chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Influenza like illness, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: flu like symptoms; chills; injection site is still tender and swollen over 4 days later.; feels like there's a lump around the injection site/ arm is hard in that area; injection site is still tender and swollen over 4 days later.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), INJECTION SITE PAIN (injection site is still tender and swollen over 4 days later.), INJECTION SITE MASS (feels like there's a lump around the injection site/ arm is hard in that area) and INJECTION SITE SWELLING (injection site is still tender and swollen over 4 days later.) in a 35-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058628) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 23-Oct-2023, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), INJECTION SITE PAIN (injection site is still tender and swollen over 4 days later.), INJECTION SITE MASS (feels like there's a lump around the injection site/ arm is hard in that area) and INJECTION SITE SWELLING (injection site is still tender and swollen over 4 days later.). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), INJECTION SITE PAIN (injection site is still tender and swollen over 4 days later.), INJECTION SITE MASS (feels like there's a lump around the injection site/ arm is hard in that area) and INJECTION SITE SWELLING (injection site is still tender and swollen over 4 days later.) had not resolved.            Concomitant medication and treatment were not provided.
Age: 81.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, COVID-19 immunisation, Chills, Decreased appetite, Diarrhoea
Clinical narrative: Revaccination with different COVID-19 vaccine; Interchange of vaccine products; Swelling; Injection site reaction; She could not eat; Diarrhea; Chills; Redness extending from injection site; Fever; Headache; Fatigue; Muscle pain; Joint pain; Nausea and vomiting; Rash; Nausea and vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), INJECTION SITE REACTION (Injection site reaction), DECREASED APPETITE (She could not eat), DIARRHOEA (Diarrhea) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Previously administered products included for Drug use for unknown indication: FLU Shot on 27-Sep-2023; for COVID-19 vaccination: Pfizer, Pfizer, Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with FLU Shot, Pfizer, Pfizer, Pfizer and Pfizer.   On 01-Oct-2023, the patient received fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 23-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 23-Oct-2023, the patient experienced SWELLING (Swelling), INJECTION SITE REACTION (Injection site reaction), DIARRHOEA (Diarrhea), CHILLS (Chills), INJECTION SITE ERYTHEMA (Redness extending from injection site), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea and vomiting), RASH (Rash ) and VOMITING (Nausea and vomiting). 23-Oct-2023, the patient experienced DECREASED APPETITE (She could not eat). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, SWELLING (Swelling), INJECTION SITE REACTION (Injection site reaction), DIARRHOEA (Diarrhea), CHILLS (Chills), INJECTION SITE ERYTHEMA (Redness extending from injection site), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea and vomiting), RASH (Rash ) and VOMITING (Nausea and vomiting) had not resolved and DECREASED APPETITE (She could not eat), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient received the shot, she had been very tired, she could not eat. The injection site was still hard as a rock and it was painful to move the left arm (Injected arm).
Age: 81.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache, Injection site erythema, Injection site reaction, Interchange of vaccine products
Clinical narrative: Revaccination with different COVID-19 vaccine; Interchange of vaccine products; Swelling; Injection site reaction; She could not eat; Diarrhea; Chills; Redness extending from injection site; Fever; Headache; Fatigue; Muscle pain; Joint pain; Nausea and vomiting; Rash; Nausea and vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), INJECTION SITE REACTION (Injection site reaction), DECREASED APPETITE (She could not eat), DIARRHOEA (Diarrhea) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Previously administered products included for Drug use for unknown indication: FLU Shot on 27-Sep-2023; for COVID-19 vaccination: Pfizer, Pfizer, Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with FLU Shot, Pfizer, Pfizer, Pfizer and Pfizer.   On 01-Oct-2023, the patient received fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 23-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 23-Oct-2023, the patient experienced SWELLING (Swelling), INJECTION SITE REACTION (Injection site reaction), DIARRHOEA (Diarrhea), CHILLS (Chills), INJECTION SITE ERYTHEMA (Redness extending from injection site), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea and vomiting), RASH (Rash ) and VOMITING (Nausea and vomiting). 23-Oct-2023, the patient experienced DECREASED APPETITE (She could not eat). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, SWELLING (Swelling), INJECTION SITE REACTION (Injection site reaction), DIARRHOEA (Diarrhea), CHILLS (Chills), INJECTION SITE ERYTHEMA (Redness extending from injection site), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea and vomiting), RASH (Rash ) and VOMITING (Nausea and vomiting) had not resolved and DECREASED APPETITE (She could not eat), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient received the shot, she had been very tired, she could not eat. The injection site was still hard as a rock and it was painful to move the left arm (Injected arm).
Age: 81.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Myalgia, Nausea, Pyrexia, Rash, Swelling
Clinical narrative: Revaccination with different COVID-19 vaccine; Interchange of vaccine products; Swelling; Injection site reaction; She could not eat; Diarrhea; Chills; Redness extending from injection site; Fever; Headache; Fatigue; Muscle pain; Joint pain; Nausea and vomiting; Rash; Nausea and vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), INJECTION SITE REACTION (Injection site reaction), DECREASED APPETITE (She could not eat), DIARRHOEA (Diarrhea) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Previously administered products included for Drug use for unknown indication: FLU Shot on 27-Sep-2023; for COVID-19 vaccination: Pfizer, Pfizer, Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with FLU Shot, Pfizer, Pfizer, Pfizer and Pfizer.   On 01-Oct-2023, the patient received fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 23-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 23-Oct-2023, the patient experienced SWELLING (Swelling), INJECTION SITE REACTION (Injection site reaction), DIARRHOEA (Diarrhea), CHILLS (Chills), INJECTION SITE ERYTHEMA (Redness extending from injection site), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea and vomiting), RASH (Rash ) and VOMITING (Nausea and vomiting). 23-Oct-2023, the patient experienced DECREASED APPETITE (She could not eat). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, SWELLING (Swelling), INJECTION SITE REACTION (Injection site reaction), DIARRHOEA (Diarrhea), CHILLS (Chills), INJECTION SITE ERYTHEMA (Redness extending from injection site), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea and vomiting), RASH (Rash ) and VOMITING (Nausea and vomiting) had not resolved and DECREASED APPETITE (She could not eat), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient received the shot, she had been very tired, she could not eat. The injection site was still hard as a rock and it was painful to move the left arm (Injected arm).
Age: 81.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vomiting
Clinical narrative: Revaccination with different COVID-19 vaccine; Interchange of vaccine products; Swelling; Injection site reaction; She could not eat; Diarrhea; Chills; Redness extending from injection site; Fever; Headache; Fatigue; Muscle pain; Joint pain; Nausea and vomiting; Rash; Nausea and vomiting; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), INJECTION SITE REACTION (Injection site reaction), DECREASED APPETITE (She could not eat), DIARRHOEA (Diarrhea) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Previously administered products included for Drug use for unknown indication: FLU Shot on 27-Sep-2023; for COVID-19 vaccination: Pfizer, Pfizer, Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with FLU Shot, Pfizer, Pfizer, Pfizer and Pfizer.   On 01-Oct-2023, the patient received fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 23-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 23-Oct-2023, the patient experienced SWELLING (Swelling), INJECTION SITE REACTION (Injection site reaction), DIARRHOEA (Diarrhea), CHILLS (Chills), INJECTION SITE ERYTHEMA (Redness extending from injection site), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea and vomiting), RASH (Rash ) and VOMITING (Nausea and vomiting). 23-Oct-2023, the patient experienced DECREASED APPETITE (She could not eat). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, SWELLING (Swelling), INJECTION SITE REACTION (Injection site reaction), DIARRHOEA (Diarrhea), CHILLS (Chills), INJECTION SITE ERYTHEMA (Redness extending from injection site), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea and vomiting), RASH (Rash ) and VOMITING (Nausea and vomiting) had not resolved and DECREASED APPETITE (She could not eat), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient received the shot, she had been very tired, she could not eat. The injection site was still hard as a rock and it was painful to move the left arm (Injected arm).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: covid 19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (covid 19) in a 67-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 059A21A) for COVID-19 vaccination.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:DM, mild asthma. coronary artery disease.  Concurrent medical conditions included Diabetes mellitus, Asthma and Coronary artery disease.    On 08-Jun-2022, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 28-Aug-2023,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2023, SARS-CoV-1 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant and treatment medication were provided. Patient had mild symptoms which lasted for 7 days and stayed at home. He took Paxlovid. It took him 14 days before he had 2 negative tests 48 hours apart. He had previous vaccinations of 1st dose on 22Dec2020 with lot number EK5730, 2nd dose on 11Jan2021 with lot number EK1283, 3rd dose on 19Aug2021 with lot number FC3181.
Sex: M
Vaccine: PPV
Symptoms: Central venous catheterisation, Chemotherapy, Intravesical immunotherapy, Limb mass, Malignant melanoma stage IV
Clinical narrative: about 7 weeks after that pneumonia shot that's when that lump started to show up in the arm/taking Braftovi-Mektovi for stage IV melanoma cancer, it started with a lump on his right arm; 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 78-year-old male 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: MALIGNANT MELANOMA (medically significant), outcome "unknown", described as "about 7 weeks after that pneumonia shot that's when that lump started to show up in the arm/taking Braftovi-Mektovi for stage IV melanoma cancer, it started with a lump on his right arm". Therapeutic measures were taken as a result of malignant melanoma. Patient's regular doctor told him to get a flu shot, or at least a pneumonia shot. He got it and about 7 weeks after that pneumonia shot that's when that lump started to show up in the arm. Patient is taking Braftovi-Mektovi for stage IV melanoma cancer. He stated that it started with a lump on his right arm, they had him on hemotherapy, immunotherapy, two 2 drugs that they IV (intravenous) in a port on his chest, it was a double dose.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht crm197 protein), pneumococcal 13-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 at 13:15 as dose 5 (booster), single (Lot number: G36738) at the age of 61 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Jul2022 as dose 4 (booster), single (Lot number: Fm7553), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 13Jul2021 at 13:15 as dose 1, single (Lot number: Fa6780), in left arm, on 03Aug2021 at 13:15 as dose 2, single (Lot number: Fa6780), in left arm and on 10Jan2022 at 13:15 as dose 3 (booster), single (Lot number: Fl3198), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin and sulfa drugs" (unspecified if ongoing), notes: No other medical history; "Known allergies: Penicillin and sulfa drugs" (unspecified if ongoing), notes: No other medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID as covid-19 treatment from 12Oct2023 to 16Oct2023.   Product investigation results was received on 23Oct2023 for Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml vial x 1 adult 10 x 2.25ml Multidose (Lot number: FM7553): Conclusion of Previously Completed Investigation (RA): The complaint for "Pfizer Biontech Covid-19 Vaccine" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM7553. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. RA (withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Age: 76.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Movement disorder, Pain in extremity
Clinical narrative: I had my shot on 11Oct2023. On 14Oct2023, I began to have intermittent pain in my hips, especially at night. Five days following the shot, the pain moved from my hips to my right leg.; It is difficult for me to move up and down from a chair or in and out of a car; I had my shot on 11Oct2023. On 14Oct2023, I began to have intermittent pain in my hips, especially at night. Five days following the shot, the pain moved from my hips to my right leg.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 as dose 1, single (Lot number: HG4671) at the age of 76 years, in left arm for covid-19 immunisation; for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 11Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacture unknown.), for Covid-19 Immunization; Covid-19 vaccine (Dose 2; Manufacture unknown.), for Covid-19 Immunization; Covid-19 vaccine (Dose 3; Manufacture unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 4; Manufacture unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 5; Manufacture unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose 6; Manufacture unknown), for Covid-19 Immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 14Oct2023 at 12:00, outcome "not recovered", PAIN IN EXTREMITY (non-serious) with onset 16Oct2023, outcome "not recovered" and all described as "I had my shot on 11Oct2023. On 14Oct2023, I began to have intermittent pain in my hips, especially at night. Five days following the shot, the pain moved from my hips to my right leg."; MOVEMENT DISORDER (non-serious) with onset 16Oct2023, outcome "not recovered", described as "It is difficult for me to move up and down from a chair or in and out of a car". Therapeutic measures were not taken as a result of arthralgia, pain in extremity, movement disorder. Additional information: The patient had the shot on 11Oct2023. On 14Oct2023, the patient began to have intermittent pain in hips, especially at night. Five days following the shot, the pain moved from hips to right leg. The pain felt like a sharp pinching sensation. It is difficult for the patient to move up and down from a chair or in and out of a car. As of today, Oct2023, the pain has moved to the hips again. The pain continues to be present in both sides of the hips. The patient has been taking Advil almost everyday for the last 9 days.   The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle disorder
Clinical narrative: With every dose of the vaccine caller has had muscle problems; 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 76-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (ongoing), notes: in her 30s when started; "Hashimoto's" (ongoing); "Fibromyalgia" (ongoing); "Sjogren's" (ongoing). The patient's family history included: "Rheumatoid arthritis" (ongoing), notes: in her late 30s. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/ lot: EN6205, Anatomical location: Upper left arm, Time: sometime in morning), administration date: 02Mar2021, for Covid-19 immunization, reaction(s): "polymyalgia rheumatica", "had muscle problems", "arm irritation", "arm tenderness"; bnt162b2 (DOSE 2, SINGLE, Batch/ lot: ER8727, Anatomical location: Upper left arm, Time: sometime in morning), administration date: 23Mar2021, for Covid-19 immunization, reaction(s): "polymyalgia rheumatica", "every muscle in body was bothering patient/ muscle problems", "arm sensitive/ had tenderness", "leg cramps", "very tired", "headache", "sore throat"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot: 30135BA, Anatomical location: Upper left arm, Time: sometime in morning), administration date: 21Oct2021, for Covid-19 immunization, reaction(s): "Pericarditis", "couldn't breathe", "with every dose of the vaccine caller has had muscle problems". The following information was reported: MUSCLE DISORDER (non-serious), outcome "unknown", described as "With every dose of the vaccine caller has had muscle problems". Therapeutic measures were taken as a result of muscle disorder.  Additional information: Patient's rheumatologist prescribed the Prednesol. Reporter's aunt had rheumatoid arthritis. No investigations were carried out. The time of administration of suspect dose 4 was sometime in morning.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300337361 same patient/vaccine, different doses/event.;
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle disorder
Clinical narrative: with every dose of the vaccine caller has had muscle problems; 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 77-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Apr2023 as dose 5 (booster), single (Lot number: GJ6742) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (ongoing), notes: in her late 30s. Doctor tried to figure out if it was rheumatoid arthritis or Lupus.; "Hashimoto's" (ongoing), notes: Hashimoto's; "Fibromyalgia" (ongoing), notes: Fibromyalgia; "Sjogren's" (ongoing), notes: Sjogren's. The patient's family history included: "Rheumatoid arthritis" (ongoing), notes: in her late 30s. Doctor tried to figure out if it was rheumatoid arthritis or Lupus. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: EN6205, Anatomical location: Upper left arm), administration date: 02Mar2021, for Covid-19 immunization, reaction(s): "polymyalgia rheumatica", "had muscle problems", "arm irritation", "arm tenderness"; bnt162b2 (DOSE 2, SINGLE, Batch/Lot number: ER8727, Anatomical location: Upper left arm), administration date: 23Mar2021, for Covid-19 immunization, reaction(s): "arm sensitive/ had tenderness", "every muscle in body was bothering patient/ muscle problems", "leg cramps", "very tired", "Headache", "sore throat", "polymyalgia rheumatica"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number: 30135BA, Anatomical location: Upper left arm), administration date: 21Oct2021, for Covid-19 immunization, reaction(s): "with every dose of the vaccine caller has had muscle problems", "Pericarditis", "couldn't breathe"; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot number: GH9694, Anatomical location: Upper left arm), administration date: 21Sep2022, for Covid-19 immunization, reaction(s): "with every dose of the vaccine caller has had muscle problems". The following information was reported: MUSCLE DISORDER (non-serious) with onset 2023, outcome "unknown", described as "with every dose of the vaccine caller has had muscle problems".  Additional information: It was clarified and confirmed that caller had all of the Pfizer COVID-19 vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300337361 same patient/vaccine, different doses/event.;
Age: 63.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Headache, Migraine, Nausea, Pain
Clinical narrative: nausea; vomiting; body ache; exhaustion; next 2 days horrible headache with 2 migraine sat and sunday; Monday still headache but not as bad.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 17Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for influenza immunisation. The patient's relevant medical history included: "Known allergies: Nuts" (unspecified if ongoing), notes: Known allergies: Nuts; "Known allergies: mouth sores" (unspecified if ongoing), notes: Known allergies: mouth sores; "Cholesterol" (unspecified if ongoing), notes: cholesterol medi. Concomitant medication(s) included: PROZAC; WELLBUTRIN; LEVOTHYROXINE. The following information was reported: HEADACHE (non-serious) with onset Oct2023, outcome "recovering", described as "Monday still headache but not as bad."; MIGRAINE (non-serious) with onset Oct2023, outcome "not recovered", described as "next 2 days horrible headache with 2 migraine sat and sunday"; PAIN (non-serious) with onset 18Oct2023 at 05:00, outcome "recovering", described as "body ache"; FATIGUE (non-serious) with onset 18Oct2023 at 05:00, outcome "recovering", described as "exhaustion"; NAUSEA (non-serious) with onset 18Oct2023 at 05:00, outcome "recovering"; VOMITING (non-serious) with onset 18Oct2023 at 05:00, outcome "recovering". Therapeutic measures were taken as a result of nausea, vomiting, pain, fatigue, migraine, headache.  Additional information: Patient experienced the nausea, vomiting, body ache and exhaustion first day, next 2 days same side effects without vomiting. next 2 days horrible headache with 2 migraine sat and sunday. Monday still headache but not as bad. Medication did not touch the paid of the migraine. Patient was treated with tylenol, then tried ibupophen, then tried Flexeril. Patient did not had COVID prior vaccination and not tested positive for Covid.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vomiting
Clinical narrative: nausea; vomiting; body ache; exhaustion; next 2 days horrible headache with 2 migraine sat and sunday; Monday still headache but not as bad.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 17Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for influenza immunisation. The patient's relevant medical history included: "Known allergies: Nuts" (unspecified if ongoing), notes: Known allergies: Nuts; "Known allergies: mouth sores" (unspecified if ongoing), notes: Known allergies: mouth sores; "Cholesterol" (unspecified if ongoing), notes: cholesterol medi. Concomitant medication(s) included: PROZAC; WELLBUTRIN; LEVOTHYROXINE. The following information was reported: HEADACHE (non-serious) with onset Oct2023, outcome "recovering", described as "Monday still headache but not as bad."; MIGRAINE (non-serious) with onset Oct2023, outcome "not recovered", described as "next 2 days horrible headache with 2 migraine sat and sunday"; PAIN (non-serious) with onset 18Oct2023 at 05:00, outcome "recovering", described as "body ache"; FATIGUE (non-serious) with onset 18Oct2023 at 05:00, outcome "recovering", described as "exhaustion"; NAUSEA (non-serious) with onset 18Oct2023 at 05:00, outcome "recovering"; VOMITING (non-serious) with onset 18Oct2023 at 05:00, outcome "recovering". Therapeutic measures were taken as a result of nausea, vomiting, pain, fatigue, migraine, headache.  Additional information: Patient experienced the nausea, vomiting, body ache and exhaustion first day, next 2 days same side effects without vomiting. next 2 days horrible headache with 2 migraine sat and sunday. Monday still headache but not as bad. Medication did not touch the paid of the migraine. Patient was treated with tylenol, then tried ibupophen, then tried Flexeril. Patient did not had COVID prior vaccination and not tested positive for Covid.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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) from product quality group. The reporter is the patient.  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Lot number: HH7595) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Diltiazem for Hypertension, notes: Hypertension - under control w/ Diltiazem; Atorvastatin for Hyperlipidemia, notes: Hyperlipidemia, under control with atorvastatin. Vaccination history included: bnt162b2 (vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=07Oct2022,, Vaccine lot number=GJ6665,, Vaccine lot unknown=False,, Vaccine dose number=5,, Vaccine dose number unknown=False), administration date: 07Oct2022, when the patient was 71-year-old, for COVID-19 immunization; bnt162b2 (vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=11Apr2022,, Vaccine lot number=FK9894,, Vaccine lot unknown=False,, Vaccine dose number=4,, Vaccine dose number unknown=False), administration date: 11Apr2022, when the patient was 71-year-old, for COVID-19 immunization; bnt162b2 (vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=26Sep2021,, Vaccine administration date=26Sep2021,, Vaccine lot number=FC3181,, Vaccine lot unknown=False,, Vaccine dose number=3,, Vaccine dose number unknown=False), administration date: 26Sep2021, when the patient was 70-year-old, for COVID-19 immunization; bnt162b2 (vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=08Mar2021,, Vaccine lot number=EN6205,, Vaccine lot unknown=False,, Vaccine dose number=2,, Vaccine dose number unknown=False), administration date: 08Mar2021, when the patient was 70-year-old, for COVID-19 immunization; bnt162b2 (vaccine brand=Pfizer / BioNTech,, Vaccine brand unknown=False,, Vaccine administration date=11Feb2021,, Vaccine lot number=EM9810,, Vaccine lot unknown=False,, Vaccine dose number=1,, Vaccine dose number unknown=False), administration date: 11Feb2021, when the patient was 69-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Oct2023) Negative; (23Oct2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, which included Paxlovid from 12Oct2023 to 16Oct2023 (Lot number=192534OA).
Sex: U
Vaccine: COVID19
Symptoms: Shock
Clinical narrative: shock; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: SHOCK (medically significant), outcome "unknown". Clinical information: The patient reported that they called because they had side effects. They already had the shock and they had serious side effects from it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain, Myalgia, Pain in extremity, Tenderness
Clinical narrative: shoulder is aching and tender; lower part of arm is starting to join in the painful aching; muscle and shoulder is aching and tender; Injection was painful that night; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 08Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Sep2023, outcome "not recovered", described as "Injection was painful that night"; ARTHRALGIA (non-serious), outcome "unknown", described as "shoulder is aching and tender"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "lower part of arm is starting to join in the painful aching"; MYALGIA (non-serious), outcome "unknown", described as "muscle and shoulder is aching and tender".  Additional information: On 08Sep2023, the patient recieved the ABRYSVO inj. from (Pharmacy name) here in (city name withheld) (state name withheld). The injection was painful that night. Now the Inj is still there and getting worse. The patient's muscle and shoulder is aching and tender. The lower part of arm is starting to join in the painful aching. The patient asked if there was something that they can do to relieve this ache, something to apply, heat, cold, ice, aspirin, balm. The patient asked for a suggestion. The patient does not get "allergy Sx's" (as reported) and is healthy. The patient was not asking for a diagnosis.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Feels a little dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna shot (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 23Oct2023, outcome "unknown", described as "Feels a little dizzy"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 23Oct2023, outcome "unknown".  Additional information: Just got it about 15 minutes ago. Previously had the Moderna, is all caught up with shots. Something happened, that kind of alarmed her. The drugstore seemed to think it was ok. Wants to be reassured. Usually, will ask to aspirate syringe so, blood doesn't get back in. Did not ask this time, they put shot in, needle did not go back in to the apparatus, it is supposed to, was still out. She asked if she got the shot. They said yes, have to be careful because it is really sharp. Said, it didn't retract like it was supposed to. Had others, has not had this happen before. They put the needle hazard thing, needle was still sticking out. Was told, they think she got the shot.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Dizziness, Flatulence, Headache, Malaise
Clinical narrative: Interchange of vaccine products; Feels a little dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna shot (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 23Oct2023, outcome "unknown", described as "Feels a little dizzy"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 23Oct2023, outcome "unknown".  Additional information: Just got it about 15 minutes ago. Previously had the Moderna, is all caught up with shots. Something happened, that kind of alarmed her. The drugstore seemed to think it was ok. Wants to be reassured. Usually, will ask to aspirate syringe so, blood doesn't get back in. Did not ask this time, they put shot in, needle did not go back in to the apparatus, it is supposed to, was still out. She asked if she got the shot. They said yes, have to be careful because it is really sharp. Said, it didn't retract like it was supposed to. Had others, has not had this happen before. They put the needle hazard thing, needle was still sticking out. Was told, they think she got the shot.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Needle issue
Clinical narrative: Interchange of vaccine products; Feels a little dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna shot (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: DIZZINESS (non-serious) with onset 23Oct2023, outcome "unknown", described as "Feels a little dizzy"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 23Oct2023, outcome "unknown".  Additional information: Just got it about 15 minutes ago. Previously had the Moderna, is all caught up with shots. Something happened, that kind of alarmed her. The drugstore seemed to think it was ok. Wants to be reassured. Usually, will ask to aspirate syringe so, blood doesn't get back in. Did not ask this time, they put shot in, needle did not go back in to the apparatus, it is supposed to, was still out. She asked if she got the shot. They said yes, have to be careful because it is really sharp. Said, it didn't retract like it was supposed to. Had others, has not had this happen before. They put the needle hazard thing, needle was still sticking out. Was told, they think she got the shot.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site pain
Clinical narrative: Injection site pain/arm pain at the injection; Arm discomfort; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient received bnt162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3248, Expiration Date: Apr2021) at the age of 69 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing), notes: She is taking Amlodipine and Losartan but cannot recall the date the hypertension began; "prediabetic" (ongoing), notes: prediabetic began many years ago, maybe 4-5 years ago and she takes Metformin for that. Concomitant medication(s) included: AMLODIPINE taken for hypertension (ongoing); LOSARTAN taken for hypertension (ongoing). The following information was reported: LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Arm discomfort"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Injection site pain/arm pain at the injection".  Additional information: Patient cannot recall the date the hypertension began and it was all prior to receiving the Pfizer covid vaccine back in 2021 and prior to this booster vaccine that she got for 2023. The caller's mother and the caller both experienced that pain at the injection site but the caller had to seek medical attention for the other issues. It was just had the arm discomfort and she did not call it in because she expected that for the initial covid shots and that is what the package saID. The caller did not take Tylenol.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300347227 same patient, vaccine, different dose and event;US-PFIZER INC-202300347242 same reporter, vaccine, different patient and event;
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Ill for 36 hours post vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset 13Oct2023 at 19:00, outcome "recovered" (Oct2023), described as "Ill for 36 hours post vaccination". Therapeutic measures were not taken as a result of illness.  Additional information: Patient denied taking other medication in two weeks or for any other vaccine in four weeks. Patient denied for covid tested prior or post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Angiogram, Asthenia, Body temperature, Computerised tomogram abdomen
Clinical narrative: test positive; test positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ3274) at the age of 36 years intramuscular, in left deltoid for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Mar2021 as dose 1, 0.3 ml single (Lot number: ER2613), in left arm, on 09Apr2021 as dose 2, 0.3 ml single (Lot number: EW0158), in left deltoid and on 10Dec2021 as dose 3 (booster), 0.3 ml single (Lot number: FJ8757), in left deltoid, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Mar2023, outcome "unknown" and all described as "test positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (24Mar2023) positive; SARS-CoV-2 test: (21Feb2022) Detected; (24Mar2023) positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300135086 same patient/vaccine, different dose and event;