chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: RV1, RV1
Symptoms: Incomplete course of vaccination
Clinical narrative: Dose 2 has not been administered as of yet; patient received the first dose of rotarix 26 weeks and 1 day ago; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a neonate male patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included Rota (Rotarix lyophilized formulation) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Rotarix lyophilized formulation. On an unknown date, the patient did not receive the 2nd dose of Rotarix lyophilized formulation. In MAR-2023, an unknown time after receiving Rotarix lyophilized formulation and not applicable after receiving Rotarix lyophilized formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: patient received the first dose of rotarix 26 weeks and 1 day ago). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Dose 2 has not been administered as of yet).  The outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-SEP-2023 The patient received the 1st dose of Rotarix before recommended age, which led to inappropriate age at vaccine administration and till the time of reporting the patient did not receive the 2nd dose of Rotarix, which led to incomplete course of vaccination. The reporter did not consent to follow-up. No additional information provided.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Medical Assistant administered a dose of Engerix-B to a 65 year old male patient on 20Sep2023 from lot 7XY23, which had an expiration date of 29Apr2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 65-year-old male patient who received HBV (Engerix B) (batch number 7XY23, expiry date 29-APR-2023) for prophylaxis.   On 20-SEP-2023, the patient received the 1st dose of Engerix B. On 20-SEP-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Medical Assistant administered a dose of Engerix-B to a 65 year old male patient on 20Sep2023 from lot 7XY23, which had an expiration date of 29Apr2023).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2023 Nurse reports that a Medical Assistant administered a dose of Engerix-B patient on 20th September 2023 which had an expiration date of 29th April 2023 which led to expired vaccine used.  This was the patient's first dose in the series. At the time of reporting, the dose has not been repeated. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: receives one dose of Shingrix but it has now been over a year and they never received the second dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: receives one dose of Shingrix but it has now been over a year and they never received the second dose).The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2023 The reporter wanted to know if a patient received one dose of Shingrix but it had now been over a year and they never received the second dose, could we give it or we had to start all over with the series. Till the time of reporting , the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received second dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 03 February 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received second dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2023 The reporter stated that she got her first dose of Shingrix and had not yet received her second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received dose 1 of shingrix on 8/3/2023 and dose 2 on 8/16/2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number YZ9F7, expiry date 08-JUL-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 16-AUG-2023, the patient received the 2nd dose of Shingrix. On 16-AUG-2023, an unknown time after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short (Verbatim: received dose 1 of shingrix on 8/3/2023 and dose 2 on 8/16/2023).The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date:21-Sep-2023 The patient received 1st dose of Shingrix on 3rd August 2023. No reactions were reported. The reporter consented to follow up via postal. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: Incomplete dose/part of a dose of Arexvy leaked from the needle; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 63-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7L273) for prophylaxis.   On 21-SEP-2023, the patient received Arexvy. On 21-SEP-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: Incomplete dose/part of a dose of Arexvy leaked from the needle).The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date:21-Sep-2023 The reporter called to inform that earlier that day, during administration, part of a dose of Arexvy leaked from the needle, which led to incomplete dose administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: M
Vaccine: RSV
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: does not feel good; aches and pains; low grade fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a adult male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-SEP-2023, the patient received Arexvy. In SEP-2023, an unknown time after receiving Arexvy, the patient experienced pain (Verbatim: aches and pains) and low grade fever (Verbatim: low grade fever). On 21-SEP-2023, the patient experienced feeling unwell (Verbatim: does not feel good).  The outcome of the pain, low grade fever and feeling unwell were not resolved.   It was unknown if the reporter considered the pain, low grade fever and feeling unwell to be related to Arexvy.     It was unknown if the company considered the pain, low grade fever and feeling unwell to be related to Arexvy.   Additional Information: GSK Receipt Date: 21-SEP-2023 The patient reported he got the Arexvy vaccine and next day of vaccination he was not feeling good. He also had aches and pains. He had low grade fever. The patient did not want to provide any information. The reporter did not consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the diluent of Arexvy was administered; only the diluent of Arexvy was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 19-SEP-2023, the patient received Arexvy. On 19-SEP-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: only the diluent of Arexvy was administered) and inappropriate dose of vaccine administered (Verbatim: only the diluent of Arexvy was administered).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 21-SEP-2023 The pharmacist reported that only the diluent of Arexvy was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix vaccine was administered to a 2-year-old patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 18-SEP-2023, the patient received Kinrix. On 18-SEP-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix vaccine was administered to a 2-year-old patient.). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-SEP-2023 The reporter was Medical assistant. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up via email.
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Administration of Infanrix instead of Boostrix; 11 years old patient received Infanrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 03-MAR-2024) for prophylaxis.   On 16-AUG-2023, the patient received Infanrix. On 16-AUG-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Administration of Infanrix instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: 11 years old patient received Infanrix vaccine). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-SEP-2023 The reporter reported that the 11 month old patient received Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter asked if the patient had to receive Boostrix. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient received the first dose of Shingrix in 2019 and the 2nd dose on 5Jul2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number K4TG5, expiry date 31-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On 05-JUL-2023, the patient received the 2nd dose of Shingrix. On 05-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: a patient received the first dose of Shingrix in 2019 and the 2nd dose on 5Jul2023).The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 22-SEP-2023 The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not ask about follow up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 36.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient who is age 36 with NO immunocompromise who received one dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 36-year-old male patient who received Herpes zoster (Shingrix) (batch number ZS3D7) for prophylaxis.   Additional patient notes included Not immunocompromised..   On 13-SEP-2023, the patient received the 1st dose of Shingrix. On 13-SEP-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient who is age 36 with NO immunocompromise who received one dose of Shingrix).  The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt date: 22-SEP-2023 A pharmacist reported that a patient who was age 36 with no immunocompromised who received one dose of Shingrix.  The reporter stated that he/she are trying to determine the next steps, and whether or not the patient should receive dose 2 on the typical 2-6m schedule, or if it should be deferred. The 36 years old patient received Shingrix which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure difference of extremities, Blood pressure measurement, Dysgeusia, Head discomfort, Hypertension
Clinical narrative: FLUIDS RUSHING TO HEAD; 2 DIFFERENT BLOOD PRESSURE READINGS ON TWO DIFFERENT ARMS LIKE 40 OR 50 POINTS; LEFT ARM WAS NUMB; METAL TASTE IN MOUTH; BLOOD PRESSURE 260/220; BLOOD PRESSURE WAS SUPER LOW LIKE 50/30; This spontaneous report received from a patient concerned a 36 year old female. The patient's weight was 145 pounds, and height was 64 inches. The patient's past medical history included: transient vertebrobasilar insufficiency (TVI) (in 2018). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: unknown) dose was not reported, 1 total was administered on left arm on 20-SEP-2021 for covid-19 prophylaxis. Age at time of vaccination 36 years old. No concomitant medications were reported. On 20-SEP-2021, the patient experienced metal taste in mouth right almost instantaneously after vaccination. On an unspecified date in 2021, the patient's blood pressure was going up to 260/220 and experienced fluids rushing through head which patient felt scary. Patient stated, symptoms were coming and going. Last time patient was sitting at physician office and patient's blood pressure was super low like 50/30 and reported as it will do in like 30 seconds then it will go really high. Then it was 200/250. Patient asked if it could be mast cell. Patient continued reporting sometimes patient had 2 different blood pressure readings on two different arms like 40 or 50 points. Patient also reported when her blood pressure was super high whole left arm was numb patient had extremely different blood pressures on her arms, and patient felt like going to have a heart attack or stroke in the next year. Treatment medications included: cortisone shot right after the vaccine. Patient had multiple emergency room (ER) visits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the metal taste in mouth, fluids rushing to head, left arm was numb, blood pressure 260/220, blood pressure was super low like 50/30 and 2 different blood pressure readings on two different arms like 40 or 50 points was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230962553.; Sender's Comments: V0: 20230952401-blood pressure 260/220, blood pressure was super low like 50/30. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypotension
Clinical narrative: FLUIDS RUSHING TO HEAD; 2 DIFFERENT BLOOD PRESSURE READINGS ON TWO DIFFERENT ARMS LIKE 40 OR 50 POINTS; LEFT ARM WAS NUMB; METAL TASTE IN MOUTH; BLOOD PRESSURE 260/220; BLOOD PRESSURE WAS SUPER LOW LIKE 50/30; This spontaneous report received from a patient concerned a 36 year old female. The patient's weight was 145 pounds, and height was 64 inches. The patient's past medical history included: transient vertebrobasilar insufficiency (TVI) (in 2018). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: unknown) dose was not reported, 1 total was administered on left arm on 20-SEP-2021 for covid-19 prophylaxis. Age at time of vaccination 36 years old. No concomitant medications were reported. On 20-SEP-2021, the patient experienced metal taste in mouth right almost instantaneously after vaccination. On an unspecified date in 2021, the patient's blood pressure was going up to 260/220 and experienced fluids rushing through head which patient felt scary. Patient stated, symptoms were coming and going. Last time patient was sitting at physician office and patient's blood pressure was super low like 50/30 and reported as it will do in like 30 seconds then it will go really high. Then it was 200/250. Patient asked if it could be mast cell. Patient continued reporting sometimes patient had 2 different blood pressure readings on two different arms like 40 or 50 points. Patient also reported when her blood pressure was super high whole left arm was numb patient had extremely different blood pressures on her arms, and patient felt like going to have a heart attack or stroke in the next year. Treatment medications included: cortisone shot right after the vaccine. Patient had multiple emergency room (ER) visits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the metal taste in mouth, fluids rushing to head, left arm was numb, blood pressure 260/220, blood pressure was super low like 50/30 and 2 different blood pressure readings on two different arms like 40 or 50 points was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230962553.; Sender's Comments: V0: 20230952401-blood pressure 260/220, blood pressure was super low like 50/30. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Disability, Insomnia
Clinical narrative: after getting the vaccine, his mind started to feel foggy, he has felt like walking in a trampoline; Couldn't sleep; This spontaneous case was reported by a patient and describes the occurrence of BRAIN FOG (after getting the vaccine, his mind started to feel foggy, he has felt like walking in a trampoline) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had participated in a Moderna RSV study 2 years ago. Patient was non Moderna clinical trial participant.     On an unknown date, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRAIN FOG (after getting the vaccine, his mind started to feel foggy, he has felt like walking in a trampoline) (seriousness criterion medically significant) and INSOMNIA (Couldn't sleep). At the time of the report, BRAIN FOG (after getting the vaccine, his mind started to feel foggy, he has felt like walking in a trampoline) and INSOMNIA (Couldn't sleep) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  Patient confirmed that the side effects which the patient experienced were not during the time when the patient was in the study but happened during the time when the patient received the third dose of Moderna COVID-19 vaccine. Reported that patient got disabled after getting the Moderna Vaccine.  Treatment information was not reported.  Company comment- This is a spontaneous case concerning a male patient of unknown age with no medical history reported who experienced the unexpected and serious (medically significant) event brain fog. A dose of Spikevax (COVID19 Vaccine, mRNA) 2023-2024 Formula, given as a third dose of COVID vaccine schedule, was administered. It was reported patient got disabled after getting the Moderna vaccine, his mind started to feel foggy, he felt like walking in a trampoline and couldn't sleep. The benefit-risk relationship of Spikevax (COVID19 Vaccine, mRNA) 2023-2024 Formula is not affected by this report.
Sex: M
Vaccine: COVID19-2
Symptoms: Pericarditis
Clinical narrative: Suspected pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Suspected pericarditis) in a male patient of an unknown age 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 COVID-19 vaccination: BNT162B2 (previous 4 doses). Past adverse reactions to the above products included No adverse event with BNT162B2.    On an unknown date, the patient received fifth 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 PERICARDITIS (Suspected pericarditis) (seriousness criterion medically significant). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Pericarditis, at an unspecified dose and frequency. At the time of the report, PERICARDITIS (Suspected pericarditis) had resolved.            Concomitant medication was not provided. After taking Aspirin, event pericarditis resolved within a couple of days.  Company comment: This spontaneous case concerns a male patient of unknown age, with no medical history information reported, who experienced the expected serious (medically significant) event of pericarditis. The event occurred on an unknown date after the fifth dose of Spikevax bivalent BA.4/BA.5. The patient received 4 doses of Pfizer vaccine previously. As reported, the patient had suspected pericarditis after fifth dose but after taking Aspirin, it resolved within a couple of days. No further information about the event was provided. The benefit-risk relationship of Spikevax bivalent BA.4/BA.5 is not affected by this report.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: sore arms and normal soreness in the muscle; sore arms and normal soreness in the muscle; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arms and normal soreness in the muscle) and MYALGIA (sore arms and normal soreness in the muscle) in an 87-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.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   In 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In 2023, received sixth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arms and normal soreness in the muscle) and MYALGIA (sore arms and normal soreness in the muscle). At the time of the report, PAIN IN EXTREMITY (sore arms and normal soreness in the muscle) and MYALGIA (sore arms and normal soreness in the muscle) outcome was unknown.        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.   No relevant concomitant medications were reported. She had 2 Moderna COVID-19 shots in 2021 and Moderna COVID-19 booster in 2021. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741816 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741816:same Reporter Booster dose
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Chills, Decreased appetite, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: sore arms and normal soreness in the muscle; sore arms and normal soreness in the muscle; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arms and normal soreness in the muscle) and MYALGIA (sore arms and normal soreness in the muscle) in an 87-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.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   In 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In 2023, received sixth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arms and normal soreness in the muscle) and MYALGIA (sore arms and normal soreness in the muscle). At the time of the report, PAIN IN EXTREMITY (sore arms and normal soreness in the muscle) and MYALGIA (sore arms and normal soreness in the muscle) outcome was unknown.        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.   No relevant concomitant medications were reported. She had 2 Moderna COVID-19 shots in 2021 and Moderna COVID-19 booster in 2021. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741816 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741816:same Reporter Booster dose
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: sore arms and normal soreness in the muscle; sore arms and normal soreness in the muscle; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arms and normal soreness in the muscle) and MYALGIA (sore arms and normal soreness in the muscle) in an 87-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.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   In 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In 2023, received sixth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arms and normal soreness in the muscle) and MYALGIA (sore arms and normal soreness in the muscle). At the time of the report, PAIN IN EXTREMITY (sore arms and normal soreness in the muscle) and MYALGIA (sore arms and normal soreness in the muscle) outcome was unknown.        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.   No relevant concomitant medications were reported. She had 2 Moderna COVID-19 shots in 2021 and Moderna COVID-19 booster in 2021. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741816 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741816:same Reporter Booster dose
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Myalgia, Vaccination site pain
Clinical narrative: Sore arm at site of injection; Some mild muscle/shoulder aches; Some mild muscle/shoulder aches; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Sore arm at site of injection), MYALGIA (Some mild muscle/shoulder aches) and ARTHRALGIA (Some mild muscle/shoulder aches) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced VACCINATION SITE PAIN (Sore arm at site of injection), MYALGIA (Some mild muscle/shoulder aches) and ARTHRALGIA (Some mild muscle/shoulder aches). At the time of the report, VACCINATION SITE PAIN (Sore arm at site of injection), MYALGIA (Some mild muscle/shoulder aches) and ARTHRALGIA (Some mild muscle/shoulder aches) outcome was unknown.            Concomitant product use was not provided by the reporter.  After receiving Moderna Vaccine in first 48 hours patient experienced sore arm at site of injection, some mild muscle/shoulder aches. The patient had nothing that has interfered with daily activity.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Pyrexia
Clinical narrative: Dizzy; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and PYREXIA (FEVER) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016J21-2A, 091D21A, 047A21A and 006M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised, Psoriatic arthritis and Allergy (allergic to things but can't remember what they are).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy) and PYREXIA (FEVER). At the time of the report, DIZZINESS (Dizzy) and PYREXIA (FEVER) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.1.         Concomitant medications were not reported.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741940 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741940:same Reporter Monovalent  dose
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Pain in extremity
Clinical narrative: weak; had to run to the bathroom, it came out as watery; dizzy spells; arm hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurting ), ASTHENIA (weak), DIARRHOEA (had to run to the bathroom, it came out as watery) and DIZZINESS (dizzy spells) in a 72-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 205E23A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza on 12-Sep-2023 and Pfizer. Past adverse reactions to the above products included No adverse event with Influenza and Pfizer.    On 25-Sep-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PAIN IN EXTREMITY (arm hurting ). On 26-Sep-2023, the patient experienced ASTHENIA (weak), DIARRHOEA (had to run to the bathroom, it came out as watery) and DIZZINESS (dizzy spells). At the time of the report, PAIN IN EXTREMITY (arm hurting ) outcome was unknown and ASTHENIA (weak), DIARRHOEA (had to run to the bathroom, it came out as watery) and DIZZINESS (dizzy spells) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  On 25Sep2023, patient took first Moderna vaccine and had totally worse effects based on what we had before with our prior Pfizer doses. Patient arm was hurting like before, but other things that going through was bothering me. On 26Sep2023, patient felt like having dizzy spells, so patient checked temperature it was 98. Patient was tired and could not make coffee, but when did it took a while to make. Patient also felt weak. After having coffee and snack, patient had to run to the bathroom, it came out as watery, on 27Sep2023 morning patient felt the same thing after having coffee, but not to run to the bathroom yet.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-742482 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2023: Live significant follow-up received contains Historical vaccine, patient details added, and reference id updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742482:Wife Case (same reporter different patient)
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Headache, Pain, Pyrexia
Clinical narrative: body aches; Earache; Fever; headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (body aches), EAR PAIN (Earache), PYREXIA (Fever) and HEADACHE (headache) in a 72-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 058A22A) for COVID-19 prophylaxis.     The patient's past medical history included CPAP. Previously administered products included for Product used for unknown indication: J&J ((Lot# & Exp. Date: unknown)) on 17-Mar-2021 and J&J ((Lot# & Exp. Date: unknown)) on 28-Oct-2021. Past adverse reactions to the above products included No adverse event with J&J and J&J. Concurrent medical conditions included Diabetes, Atrial fibrillation, Congestive heart failure, Blood pressure high and Sleep apnea. Concomitant products included LISINOPRIL, CARVEDILOL, FUROSEMIDE, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN N), INSULIN HUMAN (NOVOLIN R), ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN C [ASCORBIC ACID], CHONDROITIN SULFATE SODIUM, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE]), MACROGOL 3350 (MIRALAX), SENNOSIDE A+B (SENOKOT), HYDROXYZINE HCL, VITAMIN D3, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and TART CHERRY for an unknown indication.    On 17-Jun-2022, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), EAR PAIN (Earache), PYREXIA (Fever) and HEADACHE (headache). At the time of the report, PAIN (body aches), EAR PAIN (Earache), PYREXIA (Fever) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient wife was stated that both had satisfaction vaccination in the past. Little things like the body aches and fever. Patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that patient did not receive any other vaccine at the same time as the Moderna Spikevax or within 4 months. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742491 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742491:Master case for Spikevax 6th Dose (2023-2024 formula)
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hot flush, Menopausal symptoms, SARS-CoV-2 test
Clinical narrative: menopause symptoms worse; COVID-19; HOT FLASHES; This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (HOT FLASHES), MENOPAUSAL SYMPTOMS (menopause symptoms worse) and COVID-19 (COVID-19) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. 04521A, 016/20A and 027/20P) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high and Drug allergy (Unspecified drug). Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HCTZ) for an unknown indication.   On 13-Jan-2021, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced HOT FLUSH (HOT FLASHES). On 24-May-2023, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced MENOPAUSAL SYMPTOMS (menopause symptoms worse). At the time of the report, HOT FLUSH (HOT FLASHES) and MENOPAUSAL SYMPTOMS (menopause symptoms worse) had not resolved and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2023, SARS-CoV-2 test: (Positive) Nasal Swab.         Patient received first dose of Moderna vaccine at 03:00 PM. The patient received second dose of Moderna vaccine at 01:00 PM. Patient had hot flashes like patient never had before. Patient sweating so badly so patient makeup runs and hair was constantly feeling oily like patient took a 5-mile run. Patient got period back exactly one month after her second vaccine, Monthly periods lasted for 6 months, then tapered off. Patient menopause symptoms round 2 were significantly worse than menopause round 1. Prior to vaccination, patient not diagnosed with COVID-19.  Treatment medications were not reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eructation, Malaise, Musculoskeletal pain, Vaccination site pain
Clinical narrative: she felt lousy with malaise and epigastralgia; She woke up several times due to epigastralgia and burping; generalized musculosceletal pain; epigastric pain/She woke up several times due to epigastralgia and burping; at 3 am had vomiting 1 episode 12 hours after vaccine administration.; injection site pain; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (she felt lousy with malaise and epigastralgia), ERUCTATION (She woke up several times due to epigastralgia and burping), MUSCULOSKELETAL PAIN (generalized musculosceletal pain), ABDOMINAL PAIN UPPER (epigastric pain/She woke up several times due to epigastralgia and burping) and VOMITING (at 3 am had vomiting 1 episode 12 hours after vaccine administration.) in a 58-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     She had not vomited even once on the past 20 plus years.     On 16-Sep-2023 at 2:30 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 17-Sep-2023, the patient experienced MALAISE (she felt lousy with malaise and epigastralgia), ERUCTATION (She woke up several times due to epigastralgia and burping), MUSCULOSKELETAL PAIN (generalized musculosceletal pain), ABDOMINAL PAIN UPPER (epigastric pain/She woke up several times due to epigastralgia and burping), VOMITING (at 3 am had vomiting 1 episode 12 hours after vaccine administration.) and VACCINATION SITE PAIN (injection site pain). The patient was treated with CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM BICARBONATE (GAVISCON ANTIACIDE ANTIREFLUX) in September 2023 at a dose of 4 tablets and PARACETAMOL (TYLENOL) in September 2023 at an unspecified dose and frequency. At the time of the report, MALAISE (she felt lousy with malaise and epigastralgia), ERUCTATION (She woke up several times due to epigastralgia and burping), MUSCULOSKELETAL PAIN (generalized musculosceletal pain), ABDOMINAL PAIN UPPER (epigastric pain/She woke up several times due to epigastralgia and burping), VOMITING (at 3 am had vomiting 1 episode 12 hours after vaccine administration.) and VACCINATION SITE PAIN (injection site pain) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No relevant concomitant medications were reported. Malaise, injection site pain, epigastric pain started a few hours after administration, which was at 2:30 pm EST on Saturday. Took antacid Gaviscon 4 tablets during the evening without improvement. She went to bed at midnight and took a Tylenol PM before going to bed. She had not vomited even once on the past 20 plus years so this was likely caused by the vaccine product. It had been more than 24 hours since administration and still she felt lousy with malaise and epigastralgia, generalized musculosceletal pain, and pain at the injection site.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: she felt lousy with malaise and epigastralgia; She woke up several times due to epigastralgia and burping; generalized musculosceletal pain; epigastric pain/She woke up several times due to epigastralgia and burping; at 3 am had vomiting 1 episode 12 hours after vaccine administration.; injection site pain; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (she felt lousy with malaise and epigastralgia), ERUCTATION (She woke up several times due to epigastralgia and burping), MUSCULOSKELETAL PAIN (generalized musculosceletal pain), ABDOMINAL PAIN UPPER (epigastric pain/She woke up several times due to epigastralgia and burping) and VOMITING (at 3 am had vomiting 1 episode 12 hours after vaccine administration.) in a 58-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     She had not vomited even once on the past 20 plus years.     On 16-Sep-2023 at 2:30 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 17-Sep-2023, the patient experienced MALAISE (she felt lousy with malaise and epigastralgia), ERUCTATION (She woke up several times due to epigastralgia and burping), MUSCULOSKELETAL PAIN (generalized musculosceletal pain), ABDOMINAL PAIN UPPER (epigastric pain/She woke up several times due to epigastralgia and burping), VOMITING (at 3 am had vomiting 1 episode 12 hours after vaccine administration.) and VACCINATION SITE PAIN (injection site pain). The patient was treated with CALCIUM CARBONATE, SODIUM ALGINATE, SODIUM BICARBONATE (GAVISCON ANTIACIDE ANTIREFLUX) in September 2023 at a dose of 4 tablets and PARACETAMOL (TYLENOL) in September 2023 at an unspecified dose and frequency. At the time of the report, MALAISE (she felt lousy with malaise and epigastralgia), ERUCTATION (She woke up several times due to epigastralgia and burping), MUSCULOSKELETAL PAIN (generalized musculosceletal pain), ABDOMINAL PAIN UPPER (epigastric pain/She woke up several times due to epigastralgia and burping), VOMITING (at 3 am had vomiting 1 episode 12 hours after vaccine administration.) and VACCINATION SITE PAIN (injection site pain) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No relevant concomitant medications were reported. Malaise, injection site pain, epigastric pain started a few hours after administration, which was at 2:30 pm EST on Saturday. Took antacid Gaviscon 4 tablets during the evening without improvement. She went to bed at midnight and took a Tylenol PM before going to bed. She had not vomited even once on the past 20 plus years so this was likely caused by the vaccine product. It had been more than 24 hours since administration and still she felt lousy with malaise and epigastralgia, generalized musculosceletal pain, and pain at the injection site.