chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no adverse event; Medical assistant reported a temperature excursion which was administered to the patient; This spontaneous report was received from a medical assistant concerning, a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.     On 03-APR-2021 the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), 1 dosage form (lot number T024831 which was verified to be a valid lot number, expiration date reported and upon internal validation established as 18-NOV-2022), as prophylaxis (frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion above 9 degree Celsius (°C) (9.3C) during a time frame of 0 hours 46 minutes and 0 seconds, as recorded by data logger. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T024831; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001382: US-009507513-2104USA001375: US-009507513-2104USA001383: US-009507513-2104USA001385: US-009507513-2104USA001386:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Medical assistant reported a temperature excursion which was administered to the patient; This spontaneous report was received from a medical assistant concerning, a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.     On 03-APR-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form orally (lot number 1691132 which was verified to be a valid lot number, expiration date reported and upon internal validation established as 30-NOV-2021), as prophylaxis (frequency and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion above 9 degree Celsius (°C) (9.3C) during a time frame of 0 hours 46 minutes and 0 seconds, as recorded by data logger. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001375: US-009507513-2104USA001383: US-009507513-2104USA001384: US-009507513-2104USA001382: US-009507513-2104USA001386:
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Medical assistant reported a temperature excursion which was administered to the patient; This spontaneous report was received from a medical assistant concerning, a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.     On 03-APR-2021, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) thimerosal-free (RECOMBIVAX HB), 1 dosage form (lot number T033149 which was verified to be a valid lot number, expiration date reported and upon internal validation established as 19-NOV-2022), as prophylaxis (frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion above 9 degree Celsius (°C) (9.3C) during a time frame of 0 hours 46 minutes and 0 seconds, as recorded by data logger. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033149; expirationdate: 19-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001384: US-009507513-2104USA001383: US-009507513-2104USA001382: US-009507513-2104USA001375: US-009507513-2104USA001385:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: UNSPECIFIED REACTION TO THE VACCINE; This spontaneous report received from a patient concerned multiple patients. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified reaction to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified reaction to the vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210355323.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pain, Parosmia
Clinical narrative: PUFFY EYES; BODY ACHES; WEAK; SINUS DRAINAGE; WIPED OUT; HORRIBLE SLEEP; BAD TASTE IN MOUTH; SMELL SOMETHING FUNNY IN NOSE; FEVER; VIOLENT SHIVERING; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced horrible sleep. On 28-MAR-2021, the subject experienced bad taste in mouth. On 28-MAR-2021, the subject experienced smell something funny in nose. On 28-MAR-2021, the subject experienced violent shivering. On 28-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced sinus drainage. On 29-MAR-2021, the subject experienced body aches. On 29-MAR-2021, the subject experienced weak. On 29-MAR-2021, the subject experienced wiped out. On 02-APR-2021, the subject experienced puffy eyes. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from horrible sleep, and violent shivering on 29-MAR-2021, had not recovered from fever, weak, body aches, sinus drainage, wiped out, and puffy eyes, and the outcome of bad taste in mouth and smell something funny in nose was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Pyrexia, Sinus operation, Somnolence, Taste disorder
Clinical narrative: PUFFY EYES; BODY ACHES; WEAK; SINUS DRAINAGE; WIPED OUT; HORRIBLE SLEEP; BAD TASTE IN MOUTH; SMELL SOMETHING FUNNY IN NOSE; FEVER; VIOLENT SHIVERING; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced horrible sleep. On 28-MAR-2021, the subject experienced bad taste in mouth. On 28-MAR-2021, the subject experienced smell something funny in nose. On 28-MAR-2021, the subject experienced violent shivering. On 28-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced sinus drainage. On 29-MAR-2021, the subject experienced body aches. On 29-MAR-2021, the subject experienced weak. On 29-MAR-2021, the subject experienced wiped out. On 02-APR-2021, the subject experienced puffy eyes. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from horrible sleep, and violent shivering on 29-MAR-2021, had not recovered from fever, weak, body aches, sinus drainage, wiped out, and puffy eyes, and the outcome of bad taste in mouth and smell something funny in nose was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Fatigue, Feeling abnormal, Nausea, Pain in extremity
Clinical narrative: TINGLING IN HEART/TINGLING IN LEFT ARM AND NECK OF LEFT SIDE; LOOPY; WORDS NOT COMING OUT RIGHT; SORE ARM; TIREDNESS; NAUSEA; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A and expiry: not reported) dose was not reported, administered on 02-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced tingling in heart/tingling in left arm and neck of left side. On 02-APR-2021, the subject experienced loopy. On 02-APR-2021, the subject experienced words not coming out right. On 02-APR-2021, the subject experienced sore arm. On 02-APR-2021, the subject experienced tiredness. On 02-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and words not coming out right, and had not recovered from tiredness, loopy, sore arm, and tingling in heart/tingling in left arm and neck of left side. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: TINGLING IN HEART/TINGLING IN LEFT ARM AND NECK OF LEFT SIDE; LOOPY; WORDS NOT COMING OUT RIGHT; SORE ARM; TIREDNESS; NAUSEA; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A and expiry: not reported) dose was not reported, administered on 02-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced tingling in heart/tingling in left arm and neck of left side. On 02-APR-2021, the subject experienced loopy. On 02-APR-2021, the subject experienced words not coming out right. On 02-APR-2021, the subject experienced sore arm. On 02-APR-2021, the subject experienced tiredness. On 02-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and words not coming out right, and had not recovered from tiredness, loopy, sore arm, and tingling in heart/tingling in left arm and neck of left side. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lumbar radiculopathy, Paraesthesia, X-ray
Clinical narrative: LUMBAR RADICULOPATHY; NUMBNESS ON BOTH ARMS; TINGLING ON BOTH ARMS; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting, the patient had no known allergies, patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced lumbar radiculopathy. On 28-MAR-2021, the subject experienced numbness on both arms. On 28-MAR-2021, the subject experienced tingling on both arms.  On 30-MAR-2021, Laboratory data included: X-ray (NR: not provided) Lumbar radiculopathy diagnosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lumbar radiculopathy, numbness on both arms, and tingling on both arms. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pyrexia, Vertigo
Clinical narrative: CONSTANT NAUSEA AROUND 1 AM; SEVERE HEADACHE; DIZZINESS DESCRIBED AS VERTIGO (WORSENS WHEN HEAD MOVES); FEVER; This spontaneous report received from a consumer concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included bilateral knee replacements, and concurrent conditions included bipolar disorder, non alcohol user, cigarette smoker, migraines, and type 2 diabetes. The patient had no known allergies or drug abuse/illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on left arm 03-APR-2021 at around 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included paliperidone palmitate for bipolar disorder.  On 03-APR-2021, around 22:00, the patient experienced severe headache, dizziness described as vertigo (worsened when head moves) and fever around 100 degrees. On 04-APR-2021, around 1:00, the patient experienced constant nausea. Treatment medications (date unspecified) included: acetylsalicylic acid/caffeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, dizziness described as vertigo (worsens when head moves), constant nausea around 1 am, and fever. 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Erythema, Hypertension, Peripheral swelling
Clinical narrative: BLOOD PRESSURE SLIGHTLY HIGHER  THAN NORMAL; DIZZY AND LIGHT HEADEDNESS; SWOLLEN ARM; REDNESS; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at 12:20 to right arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced dizzy and light headedness. On 31-MAR-2021, the subject experienced swollen arm. On 31-MAR-2021, the subject experienced redness. On 02-APR-2021, the subject experienced blood pressure slightly higher than normal. Laboratory data included: Blood pressure (NR: not provided) 157/72. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen arm, and redness, and had not recovered from dizzy and light headedness, and blood pressure slightly higher than normal. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 28-MAR-2021, the subject experienced confirmed covid-19 infection.  Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection. This report was non-serious. The suspected product quality complaint has been confirmed to be there was insufficient time elapsed for immunity to be developed. product quality complaint was voided. based on the PQC evaluation/investigation performed.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case assessed as non serious.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Injection site pain, Motion sickness
Clinical narrative: BLACK WATERY STOOLS; MOTION SICKNESS; STOMACH CRAMPS; NAUSEA; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 47 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included stomach cramps got progressively worse, and 6 episodes of diarrhea, 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: 1808978 and expiry date: not reported) dose was not reported, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced injection site pain. On 01-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced motion sickness. On 02-APR-2021, the subject experienced stomach cramps. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced black watery stools. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 01-APR-2021, was recovering from headache, and had not recovered from nausea, motion sickness, stomach cramps, and black watery stools. This report was non-serious.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: BLACK WATERY STOOLS; MOTION SICKNESS; STOMACH CRAMPS; NAUSEA; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 47 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included stomach cramps got progressively worse, and 6 episodes of diarrhea, 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: 1808978 and expiry date: not reported) dose was not reported, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced injection site pain. On 01-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced motion sickness. On 02-APR-2021, the subject experienced stomach cramps. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced black watery stools. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 01-APR-2021, was recovering from headache, and had not recovered from nausea, motion sickness, stomach cramps, and black watery stools. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Cough, Depressed mood, Diarrhoea, Dyspepsia
Clinical narrative: ARTHRITIS FLARE UP JOINTS SEVERELY BURNING AND PAINFUL; DEPRESSING  FEELING; SEVERE VERTIGO; UNCONTROLLABLE ITCHING IN TORSO; DIARRHEA; NON-PRODUCTIVE DRY COUGH; INDIGESTION; PRESSURE IN HER HEAD; RINGING AND BUZZING IN HER EARS; FEELS VERY SICK; SEVERE FATIGUE; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis (but has been under control for years), some vertigo (years ago, but has been under control for years also), pollen allergy, and pet dander allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced arthritis flare up joints severely burning and painful. On 26-MAR-2021, the subject experienced depressing feeling. On 26-MAR-2021, the subject experienced severe vertigo. On 26-MAR-2021, the subject experienced uncontrollable itching in torso. On 26-MAR-2021, the subject experienced diarrhea. On 26-MAR-2021, the subject experienced non-productive dry cough. On 26-MAR-2021, the subject experienced indigestion. On 26-MAR-2021, the subject experienced pressure in her head. On 26-MAR-2021, the subject experienced ringing and buzzing in her ears. On 26-MAR-2021, the subject experienced feels very sick. On 26-MAR-2021, the subject experienced severe fatigue. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 30-MAR-2021, and headache on 02-APR-2021, and had not recovered from severe vertigo, uncontrollable itching in torso, arthritis flare up joints severely burning and painful, non-productive dry cough, severe fatigue, depressing feeling, indigestion, ringing and buzzing in her ears, pressure in her head, nausea, and feels very sick. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Headache, Malaise, Nausea
Clinical narrative: ARTHRITIS FLARE UP JOINTS SEVERELY BURNING AND PAINFUL; DEPRESSING  FEELING; SEVERE VERTIGO; UNCONTROLLABLE ITCHING IN TORSO; DIARRHEA; NON-PRODUCTIVE DRY COUGH; INDIGESTION; PRESSURE IN HER HEAD; RINGING AND BUZZING IN HER EARS; FEELS VERY SICK; SEVERE FATIGUE; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis (but has been under control for years), some vertigo (years ago, but has been under control for years also), pollen allergy, and pet dander allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced arthritis flare up joints severely burning and painful. On 26-MAR-2021, the subject experienced depressing feeling. On 26-MAR-2021, the subject experienced severe vertigo. On 26-MAR-2021, the subject experienced uncontrollable itching in torso. On 26-MAR-2021, the subject experienced diarrhea. On 26-MAR-2021, the subject experienced non-productive dry cough. On 26-MAR-2021, the subject experienced indigestion. On 26-MAR-2021, the subject experienced pressure in her head. On 26-MAR-2021, the subject experienced ringing and buzzing in her ears. On 26-MAR-2021, the subject experienced feels very sick. On 26-MAR-2021, the subject experienced severe fatigue. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 30-MAR-2021, and headache on 02-APR-2021, and had not recovered from severe vertigo, uncontrollable itching in torso, arthritis flare up joints severely burning and painful, non-productive dry cough, severe fatigue, depressing feeling, indigestion, ringing and buzzing in her ears, pressure in her head, nausea, and feels very sick. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tinnitus, Vertigo
Clinical narrative: ARTHRITIS FLARE UP JOINTS SEVERELY BURNING AND PAINFUL; DEPRESSING  FEELING; SEVERE VERTIGO; UNCONTROLLABLE ITCHING IN TORSO; DIARRHEA; NON-PRODUCTIVE DRY COUGH; INDIGESTION; PRESSURE IN HER HEAD; RINGING AND BUZZING IN HER EARS; FEELS VERY SICK; SEVERE FATIGUE; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis (but has been under control for years), some vertigo (years ago, but has been under control for years also), pollen allergy, and pet dander allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced arthritis flare up joints severely burning and painful. On 26-MAR-2021, the subject experienced depressing feeling. On 26-MAR-2021, the subject experienced severe vertigo. On 26-MAR-2021, the subject experienced uncontrollable itching in torso. On 26-MAR-2021, the subject experienced diarrhea. On 26-MAR-2021, the subject experienced non-productive dry cough. On 26-MAR-2021, the subject experienced indigestion. On 26-MAR-2021, the subject experienced pressure in her head. On 26-MAR-2021, the subject experienced ringing and buzzing in her ears. On 26-MAR-2021, the subject experienced feels very sick. On 26-MAR-2021, the subject experienced severe fatigue. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 30-MAR-2021, and headache on 02-APR-2021, and had not recovered from severe vertigo, uncontrollable itching in torso, arthritis flare up joints severely burning and painful, non-productive dry cough, severe fatigue, depressing feeling, indigestion, ringing and buzzing in her ears, pressure in her head, nausea, and feels very sick. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: CHILLS; HEADACHE; FEVER; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced headache. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced nausea. On 03-APR-2021 10:30, Laboratory data included: COVID-19 antigen test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, headache, fever, and nausea on 01-APR-2021. This report was non-serious. This report was associated with product quality complaint: 90000175236  The suspected product quality complaint has been confirmed to be this record indicates a medical adverse event for the patient. there is no product quality issue reported. approval to void this record due to no pqc identified. based on the PQC evaluation/investigation performed.; Sender's Comments: V0:Medical Assessment comment not required as per standard procedure as the case is assessed as non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Rash
Clinical narrative: FEELS LIKE SOAR BURNING SENSATION ON LOWER BACK; RASH ON LOWER BACK SPREADING; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 29-MAR-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced rash on lower back spreading. On 31-MAR-2021, the subject experienced feels like soar burning sensation on lower back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on lower back spreading, and feels like soar burning sensation on lower back. 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.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Headache, Lethargy, Nausea
Clinical narrative: SHORTNESS OF BREATH; FULL BODY ACHE; JOINTS HURT; SEVERE HEADACHE; NAUSEA; SENSITIVITY TO LIGHT; LETHARGIC; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 15:25 for prophylactic vaccination. Concomitant medications included benzylpenicillin for drug used for unknown indication. On APR-2021, the subject experienced lethargic. On 02-APR-2021, the subject experienced sensitivity to light. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021 01:15, the subject experienced shortness of breath. On 02-APR-2021 01:15, the subject experienced full body ache. On 02-APR-2021 01:15, the subject experienced joints hurt. On 02-APR-2021 01:15, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, full body ache, and severe headache on 03-APR-2021 09:35, had not recovered from lethargic, and the outcome of joints hurt, nausea and sensitivity to light was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Photosensitivity reaction
Clinical narrative: SHORTNESS OF BREATH; FULL BODY ACHE; JOINTS HURT; SEVERE HEADACHE; NAUSEA; SENSITIVITY TO LIGHT; LETHARGIC; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 15:25 for prophylactic vaccination. Concomitant medications included benzylpenicillin for drug used for unknown indication. On APR-2021, the subject experienced lethargic. On 02-APR-2021, the subject experienced sensitivity to light. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021 01:15, the subject experienced shortness of breath. On 02-APR-2021 01:15, the subject experienced full body ache. On 02-APR-2021 01:15, the subject experienced joints hurt. On 02-APR-2021 01:15, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, full body ache, and severe headache on 03-APR-2021 09:35, had not recovered from lethargic, and the outcome of joints hurt, nausea and sensitivity to light was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blood potassium, Blood potassium decreased, Chest pain
Clinical narrative: LOSS OF SMELL; LOSS OF TASTE; NECK STIFFNESS; VOMITING; LIGHTHEADEDNESS; LOW POTASSIUM; BACK STIFFNESS; MIGRAINE WITH LIGHT SENSITIVITY; INTERMITTENT COUGHING; BURPING; CHEST PAIN; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical issues or known low potassium prior to receiving vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on left deltoid muscle on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced loss of smell. On MAR-2021, the subject experienced loss of taste. On MAR-2021, the subject experienced neck stiffness. On MAR-2021, the subject experienced vomiting. On MAR-2021, the subject experienced lightheadedness. On MAR-2021, the subject experienced low potassium. On MAR-2021, the subject experienced back stiffness. On MAR-2021, the subject experienced migraine with light sensitivity. On MAR-2021, the subject experienced intermittent coughing. On MAR-2021, the subject experienced burping. On MAR-2021, the subject experienced chest pain. On MAR-2021, the subject experienced fatigue. Laboratory data included: Potassium (NR: not provided) low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of smell, and loss of taste on 2021, and the outcome of neck stiffness, intermittent coughing, vomiting, lightheadedness, fatigue, burping, low potassium, back stiffness, chest pain and migraine with light sensitivity 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: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Eructation, Fatigue, Migraine
Clinical narrative: LOSS OF SMELL; LOSS OF TASTE; NECK STIFFNESS; VOMITING; LIGHTHEADEDNESS; LOW POTASSIUM; BACK STIFFNESS; MIGRAINE WITH LIGHT SENSITIVITY; INTERMITTENT COUGHING; BURPING; CHEST PAIN; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical issues or known low potassium prior to receiving vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on left deltoid muscle on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced loss of smell. On MAR-2021, the subject experienced loss of taste. On MAR-2021, the subject experienced neck stiffness. On MAR-2021, the subject experienced vomiting. On MAR-2021, the subject experienced lightheadedness. On MAR-2021, the subject experienced low potassium. On MAR-2021, the subject experienced back stiffness. On MAR-2021, the subject experienced migraine with light sensitivity. On MAR-2021, the subject experienced intermittent coughing. On MAR-2021, the subject experienced burping. On MAR-2021, the subject experienced chest pain. On MAR-2021, the subject experienced fatigue. Laboratory data included: Potassium (NR: not provided) low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of smell, and loss of taste on 2021, and the outcome of neck stiffness, intermittent coughing, vomiting, lightheadedness, fatigue, burping, low potassium, back stiffness, chest pain and migraine with light sensitivity 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: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vomiting
Clinical narrative: LOSS OF SMELL; LOSS OF TASTE; NECK STIFFNESS; VOMITING; LIGHTHEADEDNESS; LOW POTASSIUM; BACK STIFFNESS; MIGRAINE WITH LIGHT SENSITIVITY; INTERMITTENT COUGHING; BURPING; CHEST PAIN; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical issues or known low potassium prior to receiving vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on left deltoid muscle on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced loss of smell. On MAR-2021, the subject experienced loss of taste. On MAR-2021, the subject experienced neck stiffness. On MAR-2021, the subject experienced vomiting. On MAR-2021, the subject experienced lightheadedness. On MAR-2021, the subject experienced low potassium. On MAR-2021, the subject experienced back stiffness. On MAR-2021, the subject experienced migraine with light sensitivity. On MAR-2021, the subject experienced intermittent coughing. On MAR-2021, the subject experienced burping. On MAR-2021, the subject experienced chest pain. On MAR-2021, the subject experienced fatigue. Laboratory data included: Potassium (NR: not provided) low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of smell, and loss of taste on 2021, and the outcome of neck stiffness, intermittent coughing, vomiting, lightheadedness, fatigue, burping, low potassium, back stiffness, chest pain and migraine with light sensitivity 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: SORE THROAT; HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203172,  expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination, vaccinated at left arm. No concomitant medications were reported. On 02-APR-2021, the subject experienced sore throat. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and sore throat was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle spasms, Pain, Pain in extremity
Clinical narrative: MUSCLE CRAMPS; BODY ACHE; PAIN TO ARM; FATIGUE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 32 year old male. The patient's weight was 185 pounds, and height was not reported. The patient's past medical history included covid-19, and concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included no known drug allergies. patient had no history of drug abuse or illicit drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and  expiry: UNKNOWN) dose was not reported, administered on left arm 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced muscle cramps. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced pain to arm. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps on 10-MAR-2021, body ache, fever, and headache on 12-MAR-2021, pain to arm on 17-MAR-2021, and fatigue on 24-MAR-2021. 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: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: MUSCLE CRAMPS; BODY ACHE; PAIN TO ARM; FATIGUE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 32 year old male. The patient's weight was 185 pounds, and height was not reported. The patient's past medical history included covid-19, and concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included no known drug allergies. patient had no history of drug abuse or illicit drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and  expiry: UNKNOWN) dose was not reported, administered on left arm 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced muscle cramps. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced pain to arm. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps on 10-MAR-2021, body ache, fever, and headache on 12-MAR-2021, pain to arm on 17-MAR-2021, and fatigue on 24-MAR-2021. 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: Back pain, Chills, Hyperhidrosis, Injection site pain, Lethargy
Clinical narrative: STIFFNESS IN MIDDLE LOWER BACK AROUND SPINE; SEVERE ACHE IN MIDDLE LOWER BACK AROUND SPINE; SEVERE BODY ACHES,SHARP ACHES AND PAINS; UNCOMFORTABLE TO MOVING AROUND; HEAVILY SWEATING; LETHARGY; WENT TO BED EARLY BUT SLEEP WAS REPEATEDLY INTERRUPTED; CHILLS; INJECTION SITE ACHES LIKE A BIG FRESH BRUISE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. On an unspecified date, the subject experienced stiffness in middle lower back around spine, severe ache in middle lower back around spine, severe body aches, sharp aches and pains, uncomfortable to moving around, heavily sweating, lethargy, went to bed early but sleep was repeatedly interrupted, chills, injection site aches like a big fresh bruise, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe body aches, sharp aches and pains, uncomfortable to moving around, chills, fever, heavily sweating, stiffness in middle lower back around spine, severe ache in middle lower back around spine, lethargy, injection site aches like a big fresh bruise and went to bed early but sleep was repeatedly interrupted was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain, Pyrexia, Sleep disorder
Clinical narrative: STIFFNESS IN MIDDLE LOWER BACK AROUND SPINE; SEVERE ACHE IN MIDDLE LOWER BACK AROUND SPINE; SEVERE BODY ACHES,SHARP ACHES AND PAINS; UNCOMFORTABLE TO MOVING AROUND; HEAVILY SWEATING; LETHARGY; WENT TO BED EARLY BUT SLEEP WAS REPEATEDLY INTERRUPTED; CHILLS; INJECTION SITE ACHES LIKE A BIG FRESH BRUISE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. On an unspecified date, the subject experienced stiffness in middle lower back around spine, severe ache in middle lower back around spine, severe body aches, sharp aches and pains, uncomfortable to moving around, heavily sweating, lethargy, went to bed early but sleep was repeatedly interrupted, chills, injection site aches like a big fresh bruise, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe body aches, sharp aches and pains, uncomfortable to moving around, chills, fever, heavily sweating, stiffness in middle lower back around spine, severe ache in middle lower back around spine, lethargy, injection site aches like a big fresh bruise and went to bed early but sleep was repeatedly interrupted was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.