chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw, Rash
Clinical narrative: Pain on the right side of her face; Earache; Jaw pain; Headache; Linear rash along her jawline; Soreness at the injection site; Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th May 2022, the patient received the 1st dose of Shingrix. On 13th May 2022, 1 days after receiving Shingrix, the patient experienced injection site pain and muscle pain. On 23rd May 2022, the patient experienced facial pain, ear pain, jaw pain, headache and rash. On an unknown date, the outcome of the injection site pain, muscle pain, facial pain, ear pain, jaw pain, headache and rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, muscle pain, facial pain, ear pain, jaw pain, headache and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-MAY-2022 Reporter's Comments: The reporter was patient who called to report side effects from Shingrix vaccination. She stated she received her first dose of Shingrix and the following day after vaccination, she developed soreness at the injection site and muscle pain (Myalgia). The patient states these symptoms was gotten better but not completely resolved. The patient also stated that early week approximately 23rd May 2022, 11 days after receiving Shingrix she began to develop pain on the right side of her face, an earache, jaw pain, headache and a linear rash along her jawline. These had not yet resolved. The patient was referred to healthcare professional and provided medical advised disclaimer. The reporter was consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received the 1st dose 2 years ago before the pandemic.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on unknown date, 2 years before date of reporting).   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 Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: Pharmacist unable to provide first dose details and declined to provide any patient details. Pharmacist called in to inquire for Shingrix second dose and asked whether they could restart or finish last dose. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix day before reporting and he started to experience a fever after his dose. The reporter did not consent to follow-up.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient administrated with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva468a, expiry date 31st March 2022) for prophylaxis.   On 25th May 2022, the patient received Menveo. On 25th May 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 27-May-2022 Reporter's Comments: The medical assistance reported that a patient was administrated with an expired dose of Menveo. The vaccine expired on March 2022. No adverse event was reported . The reporter consented to follow up. Additional Supportive Information: The patient was administrated with an expired dose of Menveo which led to expired vaccine used.
Age: 29.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 29-year-old male patient who received HAV (Havrix adult) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th May 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 27th May 2022, unknown after receiving Havrix adult 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: 27-May-2022 Reporter's Comments: The pharmacist reported they inadvertently administered an expired dose of Havrix  to a patient. The pharmacist inquired any side effects to look for. The reporter did not consent to follow-up. Additional Supportive Information: The patient was administrated with an expired dose of havrix which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Never got the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   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 Information: GSK Receipt Date: 27-May-2022 Reporter's Comments: The health care professional reported patient got first dose of shingrix in 2019 never got the 2nd dose. The patient was immunocompetent. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. The details were reported for 1st dose.  Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed shingles after first dose; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2021, the patient received the 1st dose of Shingrix. On 27th May 2022, between 4 and 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-MAY-2022 Reporter's Comment: Pharmacist reported that the patient developed shingles after first dose of Shingrix. HCP (Health Care Professional) could not provide lot number, expiration date and exact date of first vaccination. The reporter consented to follow-up.
Age: 7.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7 year old given Boostrix/Boostrix in 2022, Tdap in 2021, not received any DTaP or Tdap prior; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number MY5G5, expiry date 31st January 2023) for prophylaxis.   Previously administered products included Tdap vaccine (received a dose of Tdap of unknown brand in September 2021 at age of 6 years from another provider and no further details were available regarding the dose ).   On 22nd March 2022, the patient received Boostrix. On 22nd March 2022, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 27-May-2022 Reporter's comment: The patient was a refugee and prior to the dose of Tdap given in September of 2021, had not received any DTaP or Tdap doses.  The pharmacist stated that Boostrix was given to a 7 years old patient. No further details were provided at the time of the call. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Boostrix at 7 years old age, which led to inappropriate age at vaccine administration.
Age: 51.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Overdose
Clinical narrative: received 3 doses on 25-MAY-2022; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 51-year-old female patient who received HBV (Engerix B adult) (batch number tb3kn, expiry date 3rd December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B adult) (batch number tb3kn, expiry date unknown) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B adult) (batch number tb3kn, expiry date 3rd December 2023) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th May 2022, the patient received Engerix B adult (intramuscular) .5 ml, Engerix B Pre-Filled Syringe Device, Engerix B adult (intramuscular) .5 ml, Engerix B Pre-Filled Syringe Device, Engerix B adult (intramuscular) .5 ml and Engerix B Pre-Filled Syringe Device. On 25th May 2022, unknown after receiving Engerix B adult, Engerix B Pre-Filled Syringe Device, Engerix B adult, Engerix B Pre-Filled Syringe Device, Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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: 27 May 2022 Reporter's comment: The reporter was an administrator for a clinic who reported that a patient received 3 doses of Engerix B on same day. The  reporter consented to follow up. Additional Supportive Information: The patient received 3 doses of Engerix B on same day which led to overdose.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Illness, Incomplete course of vaccination, Surgery, Vomiting
Clinical narrative: fatigued; sick to the point of vomiting; sick to the point of vomiting; got first about 5 years ago, has not received second; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fatigue, sickness, vomiting and incomplete course of vaccination. On an unknown date, the outcome of the fatigue and vomiting were recovered/resolved and the outcome of the sickness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the fatigue, sickness and vomiting to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-May-2022 Reporter's Comments: The reporter was the patient and reported that she got her first Shingrix vaccine, in an unknown arm, about 5 years ago and had not received her second Shingrix vaccine yet.  The first Shingrix vaccine made her very fatigued and sick to the point of vomiting. The reporter did not remember the details of when the symptoms started or ended. The reporter was now having surgery was 2 months and wanted to get the second Shingrix vaccine.  The reporter health care professional told her it was fine to get. The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting the patient received the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in October 2021, not yet received second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on October 2021).   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 not recovered/not resolved.       Additional Information: GSK Receipt Date: 27-May-2022 Reporter's Comments: The case was reported by patient. The patient reported received first dose of Shingrix in October of 2021 and not received second dose yet. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: contact dermatitis; arm has now changed into a red rectangle that has texture to it; red area at the injection site; hard area at the injection site; warm area at the injection site; swollen area at the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 5J27J, expiry date unknown) for prophylaxis.   On 19th May 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2022, less than 2 weeks after receiving Shingrix, the patient experienced contact dermatitis and skin texture abnormal. On 20th May 2022, the patient experienced injection site erythema, injection site induration, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site warmth and injection site swelling were recovered/resolved and the outcome of the contact dermatitis and skin texture abnormal were unknown.   The reporter considered the injection site erythema, injection site induration, injection site warmth, injection site swelling, contact dermatitis and skin texture abnormal to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine in the left deltoid and on the following day she developed a red, hard, warm, swollen area at the injection site that stayed like that for about 5 to 6 days. The patient stated that during the time when her arm was swollen, she iced it and wrapped it for 2 days (while at work).  That same area of her arm had now changed into a red rectangle that had texture to it. The patient also stated that area now it looked like a contact dermatitis. The patient did not have the expiration date of the vaccine but did have the lot number.  The reporter consented to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin texture abnormal
Clinical narrative: contact dermatitis; arm has now changed into a red rectangle that has texture to it; red area at the injection site; hard area at the injection site; warm area at the injection site; swollen area at the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 5J27J, expiry date unknown) for prophylaxis.   On 19th May 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2022, less than 2 weeks after receiving Shingrix, the patient experienced contact dermatitis and skin texture abnormal. On 20th May 2022, the patient experienced injection site erythema, injection site induration, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site warmth and injection site swelling were recovered/resolved and the outcome of the contact dermatitis and skin texture abnormal were unknown.   The reporter considered the injection site erythema, injection site induration, injection site warmth, injection site swelling, contact dermatitis and skin texture abnormal to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine in the left deltoid and on the following day she developed a red, hard, warm, swollen area at the injection site that stayed like that for about 5 to 6 days. The patient stated that during the time when her arm was swollen, she iced it and wrapped it for 2 days (while at work).  That same area of her arm had now changed into a red rectangle that had texture to it. The patient also stated that area now it looked like a contact dermatitis. The patient did not have the expiration date of the vaccine but did have the lot number.  The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: feeling shingles outbreak coming/Feeling like shingles-; This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd May 2022, the patient received Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-MAY-2022 Reporter's Comment: Pharmacist reported that a patient received a dose of Shingrix vaccine last sunday and was feeling like an outbreak was coming (clarified, felt like a shingles outbreak was coming). The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: nerve pain; leg pain; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2022, the patient received the 1st dose of Shingrix. On 3rd May 2022, between 1 and 2 months after receiving Shingrix, the patient experienced nerve pain and leg pain. On an unknown date, the outcome of the nerve pain and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain and leg pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine about a month and a half ago (date unknown) and experienced leg pain which she described as nerve pain. The above symptom had not yet resolved.  The patient followed up with her HCP (Health Care Professional).  Provided medical advise disclaimer. The reporter did not consent to follow-up.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dysgeusia
Clinical narrative: UNPLEASANT METALLIC TASTE; COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 56 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergy. The patient received covid-19 vaccine ad26.cov2.s  (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: unknown) dose was not reported, 1 total, administered on 27-MAY-2021 at 12:00 P.M to left arm for prophylactic vaccination. Age at time of vaccination 55 years old. No concomitant medications were reported. On an unspecified date in MAY-2022, the patient experienced covid-19 infection (dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. The patient additionally received booster non-company suspect vaccine included Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin not reported, route of admin not reported, batch number: FN2908 expiry: unknown) dose was not reported, administered on 11-MAY-2022 at 14:00 PM to left arm for prophylactic vaccination. On 14-MAY-2022, the patient was started taking non-company suspect drugs Paxlovid (form of admin not reported, route of admin not reported, batch number: GA5120 expiry: unknown) dose and frequency were not reported for covid-19 treatment. The date of last administration of Paxlovid was 18-MAY-2022. On 14-MAY-2022 at 15:00 after 2-3 hours after medication, the patient started experienced unpleasant metallic taste in her mouth (dose number in series 2). The action taken with tozinameran was not applicable. The patient was recovering from unpleasant metallic taste. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Inappropriate schedule of product administration, Off label use
Clinical narrative: UNSPECIFIED ADVERSE EVENT/REACTION; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; 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: yeast allergy, and vinegar allergy. 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, and dose, 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 patient experienced unspecified adverse event/reaction, inappropriate schedule of vaccine administered, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unspecified adverse event/reaction, inappropriate schedule of vaccine administered and off label use was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anxiety, Dyspnoea, Gastrooesophageal reflux disease, Panic disorder
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; ACID REFLUX; PANIC; ANXIETY; STOMACH PAIN; LONG TERM BREATHING ISSUES; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 41 year old adult male. The patient's height, and weight were not reported. The patient's past medical history included: allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered to left arm on 14-APR-2021 for prophylactic vaccination. Age at time of vaccination 40 years old. The batch number was not reported and has been requested.  The patient received non-company co-suspect drug Paxlovid (nirmatrelvir, ritonavir) (form of admin and route of admin not reported) therapy started on 17-APR-2022 and therapy ended on 22-APR-2022 for covid-19 treatment. Concomitant medications included prednisone for drug used for unknown indication.  On an unspecified date, the patient had suspected covid-19 infection (suspected clinical vaccination failure). On 18-APR-2022, the patient experienced acid reflux, panic, and anxiety diarrhea, long term breathing issues, stomach pain, joint pain The patient also had reoccurrence of symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, acid reflux, panic, anxiety, suspected clinical vaccination failure, stomach pain and long term breathing issues was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220548473-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; ACID REFLUX; PANIC; ANXIETY; STOMACH PAIN; LONG TERM BREATHING ISSUES; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 41 year old adult male. The patient's height, and weight were not reported. The patient's past medical history included: allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered to left arm on 14-APR-2021 for prophylactic vaccination. Age at time of vaccination 40 years old. The batch number was not reported and has been requested.  The patient received non-company co-suspect drug Paxlovid (nirmatrelvir, ritonavir) (form of admin and route of admin not reported) therapy started on 17-APR-2022 and therapy ended on 22-APR-2022 for covid-19 treatment. Concomitant medications included prednisone for drug used for unknown indication.  On an unspecified date, the patient had suspected covid-19 infection (suspected clinical vaccination failure). On 18-APR-2022, the patient experienced acid reflux, panic, and anxiety diarrhea, long term breathing issues, stomach pain, joint pain The patient also had reoccurrence of symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, acid reflux, panic, anxiety, suspected clinical vaccination failure, stomach pain and long term breathing issues was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220548473-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Troponin, Vaccination failure
Clinical narrative: FULMINANT MYOCARDITIS; PEA ARREST; SUSPECTED COVID 19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report was received from a literature. This report concerned a 26 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, route of admin, and batch number were not reported) dose, 01 total, administered, 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 patient experienced PEA (Pulseless electrical activity) arrest, suspected covid-19 infection, suspected clinical vaccination failure and was hospitalized (date unspecified). On an unspecified date, six months after taking the vaccine the patient had fulminant myocarditis and was hospitalized (date unspecified). The patient was hospitalized for 50 days and had an Intensive care unit (ICU) stay of 34 days and was on venoarterial extracorporeal membrane oxygenation (VA-ECMO) for nine days. The patient had survival to discharge. The patient visited an emergency room for the events. The patient was taking steroids as a treatment for COVID-19. Laboratory data (dates unspecified) included: C-reactive protein (NR: not provided) was at 2.1 mg/dL, Erythrocyte sedimentation rate (NR: not provided) 2 mm/h, LVEF (Left ventricular ejection fraction) was at 10 percent and post ECMO (extracorporeal membrane oxygenation) LVEF (NR: not provided) it was at 55 percent and Troponin (NR: not provided) was at 1.34 ng/mL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the PEA arrest, fulminant myocarditis, suspected covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0:20220551032-Covid-19 vaccine ad26.cov2.s- Fulminant Myocarditis. 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). Therefore, this event(s) is considered unassessable. 20220551032-Covid-19 vaccine ad26.cov2.s- PEA arrest, suspected covid 19 infection. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220551032-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Muscle rupture
Clinical narrative: RECENTLY TORE RIGHT CALF MUSCLE; DEEP VEIN THROMBOSIS; This spontaneous report received from a patient concerned a 40 year old male of an unspecified race and ethnicity. 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, and batch number, expiry were not reported) dose was not reported, 1 total administered on an unspecified date in 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient reported that he recently tore his right calf muscle which resulted in a deep vein thrombosis. It was reported that more than one medical professional told the patient, that this was a very rare occurrence and due to receiving the vaccine last year they could not rule out the possibility of it indirectly or directly causing this blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the recently tore right calf muscle and deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20220554269- COVID-19 VACCINE AD26.COV2.S- RECENTLY TORE RIGHT CALF MUSCLE, DEEP VEIN THROMBOSIS. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Injury
Clinical narrative: VACCINE INJURY; This spontaneous report received from a patient via a company representative 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 (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date 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 was vaccine injury victim from JNJ covid-19 vaccine (dose number in series 1).  The patient received non-company suspect vaccine included: Pfizer Biontech Covid-19 Vaccine (Tozinameran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown), dose was not reported, administered on an unspecified date for prophylactic vaccination.  On an unspecified date, the patient was vaccine injury victim from Pfizer covid-19 vaccine (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of vaccine injury was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: SUSPECTED BLOOD CLOT; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. 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, and batch number were not reported) 1 total, dose and 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 suspected blood clot. The reporter stated that his wife was in emergency room with their daughter who received Janssen Covid-19 vaccine a while ago and doctor suspected blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220555974- Covid-19 vaccine ad26.cov2.s - Suspected Blood clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, allergy, and overweight. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received Spikevax (Elasomeran) (Dose number in series 2) (form of admin, route of admin, batch number: 046C21A, expiry: unknown) dose was not reported, 1 total administered in left arm on 02-NOV-2021 for prophylactic vaccination. On 21-MAY-2022, Laboratory data included: COVID-19 virus test (NR: not provided) positive (Dose number in series 2).  On 21-MAY-2022 at 12:30, the patient experienced covid-19 test positive (Dose number in series 2). The action taken with Spikevax (Elasomeran) was not applicable. The patient received unspecified drug for covid-19 treatment from 12-MAY-2022 and date of last administration was 17-MAY-2022.  Concomitant medications included fluticasone propionate, and fluticasone propionate/salmeterol xinafoate. The patient had not recovered from covid-19 test positive. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED AFTER STORED OUTSIDE OF RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 68 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, route of admin not reported, batch number: 1822809, and expiry: 04-AUG-2022) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. Age at time of vaccination 68 years old. No concomitant medications were reported. On 11-JAN-2022, the patient experienced vaccine administered after stored outside of recommended storage conditions. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after stored outside of recommended storage conditions and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558451, 20220558511, 20220558598, 20220558439, 20220558390, 20220558638 and 20220558823.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTERED PATIENT USING AN EXPIRED VACCINE AND IMPROPERLY STORED VIAL OF THE J AND J  COVID-19 VACCINE; This spontaneous report received from a physician concerned a 54 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 08-SEP-2022) .5 ml, administered on 30-NOV-2021 for prophylactic vaccination. Age at time of vaccination 54 years old. No concomitant medications were reported. On 30-NOV-2021, the patient experienced administered patient using an expired vaccine and improperly stored vial of the j and j covid-19 vaccine. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and administered patient using an expired vaccine and improperly stored vial of the j and j covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558497, 20220558479, 20220558475, 20220558498, 20220558469 and 20220558482. This report was associated with product quality complaint: 90000233203.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTERED PATIENTS USING AN EXPIRED AND  IMPROPERLY STORED VIAL OF THE J&J  COVID-19 VACCINE; This spontaneous report received from a physician concerned a 40 year old male. 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: 211D21A, expiry: 08-SEP-2022) .5 ml, administered on 25-MAR-2022 for prophylactic vaccination. Age at time of vaccination 40 years old. No concomitant medications were reported. On 25-MAR-2022, the patient experienced administered patients using an expired and improperly stored vial of the j&j covid-19 vaccine. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered patients using an expired and improperly stored vial of the j&j covid-19 vaccine and incorrect product storage was not reported. This report was non-serious. This report was associated with product quality complaint: 90000233203. This case, from the same reporter is linked to 20220558497, 20220558479, 20220558475, 20220558469, 20220558498 and 20220558436.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF EXPIRED AND IMPROPERLY STORED VACCINE; This spontaneous report received from a physician concerned a 45 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 08-SEP-2022) .5 ml, administered on 25-MAR-2022 for prophylactic vaccination. Age at time of vaccination 45 years old. No concomitant medications were reported. On 25-MAR-2022, the patient experienced administration of expired and improperly stored vaccine. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired and improperly stored vaccine and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558497, 20220558479, 20220558475, 20220558436, 20220558469 and 20220558482.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Antibody test abnormal
Clinical narrative: THERE HAD BEEN LITTLE DROP IN THE ANTIBODY LEVEL; This spontaneous report received from a patient via a company representative concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included: contracted covid-19 infection, and other pre-existing medical conditions included: Patient was in good health. 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 SEP-2021 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 there had been little drop in the antibody level. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) little drop in antibody level. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of there had been little drop in the antibody level was not reported. This report was non-serious. This report was associated with product quality complaint: 90000233238. This case, from the same reporter is linked to 20220560642.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF VACCINE; VACCINE ADMINISTERED AFTER BEING STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 64 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, route of admin not reported, batch number: 1822809 expiry: 04-AUG-2022) dose was not reported, administered on 18-JAN-2022 for prophylactic vaccination. Age at time of vaccination 64 years old. No concomitant medications were reported. On 18-JAN-2022, the patient experienced vaccine administered after being stored outside of the recommended storage conditions. On an unspecified date, the patient experienced incorrect storage of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered after being stored outside of the recommended storage conditions and incorrect storage of vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558390, 20220558451, 20220558439, 20220558823, 20220558511, 20220558383, 20220558598, 20220558345, 20220558340, 20220558378, 20220558349 and 20220558823.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: HAVE NOT FELT THE SAME SINCE RECEIVED VACCINE; This spontaneous report received from a patient concerned a male of unspecified age. 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, and batch number were not reported) dose, 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 patient experienced have not felt the same since received vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from have not felt the same since received vaccine. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antibody test abnormal
Clinical narrative: LITTLE DROP IN THE  ANTIBODY LEVEL; This spontaneous report received from a consumer via a company representative concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 (The patient contracted Covid in FEB-2020), and other pre-existing medical conditions included: The patient was in good health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on SEP-2021 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 little drop in the antibody level. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) drop (little drop in the antibody level). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little drop in the antibody level was not reported. This report was non-serious. This case, from the same reporter is linked to 20220558518.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non-serious