chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. An 80-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis reaction". Therapeutic measures were taken as a result of anaphylactic reaction.  Clinical course: On 01Dec2022, it was reported that an (ethnicity withheld) patient started treatment on an unspecified date in Jan2021 with Pfizer BioNTech COVID-19 Vaccine at an unspecified dose/frequency for COVID-19 immunisation. It was reported the patient had an anaphylaxis reaction and she had to get "the epi pen." No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old male 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; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: He got Covid recently, was sick, but got better and is now negative; (Dec2022) Negative, notes: He got Covid recently, was sick, but got better and is now negative. Clinical course: The reporter stated "My brother (69) and I (65) get boosted each time it's necessary. He got Covid recently, was sick, but got better and is now negative. "  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: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia, Vomiting
Clinical narrative: fever (tmax 101.5); severe nausea and vomiting; severe nausea and vomiting; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the parent.  A 13-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose number unknown (booster), single (Lot number: GJ6665) at the age of 13 years for covid-19 immunisation. The patient's relevant medical history included: "Down Syndrome" (unspecified if ongoing); "mild sleep apnea" (unspecified if ongoing), notes: mild; "congenital heart defect" (unspecified if ongoing), notes: congenital heart defect. Concomitant medication(s) included: MIRALAX. Vaccination history included: Covid-19 vaccine (Primary immunisation complete, manufacturer unknown), for Covid-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset 14Dec2022, outcome "unknown", described as "fever (tmax 101.5)"; NAUSEA (non-serious), VOMITING (non-serious) all with onset Dec2022, outcome "unknown" and all described as "severe nausea and vomiting". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On evening of 14Dec2022 she developed a fever (tmax 101.5) and about 40 hours after the dose developed severe nausea and vomiting. Event took place after use of product.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have had Covid twice, with one time being after fully vaccinated; I have had Covid twice, with one time being after fully vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), . The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: I have had COVID twice. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I have had Covid twice, with one time being after fully vaccinated".  Additional information: The patient stated that he appreciated the message in the video although he had not gotten a booster for COVID. he was not sure he wanted to do it, as some people he knew had received it and have had negative reactions such as actual COVID symptoms that were moderate to severe. He has had COVID twice, with one time being after fully vaccinated [with the Pfizer COVID-19 vaccine].  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown".  Additional Information:Patient received the vaccine and side effects (fever,chills, etc) were worse than COVID infection.Event took place after use of product.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: massive heart attack; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death), outcome "fatal", described as "massive heart attack". The patient died a few weeks after receiving COVID vaccine from massive heart attack. The patient date of death was unknown. Reported cause of death: "massive heart attack". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: massive heart attack
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 13-Dec-2022 regarding an unsolicited valid non-serious case received from a patient via social media.  This case involves a patient of unknown age and gender  who developed flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry date not reported) via unknown route in unknown administration site for flu.  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of influenza vaccine.  Reportedly, I got the flu shot and I got the Flu but it would have been worse without the shot!  It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of PENTACEL was administered with no reported adverse event; Initial information was received on 13-Dec-2022 regarding an unsolicited valid non-serious case received via call center from a health professional.  This case involves 7 months old female patient who experienced expired dose of pentacel was administered with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine (HEPATITIS B) for Immunisation.  On 13-Dec-2022, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine at a dose of 0.5 ml (lot: UJ598AAA ,U7091AA, Expiry date: 05-Dec-2022) via intramuscular route in the left thigh for prophylactic vaccination.  On 13-Dec-2022 the patient developed a non-serious event of expired dose of pentacel was administered with no reported adverse event (expired product administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, ipv and HIB VACCINE (Pentacel) was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 20.0
Sex: M
Vaccine: TD
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: administered post excursion to a patient; Initial information received on 14-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 20 years old male patient to whom diphtheria -2/tetanus -5 adsorbed toxoid NO preservative adult [Tenivac] was administered post excursion, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 06-Dec-2022, the patient received an unknown dose of suspect diphtheria -2/tetanus -5 adsorbed toxoid NO preservative adult, Suspension for injection, post excursion (poor quality product administered) (strength-standard) ( lot U7189AA and expiry date - 30-Sep-2023) via intramuscular route in the left deltoid for Immunization.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong brand, age range, and dose given
Age: 1.75
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong brand, are range, and dose given
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Palpitations, Supraventricular extrasystoles
Clinical narrative: Heart palpitations (PVCs and PACs).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Heart palpitations (PVCs and PACs).
Age: 2.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: wrong vaccine, age range, brand, and dose given
Age: 0.58
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: wrong manufacturer, age range, and dose given
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alopecia areata
Clinical narrative: Alopecia Areata first developed about 2-3 weeks after 2nd dose of the vaccination on the left side of the head about 1.5 inches in radius.   The affected area increased after 1 month of the vaccination. The second affected area was noticed on the top right corner of the forehead after 1.5 months of receiving the vaccination.
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: wrong brand, dose, and age range given
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Nasal pruritus, Rhinorrhoea, Sneezing
Clinical narrative: allergic reactions to many everyday substances.  did not have allergies before. now I have runny nose itching, sneezing all the time.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Atrial fibrillation, Blood calcium normal, Blood magnesium normal, Cardioversion, Echocardiogram abnormal
Clinical narrative: Patient developed new-onset atrial fibrillation 12 days after receiving the 4th dose of the COVID Pfizer vaccine. She was 37w3d pregnant with her second child at the time of developing atrial fibrillation. She was otherwise well - no recent illnesses. She converted into normal sinus rhythm after two doses of metoprolol.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Exposure during pregnancy, Fibrin D dimer, Full blood count normal, Laboratory test normal, Right ventricular dilatation
Clinical narrative: Patient developed new-onset atrial fibrillation 12 days after receiving the 4th dose of the COVID Pfizer vaccine. She was 37w3d pregnant with her second child at the time of developing atrial fibrillation. She was otherwise well - no recent illnesses. She converted into normal sinus rhythm after two doses of metoprolol.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Ventilation/perfusion scan normal
Clinical narrative: Patient developed new-onset atrial fibrillation 12 days after receiving the 4th dose of the COVID Pfizer vaccine. She was 37w3d pregnant with her second child at the time of developing atrial fibrillation. She was otherwise well - no recent illnesses. She converted into normal sinus rhythm after two doses of metoprolol.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Contusion, Dysmenorrhoea, Heavy menstrual bleeding, Musculoskeletal pain
Clinical narrative: Sore arm - 2.5 weeks  Bruised arm (circle)- current Extremely painful and heavy 1st menstrual cycle since booster Top of stomach pain Restless legs - feels like trembling inside Back of thighs and glutes sore and stiff
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Musculoskeletal stiffness, Pain in extremity, Restless legs syndrome, Tremor
Clinical narrative: Sore arm - 2.5 weeks  Bruised arm (circle)- current Extremely painful and heavy 1st menstrual cycle since booster Top of stomach pain Restless legs - feels like trembling inside Back of thighs and glutes sore and stiff
Sex: F
Vaccine: VARZOS
Symptoms: Lung disorder, Terminal state
Clinical narrative: Terminal lung disease; This case was reported by a consumer and described the occurrence of lung disease in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced lung disease (serious criteria other: serious per reporter). On an unknown date, the outcome of the lung disease was unknown.   It was unknown if the reporter considered the lung disease to be related to Shingrix.     Additional Information: GSK receipt date: 13-DEC-2022 Reporter's comments: This report was submitted by Patient support programs via the online direct entry reporting system.  The patient self-reported this case. The patient stated that she had terminal lung disease. No additional information received and no information on other condition were provided. The reporter had consented to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 ALMOST A YEAR AFTER THE VACCINATION; This spontaneous report received from a patient via a company representative via social media concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient was previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 almost a year after the vaccination (Dose number in series 2).  It was reported that "I took them too. I know first hand that they don't keep you from getting COVID-19, and as far as I know they don't keep you from spreading it. I also know that I had COVID-19 before the vaccination and almost a year after the vaccination. No difference, exactly the same, so it didn't reduce the severity. Did they actually give me a vaccination or was it saline solution both times". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 almost a year after the vaccination was not reported. This report was non-serious. This report was associated with product quality complaint 90000263493. This case, from the same reporter is linked to 20221234743, 20221235149, 20221235383 and 20221234779.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: DIFFERENT KINDS OF PAIN EVERY DAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced different kinds of pain every day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from different kinds of pain every day. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago; No adverse event; Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-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 15-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago), PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago) 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 EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago).    No concomitant product use was reported.  The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that the Moderna Covid-19 vaccine given from a vial that had been punctured more than 12 hours ago. Vaccine was at room temperature for 18 hours after puncture. Dose given in the 18th hour.  No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No adverse event; Dose 1 Janssen, Dose 2 (booster) Moderna 0.5ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Dose 1 Janssen, Dose 2 (booster) Moderna 0.5ml) and NO ADVERSE EVENT (No adverse event) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Denied allergies to medication, food and other products  The patient had not been diagnosed or tested positive for COVID-19. No chronic and acute illness at the time of vaccination and one month prior.  Previously administered products included for Drug use for unknown indication: Janssen (Dose 1) on 13-Mar-2021. Past adverse reactions to the above products included No adverse event with Janssen. Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) for an unknown indication.    On 07-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Dose 1 Janssen, Dose 2 (booster) Moderna 0.5ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Dose 1 Janssen, Dose 2 (booster) Moderna 0.5ml) 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 ACCIDENTAL OVERDOSE (Dose 1 Janssen, Dose 2 (booster) Moderna 0.5ml).    No prescriptions, over the counter medications, dietary supplements or herbal medicines being taken at the time of vaccination and or at the time of adverse event.  Treatment information was not provided.  This case was reported for 10th patient out of 20 patients.   This case was linked to MOD-2022-665504 (Patient Link).
Age: 77.0
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I took the flu shot twice, got the flu immediately; Initial information received on 12-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a 77 years old and unknown gender patient took the Influenza Vaccine shot twice, got the flu immediately.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, strength, frequency, formulation, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date the patient took the flu shot twice, got the flu immediately (influenza) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: F
Vaccine: HPV9
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: The caller said experienced "the normal soreness" after the injection; she received the intramuscular injection in her "L side buttocks; This spontaneous report was received from a healthcare student who was also a consumer referring to herself, a currently 24-year-old female patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unspecified date (also reported as "approximately 1-2 years ago"), the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (anatomical location: left side buttocks outer area; strength, lot#, and expiration date were not reported) via intramuscular administration for prophylaxis (product administered at inappropriate site).  On an unspecified date after the injection, the patient experienced "the normal soreness" (pain). The outcome of pain was not reported. The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and pain was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: shingleson forehead and nasal bridge; vesicles; This case was reported by a physician via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th December 2022, 4 days after receiving Shingrix, the patient experienced shingles and vesicles. On an unknown date, the outcome of the shingles and vesicles were not recovered/not resolved.   It was unknown if the reporter considered the shingles and vesicles to be related to Shingrix.     Additional Information: GSK Receipt date: 13th December 2022. Reporter's Comment: The patient received Shingrix in the left arm. The patient presented to the doctors office today with shingles on the midline of his forehead and down his nasal bridge.   The reported did not consent to follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SO SICK; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis (RA) (the patient was on rheumatoid arthritis medication).  The patient previously received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown), dose was not reported, frequency 1 total, start therapy date were not reported for covid-19 prophylaxis.  On an unspecified date, the patient was so sick following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The outcome of so sick was not reported.  The patient received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, frequency 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient got so sick (dose number in series 2). The patient did not know even if the administered vaccine works or not because of the patient's medications. The patient was unable to confirm how many shots were received. The reporter stated that "Johnson and Johnson I get so sick every single covid shot too. No other vaccine makes me sick. I am on meds for RA. Idk even if it works on me because of my meds''. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of so sick was not reported. This report was non-serious. This case is a duplicate of 20221238194. This case, involving the same patient is linked to 20221238175 (dose number in series 1).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion; no adverse event; Temperature excursion occurred on 29-Nov-2022 and administered to the patient on 05-Dec-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29-Nov-2022 and administered to the patient on 05-Dec-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Dec-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 05-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29-Nov-2022 and administered to the patient on 05-Dec-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29-Nov-2022 and administered to the patient on 05-Dec-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (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 (Temperature excursion occurred on 29-Nov-2022 and administered to the patient on 05-Dec-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion).    No concomitant medications were reported.  On 29-Nov-2022, temperature excursion occurred, and a dose was administered to the patient on 05-Dec-2022. No further information was provided.  No treatment medications were reported.  This case contains information for the first of two patients received vaccine on 05-Dec-2022 as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-688123 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688123:patient 2 case out of two patients received vaccine on 05-Dec-2022
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) 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 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Patient had received primary series and booster.She didn't get COVID right after the shot,She got COVID in September.                                   No treatment information was provided by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Immunocompromised patient received booster dose of 0.25 mL from Monovalent vaccine instead of Bivalent dose on 15Dec.2022; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Immunocompromised patient received booster dose of 0.25 mL from Monovalent vaccine instead of Bivalent dose on 15Dec.2022) and NO ADVERSE EVENT (No Adverse event) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015B22A, 037A22B, 047C21A, 002A21A and 012M20A) for COVID-19 prophylaxis.     Never diagnosed with COVID-19. No known allergies. No parental vaccine exposure.  Concurrent medical conditions included AIDS.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Immunocompromised patient received booster dose of 0.25 mL from Monovalent vaccine instead of Bivalent dose on 15Dec.2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Immunocompromised patient received booster dose of 0.25 mL from Monovalent vaccine instead of Bivalent dose on 15Dec.2022) 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 (Immunocompromised patient received booster dose of 0.25 mL from Monovalent vaccine instead of Bivalent dose on 15Dec.2022).    Concomitant medication list was not provided. Treatment information was not provided.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever; achy all over; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever) and MYALGIA (achy all over) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061D22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 03-Mar-2021 and PFIZER BIONTECH COVID-19 VACCINE on 24-Mar-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 13-Dec-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 13-Dec-2022, the patient experienced PYREXIA (fever) and MYALGIA (achy all over). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of extra strength and IBUPROFEN (MOTRIN [IBUPROFEN]) for Myalgia, at a dose of 600 milligram. At the time of the report, PYREXIA (fever) and MYALGIA (achy all over) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Dysgeusia, Frustration tolerance decreased, Impaired work ability, Insomnia, Loss of personal independence in daily activities
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED WORK ABILITY (i missed work), INSOMNIA (still not able to sleep properly), MOBILITY DECREASED (Could not move properly, bathroom properly), DYSGEUSIA (food tasting like metallic) and FRUSTRATION TOLERANCE DECREASED (frustrated) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. 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 IMPAIRED WORK ABILITY (i missed work), INSOMNIA (still not able to sleep properly), MOBILITY DECREASED (Could not move properly, bathroom properly), DYSGEUSIA (food tasting like metallic), FRUSTRATION TOLERANCE DECREASED (frustrated) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not bathroom properly). At the time of the report, IMPAIRED WORK ABILITY (i missed work) had resolved and INSOMNIA (still not able to sleep properly), MOBILITY DECREASED (Could not move properly, bathroom properly), DYSGEUSIA (food tasting like metallic), FRUSTRATION TOLERANCE DECREASED (frustrated) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not bathroom properly) had not resolved. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered IMPAIRED WORK ABILITY (i missed work) to be related. No further causality assessments were provided for INSOMNIA (still not able to sleep properly), MOBILITY DECREASED (Could not move properly, bathroom properly), DYSGEUSIA (food tasting like metallic), FRUSTRATION TOLERANCE DECREASED (frustrated) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not bathroom properly). Concomitant medication list was not provided. It was reported that the patient received the vaccine and missed work for 2 weeks because of it. Patient wanted to know when these symptoms were going to leave the patient. The patient was more frustrated than before after this shot was given to patient. Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Mobility decreased
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED WORK ABILITY (i missed work), INSOMNIA (still not able to sleep properly), MOBILITY DECREASED (Could not move properly, bathroom properly), DYSGEUSIA (food tasting like metallic) and FRUSTRATION TOLERANCE DECREASED (frustrated) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. 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 IMPAIRED WORK ABILITY (i missed work), INSOMNIA (still not able to sleep properly), MOBILITY DECREASED (Could not move properly, bathroom properly), DYSGEUSIA (food tasting like metallic), FRUSTRATION TOLERANCE DECREASED (frustrated) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not bathroom properly). At the time of the report, IMPAIRED WORK ABILITY (i missed work) had resolved and INSOMNIA (still not able to sleep properly), MOBILITY DECREASED (Could not move properly, bathroom properly), DYSGEUSIA (food tasting like metallic), FRUSTRATION TOLERANCE DECREASED (frustrated) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not bathroom properly) had not resolved. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered IMPAIRED WORK ABILITY (i missed work) to be related. No further causality assessments were provided for INSOMNIA (still not able to sleep properly), MOBILITY DECREASED (Could not move properly, bathroom properly), DYSGEUSIA (food tasting like metallic), FRUSTRATION TOLERANCE DECREASED (frustrated) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not bathroom properly). Concomitant medication list was not provided. It was reported that the patient received the vaccine and missed work for 2 weeks because of it. Patient wanted to know when these symptoms were going to leave the patient. The patient was more frustrated than before after this shot was given to patient. Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; Poor quality product administered; Temperature excursion occurred; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-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 29-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred) 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 (Poor quality product administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred).    No concomitant medications were reported.   No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-687690, US-MODERNATX, INC.-MOD-2022-687785, US-MODERNATX, INC.-MOD-2022-687787, US-MODERNATX, INC.-MOD-2022-687788 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687690:Original case US-MODERNATX, INC.-MOD-2022-687785: US-MODERNATX, INC.-MOD-2022-687787: US-MODERNATX, INC.-MOD-2022-687788:
Sex: U
Vaccine: COVID19-2
Symptoms: Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) 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. Previously administered products included for Product used for unknown indication: Macrobid (The patient was taking Macrobid as a prevention and developed Cough/ Raspy voice.). Past adverse reactions to the above products included Cough with Macrobid. On 30-Nov-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 an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown. No concomitant medicine was reported. No treatment medicine was reported. This case was linked to MOD-2022-679102 (Patient Link).