chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Computerised tomogram abnormal, Herpes zoster
Clinical narrative: shingles; back pain, he had to go to ER; Extreme stomach pain, had to go to ER; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2022, the patient received the 1st dose of Shingrix. On 7th December 2022, 7 days after receiving Shingrix, the patient experienced back pain and stomach pain. On 11th December 2022, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the back pain and stomach pain were unknown.   The reporter considered the shingles, back pain and stomach pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-DEC-2022 Reporter's comments : The patient had stated that, he got the first Shingrix dose in left arm.  He stated that, one week later on 07 December 2022, he had extreme stomach and back pain and had to go the Emergency room (ER). He stated that a cat scan was taken at the ER.  He had reported, after seeing his physician on 12 December 2022.  The patient had stated that, he has had shingles since 11 December 2022.  The patient had stated that, he had filled out a GSK online questionnaire saying that he got shingles from Shingrix.  He was unsure whether he had filled out a online safety AE report.  No further information was reported to the agent by the patient. The patient did not know the lot number or expiration date of the Shingrix that, he had received.  The reporter did not consent to follow-up. Additional supportive information: 11 days receiving Shingrix, the patient experienced shingles.
Age: 54.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 54-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st December 2022, the patient received the 1st dose of Havrix (intramuscular) and Havrix Pre-Filled Syringe Device. On 21st December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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-Dec-2022 Reporter's comment: The call transferred to medical information department for further information on expired vaccines. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix in right deltoid, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose a year ago, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose over a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. The action taken with Shingrix was unknown. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 22-Dec-2022 Reporter's comment: The reporter asked about vaccination date for first dose but did not had it because it was at a different pharmacy, did not had information on batch nor expiration date either because of same reason. Second dose has not been administered. The reporter consented to follow-up via email. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 20-Jun-2022, 2nd on 18-Nov-2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 77-year-old male patient who received HAB (Twinrix) (batch number J477Y, expiry date 24th May 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix  (received first dose on 20th June 2022).   On 8th November 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 8th November 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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-Dec-2022 Reporter's comment: The reporter called in to ask the validity of the doses given to a patient of Twinrix.  The third dose was received on 21st December 2022.  Data for the adverse event report was given, including information pertaining to patient and each vaccine's lot number and expiration date. The vaccine administration facility was the same as primary reporter. The call was escalated to second line. The reporter consented to follow-up. Additional supportive information: The patient received the second dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule. As it was not clear that the reported batch number and expiration date (43SYY and 31st January 2023 and 2KL55 and 30th September 2023) were for which dose, therefore this information was captured in narrative and for further clarification query was raised.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Condition aggravated, Dyspnoea, Inflammation, Inflammatory marker increased
Clinical narrative: tachycardia; inflammation in her body; could not get up from the floor; muscle pain /could not get up; shortness of breath; no muscle strength / in legs; congestive heart failure; hospitalized for decomposition of muscles; This case was reported by a consumer via call center representative and described the occurrence of muscle degeneration in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included congestive heart failure. Previously administered products included Shingrix (received 1st dose in July 2022). Concurrent medical conditions included autoimmune disorder.   In October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a month after receiving Shingrix, the patient experienced muscle degeneration (serious criteria hospitalization), muscle pain (serious criteria hospitalization), shortness of breath (serious criteria hospitalization), muscle weakness (serious criteria hospitalization), inflammation (serious criteria hospitalization) and mobility decreased (serious criteria hospitalization). On 28th October 2022, the patient experienced tachycardia (serious criteria hospitalization). On an unknown date, the patient experienced congestive heart failure (serious criteria hospitalization and GSK medically significant). The patient was treated with milrinone. On an unknown date, the outcome of the muscle degeneration, shortness of breath, muscle weakness, inflammation, mobility decreased and congestive heart failure were unknown and the outcome of the muscle pain and tachycardia were not recovered/not resolved.   It was unknown if the reporter considered the muscle degeneration, muscle pain, shortness of breath, muscle weakness, tachycardia, inflammation, mobility decreased and congestive heart failure to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR192857   Additional Information: GSK Receipt Date: 23 DEC 2022 Reporter's comment: The patient reported that got Shingrix vaccine in July 2022 and October of 2022.  The patient reported had muscle pain, shortness of breath, and no muscle strength right after getting the second Shingrix shot, further described her muscle pain by saying said she could not get up from the floor and had no strength in her legs.  The patient said was hospitalized from 28th October 2022 to 31st October 2022  for decomposition of muscles. Patient said had tachycardia since her 28th October 2022 hospitalization. The patient reported said her doctor said there was inflammation in body based off her labs from the 28th October 2022 hospital visit. The patient also reported that was hospitalized from 9th December 2022 to 17th December 2022 for congestive heart failure and tachycardia. During that hospital stay she tried Milrinone intravenous that made her tachycardia worse. Patient reported that had congestive heart failure before getting Shingrix.; Sender's Comments:  US-GSK-US2022AMR192857:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Muscle atrophy, Muscular weakness, Myalgia, Tachycardia
Clinical narrative: tachycardia; inflammation in her body; could not get up from the floor; muscle pain /could not get up; shortness of breath; no muscle strength / in legs; congestive heart failure; hospitalized for decomposition of muscles; This case was reported by a consumer via call center representative and described the occurrence of muscle degeneration in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included congestive heart failure. Previously administered products included Shingrix (received 1st dose in July 2022). Concurrent medical conditions included autoimmune disorder.   In October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a month after receiving Shingrix, the patient experienced muscle degeneration (serious criteria hospitalization), muscle pain (serious criteria hospitalization), shortness of breath (serious criteria hospitalization), muscle weakness (serious criteria hospitalization), inflammation (serious criteria hospitalization) and mobility decreased (serious criteria hospitalization). On 28th October 2022, the patient experienced tachycardia (serious criteria hospitalization). On an unknown date, the patient experienced congestive heart failure (serious criteria hospitalization and GSK medically significant). The patient was treated with milrinone. On an unknown date, the outcome of the muscle degeneration, shortness of breath, muscle weakness, inflammation, mobility decreased and congestive heart failure were unknown and the outcome of the muscle pain and tachycardia were not recovered/not resolved.   It was unknown if the reporter considered the muscle degeneration, muscle pain, shortness of breath, muscle weakness, tachycardia, inflammation, mobility decreased and congestive heart failure to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR192857   Additional Information: GSK Receipt Date: 23 DEC 2022 Reporter's comment: The patient reported that got Shingrix vaccine in July 2022 and October of 2022.  The patient reported had muscle pain, shortness of breath, and no muscle strength right after getting the second Shingrix shot, further described her muscle pain by saying said she could not get up from the floor and had no strength in her legs.  The patient said was hospitalized from 28th October 2022 to 31st October 2022  for decomposition of muscles. Patient said had tachycardia since her 28th October 2022 hospitalization. The patient reported said her doctor said there was inflammation in body based off her labs from the 28th October 2022 hospital visit. The patient also reported that was hospitalized from 9th December 2022 to 17th December 2022 for congestive heart failure and tachycardia. During that hospital stay she tried Milrinone intravenous that made her tachycardia worse. Patient reported that had congestive heart failure before getting Shingrix.; Sender's Comments:  US-GSK-US2022AMR192857:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Sarcoidosis
Clinical narrative: EXACERBATED SARCOIDOSIS SYMPTOMS; This spontaneous report received from a patient via a company representative via social media (J and J Corporate) 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: sarcoidosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total, administered 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 exacerbated sarcoidosis symptoms and had hard enough time fighting the horrible rare disease for which no one knows how to treat. It was reported that "I just read where the COVID vac may have caused some people to have Sarcoidosis and or at least exacerbated my symptoms. I'm having a hard enough time fighting this horrible rare disease that no one knows how to treat, let alone the fact if I get the booster I can have a flare. No more for me". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from exacerbated sarcoidosis symptoms. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221257157.; Sender's Comments: V0: 20221257169-exacerbated sarcoidosis symptoms. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Muscle spasms, Visual impairment
Clinical narrative: GRAND MAL SEIZURE; VISION SUDDENLY GOT MUCH WORSE; LEG CRAMPS; This spontaneous report received from a consumer via a company representative through social media (J and J Corporate) concerned a male of unspecified age, race and ethnicity. 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 not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date 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 grand mal seizure, vision suddenly got much worse for which the eye doctor was shocked (physician office) and also had leg cramps that made patient and his wife to wake up at night.  The reporter stated that "My husband had a grand mal seizure after the J and J vax. Vision suddenly got much worse, too. Our eye doctor was shocked. Also leg cramps that wake us both up at night. 13K dollars in medical bills. Never again". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the grand mal seizure, vision suddenly got much worse and leg cramps was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20221257823- Grand mal seizures- The event has a 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: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: LOST TWO FRIENDS; This spontaneous report received from a consumer via a company representative concerned multiple patients (2 friends) of an unspecified age, sex, race and ethnicity.  The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date 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 reporter lost two friends (death). The reporter stated that "I lost two friends and one very sick after taking vaccines in relation to Covid19. I never took any of them after researching the data and the complexity of the double tongue information coming out when the outbreak first appeared.  The cause of death and date of death was not reported. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221257738 and 20221261382.; Sender's Comments: V0: 20221257837-Lost two friends. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Death, Emotional distress
Clinical narrative: DIED; SUFFERING; This spontaneous report received from a consumer via a company representative concerned multiple patients of an unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 in total, 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 patients were suffering (unspecified). On an unspecified date, the patients died from an unknown cause of death. It was unknown if an autopsy was performed. It was reported that, "I can tell you so many people I personally know are suffering or died from this shot. Yet there are others everywhere trying to stifle stories like yours. Maybe others will learn something if they read some of the suffering". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suffering was not reported. This report was serious (Death).; Sender's Comments: V0-20221259339-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Death, Off label use
Clinical narrative: IT KILLED; OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer through via a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received 2 doses (2 shots) of covid-19 vaccine (unspecified manufacturer) (dose number in series: 1) (form of admin, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with 2 doses of covid-19 vaccine (unspecified manufacturer) (dose number in series: 1). The patient had previously received first booster of covid-19 vaccine ad26.cov2.s (dose number in series: 2) (unspecified manufacturer) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first booster of covid-19 vaccine ad26.cov2.s (dose number in series: 2) The patient received second booster of covid-19 vaccine ad26.cov2.s (dose number in series: 3) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was off label dosing frequency and revaccination with different covid-19 vaccine (dose number in series: 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  The reporter reported that it (vaccine) killed (death) patient on an unspecified date (dose number in series: 3). On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. It was reported that "It Killed my sister 2 shots & double boosted". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from unknown cause of death on an unspecified date, and the outcome of off label dosing frequency and revaccination with different covid-19 vaccine was not reported. This report was serious (Death). This case, from the same reporter is linked to 20221259495.; Sender's Comments: V0: 20221259488 - It killed. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative concerned 06 multiple patients. 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, expiry: UNKNOWN) dose was not reported, 1 total, administered on 2021 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 patients experienced death. On 2021, the patients died from unknown cause of death. It was unknown whether an autopsy was performed or not. It was reported as "No problems yet. You have 2 to 5 years. It Killed my sister, 2 shots & double boosted. And I've had 6 of my young friends in the last year die after taking the jab. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221259488.; Sender's Comments: V0-20221259495-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Renal infarct, Thrombosis, Vasculitis
Clinical narrative: BLOOD CLOTS/SLOUGHING CLOTS; MULTIPLE BILATERAL KIDNEY INFARCTS; BLOOD VESSEL INFLAMMATION; This spontaneous report received from a parent via a company representative through social media concerned a male of unspecified age, race and ethnicity. 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 and expiry were not reported) dose, start therapy date were not reported, 1 total administered 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 blood clots/sloughing clots, multiple bilateral kidney infarcts, and blood vessel inflammation. Laboratory data (dates unspecified) included: 13 Blood test shows zero clotting factor diseases or predisposition to those diseases. Treatment medications (dates unspecified) included: hydroxychloroquine.  It was reported as "our son threw blood clots and suffered multiple bilateral kidney infarcts after his shot. He's lucky those clots didn't lodge in his heart or brain...and 13 blood tests prove he has zero clotting factor diseases or predisposition to those diseases. He did have blood vessel inflammation and was forming and sloughing clots due to that damn shot.. Hydroxychloroquine was prescribed to reduce the inflammation. So far so good. How many people would still be alive today if HCQ was used in the early course of covid to treat the massive inflammation that ravages bodies in severe cases......makes me sick how big pharma and this administration have treated..... and of course, no one can be held liable...how very convenient ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots/sloughing clots, multiple bilateral kidney infarcts and blood vessel inflammation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20221259540- Multiple bilateral kidney infarcts- The event has a 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.  V0-20221259540- Blood clots/sloughing clots- The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM FOR A FEW DAYS; This spontaneous report received from a patient via a company representative concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included: prostate cancer (prostate removed), and prostate removed, and concurrent conditions included: raynaud's syndrome, diverticulosis, and prediabetes, and other pre-existing medical conditions included: The patient received pneumonia vaccines and shingles vaccines (unspecified dates). The patient did not have covid. 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. Age at time of vaccination 8 decade old. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included influenza vaccine for prophylactic vaccination. On an unspecified date, the patient experienced sore arm for a few days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm for a few days. This report was non-serious. This case, from the same reporter is linked to 20221260594.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM FOR A FEW DAYS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had received pneumonia vaccines and shingles vaccines (unspecified date). The patient have not had covid. 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. Concomitant medications included influenza vaccine for prophylactic vaccination. On an unspecified date, the patient experienced sore arm for a few days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm for a few days. This report was non-serious. This case, from the same reporter is linked to 20221260450.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: PERMANENTLY DAMAGED; This spontaneous report received from a consumer via a company representative through social media (J and J corporate) concerned multiple patients of an unspecified sex, age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered 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 patients experienced permanently damaged (adverse event nos), and was hospitalized (in and out of the hospital constantly). It was reported as "you're pretty clueless to think her hysteria caused her conditions. Just plug along like a good little citizen and ask no questions. Some day, you will wake up because it will happen to you or someone you know. I have friends in and out of the hospital constantly after receiving these vaccines. Some used to think like you. Permanently damaged with no solution in sight. It's the criminal what these companies have gotten away with. But guess what They're making more vaccines because they got away with it and they are looking to do it all over again. In to of that, they can prescribe more drugs to those damaged. More for them". The number of days of hospitalization was not reported and it was unsure if the patients was discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of permanently damaged was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20221260646- Permanently damaged- Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; 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 suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000264965.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: VERY SICK; This spontaneous report received from a consumer 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 very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20221257837 and 20221257738.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; 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 was not reported, administered on APR-2021 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 suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000265083 This case, from the same reporter is linked to 20221263145.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 12 hours post first puncture.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post first puncture) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Dec-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) .5 milliliter. On 23-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 (Dose administered after 12 hours post first puncture.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post first puncture.) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post first puncture.).    No concomitant products were reported by the reporter.  It was unknown if patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine. Patient received first dose on 07-Apr-2021, second dose on 05-May-2021 and first booster on 29-Dec-2021 all from Moderna. Patient was administered with vaccine after 12 hours post puncture. Patient did not reported any side effects.  No treatment medication reported by the reporter.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Magnetic resonance imaging, Tinnitus
Clinical narrative: Sudden right hearing loss; Tinnitus of right ear; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS UNILATERAL (Sudden right hearing loss) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21H) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2022, the patient experienced DEAFNESS UNILATERAL (Sudden right hearing loss) (seriousness criterion medically significant) and TINNITUS (Tinnitus of right ear). At the time of the report, DEAFNESS UNILATERAL (Sudden right hearing loss) and TINNITUS (Tinnitus of right ear) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: showed no issues of concern.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   It was reported that after the booster patient had sudden right hearing loss and tinnitus of right ear.  Patient went to three doctor's and the expert ENT doctor, advised an MR Brain internal auditory canal temporal bond (MRI).  Treatment medication was not provided.  Company Comment: This spontaneous case concerns a 54-year old male patient with no medical history reported, who experienced the unexpected Serious (medically significant) event of deafness unilateral (sudden right hearing loss), around 25 days after receiving the booster dose of mRNA-1273 Vaccine. Patient also experienced tinnitus (non serious) in the same ear around the same time. Patient was advised an MR Brain Internal Auditory Canal Temporal Bond (MRI). The MRI showed no issues of concern. It is unknown if the patient experienced any additional symptoms/events. Events had not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 54-year old male patient with no medical history reported, who experienced the unexpected Serious (medically significant) event of deafness unilateral (sudden right hearing loss), around 25 days after receiving the booster dose of mRNA-1273 Vaccine. Patient also experienced tinnitus (non serious) in the same ear around the same time. Patient was advised an MR Brain  Internal Auditory Canal Temporal Bond (MRI). The MRI showed no issues of concern. It is unknown if the patient experienced any additional symptoms/events. Events had not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 94.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I got Covid after my 2nd booster in the last week in August 2022.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I got Covid after my 2nd booster in the last week in August 2022.) in a 94-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In August 2022, the patient experienced COVID-19 (I got Covid after my 2nd booster in the last week in August 2022.). At the time of the report, COVID-19 (I got Covid after my 2nd booster in the last week in August 2022.) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication was provided.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Dose administered after 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post puncture) and NO ADVERSE EVENT (No Adverse Event) in an 18-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 23-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 23-Dec-2022,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post puncture) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours post puncture).    No relevant concomitant medications were reported.  No treatment information was provided.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; got Moderna Bivalent for 1st dose of series, instead of Moderna Monovalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (got Moderna Bivalent for 1st dose of series, instead of Moderna Monovalent) and NO ADVERSE EVENT (no adverse event) in a 65-year-old 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.     No Medical History information was reported.    On 27-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 27-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (got Moderna Bivalent for 1st dose of series, instead of Moderna Monovalent). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (got Moderna Bivalent for 1st dose of series, instead of Moderna Monovalent) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (got Moderna Bivalent for 1st dose of series, instead of Moderna Monovalent).    Concomitant medication was not reported. Treatment drug was not reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Rash, Rash pruritic
Clinical narrative: rash which was prevalent in the evening located on her stomach and arms; rash is itchy; swollen lymph nodes; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), LYMPHADENOPATHY (swollen lymph nodes), RASH (rash which was prevalent in the evening located on her stomach and arms) and RASH PRURITIC (rash is itchy) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Allergy to cats and aspirin, no concomitant medical conditions.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (lot number 039K20A ) on 14-Jan-2021, Moderna COVID-19 Vaccine (lot number 031L20A ) on 11-Feb-2021, Moderna COVID-19 Vaccine (1st booster, lot number 012F21A ) on 30-Nov-2021, Moderna COVID-19 Vaccine (2nd booster and lot number 038H22A) on 01-Jul-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Allergy to animal and Drug allergy.    On 15-Dec-2022, 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 17-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced OROPHARYNGEAL PAIN (sore throat). On 18-Dec-2022, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). On 24-Dec-2022, the patient experienced RASH (rash which was prevalent in the evening located on her stomach and arms) and RASH PRURITIC (rash is itchy). At the time of the report, OROPHARYNGEAL PAIN (sore throat), LYMPHADENOPATHY (swollen lymph nodes), RASH (rash which was prevalent in the evening located on her stomach and arms) and RASH PRURITIC (rash is itchy) was resolving.        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 concomitant medicine were reported. It was reported that the patient was fine from 15-16-Dec-2022 but on 17-Dec-2022, she came down with a sore throat. On 18-Dec-2022, patient had swollen lymph nodes under her jaw on the right side (the bivalnet booster was administered on the left arm). From 24 to 27-Dec-2022, she noticed rash which was prevalent in the evening located on her stomach and arms. The rash is itchy. The patient stated that the lymph nodes have gotten smaller and the rash lighter. No treatment medicine were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Moderna Bivalent Booster that was administered past the expiration/beyond-use date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent Booster that was administered past the expiration/beyond-use date) 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. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent Booster that was administered past the expiration/beyond-use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent Booster that was administered past the expiration/beyond-use date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent Booster that was administered past the expiration/beyond-use date).    NDC was reported as 80777-0282-05.  No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.