chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received vaccine that underwent a temperature excursion in the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine that underwent a temperature excursion in the freezer) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.       No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer.   Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.   Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.  Patient did not reported any adverse event.  No treatment medications were provided.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine that underwent a temperature excursion in the Freezer), POOR QUALITY PRODUCT ADMINISTERED (patients received vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     Concomitant medications were not reported.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the freezer. No adverse event reported.  Treatment medications were not reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: vial underwent a temperature excursion; No adverse event; patient received vaccine from vial that underwent a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion).    No concomitant medication was reported.   The pharmacist reported that, temperature excursion occurred several days ago in the freezer.The patient received vaccine that underwent a temperature excursion in the freezer, and they just found out about the excursion in an audit. No adverse event reported for the patient.   No treatment medication was reported.
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 35-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.       No concomitant medications were reported.  The pharmacist reported that, temperature excursion occurred several days ago in the freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer, and they just found out about the excursion in an audit.   No adverse event reported for the patient.  No treatment medications were reported.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.       Concomitant medications details was not reported.  Reportedly, the pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The patient received vaccine from a vial that underwent a temperature excursion in the freezer.  The patient received the booster dose.  All the vaccines were found to be viable.  Treatment details was not reported.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received vaccine that underwent a temperature excursion in the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (Received vaccine that underwent a temperature excursion in the freezer) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.      No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer.   Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.   Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question.  Patient did not reported any adverse event.  No treatment medications were provided.
Age: 95.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine that underwent a temperature excursion in the Freezer), POOR QUALITY PRODUCT ADMINISTERED (patients received vaccine that underwent a temperature excursion in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 95-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer. No adverse event reported. Treatment medications were not reported.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received vaccine from vial that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (vial underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Specific product reported as yes, specific product known from provided information.       The pharmacist reported that, temperature excursion occurred several days ago in the freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the freezer, and they just found out about the excursion in an audit. No adverse event reported for the patient.   No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.      No concomitant medications were reported.  The pharmacist reported that, temperature excursion occurred several days ago in the freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer, and they just found out about the excursion in an audit.   No adverse event reported for the patient.  No treatment medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.     Concomitant medications details was not reported.  Reportedly, the pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. The patient received vaccine from a vial that underwent a temperature excursion in the freezer.  The patient received the booster dose.  All the vaccines were found to be viable.  Treatment details was not reported.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Gave a patient the moderna monovalent vaccine instead of bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Gave a patient the moderna monovalent vaccine instead of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a 9-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Gave a patient the moderna monovalent vaccine instead of bivalent booster dose).    No concomitant product reported by the reporter. It was unknown if patient had allergies to medication, foods and other products.  It was unknow if patient had ever been diagnosed with and or tested positive with COVID-19. Chronic and Acute illness at the time of vaccination and up to one month before was unknown. No treatment medication reported by the reporter.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, Feeling abnormal, Insomnia, Pain, Pain in extremity
Clinical narrative: hu This spontaneous case was reported by a patient and describes the occurrence of PAIN (hurting very much/had aches), INSOMNIA (could not sleep), FEELING ABNORMAL (thinks that there was something that got a hold of him badly and made him ill.), PAIN IN EXTREMITY (shooting pain on his legs, arms all day and all night long) and BACK PAIN (shooting pain on his back all day and all night long) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.          On 26-Nov-2021, Received 1st booster dose of moderna and lot number was 019F21A, 2nd booster dose on  22-Jun-2022 and no lot number.  Patient had the omicron vaccine and that night he had fever and was hurting very much. He had aches and shooting pain on his legs, arms and back all day and all night long. He could not sleep. He thought he was going to be put in a hospital and thinks that there was something that got a hold of him badly and made him ill. He took Tylenol Extra Strength from, but it did not help at all. His symptoms resolved around midday of 21-Nov-2022.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: hu This spontaneous case was reported by a patient and describes the occurrence of PAIN (hurting very much/had aches), INSOMNIA (could not sleep), FEELING ABNORMAL (thinks that there was something that got a hold of him badly and made him ill.), PAIN IN EXTREMITY (shooting pain on his legs, arms all day and all night long) and BACK PAIN (shooting pain on his back all day and all night long) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.          On 26-Nov-2021, Received 1st booster dose of moderna and lot number was 019F21A, 2nd booster dose on  22-Jun-2022 and no lot number.  Patient had the omicron vaccine and that night he had fever and was hurting very much. He had aches and shooting pain on his legs, arms and back all day and all night long. He could not sleep. He thought he was going to be put in a hospital and thinks that there was something that got a hold of him badly and made him ill. He took Tylenol Extra Strength from, but it did not help at all. His symptoms resolved around midday of 21-Nov-2022.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had 1 dose of vaccine administered 1 day past the beyond use date.), PRODUCT STORAGE ERROR (We had 1 dose of vaccine administered 1 day past the beyond use date.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.      Vial size was reported as 2.5 milliliter. Reporter not sure about the date the vaccine was stored on refrigerator but reported likely, 30 days prior to 21-Nov-2022. The vial  did not undergo any temperature excursions. Only 1 dose was administered.   No treatment medications were reported.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administered 0.5mls of Moderna of 6m-5 year vaccine to an 8 year old patient.) and NO ADVERSE EVENT (No adverse event) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Administered 0.5mls of Moderna of 6m-5 year vaccine to an 8 year old patient.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administered 0.5mls of Moderna of 6m-5 year vaccine to an 8 year old patient.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administered 0.5mls of Moderna of 6m-5 year vaccine to an 8 year old patient.).    No concomitant medications were reported. It was reported that the  patient was given 0.5mls of Moderna of 6m-5 year vaccine to an 8 year old in error and asking if it was equivalent.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (testing positive for COVID after vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (testing positive for COVID after vaccination). At the time of the report, COVID-19 (testing positive for COVID after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.   No concomitant medications was reported. No treatment drug details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Had a reaction to dose 1) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Had a reaction to dose 1). At the time of the report, IMMUNISATION REACTION (Had a reaction to dose 1) outcome was unknown.        mRNA-1273 (Spikevax) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided. Patient was a senior and took 4 doses of Moderna. No treatment medication was provided.      Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: patient had a headache after each dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (patient had a headache after each dose of the Moderna Covid-19 vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Occipital neuralgia. Concurrent medical conditions included Hyperparathyroidism, Osteoporosis and Migraine. Concomitant products included ZOLMITRIPTAN (ZOMIG) and UBROGEPANT (UBRELVY) for Migraine, CLONAZEPAM (KLONOPIN), TRAZODONE, GABAPENTIN (NEURONTIN [GABAPENTIN]) and ERENUMAB (AIMOVIG [ERENUMAB]) for an unknown indication.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HEADACHE (patient had a headache after each dose of the Moderna Covid-19 vaccine). In 2021, HEADACHE (patient had a headache after each dose of the Moderna Covid-19 vaccine) had resolved.            The patient received the first dose of the Moderna Covid-19 vaccine early in 2021. Patient had a headache that lasted 1 to 2 days. After 28 days, the patient received the second dose of the Moderna Covid-19 vaccine. Patient had a headache for a week. Headache started 2 days after she received the vaccine. The patient received the first Moderna Monovalent booster dose about 6 months after the 2nd dose of primary series. Patient had a Headache that lasted for 10 days. The patient used Migraine medication which helped to take the edge off her Headache. Patient used Zomig and Ubrelvy.   This case was linked to MOD-2022-677452 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had a reaction to dose 3) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (had a reaction to dose 3). At the time of the report, IMMUNISATION REACTION (had a reaction to dose 3) outcome was unknown.            Concomitant drugs were not reported. It was reported that patient had 4 doses of Moderna and patient was a senior. Treatment medications were not provided.      Reporter did not allow further contact
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 year old was administered expired monovalent Moderna vaccine for the first dose of his primary series), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial undergo temperature excursion), PRODUCT STORAGE ERROR (The vial was removed from freezer which expired on 17-nov-2022 and was administered on 21-nov-2022) and NO ADVERSE EVENT (No adverse event) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.       No concomitant medications were reported. The storage condition at the time of the excursion was frozen. The vial had undergone  temperature excursions. It was unknown whether the patient previously had a Covid-19 infection.   The vial size was 2.5 ml. No other adverse reactions were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got COVID) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID). At the time of the report, COVID-19 (got COVID) outcome was unknown.            No concomitant medication was reported.  Patient had only received the Moderna vaccine and the Moderna boosters. Patient received the Moderna vaccine and then received the Moderna booster. After receiving the new bivalent booster about a month ago and patient got COVID. Patient had previously been around COVID and worked around COVID many times and had children with COVID in the house and never received COVID after taking the regular boosters. Patient said that the new bivalent booster might not be as effective.  No treatment medication was reported.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for COVID) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Specific product reported: No, product was inferred.    On 16-Feb-2021, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis
Clinical narrative: 41-year-old woman who developed severe hepatitis after her first dose of a Moderna shot.; This spontaneous case was reported by a consumer and describes the occurrence of HEPATITIS (41-year-old woman who developed severe hepatitis after her first dose of a Moderna shot.) in a 41-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATITIS (41-year-old woman who developed severe hepatitis after her first dose of a Moderna shot.) (seriousness criterion medically significant). At the time of the report, HEPATITIS (41-year-old woman who developed severe hepatitis after her first dose of a Moderna shot.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant products reported. No treatment products reported.  Company Comment: This spontaneous case concerns a 41-year-old, female patient with no medical history information reported who experienced the unexpected, serious (medically significant) event of Hepatitis which occurred on unknown interval after receiving the first dose of mRNA-1273. The clinical course, risk factors, diagnostic evaluation including hepatitis profile, liver biopsy, liver enzymes and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 41-year-old, female patient with no medical history information reported who experienced the unexpected, serious (medically significant) event of Hepatitis which occurred on unknown interval after receiving the first dose of mRNA-1273. The clinical course, risk factors, diagnostic evaluation including hepatitis profile, liver biopsy, liver enzymes and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: threw up 1 dose of xeljanz xr after receiving covid booster.; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "felty's syndrome" (unspecified if ongoing), notes: patient has history of felty's syndrome. Concomitant medication(s) included: XELJANZ XR oral taken for rheumatoid arthritis, start date: 01Oct2022 (ongoing). Past drug history included: Prednisone; Humira. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "threw up 1 dose of xeljanz xr after receiving covid booster.".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Body temperature, Malaise, Pyrexia
Clinical narrative: Fever of 100.2, feel weak and horrible.; Fever of 100.2, feel weak and horrible.; Fever of 100.2, feel weak and horrible.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 at 11:15 as dose 4 (booster), single (Lot number: GL0446) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), ASTHENIA (non-serious), MALAISE (non-serious) all with onset 22Nov2022, outcome "not recovered" and all described as "Fever of 100.2, feel weak and horrible.". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pyrexia, asthenia, malaise.  Additional information: It was also reported that patient had covid prior to vaccination. There was no covid tested post vaccination and no known allergies.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pain in extremity
Clinical narrative: got the first 2 J&J Jansen vaccines originally, then got the J&J Jansen booster; Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 74 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: j&j jansen vaccine (DOSE 1, SINGLE; Lot number: 1808982), administration date: 08Apr2021, when the patient was 73-year-old, for COVID-19 immunization; j&j jansen vaccine (DOSE 2, SINGLE; Lot number: 2, then either a 1 or L, then either a 1 or I, then D21A so either: 21LD21A, 211D21A, 2LLD21A, 2L1D21A or 2LID21A; this was from the CDC vaccine record card and was handwritten, hard to read.), administration date: 27Nov2021, when the patient was 74-year-old, for COVID-19 immunization; J&j jansen vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21May2022, outcome "recovered" (23May2022), described as "Sore arm"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21May2022, outcome "unknown", described as "got the first 2 J&J Jansen vaccines originally, then got the J&J Jansen booster".  Additional information: For COVID she got the first 2 J&J Jansen vaccines originally. Then she got the J&J Jansen booster which was basically the same vaccine. Then she got the first Pfizer booster and had no bad effect from it at all. In fact she had less effects from the Pfizer booster than from the 2 J&J. With the Pfizer Booster it wasn't bad, but you could notice something, just a little bit of a sore arm; but she had no adverse effects or symptoms.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201325205 same patient, different product (dose number) and different event;
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Vaccination site pain
Clinical narrative: Site injection pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Nov2022 at 02:00, outcome "recovering", described as "Site injection pain"; HEADACHE (non-serious) with onset 23Nov2022 at 02:00, outcome "recovering". Therapeutic measures were not taken as a result of vaccination site pain, headache.  Additional information: The patient had no known allergies. The patient did not receive any other vaccine within the four weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Each time I was extremely itchy on my scalp and in all joint areas; peri-orbital redness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2587) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTROGEN. Past drug history included: Neomycin for Known allergies: Neomycin. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization, reaction(s): "peri-orbital redness", "Each time I was extremely itchy on my scalp and in all joint areas"; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization, reaction(s): "peri-orbital redness", "Each time I was extremely itchy on my scalp and in all joint areas". The following information was reported: PRURITUS (non-serious), outcome "recovered", described as "Each time I was extremely itchy on my scalp and in all joint areas"; ERYTHEMA (non-serious), outcome "recovered", described as "peri-orbital redness".  Additional information: The patient received more than 3 doses. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Each time patient was extremely itchy on scalp and in all joint areas. Itching lasted for several hours. Patient also had peri-orbital redness each time. Adverse event start date/time was also reported as 09Mar2021 at 12:00 PM.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201325408 same reporter/patient/event, different vaccine dose;US-PFIZER INC-202201325409 same reporter/patient/event, different vaccine dose;
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Paraesthesia, SARS-CoV-2 test, Urinary retention
Clinical narrative: Developed paresthesias in legs and urinary retention; Developed paresthesias in legs and urinary retention; This is a literature report.  A 31-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: One year ago; "transient leg paresthesias" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: URINARY RETENTION (medically significant), PARAESTHESIA (medically significant), all with latency 4 weeks after the suspect product(s) administration, outcome "not recovered" and all described as "Developed paresthesias in legs and urinary retention". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: T2 hyperintensity from lower medulla to the conus; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of urinary retention, paraesthesia.  Clinical course: A year prior, he contracted COVID-19 and had transient leg paresthesias. MRI demonstrated T2 hyperintensity from lower medulla to the conus. He received five days of intravenous methylprednisolone followed by oral prednisone. He remains symptomatic requiring gabapentin, baclofen and tamsulosin.; Sender's Comments: Based on the available information, the causal relationship of the reported serious events URINARY RETENTION (medically significant), PARAESTHESIA cannot be excluded for the suspect product COVID-19 Vaccine - Manufacturer Unknown. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200110398 Same Article/event/drug and different patient.;
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Muscular weakness, Nerve conduction studies, Respiratory failure
Clinical narrative: Guillian- Barre Syndrome was diagnosed based on nerve conduction studies; respiratory failure; leg weakness; This is a literature report.  A 75-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "diabetes mellitus" (ongoing); "Crohns disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant, life threatening), 3 days after the suspect product(s) administration, outcome "unknown", described as "Guillian- Barre Syndrome was diagnosed based on nerve conduction studies"; RESPIRATORY FAILURE (medically significant, life threatening), 3 days after the suspect product(s) administration, outcome "unknown"; MUSCULAR WEAKNESS (non-serious), 3 days after the suspect product(s) administration, outcome "unknown", described as "leg weakness". The patient underwent the following laboratory tests and procedures: Nerve conduction studies: Guillian-Barre Syndrome was diagnosed. Therapeutic measures were taken as a result of guillain-barre syndrome.  Clinical course: Patient with hypertension, diabetes mellitus and Crohn's disease developed leg weakness, complicated by respiratory failure, three days after her first dose. Guillian-Barre Syndrome was diagnosed based on nerve conduction studies. She received PLEX followed by IVIG. She can now ambulate with a walker. These cases raise concern that mRNA vaccinations may be associated with neurologic complications due to heightened immune reactivity.; Sender's Comments: Based on the available information in the case, the causal association between the events Guillian- Barre Syndrome, respiratory failure, muscular weakness and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200110398 Same article/durg and different patient/event;
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block, Nasopharyngeal swab
Clinical narrative: Heart blockage that I never had before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Aug2022 at 12:45 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: ATRIOVENTRICULAR BLOCK (non-serious) with onset 23Nov2022 at 15:00, outcome "recovering", described as "Heart blockage that I never had before". The event "heart blockage that i never had before" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of atrioventricular block.  Additional information: There were no other vaccine in four weeks. The patient was tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood creatinine, C-reactive protein, Renal function test, SARS-CoV-2 test
Clinical narrative: AKI; AIN; This is a literature report.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; pembrolizumab (PEMBROLIZUMAB), (Batch/Lot number: unknown) for bladder cancer. The patient's relevant medical history included: "Bladder cancer" (ongoing), notes: was on Pembrolizumab. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ACUTE KIDNEY INJURY (medically significant), outcome "recovering", described as "AKI"; TUBULOINTERSTITIAL NEPHRITIS (medically significant), outcome "recovering", described as "AIN". The patient underwent the following laboratory tests and procedures: Blood creatinine: 2.18 mg/dl, notes: (b/1 0.8 mg/dL); C-reactive protein: 40 mg/dl; less than 3, notes: prior; Renal function test: Returned to baseline; SARS-CoV-2 test: Negative; Urine protein/creatinine ratio: 3797, notes: Units: mcg/g Cr (Normal less than 190) Elevated. The action taken for pembrolizumab was dosage permanently withdrawn.  Clinical course: The patient with h/o bladder cancer on pembrolizumab developed AKI. 3 weeks prior she got a booster dose of Pfizer SARS-CoV-2 vaccine. ICPi was discontinued. The patient declined kidney biopsy. Kidney function returned to baseline in 6 weeks without steroids. The cause of AKI was presumed to be AIN based on the elevated uRBP/Cr ratio.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, the causal association between the events Acute kidney injury, Tubulointerstitial nephritis and suspect drug BNT162b2 cannot be cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201326258 Same article/drug/event different patient;US-PFIZER INC-PV202200110499 Same article/drug/event different patient;