chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: WEIRD SPINNING; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION/FEVER/SPLITTING HEADACHE/SINUS PRESSURE/COUGH/CONGESTION/FEELING SICK; FELT ROTTEN AFTER THE SHOT/FELT LIKE BRAIN WAS FLOATING IN HOT WATER; This spontaneous report received from a patient concerned a 51 year old female. Initial information was processed along with the additional information received on 26-JUL-2021 The patient's height, and weight were not reported. The patient's past medical history included Lyme disease, and concurrent conditions included non-smoker, alcohol user (Occasional glass of wine), and penicillin allergy. The patient was not pregnant at the time of reporting. The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 07-AUG-2021) dose was not reported, 1 total administered to left arm on 16-MAY-2021 for prophylactic vaccination. Concomitant medications included vitamins nos.  On 16-MAY-2021, after the vaccination, the patient felt rotten for a day and a half but no other side effects. On 23-JUL-2021, the patient started experiencing fever, splitting headache and sinus pressure. On 24-JUL-2021, the patient went to get a rapid covid-19 test and result came as positive to Covid-19 (suspected covid-19 infection and suspected clinical vaccination failure). The patient also had symptoms such as congestion, headache, and cough which was present at the time of reporting. It was reported that, the patient's symptoms were like waves sometimes she felt better then she felt sick. The patient stated that her fever was 99 F and not more than 100 F. The patient also stated that she felt like her brain was floating in hot water and felt weird spinning.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt rotten after the shot/felt like brain was floating in hot water on MAY-2021, had not recovered from suspected covid-19 infection/fever/splitting headache/sinus pressure/cough/congestion/feeling sick, and the outcome of suspected clinical vaccination failure and weird spinning was not reported. This report was serious (Other Medically Important Condition). This report was associated with product complaint number 90000187262. The suspected product quality complaint has been confirmed to be not voided (meet PQC) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210755349-COVID-19 VACCINE AD26.COV2.S-Suspected clinical  vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: WEIRD SPINNING; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION/FEVER/SPLITTING HEADACHE/SINUS PRESSURE/COUGH/CONGESTION/FEELING SICK; FELT ROTTEN AFTER THE SHOT/FELT LIKE BRAIN WAS FLOATING IN HOT WATER; This spontaneous report received from a patient concerned a 51 year old female. Initial information was processed along with the additional information received on 26-JUL-2021 The patient's height, and weight were not reported. The patient's past medical history included Lyme disease, and concurrent conditions included non-smoker, alcohol user (Occasional glass of wine), and penicillin allergy. The patient was not pregnant at the time of reporting. The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 07-AUG-2021) dose was not reported, 1 total administered to left arm on 16-MAY-2021 for prophylactic vaccination. Concomitant medications included vitamins nos.  On 16-MAY-2021, after the vaccination, the patient felt rotten for a day and a half but no other side effects. On 23-JUL-2021, the patient started experiencing fever, splitting headache and sinus pressure. On 24-JUL-2021, the patient went to get a rapid covid-19 test and result came as positive to Covid-19 (suspected covid-19 infection and suspected clinical vaccination failure). The patient also had symptoms such as congestion, headache, and cough which was present at the time of reporting. It was reported that, the patient's symptoms were like waves sometimes she felt better then she felt sick. The patient stated that her fever was 99 F and not more than 100 F. The patient also stated that she felt like her brain was floating in hot water and felt weird spinning.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt rotten after the shot/felt like brain was floating in hot water on MAY-2021, had not recovered from suspected covid-19 infection/fever/splitting headache/sinus pressure/cough/congestion/feeling sick, and the outcome of suspected clinical vaccination failure and weird spinning was not reported. This report was serious (Other Medically Important Condition). This report was associated with product complaint number 90000187262. The suspected product quality complaint has been confirmed to be not voided (meet PQC) based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210755349-COVID-19 VACCINE AD26.COV2.S-Suspected clinical  vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Panic attack
Clinical narrative: PANIC ATTACKS; LONG-TERM DIZZINESS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced panic attacks, and long-term dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the long-term dizziness and panic attacks was not reported. This report was non-serious. This case, from the same reporter is linked to 20210754977 and 20210759716.; Sender's Comments: V0 :  Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: TINNITUS; EAR DISCOMFORT, EAR PRESSURE, EAR FULLNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced tinnitus, and ear discomfort, ear pressure, ear fullness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tinnitus and ear discomfort, ear pressure, ear fullness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210758691 and 20210758713.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: SKIN FALLS  OFF; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced skin falls off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of skin falls off was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Off label use, Product administered to patient of inappropriate age
Clinical narrative: ANAPHYLAXIS; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a consumer via other company (Pfizer Inc.) concerned 4 patients. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, patients experienced anaphylaxis, inappropriate age at vaccine administration, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anaphylaxis, inappropriate age at vaccine administration and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 ;20210756606-JANSSEN COVID-19 VACCINE-Anaphylaxis. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: HIV antigen, Lymphocyte count, Meningitis viral, Pain, Pyrexia
Clinical narrative: VARICELLA ZOSTER VIRUS MENINGITIS; ACHES; RIGHT LEG (L5 DERMATOME) INVOLVEMENT WITH VESICULAR SKIN LESIONS; FEVER; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) was received on 23-Jul-2021 and concerned a 34-year-old female with unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no past medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: Unknown) dose 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. It was reported that 2 weeks after vaccination on an unspecified date, the patient experienced significant immunological response like fever and ache to the vaccine. On an unspecified date, the patient had right leg (L5 dermatome) involvement with vesicular skin lesions and headache with eventual diagnosis of varicella zoster virus meningitis (VZV meningitis). Laboratory data (dates unspecified) included: Absolute lymphocyte count (NR: not provided) Normal, and HIV antigen (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, varicella zoster virus meningitis and right leg (l5 dermatome) involvement with vesicular skin lesions was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210756694-covid-19 vaccine ad26.cov2-varicella zoster virus meningitis. 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: F
Vaccine: COVID19
Symptoms: Rash vesicular
Clinical narrative: VARICELLA ZOSTER VIRUS MENINGITIS; ACHES; RIGHT LEG (L5 DERMATOME) INVOLVEMENT WITH VESICULAR SKIN LESIONS; FEVER; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) was received on 23-Jul-2021 and concerned a 34-year-old female with unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no past medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: Unknown) dose 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. It was reported that 2 weeks after vaccination on an unspecified date, the patient experienced significant immunological response like fever and ache to the vaccine. On an unspecified date, the patient had right leg (L5 dermatome) involvement with vesicular skin lesions and headache with eventual diagnosis of varicella zoster virus meningitis (VZV meningitis). Laboratory data (dates unspecified) included: Absolute lymphocyte count (NR: not provided) Normal, and HIV antigen (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, varicella zoster virus meningitis and right leg (l5 dermatome) involvement with vesicular skin lesions was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210756694-covid-19 vaccine ad26.cov2-varicella zoster virus meningitis. 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: PRURITUS THROUGHOUT THE BODY ALTERNATES IN DIFFERENT AREAS OF THE BODY/ ITCHINESS (BACK OF LEFT ANKLE, BACK OF BOTH ARMS, SIDE OF LEFT LEG ON CALF AREA AND WAIST AREA,LEFT HAND),ITCHY AREAS WITH RED MINOR BUMPS SIZE OF A QUARTER TO HALF-A DOLLAR LIKE; This spontaneous report received from a patient concerned a 68 year old male. The patient's weight was 262 pounds, and height was 69 inches. The patient's past medical history included rheumatic fever in childhood, and concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced pruritus throughout the body alternates in different areas of the body/ itchiness (back of left ankle, back of both arms, side of left leg on calf area and waist area, left hand), itchy areas with red minor bumps size of a quarter to half-a dollar like mosquito bites. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pruritus throughout the body alternates in different areas of the body/ itchiness (back of left ankle, back of both arms, side of left leg on calf area and waist area,left hand),itchy areas with red minor bumps size of a quarter to half-a dollar like mosquito bites. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 53 year old male. Initial information was processed along with the additional information received on 28-JUL-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 (suspension for injection, route of admin not reported, batch number: 180525 expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-APR-2021, the patient experienced COVID-19 which was suspected vaccination failure and suspected covid-19 infection. On 26-JUL-2021 the patient experienced tickle in his throat. On 27-JUL-2021 the patient experienced cold like symptoms (no fever or tiredness), cough, raspy voice and stuffy nose. 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. This report was serious (Other Medically Important Condition). This report was associated with a Product Quality Complaint: 90000187393.; Sender's Comments: V0: 20210757719-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: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Feeling abnormal, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; FELT LIKE HIT A WALL; SUDDENLY FELT VERY EXHAUSTED; This spontaneous report received from a patient concerned a 57 year old female of unknown race, and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included many environmental allergies, alcohol user, non smoker, Hashimoto's disease, vitiligo, and autoimmune disease, and the patient had no known allergies. The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 at 14:30 to right arm for prophylactic vaccination. Concomitant medications included thyroid replacement medications [both triiodothyronine (T4) and tetraiodothyronine (T3) replacement]. On 09-APR-2021, almost exactly 24 hours after receiving the vaccine, the patient felt like she hit a wall, suddenly felt very exhausted and went to sleep immediately. The patient noted no unusual effects during sleep. On 10-APR-2021, in the morning, the patient felt fine and back to normal. The patient saw her physician quarterly routinely & her physician did bloodwork routinely at each quarterly exam. Her second quarterly routine examination of the year was on 11-JUN-2021 and bloodwork was done. The patient's physician reported that she had no antibodies post covid-19 vaccine ad26.cov2.s. The patient did not know what type of serological test was done to make that determination, although she did know that it was not the one for T-cell (T lymphocyte) testing and that the testing was carried out at diagnostics center. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like hit a wall, and suddenly felt very exhausted on 10-APR-2021, and the outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187497.; Sender's Comments: V0:20210757925-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological 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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: ON AND OFF SHAKING HANDS; This spontaneous report received from a consumer concerned a 66 year old male. The patient's weight was 208 pounds, and height was 173 centimeters. The patient's past medical history included heart stent placement surgery, and concurrent conditions included high blood pressure, and cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23/JUN/2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included clopidogrel bisulfate for cholesterol. On 07-MAY-2021, the subject experienced on and off shaking hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from on and off shaking hands. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASHES (HIVES) ALL OVER THE BODY; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, non-smoker, and crohn's disease, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A214, expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. Concomitant medications included mesalazine for crohn's disease. On 09-MAY-2021, the subject experienced rashes (hives) all over the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rashes (hives) all over the body. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Decreased appetite, Fatigue, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; LOSS OF HEARING; SWOLLEN TONSILS; LOSS OF APPETITE; TIREDNESS; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a parent concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Reporter unaware about the exact date on which the patient got the COVID-19 vaccine. No concomitant medications were reported.  On unspecified date patient experienced tiredness. On 22-JUL-2021, the patient experienced suspected covid-19 infection. According to reporter patient got COVID because patient was exposed to it. The patient did not take any medications for the tiredness nor report it to Health care professional (HCP). In regards to testing positive for COVID-19, HCP was aware of this but had not been given any treatments for COVID-19 symptoms. Laboratory data included: COVID-19 virus test (NR: not provided) Positive.  On an unspecified date, the patient experienced suspected clinical vaccine failure, loss of hearing, swollen tonsils, and loss of appetite. Patient was at home isolating without medical treatment. Reporter did not have lot information but will have daughter call to provide further information on this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of hearing, and tiredness, had not recovered from suspected covid-19 infection, swollen tonsils, and loss of appetite, and the outcome of suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210758347-covid-19 vaccine ad26.cov2.s -'Suspected  clinical vaccination failure'. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20210758347-covid-19 vaccine ad26.cov2.s- suspected covid-19 infection, loss of hearing. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Tonsillar hypertrophy, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; LOSS OF HEARING; SWOLLEN TONSILS; LOSS OF APPETITE; TIREDNESS; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a parent concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Reporter unaware about the exact date on which the patient got the COVID-19 vaccine. No concomitant medications were reported.  On unspecified date patient experienced tiredness. On 22-JUL-2021, the patient experienced suspected covid-19 infection. According to reporter patient got COVID because patient was exposed to it. The patient did not take any medications for the tiredness nor report it to Health care professional (HCP). In regards to testing positive for COVID-19, HCP was aware of this but had not been given any treatments for COVID-19 symptoms. Laboratory data included: COVID-19 virus test (NR: not provided) Positive.  On an unspecified date, the patient experienced suspected clinical vaccine failure, loss of hearing, swollen tonsils, and loss of appetite. Patient was at home isolating without medical treatment. Reporter did not have lot information but will have daughter call to provide further information on this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of hearing, and tiredness, had not recovered from suspected covid-19 infection, swollen tonsils, and loss of appetite, and the outcome of suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210758347-covid-19 vaccine ad26.cov2.s -'Suspected  clinical vaccination failure'. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20210758347-covid-19 vaccine ad26.cov2.s- suspected covid-19 infection, loss of hearing. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Fat tissue increased, Influenza, Muscle atrophy, Nasopharyngitis, Pain
Clinical narrative: BODY ACHE; MUSCLES GETTING LOOSE; WEIGHT GAIN; BODY ACCUMULATING FATS; BODY PRODUCING LESS SEMEN; FEVER; COLD; FLU; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 140 pounds, and height was 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced cold. On 07-APR-2021, the subject experienced flu. On an unspecified date, the subject experienced body ache, muscles getting loose, weight gain, body accumulating fats, body producing less semen, and fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fever, and had not recovered from cold, flu, muscles getting loose, weight gain, body accumulating fats, and body producing less semen. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Semen volume decreased, Weight increased
Clinical narrative: BODY ACHE; MUSCLES GETTING LOOSE; WEIGHT GAIN; BODY ACCUMULATING FATS; BODY PRODUCING LESS SEMEN; FEVER; COLD; FLU; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 140 pounds, and height was 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced cold. On 07-APR-2021, the subject experienced flu. On an unspecified date, the subject experienced body ache, muscles getting loose, weight gain, body accumulating fats, body producing less semen, and fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fever, and had not recovered from cold, flu, muscles getting loose, weight gain, body accumulating fats, and body producing less semen. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: HEARING LOSS OR IMPAIREMENT; This spontaneous report received from a consumer via social media 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 not reported, batch number: Unknown) dose, 1 total administered, therapy start date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date (24 hours to within days after vaccination), the patient experienced hearing loss or impairement. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hearing loss or impairement was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210755980 and 20210758713.; Sender's Comments: V0:20210758691-COVID-19 VACCINE AD26.COV2.S-hearing loss or impairment. 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: U
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: TINNITUS; EAR FULLNESS/DISCOMFORT/PRESSURE; 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 not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced tinnitus, and ear fullness/discomfort/pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tinnitus and ear fullness/discomfort/pressure was not reported. This report was non-serious. This case, from the same reporter is linked to 20210755980 and 20210758691.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Delusion, Pain, Pyrexia
Clinical narrative: DELUSIONS; BODY PAIN; HIGH FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included pericarditis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced delusions, body pain, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, delusions and body pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: EXCRUCIATING HEADACHE; FEVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103. On 27-JUL-2021, the subject experienced excruciating headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 19-JUL-2021, and had not recovered from excruciating headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Pain, Peripheral swelling
Clinical narrative: DIARRHEA; SWOLLEN FEET AND SWOLLEN LEGS; BODY ACHES; FATIGUE; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced diarrhea, swollen feet and swollen legs, body aches, fatigue, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, headaches, body aches, diarrhea, and swollen feet and swollen legs. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: VACCINATED TWICE; This spontaneous report received from a health care professional concerned a 28 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031/043A21A expiry: UNKNOWN/05-AUG-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-JUL-2021, the subject experienced vaccinated twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccinated twice was not reported. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Insomnia, Pain in extremity
Clinical narrative: LEFT ARM WEAKNESS; PAIN ON LEFT ARM AND FINGERS; CAN'T SLEEP BECAUSE OF PAIN; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported.  The patient's past medical history included kidney stone surgery, and concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 20-MAY-2021, the subject experienced can't sleep because of pain. On 20-MAY-2021, the subject experienced pain on left arm and fingers. On 15-JUN-2021, the subject experienced left arm weakness. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported.  Treatment medications (dates unspecified) included: gabapentin, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left arm weakness, can't sleep because of pain, and pain on left arm and fingers. This report was non-serious. This case, from the same reporter is linked to 20210760712.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: DOSE WITHDRAWN TWO DAYS AGO WAS GIVEN TO A PATIENT TODAY; This spontaneous report received from a pharmacist concerned a 61 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-JUL-2021, the subject experienced dose withdrawn two days ago was given to a patient today. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose withdrawn two days ago was given to a patient today was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: LOW FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced low fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low fever, and headache. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 61 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the subject experienced out of specification product use. On an unspecified date, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage was not reported. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED TO A PATIENT 25 MINUTES AFTER THE 6 HOUR EXPIRATION TIME FRAME; EXPIRED VACCINE ADMINISTERED TO 1  PATIENT; This spontaneous report received from a pharmacist concerned a 36 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 05-AUG-2021) dose was not reported, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-JUL-2021, the subject experienced vaccine administered to a subject 25 minutes after the 6 hour expiration time frame. On 26-JUL-2021, the subject experienced expired vaccine administered to 1 subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered to 1 patient and vaccine administered to a patient 25 minutes after the 6 hour expiration time frame was not reported. This report was non-serious.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Medication error
Clinical narrative: VACCINATED 2 TIMES WITH JANSSEN COVID19 VACCINE; POTENTIAL MEDICATION ERROR; This spontaneous report received from a health care professional concerned an 82 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031 expiry: UNKNOWN, and batch number: 043A21A expiry: 05-AUG-2021) dose was not reported, administered on 11-MAR-2021, and dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination.  Concomitant medications included mrna 1273 for prophylactic vaccination.  On 27-JUL-2021, the subject experienced vaccinated 2 times with janssen covid19 vaccine.  On 27-JUL-2021, the subject experienced potential medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccinated 2 times with janssen covid19 vaccine and potential medication error was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: COUGH/COLD SYMPTOMS/RUNNY NOSE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: 07/AUG/2021) dose was not reported, administered on 12-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021, the subject experienced cough/cold symptoms/runny nose. Treatment medications (dates unspecified) included: chlorphenamine maleate/ibuprofen/phenylephrine hydrochloride, and guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough/cold symptoms/runny nose on APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: VERY WEAK SENSE OF SMELL AND JUST THAT NIGHT COULD NOT SMELL ANYMORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 27-JUL-2021 13:30 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 28-JUL-2021, the subject experienced very weak sense of smell and just that night could not smell anymore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very weak sense of smell and just that night could not smell anymore was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise, Rash pruritic, Vision blurred
Clinical narrative: BLURRED VISION; CHILLS; GENERALLY DID NOT FEEL WELL; AN ITCHY RASH THAT BROKE OUT ON TORSO; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the subject experienced an itchy rash that broke out on torso. On 25-JUL-2021, the subject experienced blurred vision. On 25-JUL-2021, the subject experienced chills. On 25-JUL-2021, the subject experienced generally did not feel well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from an itchy rash that broke out on torso, and the outcome of chills, blurred vision and generally did not feel well was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: ELIMINATE LYME DISEASE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included lyme disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported.  On an unspecified date, the subject experienced eliminate lyme disease. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of eliminate lyme disease was not reported. This report was non-serious.