chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPV, FLU3, FLU3, HEP, HEPA, RV1, TDAP
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered after temperature excursion of 31.0F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in an unspecified number of  patients 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, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, Flu Seasonal TIV Dresden (Fluarix) (batch number 2235P, expiry date unknown) for prophylaxis and Flu Seasonal TIV Quebec (Flulaval) (batch number 2235P, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Havrix, Engerix B, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Boostrix, Fluarix and Flulaval. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Havrix, Engerix B, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Boostrix, Fluarix and Flulaval, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage 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 are as follows: The case was reported immunization coordinator for multiple patients.  The age at vaccination was not reported. Immunization coordinator reported that the administration of Pediarix, Kinrix, Havrix, Engerix B, Rotarix, Boostrix, Fluarix and Flulaval after below temperature excursion of 31.0 degree F. Health care professional was unable to provide any adverse event information for the  vaccinations at the time of call.  This adverse event had affected multiple patients from October 2020 to June 2021. The reporter had provided phone number and email address. The reporter was ok with the safety team to follow-up about the adverse event information. Note- Referring sales data sheet was also out of scope, therefore reported batch number (2235P) was captured in both Fluarix and Flulaval.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose did not return within the recommended time frame to receive the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 25th September 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 age at vaccination was not applicable for this report. The pharmacist stated that, the patient did not return within the recommended time frame to receive the second dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: 4 month old was given KINRIX; Expiration date 31-AUG-2021; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st September 2021, the patient received Kinrix (intramuscular) .5 ml and Kinrix Pre-Filled Syringe Device. On 1st September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and expired vaccine used. On an unknown date, the outcome of the inappropriate age at vaccine administration and expired vaccine used were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follow: This case was reported by medical assistant.  On 1st September 2021, a 4 month old infant was accidentally given Kinrix intramuscularly which got expired on 30th August 2021, which led to inappropriate age at vaccine administration and expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Gave liquid vial without reconstituting with powder vial; Gave liquid vial without reconstituting with powder vial; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 30th August 2021, the patient received Menveo. On 30th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The nurse gave a patient the liquid Menveo vial without reconstituting with the powder vial. Shortly after that, the nurse gave the same patient a fully reconstituted dose of Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Received 3 doses in total; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA468A, expiry date 31st March 2022) for prophylaxis.   Previously administered products included Menveo (1st dose received on an unknown date). Concomitant products included Men ACWY-CRM NVS (Menveo).   On 31st August 2021, the patient received the 3rd dose of Menveo. On 31st August 2021, unknown after receiving Menveo and an unknown time after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The nurse reported that the patient received a booster dose of Menveo on 8th August 2021 and by mistake received another dose on 31st August 2021, 3 doses in total, which led to extra dose administered. The reporter consented to follow up.
Sex: U
Vaccine: DTAPHEPBIP, HEPA, TDAP
Symptoms: Product storage error
Clinical narrative: exposed to below freezing temperatures and were administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received HAV (Havrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix, Boostrix, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix, Boostrix, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 age at vaccination was not applicable to this report. On 25th August 2021, Havrix, Boostrix, and Pediarix were exposed to below freezing temperatures and were administered to an unknown group of patients, which led to incorrect storage of drug. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: market shortage; This case was reported by a consumer and described the occurrence of product supply issue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue 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, not able to get 2nd dose of Shingrix becasue of market shortage, which led to product supply issue. The reporter asked, it was been 1.5 years could go ahead and get second dose now or did have to restart the series. The reporter did not consent to follow up.
Age: 56.0
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 56 years old received Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 56-year-old patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 31st August 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. The action taken with Bexsero Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that a patient of age 56 years old received dose of Bexsero, which led to inappropriate age at vaccine administration. The reporter wanted to know if it was likely to happen any side effects. The reporter stated that, reported with the data obtained before the call disconnected. Tried to contact health care professional so as to finish collecting missing data but without success. The reporter did not consent to follow up.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: given a dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd September 2021, unknown after receiving Kinrix and Kinrix 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 details were provided as follows: The reporter stated that, the patient had been given already expired dose of Kinrix, which led to expired vaccine used. The reporter consented to follow up via email.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Fall, Fatigue, Feeling abnormal
Clinical narrative: FALL; HURT MY KNEES; FELT LIKE I GOT HIT BY A TRUCK; BODY ACHES SO BAD; MIGRAINE; COLD SWEATS ARE INSANE/SWEATING; EXHAUSTED SO TIRED; FEVER; This spontaneous report received from a patient concerned a female 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 not reported, batch number: Unk) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced body aches so bad. On AUG-2021, the patient experienced migraine. On AUG-2021, the patient experienced cold sweats are insane/sweating. On AUG-2021, the patient experienced exhausted so tired. On AUG-2021, the patient experienced fever. On 31-AUG-2021, the patient experienced felt like i got hit by a truck. On an unspecified date, the patient experienced fall, and hurt my knees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold sweats are insane/sweating, and the outcome of body aches so bad, migraine, exhausted so tired, fever, felt like i got hit by a truck, fall and hurt my knees was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Pyrexia
Clinical narrative: FALL; HURT MY KNEES; FELT LIKE I GOT HIT BY A TRUCK; BODY ACHES SO BAD; MIGRAINE; COLD SWEATS ARE INSANE/SWEATING; EXHAUSTED SO TIRED; FEVER; This spontaneous report received from a patient concerned a female 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 not reported, batch number: Unk) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On AUG-2021, the patient experienced body aches so bad. On AUG-2021, the patient experienced migraine. On AUG-2021, the patient experienced cold sweats are insane/sweating. On AUG-2021, the patient experienced exhausted so tired. On AUG-2021, the patient experienced fever. On 31-AUG-2021, the patient experienced felt like i got hit by a truck. On an unspecified date, the patient experienced fall, and hurt my knees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cold sweats are insane/sweating, and the outcome of body aches so bad, migraine, exhausted so tired, fever, felt like i got hit by a truck, fall and hurt my knees was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from consumer social media via a company representative concerned a 20 year old female of unknown 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 (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death and it was unknown if an autopsy was performed. The action taken with covid-19 vaccine was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210902775.; Sender's Comments: V0:20210902754-covid-19 vaccine  Died. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a company representative concerned multiple patients of unknown race and ethnic origin. No past medical history or concurrent conditions were reported. The patients 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, 1 total for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported. It was reported that "529 people had died of COVID-19 since 01-APR-2021. According to the ADPH, this included twenty people who were vaccinated, who did their part in the fight against COVID-19". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210903589- JANSSEN COVID-19 VACCINE Ad26.COV2.S- COVID-19. 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.; Reported Cause(s) of Death: COVID-19
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Nausea, Pain
Clinical narrative: BODY ACHES; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose and frequency were not reported from 23-JUL-2021 for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On 18-AUG-2021, the patient experienced body aches. On 18-AUG-2021, the patient experienced nausea. On 18-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with risankizumab was withdrawn. The patient recovered from body aches, nausea, and headache on 20-AUG-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: ANTIBODY LEVEL OF 14; This spontaneous report received from a patient 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 not reported, batch number: Unknown, Expiry: 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, patient's antibodies level was a 14 with the SARS-Cov-2 semi-quantitative total antibody. Patient stated that she was immunocompromised. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of antibody level of 14 was not reported. This report was serious (Other Medically Important Condition). The suspected regulatory authority has been confirmed to be voided (did not meet criteria as this record states the patient antibody level. there is no issue reported. approval to void this record due to no identified.) based on the evaluation/investigation performed.; Sender's Comments: V0: 20210904072-COVID-19 VACCINE AD26.COV2.S- antibody level of 14. 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
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Haematochezia, Rectal haemorrhage, Thrombosis, White blood cell count
Clinical narrative: BRIGHT RED BLOOD IN STOOL; ABDOMINAL PAIN; INCREASED WHITE BLOOD CELLS; POSSIBLE BLOOD CLOT; RECTAL BLEEDING; This spontaneous report received from a patient concerned a 40 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, and rectal bleeding, and had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on 01-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included Humira (adalimumab) started on 27-Jul-2021 for moderate to severe ulcerative colitis.  On AUG-2021, the patient experienced possible blood clot, rectal bleeding, and white blood cells was increased. On 25-AUG-2021, the patient experienced bright red blood in stool, and abdominal pain. On the same day she visited emergency room (ER) on early hours, and was admitted for increased white cell count, rectal bleeding and possible blood clot. She was hospitalized for 1 day and discharged late on 26-AUG-2021. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increased white blood cells, possible blood clot, rectal bleeding, bright red blood in stool, and abdominal pain. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210904116-COVID-19 VACCINE AD26.COV2.S -Possible blood clot, Increased white blood cells. 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.  20210904116-COVID-19 VACCINE AD26.COV2.S - Rectal bleeding, Bright red blood in stool, Abdominal pain. 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: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: BRIGHT RED BLOOD IN STOOL; ABDOMINAL PAIN; INCREASED WHITE BLOOD CELLS; POSSIBLE BLOOD CLOT; RECTAL BLEEDING; This spontaneous report received from a patient concerned a 40 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, and rectal bleeding, and had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on 01-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included Humira (adalimumab) started on 27-Jul-2021 for moderate to severe ulcerative colitis.  On AUG-2021, the patient experienced possible blood clot, rectal bleeding, and white blood cells was increased. On 25-AUG-2021, the patient experienced bright red blood in stool, and abdominal pain. On the same day she visited emergency room (ER) on early hours, and was admitted for increased white cell count, rectal bleeding and possible blood clot. She was hospitalized for 1 day and discharged late on 26-AUG-2021. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from increased white blood cells, possible blood clot, rectal bleeding, bright red blood in stool, and abdominal pain. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210904116-COVID-19 VACCINE AD26.COV2.S -Possible blood clot, Increased white blood cells. 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.  20210904116-COVID-19 VACCINE AD26.COV2.S - Rectal bleeding, Bright red blood in stool, Abdominal pain. 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: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke, Magnetic resonance imaging, Thrombosis
Clinical narrative: BLOOD CLOTS; ISCHEMIC STROKE; This spontaneous report received from a consumer concerned a 60 year old white and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included: stroke, which occurred on 16-OCT-2020. At that time, the patient was found on the floor in the morning at 06:30 and the stroke took out patient's left side and the bleed took out the right frontal lobe. The patient needed to relearn how to do everything from putting on clothes to brushing teeth. Concurrent conditions included: penicillin allergy, hay fever, abstains from alcohol, and non-smoker. The patient had no history drug abuse or illicit drug usage. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination on right arm. Concomitant medications included daily consumption of acetylsalicylic acid, apixaban, atorvastatin calcium, baclofen, diltiazem, escitalopram oxalate, and methylphenidate hydrochloride (not daily, depending on the day). On 27-AUG-2021, the patient experienced ischemic stroke and blood clots. The patient went to the emergency room on 27-AUG-2021 and did not initially find anything on the Magnetic resonance imaging but was called back on 28-AUG-2021 and then the patient was hospitalized and was released on 30-AUG-2021. The patient was hospitalized for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ischemic stroke, and had not recovered from blood clots. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210905634- covid-19 vaccine ad26.cov2.s-Ischemic stroke . 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: MEDICAL HISTORY 20210905634- covid-19 vaccine ad26.cov2.s-Blood clots. 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: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report, a hearsay case, received from a consumer from a recording concerned a 7 decade old male of unknown ethnicity. The patient's height, and weight were not reported. The patient was epileptic. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid, atorvastatin, carbamazepine, cetirizine, clopidogrel bisulfate, ezetimibe, metoprolol, phenytoin, and piroxicam. On an unspecified date, the patient experienced heart attack and It was not clear if it was before or after patient received the covid-19 vaccine. Consumer stated that patient had a conversation with his neurologist in AUG-2021. The action taken with covid-19 vaccine was not applicable. The outcome of heart attack was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210905680-COVID-19 VACCINE.-Heart attack. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Hypokinesia, Seizure
Clinical narrative: FELT PARALYZED FROM THE NECK UP PHYSICALLY (NOT NEUROLOGICALLY); RESUMPTION OF FACIAL PAIN; RESUMPTION OF FACIAL SEIZURES; This spontaneous report received from a patient via a company representative concerned an adult male of unspecified race and ethnic origin. Initial information was processed with additional information received on 03-SEP-2021. The patient's height, and weight were not reported.  The patient's concurrent conditions included: trigeminal neuralgia, and environmental allergies, and other pre-existing medical conditions included: The patient had no other significant history reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient was diagnosed with trigeminal neuralgia, facial pain and facial seizures 10 years ago, which has been well controlled by medication until 30-JUL-2021. The patient previously reported symptoms (facial pain) present only during very bad allergy seasons. On 30-JUL-2021, the patient experienced resumption of facial seizures and resumption of facial pain. On AUG-2021, the patient felt paralyzed from the neck up physically (not neurologically). The patient was assessed by their physician and it was determined that a blood vessel and nerve were touching, causing the facial pain and seizure/paralysis. According to the patient's physician, severe inflammation triggered by the vaccine was the cause for the return of the patient's symptoms (facial seizures and facial pain).The patient is receiving ongoing medical care to handle chronic pain symptoms. The patient may require surgical correction for relief. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from resumption of facial seizures, felt paralyzed from the neck up physically (not neurologically), and resumption of facial pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210905749-COVID-19 VACCINE AD26.COV2.S-Resumption Of Facial Seizures. 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: MEDICAL HISTORY
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE 33 MINUTES AFTER THE RECOMMENDED STORAGE TIME; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 51 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 drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 expiry: 29-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced administration of vaccine 33 minutes after the recommended storage time. On 02-SEP-2021, 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 vaccine 33 minutes after the recommended storage time and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905816 and 20210906551.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Pain
Clinical narrative: ADMINISTRATION OF VACCINE 33 MINUTES AFTER THE RECOMMENDED STORAGE TIME; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 51 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 drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 expiry: 29-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced administration of vaccine 33 minutes after the recommended storage time. On 02-SEP-2021, 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 vaccine 33 minutes after the recommended storage time and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905816 and 20210906551.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF JANSSEN COVID-19 VACCINE AFTER THE RECOMMENDED STORAGE TIME (45 MINUTES); This spontaneous report received from a health care professional concerned a 28 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have known drug allergies and had not reported any symptoms. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1816027, and expiry: 29-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced administration of janssen covid-19 vaccine after the recommended storage time (45 minutes). The action taken with covid-19 vaccine was not applicable. The outcome of administration of janssen covid-19 vaccine after the recommended storage time (45 minutes) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905756 and 20210906551.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Product storage error
Clinical narrative: ADMINISTRATION OF JANSSEN COVID-19 VACCINE AFTER THE RECOMMENDED STORAGE TIME (45 MINUTES); This spontaneous report received from a health care professional concerned a 28 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have known drug allergies and had not reported any symptoms. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1816027, and expiry: 29-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced administration of janssen covid-19 vaccine after the recommended storage time (45 minutes). The action taken with covid-19 vaccine was not applicable. The outcome of administration of janssen covid-19 vaccine after the recommended storage time (45 minutes) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905756 and 20210906551.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Body temperature increased, Fatigue, Gait inability
Clinical narrative: ARM PAIN AROUND THE INJECTION SITE; FEELING TIRED; TEMPERATURE OF 99.5 FAHRENHEIT; LYMPH NODES SWOLLEN AND HURT; UNABLE TO WALK; COULD NOT MOVE; COULD NOT BEND; BAD LOWER BACK PAIN RADIATING TO LEGS; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid disorder, asthma, sulfa allergy, levaquin allergy, seafood/shellfish allergy, penicillin allergy, non-alcohol user, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 07-SEP-2021) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced unable to walk. On 24-AUG-2021, the patient experienced could not move. On 24-AUG-2021, the patient experienced could not bend. On 24-AUG-2021, the patient experienced bad lower back pain radiating to legs. On 25-AUG-2021, the patient experienced lymph nodes swollen and hurt. On an unspecified date, the patient experienced arm pain around the injection site, feeling tired, and temperature of 99.5 fahrenheit. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move, and could not bend on 27-AUG-2021, and temperature of 99.5 fahrenheit, was recovering from bad lower back pain radiating to legs, had not recovered from lymph nodes swollen and hurt, and the outcome of feeling tired, arm pain around the injection site and unable to walk was not reported. This report was non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Injection site pain, Lymphadenopathy, Mobility decreased
Clinical narrative: ARM PAIN AROUND THE INJECTION SITE; FEELING TIRED; TEMPERATURE OF 99.5 FAHRENHEIT; LYMPH NODES SWOLLEN AND HURT; UNABLE TO WALK; COULD NOT MOVE; COULD NOT BEND; BAD LOWER BACK PAIN RADIATING TO LEGS; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid disorder, asthma, sulfa allergy, levaquin allergy, seafood/shellfish allergy, penicillin allergy, non-alcohol user, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 07-SEP-2021) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced unable to walk. On 24-AUG-2021, the patient experienced could not move. On 24-AUG-2021, the patient experienced could not bend. On 24-AUG-2021, the patient experienced bad lower back pain radiating to legs. On 25-AUG-2021, the patient experienced lymph nodes swollen and hurt. On an unspecified date, the patient experienced arm pain around the injection site, feeling tired, and temperature of 99.5 fahrenheit. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move, and could not bend on 27-AUG-2021, and temperature of 99.5 fahrenheit, was recovering from bad lower back pain radiating to legs, had not recovered from lymph nodes swollen and hurt, and the outcome of feeling tired, arm pain around the injection site and unable to walk was not reported. This report was non-serious.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Occipital neuralgia
Clinical narrative: MAJOR DIZZINESS; RIGHT OCCIPITAL NEURALGIA (HEADACHE, TINGLING IN THE HEAD); This spontaneous report received from a consumer concerned a 78 year old male. The patient's weight was 165 pounds, and height was 73 inches. The patient's concurrent conditions included: thrombocytopenia, and low level of platelets. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: gabapentin ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for right occipital neuralgia. No concomitant medications were reported. On 12-APR-2021, the patient experienced right occipital neuralgia (headache, tingling in the head). On an unspecified date, the patient experienced major dizziness. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Unknown, CAT scan (NR: not provided) Right occipital neuralgia, MRI (NR: not provided) Right occipital neuralgia, and Platelet count (NR: not provided) 139. The action taken with covid-19 vaccine ad26.cov2.s, and gabapentin was not applicable. The patient was recovering from right occipital neuralgia (headache, tingling in the head), and the outcome of major dizziness was not reported. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Disorientation, Fatigue, Pyrexia
Clinical narrative: VERY TIRED FOR THE NEXT 24 HOURS; FEVER; DISORIENTED FEELING; CHILLS; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 250 pounds, and height was 70 inches. The patient's concurrent conditions included: alcohol user, and cigarette smoker, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. Concomitant medications included ergocalciferol. On 31-AUG-2021, the patient experienced disoriented feeling. On 31-AUG-2021, the patient experienced chills. On 31-AUG-2021, the patient experienced fever. On 01-SEP-2021, the patient experienced very tired for the next 24 hours. The action taken with covid-19 vaccine was not applicable. The patient recovered from disoriented feeling, chills, and fever on 31-AUG-2021, and very tired for the next 24 hours on 01-SEP-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: VACCINE EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent concerned an infant of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 19-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid/biotin/minerals nos/nicotinic acid/retinol/tocopherol/vitamin b nos/vitamin d nos for drug used for unknown indication. On 02-SEP-2021, the patient experienced vaccine exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure via breast milk was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: TERRIBLE CHILLS; TERRIBLE FEVER; 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. The patient's pre-existing medical conditions included: Patient reported of not been sick like this in many years. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced terrible chills, and terrible fever. The action taken with covid-19 vaccine was not applicable. The outcome of the terrible fever and terrible chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: LOST ALL FEELING IN FINGERS; This spontaneous report received from a consumer concerned a female 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced lost all feeling in fingers. The action taken with covid-19 vaccine was not applicable. The outcome of lost all feeling in fingers was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Hypoaesthesia, Pyrexia, Sleep disorder, Throat irritation
Clinical narrative: THROAT IS STARTING TO GET SCRATCHY A BIT; CAN'T SLEEP; ENTIRE BODY IS NUMB; 38.30°C OF FEVER; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced throat is starting to get scratchy a bit, can't sleep, entire body is numb, and 38.30°c of fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 38.30 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the entire body is numb, can't sleep, throat is starting to get scratchy a bit and 38.30°c of fever was not reported. This report was non-serious.