chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: fully vaccinated, gets shingles/ suspected vaccination failure; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included mycophenolic acid (Cellcept).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient got fully vaccinated with Shingrix 2 years ago and still got shingles. The patient had been taking Cellcept for 12 years and was also taking Valtrex. Whenever the patient stopped taking Valtrex she got shingles. The health care professional would like to know if the patient needed to get revaccinated with Shingrix. No further details were provided at the time of the call. The patient was vaccinated at a different facility, so health care professional did not have any vaccine  information. This case was considered as suspected vaccination failure as details regarding laboratory test confirming herpes zoster were unknown at the time of reporting. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose: 2019, second: did not received; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose(0.5 ml) received on 2nd october 2019, batch number 3553N, expiry date 26th November 2021, by intramuscular route on an unknonwn arm).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. 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. The VAERS details were reported for 1st dose.
Age: 42.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dose given less than 1 month; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 42-year-old male patient who received HAB (Twinrix) (batch number GG3S5, expiry date 28th February 2022) 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.   Concomitant products included HAB (Twinrix).   On 23rd June 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd June 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 details were provded as follows: The patient received 1st dose of Twinrix on 4th June 2021. The nurse reported that, the patient received 2nd dose of Twinrix, less than 1 month from 1st dose. which led to shortening of vaccination schedule. The reporter consented to follow up. This case was linked with case US2021165606, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165606:same reporter
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Respiratory disorder
Clinical narrative: Respiratory issues; This case was reported by a physician via sales rep and described the occurrence of respiratory disorder in a female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced respiratory disorder. On an unknown date, the outcome of the respiratory disorder was unknown.   It was unknown if the reporter considered the respiratory disorder to be related to Pediarix and Pediarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Health care professional reported that the patient experienced respiratory issue after receiving Pediarix. The dates of the event, the lot number or expiration dates were unknown. No further details were known. The health care professional gave permission to be contacted concerning event. The reporter consented to follow up. This case is one of the 10 cases reported by same reporter.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first  dose in March 2020 and  second  dose in July 2021; This case was reported by a consumer and described the occurrence of drug dose administration interval too long in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2020).   In July 2021, the patient received the 2nd dose of Shingrix. In July 2021, unknown after receiving Shingrix, 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.  Additional details were provided as follows: The reporter was the patient. The reporter stated that, received 2nd dose later than the recommended time interval, whch led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: first dose expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 10th September 2021) for prophylaxis.   On 14th September 2021, the patient received the 1st dose of Shingrix. On 14th September 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The pharmacist reported that, the patient was inadvertently administered first dose of Shingrix vaccine from expired supply, which led to expired vaccine used. The reporter consented to follow up. This case was linked with cases US2021197373, US2021197375, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021197373:Same reporter US-GLAXOSMITHKLINE-US2021197375:Same reporter
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: administered vaccine from expired supply; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 10th September 2021) for prophylaxis.   On 15th September 2021, the patient received the 1st dose of Shingrix. On 15th September 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The pharmacist reported that the patient was inadvertently administered first dose of Shingrix vaccine from expired supply. The dose was expired on 10th September 2021.  The reporter consented to follow up. The case has been linked with the case US2021197375 and US2021197372, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021197375:same reporter US-GLAXOSMITHKLINE-US2021197372:same reporter
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: first dose of Shingrix vaccine from expired supply; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 10th September 2021) for prophylaxis.   On 15th September 2021, the patient received the 1st dose of Shingrix. On 15th September 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The pharmacist reported that, the patient was inadvertently administered first dose of Shingrix vaccine from expired supply, which led to expired vaccine used. The reporter consented to follow up. This case was linked with cases US2021197373, US2021197372, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021197373:same reporter US-GLAXOSMITHKLINE-US2021197372:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Fatigue; This case was reported by a consumer and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional case details were reported as follows:  The patient self-reported this case. The age at vaccination was not reported. The patient had some fatigue for 12 hours after getting the dose of the shingrix vaccine. The fatigue improved without any intervention.  No health care professional information available for reporting. The reporter did not consent to follow up. No other information was reported.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 8/26/2019, second dose 9/16/2021; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too long in a 86-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st doe received on 26th August 2019).   On 16th September 2021, the patient received the 2nd dose of Shingrix. On 16th September 2021, unknown after receiving Shingrix, 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.  Additional details were provided as follows: The pharmacist stated that, the patient received 2nd dose of Shingrix later than the recommended time interval, which led to lengthening of vaccination schedule. No medical primary care physician information provided. Spoke per Shingrix FAQ. Gave phone number for Medical Information to be provided to consumers physician. The reporter did not consent to follow up. Theis case was linked with case US2020025200, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020025200:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Administered a vx after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th September 2021, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that a Shingrix vaccine had a temperature excursion.  The lowest temperature that the vaccine reached was 22.5 degree F for 4 hours with a previous excursion for 1 hour. The pharmacist stated that a patient received a dose of one of these vaccines on 15th September 2021.  The pharmacist did not have the patient's demographic information. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration
Clinical narrative: Dark unraised mark at injection site; This case was reported by a pharmacist and described the occurrence of injection site discoloration in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved.   The reporter considered the injection site discoloration to be related to Shingrix.  Additional details were reported as follows; The pharmacist reported that the patient had a dark mark at the site of his Shingrix injection. The patient received 2nd dose of Shingrix and mentioned still the mark was present at site of injection. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not go for second dose; This case was reported by a consumer via and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in late December 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, did not go for second dose for various reasons and decided to postpone until now. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter provided very limited information when asked. The reporter gave a consent to follow-up with health care professional. However, he did not have the name of the facility, full mailing address, phone/fax number and an email address to health care professional at the time of the call. The reporter chose not to provide his personal email address. The VAERS details were reported fopr 1st dose of Shingrix.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: administered a dose already expired; This case was reported by a nurse and described the occurrence of expired vaccine used in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number PL9T9, expiry date 3rd September 2021) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 16th September 2021, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 16th September 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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 details were provided as follows: The nurse reported that medical assistant administered a dose of Rotarix which was already expired on 3rd September 2021, which led to expired vaccine used. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Nerve compression, Palpitations, Rhinorrhoea
Clinical narrative: pinched nerve; pain with lifting; fast heart beat/3-4 times/made me jump up from the sofa; He recently had been to the dentist and was prescribed pain medications; extreme fatigue/feels tired after 1/4 mile; wakes him up at night/cannot stay up late enough to watch the soccer games/going to bed at 8:30/Went to sleep at 5:30 last saturday; secretions from my nose; Left arm pain/bad pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (He recently had been to the dentist and was prescribed pain medications), SLEEP DISORDER (wakes him up at night/cannot stay up late enough to watch the soccer games/going to bed at 8:30/Went to sleep at 5:30 last saturday), NERVE COMPRESSION (pinched nerve), VACCINATION SITE MOVEMENT IMPAIRMENT (pain with lifting) and PALPITATIONS (fast heart beat/3-4 times/made me jump up from the sofa) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced RHINORRHOEA (secretions from my nose), VACCINATION SITE PAIN (Left arm pain/bad pain) and NAUSEA (nausea). On 04-Sep-2021, the patient experienced SLEEP DISORDER (wakes him up at night/cannot stay up late enough to watch the soccer games/going to bed at 8:30/Went to sleep at 5:30 last saturday). On an unknown date, the patient experienced TOOTH DISORDER (He recently had been to the dentist and was prescribed pain medications), NERVE COMPRESSION (pinched nerve), VACCINATION SITE MOVEMENT IMPAIRMENT (pain with lifting), PALPITATIONS (fast heart beat/3-4 times/made me jump up from the sofa) and FATIGUE (extreme fatigue/feels tired after 1/4 mile). On 13-Apr-2021, RHINORRHOEA (secretions from my nose), VACCINATION SITE PAIN (Left arm pain/bad pain) and NAUSEA (nausea) had resolved. At the time of the report, TOOTH DISORDER (He recently had been to the dentist and was prescribed pain medications), SLEEP DISORDER (wakes him up at night/cannot stay up late enough to watch the soccer games/going to bed at 8:30/Went to sleep at 5:30 last saturday), NERVE COMPRESSION (pinched nerve), VACCINATION SITE MOVEMENT IMPAIRMENT (pain with lifting), PALPITATIONS (fast heart beat/3-4 times/made me jump up from the sofa) and FATIGUE (extreme fatigue/feels tired after 1/4 mile) outcome was unknown.            Concomitant products included ANTIBIOTICS. No treatment medications were provided.   This case was linked to MOD-2021-317246 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Tooth disorder, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: pinched nerve; pain with lifting; fast heart beat/3-4 times/made me jump up from the sofa; He recently had been to the dentist and was prescribed pain medications; extreme fatigue/feels tired after 1/4 mile; wakes him up at night/cannot stay up late enough to watch the soccer games/going to bed at 8:30/Went to sleep at 5:30 last saturday; secretions from my nose; Left arm pain/bad pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (He recently had been to the dentist and was prescribed pain medications), SLEEP DISORDER (wakes him up at night/cannot stay up late enough to watch the soccer games/going to bed at 8:30/Went to sleep at 5:30 last saturday), NERVE COMPRESSION (pinched nerve), VACCINATION SITE MOVEMENT IMPAIRMENT (pain with lifting) and PALPITATIONS (fast heart beat/3-4 times/made me jump up from the sofa) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced RHINORRHOEA (secretions from my nose), VACCINATION SITE PAIN (Left arm pain/bad pain) and NAUSEA (nausea). On 04-Sep-2021, the patient experienced SLEEP DISORDER (wakes him up at night/cannot stay up late enough to watch the soccer games/going to bed at 8:30/Went to sleep at 5:30 last saturday). On an unknown date, the patient experienced TOOTH DISORDER (He recently had been to the dentist and was prescribed pain medications), NERVE COMPRESSION (pinched nerve), VACCINATION SITE MOVEMENT IMPAIRMENT (pain with lifting), PALPITATIONS (fast heart beat/3-4 times/made me jump up from the sofa) and FATIGUE (extreme fatigue/feels tired after 1/4 mile). On 13-Apr-2021, RHINORRHOEA (secretions from my nose), VACCINATION SITE PAIN (Left arm pain/bad pain) and NAUSEA (nausea) had resolved. At the time of the report, TOOTH DISORDER (He recently had been to the dentist and was prescribed pain medications), SLEEP DISORDER (wakes him up at night/cannot stay up late enough to watch the soccer games/going to bed at 8:30/Went to sleep at 5:30 last saturday), NERVE COMPRESSION (pinched nerve), VACCINATION SITE MOVEMENT IMPAIRMENT (pain with lifting), PALPITATIONS (fast heart beat/3-4 times/made me jump up from the sofa) and FATIGUE (extreme fatigue/feels tired after 1/4 mile) outcome was unknown.            Concomitant products included ANTIBIOTICS. No treatment medications were provided.   This case was linked to MOD-2021-317246 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Neutralising antibodies, SARS-CoV-2 antibody test, Therapy partial responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; ASYMPTOMATIC COVID-19 INFECTION; This spontaneous report was received from literature. This report concerned a patient of unspecified age, sex, race and ethnic origin. The objective of this study was to describe predominance of infection of antibody-resistant SARS-CoV-2 variants in vaccine breakthrough cases. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose and start therapy date were not reported, frequency time 1 total was administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had asymptomatic covid-19 infection which was confirmed with COVID-19 RT- PCR (Reverse transcription polymerase chain reaction) test by NP (Nasopharyngeal swab) which was positive for delta variant .Two days later, the patient underwent neutralizing antibodies test which was found to be  2851 (low response for delta variant), 11404 (WT (wild type) D614G), 5702 (alpha), 898 (beta), 11404 (gamma), 2263 (epsilon). SARS-CoV-2 IgG (Immunoglobin G) antibody spike protein test was found to be positive (3889.68), and IgG Nucleoprotein was found to be negative (0.88), and SARS-CoV-2 IgM (Immunoglobulin M) antibody test  was also (0.73) negative. Overall the interpretation of the antibody tests were failure to mount adequate antibody response to the vaccine (suspected immunological vaccination failure). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected immunological vaccination failure and asymptomatic covid-19 infection was not reported. The authors concluded that vaccine breakthrough cases were preferentially caused by circulating antibody-resistant SARS-CoV-2 variants and that symptomatic breakthrough infections may potentially transmit COVID-19 as efficiently as unvaccinated infections, regardless of the infecting lineage. Also, targeted booster vaccinations with monitoring of vaccine efficacy will likely be needed in the near future to control the viral spread in the community. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. This case, from the same reporter is linked to 20210855269 and 20210855307.; Sender's Comments: V0: 20210861203-COVID-19 VACCINE AD26.COV2.S - Suspected immunological vaccine failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: ANAPHYLAXIS; This spontaneous report was received from literature.  This report concerned a patient of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: systemic rheumatic disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced anaphylaxis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylaxis was not reported. The authors concluded that among adults with systemic rheumatic disease who received COVID-19 vaccination, patient-reported adverse events were typical of those reported in the general population. Most patients were willing to temporarily discontinue DMARDs to improve vaccine efficacy. The relatively low frequency of rheumatic disease flare requiring medications was reassuring This report was serious (Other Medically Important Condition) This case, from same literature article is linked to 20210918818, 20210918812, 20210918764, 20210918729, 20210918708, 20210918826, 20210918687, 20210918753 and 20210918737; Sender's Comments: V0: 20210918775-COVID-19 VACCINE AD26.COV2.S-Anaphylaxis- This event(s) is labeled per Information and is therefore considered potentially related.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: ALL OF THE OUTLINE SYMPTOMS OF THE WARNING OF THE JOHNSON AND JOHNSON PAMPHLET ON THE FIRST PAGE OF DESCRIPTION OF COVID 19 (HEAD BURNING UP/PAIN AND SUFFERING); This spontaneous legal report received from a patient via a company representative concerned a 45 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On 10-JUL-2021, the patient experienced all of the outline symptoms of the warning of the johnson and johnson pamphlet on the first page of description of covid 19 (head burning up/pain and suffering). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of all of the outline symptoms of the warning of the johnson and johnson pamphlet on the first page of description of covid 19 (head burning up/pain and suffering) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210920840.; Sender's Comments: V0: 20210920740-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Thrombocytopenia, Toothache
Clinical narrative: TRANSIENT THROMBOCYTOPENIA WITH GLYCOPROTEIN SPECIFIC PLATELET AUTOANTIBODIES; DENTAL PAIN; This spontaneous report was received from literature. This report concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: polymyalgia rheumatica, and acute right ear infection, and other pre-existing medical conditions included: The heparinplatelet factor 4 antibody enzyme-linked immunosorbent assay, both of which had unremarkable findings (the assay optical density was 0.057; reference, <0.400). The patient was previously treated with prednisone for polymyalgia rheumatica. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown ) one total dose, start therapy date were not reported for prophylactic vaccination. The batch number not reported has been requested. No concomitant medications were reported.  The 35 days after vaccination she developed headaches in the left temporal region, prompting evaluation by her rheumatologist for possible giant cell arteritis given her history of polymyalgia rheumatica. She did not report recurrence of polymyalgia rheumatic symptoms, and giant cell arteritis. The patient's headaches were ultimately attributed to referred dental pain due to occlusal trauma from a temporary dental bridge, and they resolved after dental intervention. The patient results were positive for platelet autoantibodies directed against all 3 glycoproteins at optical densities (transient thrombocytopenia with glycoprotein specific platelet autoantibodies). Laboratory data (dates unspecified) included: Autoantibody test (NR: not provided) Positive (units unspecified), negative, C-reactive protein (NR: not provided) 1.0 mg/L, Complete blood count (NR: not provided) Not reported, Erythrocyte sedimentation rate (NR: 0 - 22) 8 mm/h, Nuclear magnetic resonance angiography brain (NR: not provided) unremarkable findings, and Platelet count (NR: not provided) 143 X 10 9 cells/L, 429 x109 cells/L, 96 X 10 9 cells/L, 76 X 10 9 cells/L, 248 X 10 9 cells/L, 67 X 10 9 cells/L, 56 X 10 9 cells/L, 115 x 10 9 cells/L, 55 to 110 X 10 9 cells/L, 59 X 10 9 cells/L. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dental pain, and was recovering from transient thrombocytopenia with glycoprotein specific platelet autoantibodies. This report was serious (Other Medically Important Condition).  The author emphasized if antiviral spike protein antibodies cross-reactive with platelet glycoproteins resulted in this clinical presentation, thrombocytopenia due to this mechanism could occur with other SARS-CoV-2 vaccines.; Sender's Comments: V0;20210929329-covid-19 vaccine ad26.cov2. s-Thrombocytopenia with glycoprotein specific platelet autoantibodies. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Testicular swelling
Clinical narrative: TESTICLES SWELLED UP; ERECTILE DYSFUNCTION/PENIS WOULDN'T GET HARD; This spontaneous report received from a patient concerned a 44 year. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number, and expiry were not reported) dose was not reported, 1 total, administered on beginning of AUG-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, approximately 7 days later the vaccination, the patient experienced testicular swelling and went to the emergency room and was admitted to the hospital (dates unspecified). The patient also consulted with urologist, but could not provide further information. The patient was hospitalized for 7 days (date of discharge was not reported). The testicles were swollen for approximately 3 weeks. On an unspecified date, the patient also experienced erectile dysfunction. The patient experienced that his penis was not getting hard. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from testicles swelled up, and had not recovered from erectile dysfunction/penis wouldn't get hard. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210931764-COVID-19 VACCINE AD26.COV2.S- erectile dysfunction/penis wouldn't get hard, testicles swelled up. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients experienced suspected immunological vaccine failure. As per the reporter "Her physician told her that some of his patients who had the J&J vaccine did not show immunity to the spike and protein after being vaccinated on their antibody tests(negative antibody tests)." Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Negative (did not show immunity to the spike and protein). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with RA: 90000193688; Sender's Comments: V0: 20210931809-covid-19 vaccine ad26.cov2.s -suspected immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Hypoaesthesia, Lethargy, Lymphadenopathy, Nausea
Clinical narrative: SINUS INFECTION/ PAINFUL NOSE/SINUS/ SEVERE HEADACHE/ COULD NOT TOUCH HER FACE/ SICK ALL WEEKEND; BLURRY VISION; PAINFUL TEETH; VERY LETHARGIC; NAUSEOUS; SWOLLEN LYMPH NODES/ SWOLLEN GLANDS BEHIND THE KNEES/ SWOLLEN THROAT GLANDS; NUMBNESS IN THE LEFT ARM/ FELT LIKE THE AREA WHERE SHE HAD THE INJECTION WAS MISSING; TINGLY LIPS AND FACE LIKE BUGS CRAWLING AROUND; BRUISE 6 IN BENEATH THE INJECTION SITE/ GRAVITY BRUISE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included: dermal fillers, and concurrent conditions included: high blood pressure, allergy to sulfas, and reaction to vaccine in general, and other pre-existing medical conditions included: The patient was at a higher risk for blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-SEP-2021, the patient experienced bruise 6 in beneath the injection site/ gravity bruise. On 08-SEP-2021, the patient experienced numbness in the left arm/ felt like the area where she had the injection was missing. On 08-SEP-2021, the patient experienced tingly lips and face like bugs crawling around. On 09-SEP-2021, the patient experienced swollen lymph nodes/ swollen glands behind the knees/ swollen throat glands. On 10-SEP-2021, the patient experienced sinus infection/ painful nose/sinus/ severe headache/ could not touch her face/ sick all weekend. On 10-SEP-2021, the patient experienced blurry vision. On 10-SEP-2021, the patient experienced painful teeth. On 10-SEP-2021, the patient experienced very lethargic. On 10-SEP-2021, the patient experienced nauseous. On 16-SEP-2021, treatment medications included: ethambutol dihydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingly lips and face like bugs crawling around on 10-SEP-2021, had not recovered from sinus infection/ painful nose/sinus/ severe headache/ could not touch her face/ sick all weekend, and the outcome of numbness in the left arm/ felt like the area where she had the injection was missing, bruise 6 in beneath the injection site/ gravity bruise, swollen lymph nodes/ swollen glands behind the knees/ swollen throat glands, very lethargic, nauseous, painful teeth and blurry vision was not reported. This report was non-serious. This case, from the same reporter is linked to 20210933069.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Sinusitis, Toothache, Vision blurred
Clinical narrative: SINUS INFECTION/ PAINFUL NOSE/SINUS/ SEVERE HEADACHE/ COULD NOT TOUCH HER FACE/ SICK ALL WEEKEND; BLURRY VISION; PAINFUL TEETH; VERY LETHARGIC; NAUSEOUS; SWOLLEN LYMPH NODES/ SWOLLEN GLANDS BEHIND THE KNEES/ SWOLLEN THROAT GLANDS; NUMBNESS IN THE LEFT ARM/ FELT LIKE THE AREA WHERE SHE HAD THE INJECTION WAS MISSING; TINGLY LIPS AND FACE LIKE BUGS CRAWLING AROUND; BRUISE 6 IN BENEATH THE INJECTION SITE/ GRAVITY BRUISE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included: dermal fillers, and concurrent conditions included: high blood pressure, allergy to sulfas, and reaction to vaccine in general, and other pre-existing medical conditions included: The patient was at a higher risk for blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-SEP-2021, the patient experienced bruise 6 in beneath the injection site/ gravity bruise. On 08-SEP-2021, the patient experienced numbness in the left arm/ felt like the area where she had the injection was missing. On 08-SEP-2021, the patient experienced tingly lips and face like bugs crawling around. On 09-SEP-2021, the patient experienced swollen lymph nodes/ swollen glands behind the knees/ swollen throat glands. On 10-SEP-2021, the patient experienced sinus infection/ painful nose/sinus/ severe headache/ could not touch her face/ sick all weekend. On 10-SEP-2021, the patient experienced blurry vision. On 10-SEP-2021, the patient experienced painful teeth. On 10-SEP-2021, the patient experienced very lethargic. On 10-SEP-2021, the patient experienced nauseous. On 16-SEP-2021, treatment medications included: ethambutol dihydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingly lips and face like bugs crawling around on 10-SEP-2021, had not recovered from sinus infection/ painful nose/sinus/ severe headache/ could not touch her face/ sick all weekend, and the outcome of numbness in the left arm/ felt like the area where she had the injection was missing, bruise 6 in beneath the injection site/ gravity bruise, swollen lymph nodes/ swollen glands behind the knees/ swollen throat glands, very lethargic, nauseous, painful teeth and blurry vision was not reported. This report was non-serious. This case, from the same reporter is linked to 20210933069.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; BODY ACHES ALL OVER THE BODY BUT MAINLY IN THE HIPS; ARM SORENESS; FEELING FEVERISH BUT NOT A REALLY FEVER; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, in the evening of the day of vaccination (about 8 hours after vaccination), the patient had body aches all over the body but mainly in the hips, and feeling feverish but not really a fever, and arm soreness (cannot recall which arm) and were gone by 36-48 hours later. On 01-SEP-2021, the patient did an antibody blood test that showed no antibodies to the spike protein of covid-19 (negative antibody test) and developed confirmed immunological vaccination failure. Laboratory data included: COVID-19 antibody test (NR: not provided) showed no antibodies to the spike protein of covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches all over the body but mainly in the hips, arm soreness, and feeling feverish but not a really fever, and the outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with RA:90000193687.; Sender's Comments: V0: 20210934232-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Bursitis
Clinical narrative: HIP BURSITIS FLARE UP 2 WEEKS AGO; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: hip bursitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced hip bursitis flare up 2 weeks ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hip bursitis flare up 2 weeks ago. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF VACCINE (MORE THAN 6 HOURS IN FRIDGE AFTER OPENING); OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 17-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-SEP-2021, the patient experienced incorrect storage of vaccine (more than 6 hours in fridge after opening). On 17-SEP-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect storage of vaccine (more than 6 hours in fridge after opening) and out of specification product use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Pelvic inflammatory disease, Urinary tract infection
Clinical narrative: PELVIC INFLAMMATION; LITTLE URINARY TRACT INFECTION; NEGATIVE UNUSUAL SIDE EFFECTS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. No past history was reported. Patient's concurrent conditions included: food allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) were not reported, 1 total, dose was not reported, administered on 12-APR-2021 for prophylactic vaccination on right arm (patient's vaccination card says her left arm). No concomitant medications were reported.  On an unspecified date, patient experienced negative unusual side effects after the vaccine but she did not want to report that as she could not attribute those side effects to the vaccine. patient got a little Urinary tract infection (UTI) and pelvic inflammation. Patient did not go to the emergency room (ER) or to her Doctor for that. She thought she might had an infection or something before that caused those side effects. Patient mentioned the exact day after she got the shot Johnson and Johnson was paused and she was watching for any side effects of clots or reproductive organs problems. It took her body a couple of months to return to normal. She did not have any pain in the arm where she got the shot and it was an easy shot. She thought they used short syringe. She did not feel any more tired than she would feel from normal environmental factors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from negative unusual side effects, little urinary tract infection, and pelvic inflammation. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210935083-COVID-19 VACCINE AD26.COV2.S-Pelvic inflammation. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).