chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: CHEST PAIN; CHILLS; FEVER; This spontaneous report received from a parent concerned an 18 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 received non-company bnt 162 vaccine (dose number in series was 1) (form of admin, route of admin not reported, batch number: FW0161) dose was not reported, administered on 19-APR-2021 for prophylactic vaccination. On an unspecified date, the patient experienced chest pain following vaccination with non-company bnt 162 vaccine (dose number in series was 1). The patient previously received non-company bnt 162 vaccine (dose number in series was 1) (form of admin, route of admin not reported, batch number: ER8736) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. On an unspecified date, the patient experienced chest pain following vaccination with non-company bnt 162 vaccine (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, route of admin not reported, batch number: 1855191 expiry: 11-APR-2022) dose was not reported, 1 total, administered on 24-DEC-2021 to Left Deltoid for prophylactic vaccination. Concomitant medications included naproxen. On 24-DEC-2021, within 6 hours from vaccination, the patient experienced fever, chest pain and chills following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series was 2). Laboratory data (dates unspecified) included: Body temperature (not provided) 100.5 (units unspecified), Oxygen supplementation (not provided) 98 %, and Pulse rate (not provided) 90's. The patient received treatment with Aleve. Patient's chest pain symptom was faded. Patient's health care professional (HCP) suspected that the vaccination causes chest pain. Patient did not go to emergency room (ER) and was discussed with an ER doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 25-DEC-2021, and fever, and was recovering from chest pain. This report was non-serious.
Age: 57.0
Sex: M
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 concerned a 6 decade old male. Initial information was processed along with the additional information received from a regulatory authority on 30-DEC-2021. 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 (patient age at the time of vaccination was 57 years) (dose number in series: 1) (suspension for injection, route of admin not reported,  batch number: 201A21A and expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 12-APR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. The patient stated that he had not performed covid 19 test but was symptomatic and he had symptoms of diarrhea, vomiting, body aches, joints hurt, feverish and chills at the time of reporting. The patient also stated that body aches may be from exertion from throwing up (coded as suspected covid 19 infection and suspected clinical vaccination failure) (dose number in series:1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection and suspected clinical vaccination failure was not reported. The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin not reported,  batch number: 213D21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 22-NOV-2021 to the left arm for prophylactic vaccination. It was unknown whether the patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series: 2). This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority This case is a duplicate of 20211258611. The suspected regulatory authority has been confirmed to be voided (did not meet a regulatory authorities criteria)(this complaint does not describe a product quality issue and the patient was exhibiting symptoms of an infection there was no confirmatory test to confirm if this was covid-19, hence was confirmed as voided) based on the regulatory authority (product quality complaint) evaluation/investigation performed.; Sender's Comments: V0: 20211258571-COVID-19 VACCINE AD26.COV2.S-Suspeceted 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
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; This spontaneous report received from a patient concerned a 28-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 the first dose (Pfizer)on 31-MAR-2021,  and received on 21-APR-2021 second dose (Pfizer) additional non-company vaccine bnt 162 (a form of admin, route of admin, and batch number: ER8730, expiry: unknown, batch number: ER0163, expiry: unknown) dose was not reported, for prophylactic vaccination (dose number in series 1). The patient experienced fever and headache when treated with bnt 162 (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, 1 total, administered on 30-OCT-2021 for prophylactic vaccination on left arm (dose number in series 2). No concomitant medications were reported.  On 30-OCT-2021 (6 hours post vaccination), the patient experienced fever, and headache which lasted about 48 hours (dose number is series 2). It was more severe than the second Pfizer dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and headache on 01-NOV-2021. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: SEVERE HEADACHE; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: non-smoker, and non-alcohol user. The patient had no known drug allergies and no medical history of chronic illness. The patient was not pregnant at the time of reporting The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was unspecified whether patient experienced any adverse events following the administration of covid-19 vaccine ad26.cov2.s (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable The patient received non-company suspect vaccine mrna 1273 (Moderna, dose number in series: 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 06-NOV-2021 for prophylactic vaccination. On christmas eve, following mrna 1273 vaccination, it was reported that patient had a close contact with a person who had flu like symptoms prior to christmas eve, and that he was tested positive for covid-19 thereafter. On 26-DEC-2021, the patient experienced severe headache. (Dose number in series: 2) The action taken with mrna 1273 was not reported. The patient had not recovered from severe headache. This report was non-serious
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Cerebrovascular accident
Clinical narrative: STROKE; MEMORY LOSS; This spontaneous report received from a consumer via social media through company representative concerned a male 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 vaccinated with covid-19 vaccine ad26.cov2.s from an unspecified manufacturer (dose number in series 1), (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 01 in total, administered for prophylactic vaccination. No concomitant medications were reported.  No adverse events were 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 admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 in total, administered 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 memory loss and suffered a stroke. The hospital said the vaccine caused his stroke (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the memory loss and stroke was unknown (dose number in series 2) This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211258504 and 20211260708.; Sender's Comments: V0: 20211258923-covid-19 vaccine ad26.cov2.s -stroke. 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 67 year old male. 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 previously received covid-19 vaccine ad26. cov2.s (Janssen, Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, 1 total, administered on 09-MAR-2021 on left arm for prophylactic vaccination. On 10-MAR-2021, the patient experienced flu-like symptoms and recovered on 13-MAR-2021 (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-NOV-2021, the patient experienced flu-like symptoms (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms on 13-NOV-2021. This report was non-serious. This case, involving the same patient is linked to 20211258945 (Dose number in series 1 case). This case, from the same reporter is linked to 20211258107 and 20211258204.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Eye pain, Herpes zoster
Clinical narrative: PAIN IN THE RIGHT EYE SOCKET; JOINT PAIN; SHINGLES; This spontaneous report received from a patient concerned a 63 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: unknown, expiry: UNKNOWN) dose was not reported, 1 total administered on specified date in MAR-2021 for prophylactic vaccination (Dose series number 1).  On MAR-2021, the patient experienced not much reaction (Dose series number 1). The outcome of not much reaction was not reported.  The patient received booster of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: unknown) dose was not reported, 1 total administered on 02-DEC-2021 at left arm for prophylactic vaccination ( Dose series number 2).  No concomitant medications were reported. On 02-DEC-2021 (after 2 hours of vaccination), the patient had fever, chills and extreme fatigue with the booster shot which lasted for 3 days. On an unspecified day, the patient had fever of 101 and experienced body aches, big lumps on right side of head, itchy lumps, soreness, headache, pain in joints, sickness for 3 days and pain in the right eye socket. The patient went to physician and diagnosed with shingles (Dose series number 2). The physician prescribed an antiviral (valaciclovir) and she was taking Tylenol for the pain.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shingles, pain in the right eye socket and joint pain was not reported. This report was non-serious. This case, involving the same patient is linked to 20211259385.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: NOT MUCH REACTION; This spontaneous report received from a patient concerned a 63 year old female. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAR-2021, following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series was 1), the patient had not much reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not much reaction was not reported. This report was non-serious. This case, involving the same patient is linked to 20211259371 (Dose number in series 2 case).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, COVID-19, Chills, Fatigue, Feeling abnormal
Clinical narrative: SWEATING; SEVERE CHILLS; VERY HIGH FEVER TO 104; BAD HEADACHES; EXTREME FATIGUE; COULD NOT GET HER HEAD OFF OF THE PILLOW; SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a patient concerned a 58-year-old white female of unspecified ethnicity. The patient's weight was 72.57 kilograms, and height was 168 centimeters. Patient had no medical history (illness at the time of vaccination) and no family history relevant to adverse event. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: unknown) dose was not reported, 1 total, administered on 15-MAR-2021 at left upper arm for prophylactic vaccination (dose number in series 1).  On 24-NOV-2021, the patient had Covid (suspected clinical vaccination failure and covid-19 infection). Laboratory data included: COVID-19 virus test (NR: not provided) unknown (event with dose number in series 1). On 18-DEC-2021 around 10:30 am, the patient received additional non-company suspect vaccine included: BNT 162 (Pfizer) (form of admin, route of admin was not reported and batch number: FD0809 expiry: unknown) dose was not reported, administered for prophylactic vaccination on left upper arm (dose number in series 2). No concomitant medications were reported.  On 18-DEC-2021 22:30 PM, (12 hours after vaccination) the patient experienced very high fever 104 F, severe chills, patient could not get her head off of the pillow, bad headache and extreme fatigue. The patient still had a very bad headache on the day of report. She stated her fever probably broke in the middle of the last night (19-DEC-2021) because she was sweating profusely. The patient still had headache and tiredness, but they were better (all events with dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and BNT 162 was not applicable. The patient recovered from very high fever to 104, severe chills,  and could not get her head off of the pillow. The patient was recovering from bad headaches and extreme fatigue. The outcome of  sweating, covid-19 infection,  and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209409.; Sender's Comments: V0: 20211259703-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
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hyperhidrosis, Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SWEATING; SEVERE CHILLS; VERY HIGH FEVER TO 104; BAD HEADACHES; EXTREME FATIGUE; COULD NOT GET HER HEAD OFF OF THE PILLOW; SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a patient concerned a 58-year-old white female of unspecified ethnicity. The patient's weight was 72.57 kilograms, and height was 168 centimeters. Patient had no medical history (illness at the time of vaccination) and no family history relevant to adverse event. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: unknown) dose was not reported, 1 total, administered on 15-MAR-2021 at left upper arm for prophylactic vaccination (dose number in series 1).  On 24-NOV-2021, the patient had Covid (suspected clinical vaccination failure and covid-19 infection). Laboratory data included: COVID-19 virus test (NR: not provided) unknown (event with dose number in series 1). On 18-DEC-2021 around 10:30 am, the patient received additional non-company suspect vaccine included: BNT 162 (Pfizer) (form of admin, route of admin was not reported and batch number: FD0809 expiry: unknown) dose was not reported, administered for prophylactic vaccination on left upper arm (dose number in series 2). No concomitant medications were reported.  On 18-DEC-2021 22:30 PM, (12 hours after vaccination) the patient experienced very high fever 104 F, severe chills, patient could not get her head off of the pillow, bad headache and extreme fatigue. The patient still had a very bad headache on the day of report. She stated her fever probably broke in the middle of the last night (19-DEC-2021) because she was sweating profusely. The patient still had headache and tiredness, but they were better (all events with dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and BNT 162 was not applicable. The patient recovered from very high fever to 104, severe chills,  and could not get her head off of the pillow. The patient was recovering from bad headaches and extreme fatigue. The outcome of  sweating, covid-19 infection,  and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209409.; Sender's Comments: V0: 20211259703-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
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Immunisation
Clinical narrative: SWEATING; SEVERE CHILLS; VERY HIGH FEVER TO 104; BAD HEADACHES; EXTREME FATIGUE; COULD NOT GET HER HEAD OFF OF THE PILLOW; SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a patient concerned a 58-year-old white female of unspecified ethnicity. The patient's weight was 72.57 kilograms, and height was 168 centimeters. Patient had no medical history (illness at the time of vaccination) and no family history relevant to adverse event. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: unknown) dose was not reported, 1 total, administered on 15-MAR-2021 at left upper arm for prophylactic vaccination (dose number in series 1).  On 24-NOV-2021, the patient had Covid (suspected clinical vaccination failure and covid-19 infection). Laboratory data included: COVID-19 virus test (NR: not provided) unknown (event with dose number in series 1). On 18-DEC-2021 around 10:30 am, the patient received additional non-company suspect vaccine included: BNT 162 (Pfizer) (form of admin, route of admin was not reported and batch number: FD0809 expiry: unknown) dose was not reported, administered for prophylactic vaccination on left upper arm (dose number in series 2). No concomitant medications were reported.  On 18-DEC-2021 22:30 PM, (12 hours after vaccination) the patient experienced very high fever 104 F, severe chills, patient could not get her head off of the pillow, bad headache and extreme fatigue. The patient still had a very bad headache on the day of report. She stated her fever probably broke in the middle of the last night (19-DEC-2021) because she was sweating profusely. The patient still had headache and tiredness, but they were better (all events with dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and BNT 162 was not applicable. The patient recovered from very high fever to 104, severe chills,  and could not get her head off of the pillow. The patient was recovering from bad headaches and extreme fatigue. The outcome of  sweating, covid-19 infection,  and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209409.; Sender's Comments: V0: 20211259703-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
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Interchange of vaccine products, Loss of personal independence in daily activities, Off label use, Pyrexia
Clinical narrative: SWEATING; SEVERE CHILLS; VERY HIGH FEVER TO 104; BAD HEADACHES; EXTREME FATIGUE; COULD NOT GET HER HEAD OFF OF THE PILLOW; SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a patient concerned a 58-year-old white female of unspecified ethnicity. The patient's weight was 72.57 kilograms, and height was 168 centimeters. Patient had no medical history (illness at the time of vaccination) and no family history relevant to adverse event. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: unknown) dose was not reported, 1 total, administered on 15-MAR-2021 at left upper arm for prophylactic vaccination (dose number in series 1).  On 24-NOV-2021, the patient had Covid (suspected clinical vaccination failure and covid-19 infection). Laboratory data included: COVID-19 virus test (NR: not provided) unknown (event with dose number in series 1). On 18-DEC-2021 around 10:30 am, the patient received additional non-company suspect vaccine included: BNT 162 (Pfizer) (form of admin, route of admin was not reported and batch number: FD0809 expiry: unknown) dose was not reported, administered for prophylactic vaccination on left upper arm (dose number in series 2). No concomitant medications were reported.  On 18-DEC-2021 22:30 PM, (12 hours after vaccination) the patient experienced very high fever 104 F, severe chills, patient could not get her head off of the pillow, bad headache and extreme fatigue. The patient still had a very bad headache on the day of report. She stated her fever probably broke in the middle of the last night (19-DEC-2021) because she was sweating profusely. The patient still had headache and tiredness, but they were better (all events with dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and BNT 162 was not applicable. The patient recovered from very high fever to 104, severe chills,  and could not get her head off of the pillow. The patient was recovering from bad headaches and extreme fatigue. The outcome of  sweating, covid-19 infection,  and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209409.; Sender's Comments: V0: 20211259703-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
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Feeling abnormal, Injection site pain, Presyncope
Clinical narrative: WEAKNESS/NO ENERGY; BACK PAIN; ARM PAIN AT INJECTION SITE; WEIRD FEELING LIKE AGONY; FEELING LIKE FAINTING; TACHYCARDIA; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: None as per patient. The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: UNKNOWN) dose was not reported, administered on 03-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2021, the patient experienced tachycardia, weird feeling like agony, and feeling like fainting. On 03-DEC-2021, the patient experienced arm pain at injection site. On 04-DEC-2021, the patient experienced back pain. On 28-DEC-2021, the patient experienced weakness/no energy. Treatment medications (dates unspecified) included: meloxicam. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain on 07-DEC-2021, had not recovered from tachycardia, weakness/no energy, and weird feeling like agony, and the outcome of arm pain at injection site and feeling like fainting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: WEAKNESS/NO ENERGY; BACK PAIN; ARM PAIN AT INJECTION SITE; WEIRD FEELING LIKE AGONY; FEELING LIKE FAINTING; TACHYCARDIA; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: None as per patient. The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: UNKNOWN) dose was not reported, administered on 03-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2021, the patient experienced tachycardia, weird feeling like agony, and feeling like fainting. On 03-DEC-2021, the patient experienced arm pain at injection site. On 04-DEC-2021, the patient experienced back pain. On 28-DEC-2021, the patient experienced weakness/no energy. Treatment medications (dates unspecified) included: meloxicam. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain on 07-DEC-2021, had not recovered from tachycardia, weakness/no energy, and weird feeling like agony, and the outcome of arm pain at injection site and feeling like fainting was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: SORE THROAT; HEADACHES; 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. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-MAR-2021 to right arm for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received booster dose of non-company suspect vaccine included: MRNA 1273 (Moderna) (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 05-DEC-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 26-DEC-2021, the patient experienced sore throat, and headaches (dose number in series 2). On 27-DEC-2021, Laboratory data included: Antigen Rapid test ((BinaxNOW) coded as COVID-19 antigen test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s, and MRNA 1273 (Moderna) was not applicable. The outcome of the headaches and sore throat was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 29-DEC-2021. 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 (Janssen dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient received additional non-company suspect vaccine included: BNT 162 (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-DEC-2021, the patient experienced mild congestion. She stated the symptom was only upper respiratory (subsumed under suspected Covid-19 infection), no cough or fever. On 27-DEC-2021, the patient had done home kit test [not PCR (polymerase chain reaction) test] and was tested positive for Covid-19, hence had suspected clinical vaccination failure (Dose number in series 1 and 2). She was fully vaccinated. The action taken with covid-19 vaccine ad26.cov2.s, and BNT 162 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: 90000209408.; Sender's Comments: V0: 20211260954-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
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Phlebitis
Clinical narrative: PHLEBITIS; This spontaneous report received from a consumer 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 received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031) dose was not reported, 1 total, administered on 13-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the patient noticed a vein on left foot became inflamed. The patient's daughter showed a picture of vein to a her professor who was a doctor and they said it was phlebitis (Dose number in series 1) and recommended to wear compression stockings. The patient also went to MD (medical doctor). Symptom had subsided afterwards.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from phlebitis. This report was non-serious. This case, involving the same patient is linked to 20211261121 (Dose number in series 2 case).
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: ITCHY RASH; This spontaneous report received from a patient via a company representative via a social media   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 previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, administered on MAR-2021 for prophylactic vaccination. No adverse events reported post vaccination (dose number in series 1). 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 NOV-2021 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 itchy rash (dose number in series 2). The patient was just wondering if anyone had developed an itchy rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itchy rash was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tachycardia
Clinical narrative: ITCHING SENSATION ON LEFT FOOT VEIN (FEELING AS A PRICK); TACHYCARDIA; This spontaneous report received from a consumer 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 received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-Mar-2021 on left arm for prophylactic vaccination. The patient experienced phlebitis when treated with first dose of covid-19 vaccine ad26.cov2.s.  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-DEC-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in DEC-2021, the patient experienced itching sensation on left foot vein where she got phlebitis after first dose (feeling as a prick) and tachycardia (Dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itching sensation on left foot vein/ feeling as a prick and tachycardia was not reported. This report was non-serious. This case, involving the same patient is linked to 20211260960 (Dose number in series 1).
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: VERY MILD CASE; This spontaneous report received from a patient via a social media and company representative concerned a male 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, and batch number: Unknown and expiry: Unknown ) dose ,start therapy date were not reported, dose number in series 1, 1 total administered 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 very mild case (dose number in series was 1). It was reported that "Son currently has it, got J&J vax, very mild case". On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: Unknown and expiry: Unknown ) dose ,start therapy date were not reported, dose number in series 2, 1 total administered for prophylactic vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very mild case. This report was non-serious. This report was associated with product quality complaint number: 90000209146. 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 PQC evaluation/investigation performed. This case, from the same reporter is linked to 20211261126 and 20211261154.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 55 year old female. Initial information was processed along with additional information on 29-DEC-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number:1808978 expiry: UNKNOWN) dose was not reported,1 total, administered on 10-APR-2021 on left arm for prophylactic vaccination. No adverse events reported post vaccination (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number:1822811 expiry: UNKNOWN) dose was not reported,1 total, administered on 23-OCT-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 27-DEC-2021, the patient stated that she was tested positive for COVID-19, both by Rapid Antigen test and PCR (polymerase chain reaction) test (confirmed clinical vaccination failure) and received only text that stated she was positive and does not had test results. She also stated she had bad cold and thought that she had breakthrough infection and she thought she got Omicron (subsumed under confirmed Covid-19 infection) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209076.; Sender's Comments: V0: 20211261137-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: NO MAJOR REACTION; This spontaneous report received from a patient via a social media 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 was 1) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The patient felt a little tired (dose number in series 1).  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, 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 had no major reaction to the injection (Dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of no major reaction was not reported. This report was non-serious. This case, involving the same patient is linked to 20211261527 (Dose number in series was 1).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a consumer via a company representative via a social media concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported,1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No adverse events reported post vaccination (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient received non-company suspect vaccine included: MRNA 1273 (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 17-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-DEC-2021, the patient experienced heart attack and died (dose number in series 2). It was unknown if autopsy was performed. The reporter stated not the first, not the last. The patient's wife and children were crying. The action taken with MRNA 1273 was not applicable. The outcome of heart attack was fatal. This report was serious (Death).; Sender's Comments: V0:20211261251-COVID-19 VACCINE AD26.COV2.S-Heart attack. 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: HEART ATTACK
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast mass, Breast pain, Breast tenderness, Injection site pain, Myalgia
Clinical narrative: BREAST LUMP; BOTH BREASTS TENDER; BOTH BREASTS SORE; LEFT ARM MUSCLE SORENESS AT INJECTION SITE; MUSCLE SORENESS IN LEFT ARM; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 55.79 kilograms, and height was 155 centimeters. The patient was not ill at the time of vaccination. The patient did not have any vaccination within four weeks prior to the first administration date of the suspect vaccine. The patient was not on any other medications. The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 1) (suspension for injection, intramuscular, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-APR-2021 on left upper arm in the muscle for prophylactic vaccination. No concomitant medications were reported. In the afternoon of 12-APR-2021, the patient experienced muscle soreness in left arm. On an unspecified date, patient experienced a breast lump. In MAY-2021 (a month after the J and J COVID vaccine), the patient had the lumpectomy. On an unspecified date in 2021 (last spring/summer), the patient had radiation therapy which completed in JUL-2021 (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breast lump and recovering from muscle soreness in left arm. On 19-DEC-2021 14:00, the patient received additional non-company suspect vaccine bnt 162 (Dose number in series 2) (form of admin not reported, intramuscular, batch number: FD7218) dose was not reported, administered on left upper arm in the muscle for prophylactic vaccination.  On 19-DEC-2021, right after driving home, the patient experienced muscle was sore in the arm she got injection in. Muscle soreness has improved at injection site, but it was still a little sore (left arm muscle soreness at injection site).  On the morning of 20-DEC-2021, the patient experienced an unusual side effect described as, breasts got sore like a PMS (Premenstrual syndrome symptom) even though she had been through menopause for quite some time. She said both breasts were sore and tender, but the one that she had the lumpectomy and radiation in this past spring/summer was more sore. The patient also had breast tenderness. On 20-DEC-2021 and 21-DEC-2021, it was quite uncomfortable, but on 22-DEC-2021, it was still tender when patient took shower, but a little improved (Dose number in series 2).  The patient was recovering from both breasts tender, both breasts sore and left arm muscle soreness at injection site. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211261375-covid-19 vaccine ad26.cov2.s-Breast lump. 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).