chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lethargy, Swelling of eyelid
Clinical narrative: LETHARGY; UPPER LEFT EYELID IS COMPLETELY SWOLLEN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the only side effect patient experienced was lethargy (Dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lethargy was not reported. On an unspecified date in DEC-2021, the patient received additional non-company suspect vaccine BNT 162 (Dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination.  On DEC-2021, the patient experienced his upper left eyelid is completely swollen and has been twice the size of right eye. The patient also visited ER (Emergency room) and was given Zyrtec which did not worked for him and other treatment remedy was given (unspecified). (Dose number in series 2). It was reported that, he would need a steroid or anti-inflammatory.  The action taken with BNT 162 was not applicable. The outcome of the upper left eyelid is completely swollen was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema of eyelid, Eyelid pain, Eyelids pruritus, Hypersensitivity, Immunisation
Clinical narrative: LETHARGY; UPPER LEFT EYELID IS COMPLETELY SWOLLEN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the only side effect patient experienced was lethargy (Dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lethargy was not reported. On an unspecified date in DEC-2021, the patient received additional non-company suspect vaccine BNT 162 (Dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination.  On DEC-2021, the patient experienced his upper left eyelid is completely swollen and has been twice the size of right eye. The patient also visited ER (Emergency room) and was given Zyrtec which did not worked for him and other treatment remedy was given (unspecified). (Dose number in series 2). It was reported that, he would need a steroid or anti-inflammatory.  The action taken with BNT 162 was not applicable. The outcome of the upper left eyelid is completely swollen was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Interchange of vaccine products, Investigation, Irritability, Mental disorder, Off label use
Clinical narrative: LETHARGY; UPPER LEFT EYELID IS COMPLETELY SWOLLEN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the only side effect patient experienced was lethargy (Dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lethargy was not reported. On an unspecified date in DEC-2021, the patient received additional non-company suspect vaccine BNT 162 (Dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination.  On DEC-2021, the patient experienced his upper left eyelid is completely swollen and has been twice the size of right eye. The patient also visited ER (Emergency room) and was given Zyrtec which did not worked for him and other treatment remedy was given (unspecified). (Dose number in series 2). It was reported that, he would need a steroid or anti-inflammatory.  The action taken with BNT 162 was not applicable. The outcome of the upper left eyelid is completely swollen was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling of eyelid
Clinical narrative: LETHARGY; UPPER LEFT EYELID IS COMPLETELY SWOLLEN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the only side effect patient experienced was lethargy (Dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lethargy was not reported. On an unspecified date in DEC-2021, the patient received additional non-company suspect vaccine BNT 162 (Dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination.  On DEC-2021, the patient experienced his upper left eyelid is completely swollen and has been twice the size of right eye. The patient also visited ER (Emergency room) and was given Zyrtec which did not worked for him and other treatment remedy was given (unspecified). (Dose number in series 2). It was reported that, he would need a steroid or anti-inflammatory.  The action taken with BNT 162 was not applicable. The outcome of the upper left eyelid is completely swollen was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: NO MAJOR REACTIONS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced no major reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of no major reactions was not reported. This report was non-serious. This case, involving the same patient is linked to 20211261244.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SMALL HEADACHE; This spontaneous report received from a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included: thrombosis and failed back surgery and concurrent conditions included: thick varicose vein. 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, 1 total administered on 05-APR-2021 to left arm for prophylactic vaccination (dose number in series 1).  The patient experienced bleeding by ankle, bruising easy on arms, burning, dizziness, felt tired, leg pain, leg swelling, foot swelling, micro colitis, pain, sleepy, sore arm, swelling, thrombosis and burning went away, tightness in legs, calf muscle was so tight all the time, two bones fracture in right foot and warm bandana like headache when treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination (dose number in series 1).  The patient received booster of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) 1 total, dose was not reported, administered on NOV-2021 for prophylactic vaccination (dose number in series 2). The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified day in NOV-2021 a week before thanksgiving, the patient experienced small headache (Dose series number 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of small headache was not reported. This report was non-serious. This case, involving the same patient is linked to 20210436178 (dose number in series 1 case).
Sex: M
Vaccine: COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: PASSED AWAY FROM THE J&J BOOSTER SHOT; HEART ATTACK; 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 was previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose not reported, frequency 1 total, start therapy date were not reported for prophylactic vaccination (dose number in series 1). It was unknown if the patient experienced any adverse event with covid-19 vaccine ad26. cov2. s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose not reported, frequency 1 total, start therapy date were not reported for prophylactic vaccination (dose number in series 2). 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 heart attack (Dose number in series 2). On an unspecified date, the patient died from unknown cause. It was unspecified if an autopsy was performed. It was reported that "my brother just passed away from the Johnson and Johnson booster shot, he had a heart attack". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient passed away from the Johnson and Johnson vaccine booster shot on an unspecified date, and the outcome of heart attack was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20211262986-covid-19 vaccine ad26.cov2.s-passed away from the J&J booster shot, 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: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dysmenorrhoea, Headache, Injection site pain
Clinical narrative: IRREGULAR VAGINAL BLEEDING; MENSTRUAL CRAMPING; HORRIBLE LOW BACK PAIN LIKE BACK LABOR; CHILLS; SWELLING AT INJECTION SITE/ARM; PAIN AT INJECTION SITE/ARM; HEADACHE; NAUSEA; SPONTANEOUSLY BEGAN BLEEDING/ GOT PERIOD; This spontaneous report received from a patient concerned an adult female, age, race and ethnicity unknown. The patient's height, and weight were not reported. The patient's concurrent conditions included: perimenopausal for several years. The patient was not pregnant at the time of reporting. The patient previously received bnt 162 (Pfizer vaccine) (Dose number in series 1) on 24-MAR-2021 for prophylactic vaccination, and experienced severe reaction (dose number in series 1) and did not completed the series. The outcome of severe reaction was not reported. 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, frequency 1 total, administered on 27-DEC-2021 at 11:00 for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported.  On 27-DEC-2021, after receiving the vaccine the patient spontaneously began to bleed and got her period, she stated it was a weird cycle not normal. On 28-DEC-2021, the patient had reactions of headache, nausea, swollen and painful injection site/arm and chills. The patient added that she was also experiencing irregular vaginal bleeding during perimenopause, along with horrible low back pain like back labor, and reports that by 14:00 on 28-DEC-2021 she had vaginal spotting which then turned into a very heavy flow, no clots, bright red, with menstrual-like cramps. On 29-DEC-2021, the patient reported that she still had the heavy flow and the same symptoms, improving slightly except for the vaginal bleeding and injection site/arm pain which she states were the same (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, nausea, chills, horrible low back pain like back labor, and menstrual cramping, and had not recovered from irregular vaginal bleeding, swelling at injection site/arm, pain at injection site/arm, and spontaneously began bleeding/ got period. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Menstruation irregular, Nausea, Vaginal haemorrhage
Clinical narrative: IRREGULAR VAGINAL BLEEDING; MENSTRUAL CRAMPING; HORRIBLE LOW BACK PAIN LIKE BACK LABOR; CHILLS; SWELLING AT INJECTION SITE/ARM; PAIN AT INJECTION SITE/ARM; HEADACHE; NAUSEA; SPONTANEOUSLY BEGAN BLEEDING/ GOT PERIOD; This spontaneous report received from a patient concerned an adult female, age, race and ethnicity unknown. The patient's height, and weight were not reported. The patient's concurrent conditions included: perimenopausal for several years. The patient was not pregnant at the time of reporting. The patient previously received bnt 162 (Pfizer vaccine) (Dose number in series 1) on 24-MAR-2021 for prophylactic vaccination, and experienced severe reaction (dose number in series 1) and did not completed the series. The outcome of severe reaction was not reported. 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, frequency 1 total, administered on 27-DEC-2021 at 11:00 for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported.  On 27-DEC-2021, after receiving the vaccine the patient spontaneously began to bleed and got her period, she stated it was a weird cycle not normal. On 28-DEC-2021, the patient had reactions of headache, nausea, swollen and painful injection site/arm and chills. The patient added that she was also experiencing irregular vaginal bleeding during perimenopause, along with horrible low back pain like back labor, and reports that by 14:00 on 28-DEC-2021 she had vaginal spotting which then turned into a very heavy flow, no clots, bright red, with menstrual-like cramps. On 29-DEC-2021, the patient reported that she still had the heavy flow and the same symptoms, improving slightly except for the vaginal bleeding and injection site/arm pain which she states were the same (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, nausea, chills, horrible low back pain like back labor, and menstrual cramping, and had not recovered from irregular vaginal bleeding, swelling at injection site/arm, pain at injection site/arm, and spontaneously began bleeding/ got period. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS IN LEG; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no history of blood clots. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from an unspecified manufacturer (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 in total administered for prophylactic vaccination. It was unknown whether the patient had any adverse events following 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 not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, following covid-19 vaccine ad26.cov2.s vaccination, the patient experienced blood clots in leg (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in leg was unknown. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211263379- Covid-19 vaccine ad26.cov2.s-blood clots in leg. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19, 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 59 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: 043A21A, and expiry: 19-SEP-2021) dose was not reported,1 total, administered on 05-APR-2021 on right arm for prophylactic vaccination. 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 05-NOV-2021 on right arm for prophylactic vaccination.  On 27-DEC-2021, the patient took nasal swab PCR (polymerase chain reaction) test. On 28-DEC-2021, the result came positive, hence had confirmed clinical vaccination failure and confirmed covid-19 infection (Dose number in series 1 and 2). The action taken with covid-19 vaccine ad26.cov2.s, and BNT 162 was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209329. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria as the only indication the patient had Covid but does refer to any symptoms) based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20211263449-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: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: JOINT PAIN; This spontaneous report received from a consumer concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (A glass of wine with dinner), and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug usage. 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 01-APR-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 in first week of DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in DEC-2021, the patient experienced joint pain (dose number in series 2) and the reporter mentioned that the patient possibly sucked it out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of joint pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20211264134 and 20211240486.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a patient 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 previously received influenza vaccine.  The patient previously received covid-19 vaccine ad26. cov2. s from an unspecified manufacturer (suspension for injection, route of admin, and batch number: Unknown, Expiry: Unknown) dose not reported, frequency 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unknown if the patient had any adverse events with covid-19 vaccine ad26. cov2. s dose number series 1. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown, Expiry: Unknown) dose not reported, frequency 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  As per report "I was on a job working for people I've worked for before the man though not not young but in good health and spirt went to get a flue shot and the covid booster then died in 2 days after" (Dose number in series 2). On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event died was fatal. This report was serious (Death).; Sender's Comments: V0: 20211263885-covid-19 vaccine ad26.cov2.s-Died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Injection site pain, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19 SYMPTOMS; FLU-LIKE SYMPTOMS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 57-year-old male. The patient's weight was 181 pounds, and height was 71 inches. The patient's past medical history included: covid-19 (SEP-2020), patient had COVID-19 virus test which was positive, and concurrent conditions included: hypertension (well controlled) and drug allergy (allergic to most opioids). The patient previously received covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 23-AUG-2021) dose was not reported, frequency 1 total, administered at right arm on 10-APR-2021 for prophylactic vaccination (dose number in series 1). On 10-APR-2021, in the evening, the patient experienced headache, so he stayed in bed for a few days, felt "flu- like" with general body aches, injection site pain (all events with dose number series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had recovered from headache, flu like symptoms and injection site pain. The patient received booster dose 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, frequency 1 total, administered at right arm on 28-DEC-2021 for prophylactic vaccination (Dose number in series 2). Concomitant medications included influenza vaccine (received on 28-DEC-2021). The patient stated that after receiving vaccine he felt ok until this morning of 29-DEC-2021, and also checked his temperature with oral digital thermometer, which was at 99.8F. The patient stated that he was experiencing the same symptoms (flu like symptoms, headache, slight fever, injection site pain), most notable was the headache (Dose number in series 2). The patient added that he also "got a flu shot" at same time as covid-19 booster and was unsure if the symptoms he was feeling were from that, the covid booster, or if he actually had covid, as he stated that his symptoms "felt just like when he did have covid back in 2020." (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and influenza vaccine was not applicable. The patient had not recovered from flu-like symptoms, injection site pain, and covid-19 symptoms. This report was non-serious. This case, involving the same patient is linked to 20220100850.
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 female of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 31-DEC-2021. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient's 16 year old daughter who did not vaccinated got COVID and patient got it from her. The patient was previously treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, dose number is series 1, 1 total, start therapy date were not reported for prophylactic vaccination. The manufacturer was unspecified.  The reporter did not report any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown and expiry: unknown) dose, dose number in series 2, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, two months after vaccination with covid-19 vaccine ad26.cov2.s booster dose, the patient experienced covid (coded as Confirmed COVID-19 Infection and Confirmed Clinical Vaccination Failure). The patient was so sick and mentioned that if she was not vaccinated, she would have ended up in the hospital. The patient took two home tests (coded as covid-19 virus test) and that showed positive. She did not blame the vaccine at all. She never went to the doctors (dose number in series 2). On an unspecified date, Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) which was positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was associated with product quality complaint: 90000209631. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211265856-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
Age: 33.0
Sex: M
Vaccine: 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 33 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26. cov2.s for (Janssen, Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: 206A21A, expiry unknown) dose was not reported, 1 total, administered on 07-MAY-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. The patient was fully COVID vaccinated with Janssen vaccine. On 25-DEC-2021, the patient's symptoms started which were cough, fever, runny nose, congestion nasal and sneezing. On 26-DEC-2021, the patient took a COVID test and was COVID negative. On 30-DEC-2021, the patient was tested COVID positive using the JNJ supplied home rapid antigen test (coded as suspected COVID-19 infection and suspected clinical vaccination failure) (Dose number in series 1). The patient's partner tested positive on same day also and had same symptoms as patient.  The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, 1 total, administered on 13-DEC-2021 in left arm for prophylactic vaccination. 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. This case, from the same reporter is linked to 20211266272.; Sender's Comments: V0: 20211265944-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Illness, Myalgia
Clinical narrative: SICK; STOMACH PAIN; CHILLS; MUSCLE SORENESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sick, stomach pain, chills, and muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, sick, stomach pain and muscle soreness was not reported. This report was non-serious. This case, involving the same patient is linked to 20211266278.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse event
Clinical narrative: MILD SIDE EFFECTS; This spontaneous report received from a patient via social media through company representative concerned a female of unspecified age, race and ethnicity.   The patient's height, and weight were not reported. The patient's concurrent conditions included: heart condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown, expiry: Unknown) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in 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 very mild side effects from the original (Dose number in series 1). The reporter stated that ""I had the J&J vaccine. I have a heart condition. I had very mild side effects from the original". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effects was not reported. The patient received booster covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown, expiry: Unknown) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 2).  It was reported that patient did not have any adverse events with covid-19 vaccine ad26. cov2. s (dose number series 2). This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ingrowing nail
Clinical narrative: MILD SIDE EFFECTS; This spontaneous report received from a patient via social media through company representative concerned a female of unspecified age, race and ethnicity.   The patient's height, and weight were not reported. The patient's concurrent conditions included: heart condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown, expiry: Unknown) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in 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 very mild side effects from the original (Dose number in series 1). The reporter stated that ""I had the J&J vaccine. I have a heart condition. I had very mild side effects from the original". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effects was not reported. The patient received booster covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown, expiry: Unknown) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination (Dose number in series 2).  It was reported that patient did not have any adverse events with covid-19 vaccine ad26. cov2. s (dose number series 2). This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse event
Clinical narrative: INGROWN TOE NAILS; This spontaneous report received from a patient via social media via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height and weight were not reported. The patient's concurrent conditions included: heart condition. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of administration was not reported, batch number: unknown, expiry: unknown) dose was not reported, with frequency time 01 total, administered on an unspecified date for prophylactic vaccination.  On an unspecified date, following vaccination with covid-19 vaccine ad26. cov2.s, the patient had mild side effects (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 was not reported, batch number: unknown, expiry: unknown)  dose was not reported, with frequency time 01 total, administered on an unspecified date 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, following vaccination with covid-19 vaccine ad26. cov2.s, the patient had an ingrown toe nails (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable.   The outcome of ingrown toe nails was unknown (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20211266294.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ingrowing nail
Clinical narrative: INGROWN TOE NAILS; This spontaneous report received from a patient via social media via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height and weight were not reported. The patient's concurrent conditions included: heart condition. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of administration was not reported, batch number: unknown, expiry: unknown) dose was not reported, with frequency time 01 total, administered on an unspecified date for prophylactic vaccination.  On an unspecified date, following vaccination with covid-19 vaccine ad26. cov2.s, the patient had mild side effects (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 was not reported, batch number: unknown, expiry: unknown)  dose was not reported, with frequency time 01 total, administered on an unspecified date 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, following vaccination with covid-19 vaccine ad26. cov2.s, the patient had an ingrown toe nails (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable.   The outcome of ingrown toe nails was unknown (dose number in series 2). This report was non-serious. This case, involving the same patient is linked to 20211266294.
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: ARRHYTHMIA; This spontaneous report received from a consumer via a social media through company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with Covid-19 vaccine ad26. cov2.s. (manufacturer not specified) (suspension for injection, route of admin, batch number and expiry date not reported), (dose number in series 1) 01 in total administered, dose was not reported for prophylactic vaccination on an unspecified date. No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in 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) 01 in total administered on DEC-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 29-DEC-2021, the reported stated that her husband was admitted into the emergency room (ER) for arrhythmia (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arrhythmia was not reported (dose number in series 2). This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211266428-COVID-19 VACCINE AD26.COV2.S-Arrhythmia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Suspected COVID-19
Clinical narrative: EXPOSURE TO COVID-19; COVID-19 SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic. The patient previously received covid-19 vaccine ad26. cov2. s vaccine (suspension for injection, route of administration, batch number were not reported and expiry: unknown) dose was not reported, (dose number in series was 1), 01 in total was administered in APR-2021 for prophylactic vaccination.  The reporter had not reported any adverse events following vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported (dose number in series was 2), 01 in total was administered on 20-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included semaglutide (Ozempic) for indication diabetic. On an unspecified date, following the vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced exposure to coronavirus disease-19 (COVID-19) from his daughter who tested positive for COVID-19. He reported symptoms such as fatigue, nausea and headache (symptoms subsumed under event "covid-19 symptoms", dose number in series was 2). He stated that the symptoms were mild and very similar to previous side effects from taking semaglutide (Ozempic). He was not sure if symptoms were from COVID-19 or semaglutide (Ozempic) side effects. It was reported that, patient had not done any test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exposure to covid-19 and covid-19 symptoms was unknown. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Malaise
Clinical narrative: HEFTY REACTION; FELT SICK; This spontaneous report received from a patient via social media from a company representative concerned a patient of unspecified age, sex 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 (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, 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. It was reported that the patient had no reaction, following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, patient received booster dose of non-company suspect vaccine included: mrna 1273 (Moderna), (Dose number in series 2) (form of admin, route of admin not reported, batch number: unknown, expiry: unknown), dose, start therapy date were not reported for prophylactic vaccination. On an unspecified date, following vaccination with mrna 1273 (Moderna), the patient experienced hefty reaction (adverse event nos) and felt sick (Dose number in series 2). It was reported that " I had the Janssen shot and then my doctor told me to get the Moderna booster so I did". The patient "had quite a hefty reaction to the booster. Not real bad, Sickish for 2 day". The patient recovered from felt sick, and the outcome of hefty reaction was unknown. This report was non-serious.
Sex: U
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 via a company representative concerned a 73-year-old 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 not reported, batch number: Unknown and expiry: unknown) dose was not reported, 1 total administered on an unspecified date in MAR-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested.  On 08-AUG-2021, the patient tested covid positive (confirmed covid-19 infection and confirmed clinical vaccination failure). The vaccine and monoclonal antibodies worked well. The patient had mild symptoms none of which lasted more than 24 hours. The whole disease lasted 8 days or so. The patient was out of quarantine after 10 days of positive testing (dose number in series 1). Concomitant medications was reported as monoclonal antibodies; the patient's PCP (Primary care physician) ordered monoclonal antibodies to ensure that patient did not have severe symptoms. The patient received the monoclonal antibodies on 10-AUG-2021. 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 01-DEC-2021 for prophylactic vaccination (Dose number in series 2). It was not specified whether patient had any adverse reaction after vaccination (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on AUG-2021 and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000209557.; Sender's Comments: V0: 20211266632-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  20211266632-covid-19 vaccine ad26.cov2.s- confirmed 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).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a consumer via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000209708.