axillae raised maculopapular with dusky centers, depressed in center/target-like (EM? Juicier than pityriasis) slightly itchy". The event "strange raised rash bilateral axillae raised maculopapular with dusky centers, depressed in center/target-like (em? juicier than pityriasis) slightly itchy" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash maculo-papular. The patient was treated with topical ointment.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with covid-19. Since vaccination, the patient had not been tested for covid-19. Device date: 18Nov2021.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lung hyperinflation, Lymphadenopathy, Swelling
Clinical narrative: inflated in the pectoral area; pain in his joints, pains in his knees and shoulder; swelling in the lymph nodes; swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Nov2021 (Lot number: FH8028) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/lot number: FF2587, Anatomical location: Arm Left ), administration date: 26Oct2021, when the patient was 42 years old, for Covid-19 Immunization, reaction(s): "inflated in the pectoral area", "Discomfort". The following information was reported: LUNG HYPERINFLATION (non-serious), outcome "unknown", described as "inflated in the pectoral area"; ARTHRALGIA (non-serious) with onset 17Nov2021, outcome "unknown", described as "pain in his joints, pains in his knees and shoulder"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "unknown", described as "swelling in the lymph nodes"; SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "swelling".  Additional info: Patient took the first dosage on the 26Oct2021 and he got inflated in the pectoral area and had discomfort and it was disturbing him. He had taken the second dosage on 16Nov2021 and the same thing happened again and was inflated in the pectoral area. It was pectoral or breast plate below the left arm. It started the next day after the first dose. It happened again after the second dose and it was ongoing and it was stronger. The symptoms are much more than the first time on the left side. . It had been more than 72 hours since he got the shot and had the swelling. It had not gone. He was a really healthy man. He doesn't do drugs or drink. He had a good diet and was healthy. He had no underlying conditions. This happening was worse with the second dose. That area was still swelling. Vaccination Facility Type: health department of withheld. No prior Vaccinations within 4 weeks. He did not have flu vaccine or any other vaccines.   No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: Hives on left face cheek for 20 minutes between 6 and 7pm same day of first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Nov2021 15:15 (Lot number: FK5127) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hereditary Elliptocytosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 09Nov2021 18:30, outcome "recovered" (09Nov2021 18:50), described as "Hives on left face cheek for 20 minutes between 6 and 7pm same day of first dose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urticaria.  Additional information: Patient was tested for covid by Nasal Swab on 12Nov2021 result of which was negative. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient has been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected. .
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 2021SA346608 (SANOFI).  A 74 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; dupilumab (DUPIXENT) (ongoing) (Batch/Lot number: unknown) at 150 mg/ml (300 mg,qow) for dermatitis atopic; influenza vaccine (FLU VACCINE VII) (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "Egg allergy" (ongoing); "Food allergy" (ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rash". The action taken for dupilumab was unknown.  Additional information: In the context of COVID19 crisis, then batch number and expiration date were not requested. On an unknown date the patient developed a non-serious event rash (unknown latency). The event (rash) qualified for Adverse Event of Special Interest. It was reported Consumer of DUPIXENT 300mg Auto-injector is inquiring about receiving the Pfizer Covid booster shot and flu shot, and wondering if there are any data or studies, consumer stated that her last injection she developed a rash and she stated she would ask her doctor about the rash and the Covid Booster and Flu shots, she stated she is very allergic and cannot take any vaccines with egg components, she does not have the lot numbers of the product as she already discarded it  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Caller said that one of her daughter developed a bloody nose when she is just lying in bed last night around 9pm.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5 year-old female patient received bnt162b2 (BNT162B2), administration date 17Nov2021 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. The following information was reported: EPISTAXIS (non-serious) with onset 18Nov2021 21:00, outcome "unknown", described as "Caller said that one of her daughter developed a bloody nose when she is just lying in bed last night around 9pm.".  Additional information: Caller was a consumer calling for her twin daughters who received their Pfizer BioNTech COVID19 vaccine for the 5-11 years old. Caller said that one of her daughter developed a bloody nose when she is just lying in bed last night around 9pm. Caller wants to know if anyone has reported this. The pediatrician that she used to see is retired so she got a new pediatrician but at the same place. The caller hasn't called them yet but she was going to call them next. The caller did give her Tylenol after she had the vaccine, the pediatrician said to go ahead and give Tylenol afterwards so that's all she did. She took 7.5 mL.  No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Hypersensitivity, Lymphadenopathy, Pain, Rash pruritic
Clinical narrative: Allergic reaction; itching and rash on scalp, neck, ears, and shoulders; swollen lymph nodes; aches; eye pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in arm right (Lot number: FK5127) at the age of 7 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Relevant past drug history:, Name of Drug as Reported: No, Reaction: Allergy. There were no concomitant medications. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 19Nov2021 12:00, outcome "recovering", described as "Allergic reaction"; RASH PRURITIC (non-serious) with onset 19Nov2021 12:00, outcome "recovering", described as "itching and rash on scalp, neck, ears, and shoulders"; LYMPHADENOPATHY (non-serious) with onset 19Nov2021 12:00, outcome "recovering", described as "swollen lymph nodes"; PAIN (non-serious) with onset 19Nov2021 12:00, outcome "recovering", described as "aches"; EYE PAIN (non-serious) with onset 19Nov2021 12:00, outcome "recovering", described as "eye pain". Therapeutic measures were taken as a result of hypersensitivity, rash pruritic, lymphadenopathy, pain, eye pain.  Additional information: The patient had Benadryl and Tylenol as a treatment for all the events. The patient did not have any other vaccine in four weeks. The patient did not have any other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination. Vaccine facility type was pharmacy or Drug Store. Reporter did not have idea who this patient was, they will have to provide additional information so that they may identify whether the patient was seen in this office.  No follow-up attempts are possible. No further information is expected.  Follow-up (01Dec2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to HCP telephonic follow-up activity that included: Updated information: Reporter address and occupation.  No follow-up attempts are possible. No further information is expected.  Follow-up (20Dec2021): This is a spontaneous follow-up report received from a contactable consumer. This consumer reported in response to HCP letter sent that included: Updated Information: New reporter information. Additional Information: Comments/ Narrative.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Exposure via breast milk
Clinical narrative: My daughter has been coughing; am an exclusively breastfeeding mother; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 13:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known_allergies: Sulfa" (unspecified if ongoing); "if_covid_prior_vaccination: Yes" (unspecified if ongoing), notes: if_covid_prior_vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset 19Nov2021 13:30, outcome "recovering", described as "My daughter has been coughing"; EXPOSURE VIA BREAST MILK (non-serious) with onset 19Nov2021 13:30, outcome "recovering", described as "am an exclusively breastfeeding mother". Therapeutic measures were not taken as a result of cough, exposure via breast milk.  Additional information: Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had received Prenatal, vitamin D, Vitamin B, Zinc, superfoods within 2 weeks of vaccination. Patient had received within 2 weeks of vaccination. Patient had not been covid tested post vaccination. Patient had not received any treatment ae. Patient had diagnosed with COVID-19 Prior to vaccination. Patient had not been tested for COVID-19 Since the vaccination. Patient had Military Facility where the most recent COVID-19 vaccine was administered. Dizziness, Pain in the left arm, shoulder blade and collar bone, Occasional pin like feeling when breathing, Itching on the left arm, Pain in my left ovaries, Little bit of a sore throat, Felt like my throat was swollen a bit with some cotton mouth, My daughter has been coughing (I am an exclusively breastfeeding mother).   Follow-up attempts are completed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A 10 year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FK5127), at the age of 10, in left arm, on Nov 19, 2021, at 17:00, single dose, for COVID-19 immunisation. Medical history included mild seasonal allergies (unspecified if ongoing). Concomitant medication(s) included Zyrtec (cetirizine hydrochloride). The patient reported urticaria/moderate urticaria (generalized), onset Nov 19, 2021, at 21:00, with outcome of unknown. Moderate urticaria (generalized) evaluated at a physician office visit. Additional information: The event did not cause hospitalization. It was unknown if treatment received. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No follow-up attempts possible. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swelling, redness, itching, soreness around injection site lasting 6 days; Swelling, redness, itching, soreness around injection site lasting 6 days; Swelling, redness, itching, soreness around injection site lasting 6 days; Swelling, redness, itching, soreness around injection site lasting 6 days; Swollen lymph nodes in left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 (Lot number: 3230BD) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Excedrin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EN5318, Location of injection: Arm Left), administration date: 10Feb2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: EL1283, Location of injection: Arm Left), administration date: 20Jan2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 13Nov2021, outcome "recovered" (2021) and all described as "Swelling, redness, itching, soreness around injection site lasting 6 days"; LYMPHADENOPATHY (non-serious) with onset 13Nov2021, outcome "recovered" (2021), described as "Swollen lymph nodes in left armpit". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site pruritus, vaccination site pain, lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and Since the vaccination the patient has not been tested for COVID-19. Patient received treatment with Hydrocortizone cream, Tylenol for events. Seriousness was reported as non serious.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: broke out in hives; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Lot number: EN6204) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 06Mar2021, outcome "recovered" (2021), described as "broke out in hives". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria.  Additional information: AE treatment was reported as topical ointment. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks and other medications in two weeks. At the time of report, no known allergies and other medical history reported, and device date reported as 19Nov2021.  No follow-up attempts are possible. No further information is expected.