chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received HAV (Havrix) (batch number F4EL2, expiry date 11th September 2021) for prophylaxis. On 6th December 2021, the patient received the 2nd dose of Havrix. On 6th December 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided as follows: The age at vaccination was not reported. The practice manager called to report that a male patient was administered an expired dose of his Havrix vaccine, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site; 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 Men B NVS (Bexsero) 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.   In September 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than 3 months after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The case was reported by patient's mother The age at vaccination was not reported. The patient received a dose of Bexsero and had experienced soreness at injection site for approximately 7 days after receiving Bexsero. The reporter did not provided demographics for the patient. All information provided was reported. The reporter did not consented to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID POSITIVE; 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: covid-19 exposure (from husband).  On an unspecified date, the patient was treated to received covid-19 vaccine ad26.cov2.s from unspecified manufacturer (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported, 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s.  On 17-NOV-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 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 17-NOV-2021, the patient reported that, she had covid (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of covid positive was not reported.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Injection site pain
Clinical narrative: EXPIRED VACCINE ADMINISTERED 2 HOURS PAST EXPIRY TIME.; INJECTION SITE PAIN; This spontaneous report received from a health care professional 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 had no known allergies. The patient was previously treated with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, for prophylactic vaccination (unspecified manufacturer) (dose series 1).  The patient received booster dose covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211B21A expiry: UNKNOWN) dose was not reported, administered 1 total, on 15-NOV-2021 for prophylactic vaccination in the left arm (dose series 2). No concomitant medications were reported.  On 15-NOV-2021,  the patient  experienced vaccine administered 2 hours past expiry time and injection site pain. It was reported that the vial had been punctured and was past the six hour expiration time (dose series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and the outcome of expired vaccine administered 2 hours past expiry time  was unknown. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Sneezing
Clinical narrative: LOSS OF TASTE; LOSS OF SMELL; CONSTANT SNEEZING; This spontaneous report received from a patient via social media concerned a patient of unspecified age and sex of unspecified race and ethnic origin. Initial information was processed along with the additional information received on 19-NOV-2021 and 22-NOV-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) 1 in total, dose was not reported (dose number in series was 1) for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date, the patient received additional non-company suspect vaccine mRNA1273 (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination(dose number in series was 2). No concomitant medications were reported. On an unspecified date, following vaccination with mRNA 1273 and covid-19 vaccine ad26.cov2.s, the patient experienced loss of taste, loss of smell, and constant sneezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of taste, loss of smell, and constant sneezing. This report was associated with a product quality complaint (PQC): 90000203117. The suspected product quality complaint has been confirmed to be void this record due to no PQC identified based on the PQC evaluation/investigation performed. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: FLU-LIKE SYMPTOMS; CHILLS; FEVER; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (dose series 1). 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 flu-like symptoms, chills, and fever (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and flu-like symptoms was not reported. On unspecified date, the patient received booster dose (unspecified manufacturer and dosage regimen) (dose series 2). No events were reported. This report was non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: UNEXPECTED BENEFIT; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients received their initial vaccination with covid-19 vaccine ad26.cov2.s (manufacturer not specified) (dose series 1) (suspension for injection, route of admin, batch number, and expiry date were not reported) dose, start therapy date were not reported, administered for prophylactic vaccination. No adverse events were reported  (dose series 1).  The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose series 2) (suspension for injection, route of admin not reported, batch number: 1855194 expiry: 09-APR-2022) dose was not reported, administered on 18-NOV-2021 on left arm at 11:30 am for prophylactic vaccination. No concomitant medications were reported. On 18-NOV-2021, the patient experienced unexpected benefit (dose series 2). He reported that his peripheral neuropathy went away, there was no tingling, sharp pains out of no where, no numbness or cramping in feet. His feet felt great and were still feeling great at the time of reporting.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected benefit was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; HEADACHE; .This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  On an Unspecified date the patient was previously treated with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, (Dose Number in Series: 1), 1 total administered for prophylactic vaccination. The patient had not reported any adverse events (dose series 1). 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, (Dose Number in Series: 2) 1 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 body aches, chills, fever, and headache (dose series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, body aches, fever and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210432349.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site induration, Injection site mass, Injection site swelling, Pain in extremity
Clinical narrative: FEELS HARD AT INJECTION SITE; LEFT ARM SORE; PUFFY AT THE INJECTION SITE; LUMPY AT INJECTION SITE; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 168 pounds and height was not reported. The patient had no known drug or food allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported (dose number series 1), 1 in total administered on 10-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient was taking other (unspecified) medications at the time of vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number series 1). On 14-NOV-2021, the patient received additional non-company suspect vaccine mRNA 1273 (injection, intramuscular, batch number: 067F21A expiry: UNKNOWN) dose was not reported, (dose number series 2), administered to left deltoid for prophylactic vaccination. On 15-NOV-2021, following vaccination with mRNA 1273, the patient experienced left arm sore. She also reported that her left arm feels puffy at the injection site and initially it also felt lumpy at injection site. However, at the time of report (on 17-NOV-2021), the patient feels hard at injection site (dose number series 2). The action taken with covid-19 vaccine ad26.cov2.s, and mrna 1273 was not applicable. The outcome of the left arm sore, puffy at the injection site, lumpy at injection site and feels hard at injection site was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Diplopia, Eye disorder
Clinical narrative: DOUBLE VISION IN LEFT EYE; DARK SPOTS IN LEFT EYE; This spontaneous report received from a patient concerned a patient of unspecified age and sex with unspecified race and ethnicity.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously treated with non-company suspect vaccine included: MRNA 1273 ( form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. (Dose number in series 1)  On unspecified date, following vaccination with MRNA 1273, the patient had weird side effects. (Dose number in series 1)   The patient received additional covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported) dose was not reported, 1 total administered on 19-NOV-2021 for prophylactic vaccination (booster dose). The batch number was not reported and has been requested. (Dose number in series 2) No concomitant medications were reported.   On an unspecified date, the patient experienced double vision and dark spots in left eye. And have optometrist appointment on 24-Nov-2021. The patient fear of blood clots or something worse. (Dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the double vision and dark spots in left eye was not reported.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: SORE ARM; LITTLE TIRED; 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 not reported, batch number were not reported) for prophylactic vaccination on an unspecified date and had no adverse events.   The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number were not reported) dose was not reported, administered on 21-NOV-2021 for prophylactic vaccination as a booster dose. 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 21-NOV-2021, the patient experienced sore arm and little tired. (Dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the little tired and sore arm was not reported.  This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: CHILL; NOT FEELING WELL/KEPT FEELING WORST; FEVER; 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 ad26.cov2.s (dose series 1) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, start therapy date was not reported (received at 11:15 AM in spring) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After vaccination at around 4 PM, she started not feeling well. At  7 PM that day , she started having fever (unspecified temperature) and kept feeling worse. Throughout the night she had alternating fever and chill until 4 AM the next day. At 4 AM, fever started subsiding but for the next 5 days she did not feel well at all (dose series 1). On an unspecified date, the patient received booster dose of non-company Covid-19 vaccine (dose series 2 ,  unspecified manufacturer) and  stated it was not as bad as the Janssen vaccine that she received. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and the outcome of chill and not feeling well/kept feeling worst was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: ACHE; LITTLE FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex, race and ethnicity.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (dose number in series: 1) for prophylactic vaccination.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced ache, and little fatigue .(dose number in series: 1)  The patient recovered from ache, and little fatigue on an unspecified date.  On an unspecified date the patient received additional vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, (Dose Number in Series: 2) 1 total administered, 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 ache, and little fatigue. (dose number in series: 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the little fatigue and ache was not reported  This report was non-serious.  This case, involving the same patient is linked to 20211151326.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Apathy, Fatigue, Headache, Hypersomnia, Injection site pain
Clinical narrative: ON THE COACH TODAY THE ALL DAY; VERY TIRED AND EXHAUSTED; SLIGHT HEADACHE; THE INJECTION STING A LITTLE BIT; VERY DROWSY; SLEPT FOR 9.5 HOURS LAST NIGHT AND DID NOT WAKE UP TILL 9:30 MORNING; This spontaneous report received from a patient concerned a 62-year-old male of unspecified race and ethnic origin. The patient's weight was 200 pounds, and height was 69 inches. The patient's past medical history included: guillain-barre syndrome (GBS) (and cannot have the flu vaccine), and concurrent conditions included: diabetes (type II), alcohol use (3 beers per week), non-smoker, and blood pressure abnormal. The patient had no history of drug abuse or illicit drug use.  The patient experienced diarrhea and throwing up when treated with potassium citrate, and sick and very nauseous when treated with cefalexin. The patient received vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, and batch number, expiry were not reported ) dose was not reported, 01 total, administered on 09-APR-2021 for prophylactic vaccination. No adverse evets reported. No adverse event reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration not reported, batch number: 1855194, and expiry: 09-APR-2022) dose was not reported, 01 total administered on 22-NOV-2021 at 10:00 hours for prophylactic vaccination in right arm. No concomitant medications were reported. The patient was on blood pressure pill. On 22-NOV-2021, 3 hours following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2) the patient had slight headache, very tired, exhausted and was very drowsy. He slept for 9.5 hours last night (from the day of reporting) and did not wake up till 9:30 this (day of reporting) morning. He stated that, injection sting a little bit and the pharmacist told him that it was expected because it would go into the muscle. He was on the coach today the all day. The action taken with covid-19 vaccine ad26.cov2.s (dose number in series 2) was not applicable. The patient had not recovered from very tired and exhausted, slight headache, and on the coach today the all day, and the outcome of very drowsy, the injection sting a little bit and slept for 9.5 hours last night and did not wake up till 9:30 morning was not reported.  This report was non-serious. This case, from the same reporter is linked to 20211154670.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: ON THE COACH TODAY THE ALL DAY; VERY TIRED AND EXHAUSTED; SLIGHT HEADACHE; THE INJECTION STING A LITTLE BIT; VERY DROWSY; SLEPT FOR 9.5 HOURS LAST NIGHT AND DID NOT WAKE UP TILL 9:30 MORNING; This spontaneous report received from a patient concerned a 62-year-old male of unspecified race and ethnic origin. The patient's weight was 200 pounds, and height was 69 inches. The patient's past medical history included: guillain-barre syndrome (GBS) (and cannot have the flu vaccine), and concurrent conditions included: diabetes (type II), alcohol use (3 beers per week), non-smoker, and blood pressure abnormal. The patient had no history of drug abuse or illicit drug use.  The patient experienced diarrhea and throwing up when treated with potassium citrate, and sick and very nauseous when treated with cefalexin. The patient received vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, and batch number, expiry were not reported ) dose was not reported, 01 total, administered on 09-APR-2021 for prophylactic vaccination. No adverse evets reported. No adverse event reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration not reported, batch number: 1855194, and expiry: 09-APR-2022) dose was not reported, 01 total administered on 22-NOV-2021 at 10:00 hours for prophylactic vaccination in right arm. No concomitant medications were reported. The patient was on blood pressure pill. On 22-NOV-2021, 3 hours following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2) the patient had slight headache, very tired, exhausted and was very drowsy. He slept for 9.5 hours last night (from the day of reporting) and did not wake up till 9:30 this (day of reporting) morning. He stated that, injection sting a little bit and the pharmacist told him that it was expected because it would go into the muscle. He was on the coach today the all day. The action taken with covid-19 vaccine ad26.cov2.s (dose number in series 2) was not applicable. The patient had not recovered from very tired and exhausted, slight headache, and on the coach today the all day, and the outcome of very drowsy, the injection sting a little bit and slept for 9.5 hours last night and did not wake up till 9:30 morning was not reported.  This report was non-serious. This case, from the same reporter is linked to 20211154670.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: INTENSE ITCHING/ HAIR ITCHING; This spontaneous report received from a patient concerned a 57 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history was not reported. Concurrent conditions included: walnut allergy (results in itch/rash). On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination (dose series 1)(unspecified manufacturer) for prophylactic vaccination and it was unknown whether patient had any adverse events (dose series 1). The patient received covid-19 vaccine ad26.cov2.s (dose series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total administered on 09-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-NOV-2021, the patient experienced intense itching/ hair itching by 4 hours after receiving her booster (dose series 2). She reported taking diphenhydramine hydrochloride 2-3 hours after her booster but by 4 hours she was itching so bad. On 11-NOV-2021, the patient went to see a nurse practitioner and started fexofenadine hydrochloride for intense itching/ hair itching.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intense itching/ hair itching. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: CHILLS; NAUSEA; This spontaneous report received from a consumer concerned a 57 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (dose number in series: 1) for prophylactic vaccination and it was unknown whether the patient had any adverse events. 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, (dose Number in series: 2), 1 total administered on 24-NOV-2021 10:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-NOV-2021, around 12:30 to13:00 the patient began to had chills and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF VACCINE STORED UNDER REFRIGERATOR FOR ROUGHLY 20 HOURS; This spontaneous report received from a pharmacist concerned a 53 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total for prophylactic vaccination (manufacturer unspecified - series 1).   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, 1 in total, on right arm administered on 24-NOV-2021 for prophylactic vaccination (Booster dose). The vaccine was stored in refrigerator. No concomitant medications were reported.  On 24-NOV-2021, the patient received the vaccine which was stored under refrigerator for roughly 20 hours as a booster dose. The patient was well otherwise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine stored under refrigerator for roughly 20 hours was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Gait disturbance, Headache, Malaise
Clinical narrative: FOOT CRAMP; WEAK LEGS; NOT FELT GOOD/ FELT A LITTLE BIT LOUSY; FELT VERY COLD; FOOT PAIN/ HARD TO GET IN AND OUT OF CAR DUE TO FOOT PAIN/ ARM SORE/ ARM STILL ACHED A LITTLE BIT (UPPER ARM); RASH ON FACE (BOTH CHEEKS, FOREHEAD, AND NOSE); JOINTS SORE; HEADACHE; FEVER; TENSED UP ALL TENDONS IN FOOT; TROUBLE WALKING NORMAL; This spontaneous report received from a patient concerned a 61 year old female  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: Unknown), 1 in total, dose was not reported (dose number in series was 1) on 03-APR-2021 for prophylactic vaccination (unspecified manufacturer) and her arm was really tired and did not feel good for 3 days. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 20-MAR-2022) dose was not reported, 1 total, administered on 20-NOV-2021 14:00 to left arm for prophylactic vaccination (dose series was 2). No concomitant medications were reported.  On NOV-2021, the patient experienced tensed up all tendons in foot, trouble walking normal and her left side hurt as she took booster vaccination on left arm. On 21-NOV-2021,the patient feeling very cold but woke up on 24-NOV-2021 feeling warm and she mentioned she was using 2 blankets and a sleeping bag on top on her head which was very hard ,when she got up in between 7:30 to 8:30 in the morning, she could not stand on her foot due to pain /hard to get in and out of car due to foot pain and all her joints and arm was sore and still ached a little bit(upper arm). she also had headache and rashes on her both cheeks, forehead, and nose and felt a little bit lousy. On 23-NOV-2021, the patient experienced weak legs. On 24-NOV-2021, the patient experienced foot cramp.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not felt good/ felt a little bit lousy, and headache on 23-NOV-2021, and felt very cold on 24-NOV-2021, was recovering from foot pain/ hard to get in and out of car due to foot pain/ arm sore/ arm still ached a little bit (upper arm), joints sore, and rash on face (both cheeks, forehead, and nose), had not recovered from foot cramp, and the outcome of weak legs, trouble walking normal and tensed up all tendons in foot was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscular weakness, Pain in extremity, Pyrexia, Rash
Clinical narrative: FOOT CRAMP; WEAK LEGS; NOT FELT GOOD/ FELT A LITTLE BIT LOUSY; FELT VERY COLD; FOOT PAIN/ HARD TO GET IN AND OUT OF CAR DUE TO FOOT PAIN/ ARM SORE/ ARM STILL ACHED A LITTLE BIT (UPPER ARM); RASH ON FACE (BOTH CHEEKS, FOREHEAD, AND NOSE); JOINTS SORE; HEADACHE; FEVER; TENSED UP ALL TENDONS IN FOOT; TROUBLE WALKING NORMAL; This spontaneous report received from a patient concerned a 61 year old female  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: Unknown), 1 in total, dose was not reported (dose number in series was 1) on 03-APR-2021 for prophylactic vaccination (unspecified manufacturer) and her arm was really tired and did not feel good for 3 days. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 20-MAR-2022) dose was not reported, 1 total, administered on 20-NOV-2021 14:00 to left arm for prophylactic vaccination (dose series was 2). No concomitant medications were reported.  On NOV-2021, the patient experienced tensed up all tendons in foot, trouble walking normal and her left side hurt as she took booster vaccination on left arm. On 21-NOV-2021,the patient feeling very cold but woke up on 24-NOV-2021 feeling warm and she mentioned she was using 2 blankets and a sleeping bag on top on her head which was very hard ,when she got up in between 7:30 to 8:30 in the morning, she could not stand on her foot due to pain /hard to get in and out of car due to foot pain and all her joints and arm was sore and still ached a little bit(upper arm). she also had headache and rashes on her both cheeks, forehead, and nose and felt a little bit lousy. On 23-NOV-2021, the patient experienced weak legs. On 24-NOV-2021, the patient experienced foot cramp.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not felt good/ felt a little bit lousy, and headache on 23-NOV-2021, and felt very cold on 24-NOV-2021, was recovering from foot pain/ hard to get in and out of car due to foot pain/ arm sore/ arm still ached a little bit (upper arm), joints sore, and rash on face (both cheeks, forehead, and nose), had not recovered from foot cramp, and the outcome of weak legs, trouble walking normal and tensed up all tendons in foot was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tendon disorder
Clinical narrative: FOOT CRAMP; WEAK LEGS; NOT FELT GOOD/ FELT A LITTLE BIT LOUSY; FELT VERY COLD; FOOT PAIN/ HARD TO GET IN AND OUT OF CAR DUE TO FOOT PAIN/ ARM SORE/ ARM STILL ACHED A LITTLE BIT (UPPER ARM); RASH ON FACE (BOTH CHEEKS, FOREHEAD, AND NOSE); JOINTS SORE; HEADACHE; FEVER; TENSED UP ALL TENDONS IN FOOT; TROUBLE WALKING NORMAL; This spontaneous report received from a patient concerned a 61 year old female  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: Unknown), 1 in total, dose was not reported (dose number in series was 1) on 03-APR-2021 for prophylactic vaccination (unspecified manufacturer) and her arm was really tired and did not feel good for 3 days. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 20-MAR-2022) dose was not reported, 1 total, administered on 20-NOV-2021 14:00 to left arm for prophylactic vaccination (dose series was 2). No concomitant medications were reported.  On NOV-2021, the patient experienced tensed up all tendons in foot, trouble walking normal and her left side hurt as she took booster vaccination on left arm. On 21-NOV-2021,the patient feeling very cold but woke up on 24-NOV-2021 feeling warm and she mentioned she was using 2 blankets and a sleeping bag on top on her head which was very hard ,when she got up in between 7:30 to 8:30 in the morning, she could not stand on her foot due to pain /hard to get in and out of car due to foot pain and all her joints and arm was sore and still ached a little bit(upper arm). she also had headache and rashes on her both cheeks, forehead, and nose and felt a little bit lousy. On 23-NOV-2021, the patient experienced weak legs. On 24-NOV-2021, the patient experienced foot cramp.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not felt good/ felt a little bit lousy, and headache on 23-NOV-2021, and felt very cold on 24-NOV-2021, was recovering from foot pain/ hard to get in and out of car due to foot pain/ arm sore/ arm still ached a little bit (upper arm), joints sore, and rash on face (both cheeks, forehead, and nose), had not recovered from foot cramp, and the outcome of weak legs, trouble walking normal and tensed up all tendons in foot was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF VACCINE STORED OUTSIDE RECOMMENDED CONDITIONS; This spontaneous report received from a pharmacist concerned a 54 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination (series 1, initial dose from unspecified manufacturer). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Janssen series 2) (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, 1 total, administered into left arm on 24-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-NOV-2021, the patient received vaccine after being punctured for 20 hours (stored under refrigeration) for booster dose (administration of vaccine stored outside recommended conditions). The patient was well otherwise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine stored outside recommended conditions was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, COVID-19, Ear pain, Feeling abnormal, Rash macular
Clinical narrative: LACERATION OF BLOOD VESSEL; FOGGY FEELING IN HEAD; NASAL DISCHARGE; EAR ACHES; RED BLOTCHES BOTH FOREARMS; COVID-19; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) frequency 1 total, dose was not reported, administered on 08-FEB-2021, and dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported. On 2021, the patient experienced abdominal pain. On 25-SEP-2021, the patient experienced covid-19. On an unspecified date, the patient experienced laceration of blood vessel, foggy feeling in head, nasal discharge, ear aches, and red blotches both forearms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from abdominal pain on 2021, had not recovered from red blotches both forearms, and covid-19, and the outcome of laceration of blood vessel, foggy feeling in head, nasal discharge and ear aches was not reported. This report was non-serious. This case, involving the same patient is linked to 20211050610.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vascular injury
Clinical narrative: LACERATION OF BLOOD VESSEL; FOGGY FEELING IN HEAD; NASAL DISCHARGE; EAR ACHES; RED BLOTCHES BOTH FOREARMS; COVID-19; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) frequency 1 total, dose was not reported, administered on 08-FEB-2021, and dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported. On 2021, the patient experienced abdominal pain. On 25-SEP-2021, the patient experienced covid-19. On an unspecified date, the patient experienced laceration of blood vessel, foggy feeling in head, nasal discharge, ear aches, and red blotches both forearms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from abdominal pain on 2021, had not recovered from red blotches both forearms, and covid-19, and the outcome of laceration of blood vessel, foggy feeling in head, nasal discharge and ear aches was not reported. This report was non-serious. This case, involving the same patient is linked to 20211050610.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, 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 and expiry: unknown) dose was not reported, 1 total, administered on MAY-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported. On 18-NOV-2021, the patient got Covid (suspected clinical vaccination failure and suspected covid-19 infection) with minimal symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the  suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number:90000205003. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.; Sender's Comments: V0: 20211203745-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SUFFERING THE SIDE EFFECTS OF THE VACCINE; This spontaneous report received from a consumer 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. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suffering the side effects of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suffering the side effects of the vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative through social media  concerned a 40 year old patient of unspecified, sex, 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 and expiry date: Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company was unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, It was reported that "It had nothing to do with how much you care about others, you were aware that the vaccinated could still spread Covid and still contract it. Reporter also stated that patient got pretty sick with Covid and was in the ICU (Intensive Care Unit) right now on a ventilator. Patient was fully vaccinated (coded to suspected clinical vaccination failure, and suspected covid-19 infection)". The patient was hospitalized on an unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Life threatening and Hospitalization Caused / Prolonged). This report was associated with a product quality complaint 90000205504. This case, from the same reporter was linked to 20211212673 (multiple patient).; Sender's Comments: V0: 20211212261- covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20211212261- covid-19 vaccine ad26.cov2.s-suspected covid-19 infection. 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).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity
Clinical narrative: SORE ARM; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 5 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: factor v leiden. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm, nausea, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and the outcome of nausea and fatigue was not reported. This report was non-serious. This case, involving the same patient is linked to 20211218015.