chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 33-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA433A, expiry date 31st October 2021) for prophylaxis.   On 15th December 2021, the patient received Menveo. On 15th December 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported  The reporter stated that the patient received an expired dose of MENVEO, which led to expired vaccine used. The reporter consented to follow up. This is one of 6 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021261528:Same reporter US-GLAXOSMITHKLINE-US2021261523:Same reporter US-GLAXOSMITHKLINE-US2021261527:Same reporter US-GLAXOSMITHKLINE-US2021261529:Same reporter US-GLAXOSMITHKLINE-US2021261531:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2021, the patient received the 2nd dose of Shingrix (intramuscular). In December 2021, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received 2nd dose of Shingrix vaccine and had sore arm. The patient did mention she did not had side effects with Shingrix except a sore arm. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: VIOLENTLY ILL; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was vaccinated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, administered for prophylactic vaccination. No adverse events were reported (dose number in series 1). The patient received an additional company suspect covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported, administered on NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that the effects of the booster (dose number in series 2) were more than the primary vaccination (dose number in series 1). On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2) the patient was violently ill (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of violently ill was unknown. This report was non-serious. This case, from the same reporter is linked to 20211233585.
Sex: M
Vaccine: COVID19
Symptoms: Breech presentation, Foetal exposure during pregnancy
Clinical narrative: BABY WAS IN BREECH OR ABNORMAL PRESENTATION; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male neonate. The patient was enrolled in a non-company sponsored study. The patient's weight was 3.06 kilograms, and height was 20 inches. No past medical history or concurrent conditions were reported. The parent initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, for baby (transplacental), batch number: 1802072 expiry: UNKNOWN) dose was not reported, frequency one total, administered on 09-MAR-2021 for covid-19 immunisation (Dose number series 1). No concomitant medications were reported.  On 09-Mar-2021, at gestational age 24 weeks, the patient experienced foetal exposure during pregnancy. On an unspecified date, baby was in breech or abnormal presentation. At gestational age of 39 weeks and 3 days, live male neonate delivered by caesarean method of delivery. The neonate spent two days in the hospital after birth. It was reported that reason for caesarean method of delivery was breech or abnormal presentation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from baby was in breech or abnormal presentation, and foetal exposure during pregnancy. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and baby was in breech or abnormal presentation as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and foetal exposure during pregnancy was not related and between covid-19 vaccine ad26.cov2.s, and baby was in breech or abnormal presentation as related. This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20210763277.; Sender's Comments: V0: 20211238278 - covid-19 vaccine ad26.cov2.s- Foetal exposure during pregnancy. 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   20211238278 - covid-19 vaccine ad26.cov2.s  Breech presentation. This event(s) is considered related. 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Pain, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION (LITTLE BIT OF A COUGH, LOW GRADE FEVER, BODY ACHES A LITTLE BIT AND CHEST TIGHTNESS, TIRED, DRAINED  AND NO ENERGY); BODY SORENESS THE DAY OF THE VACCINE; TEMPERATURE OF 100.2 F THE NIGHT AFTER THE VACCINE; This spontaneous report received from a patient concerned a 50 year old male The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and alcohol user one glass of wine at night and other pre-existing medical conditions included: patient did not have any known drug allergies and no medical history of chronic illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204AZ1A, expiry: unknown) dose was not reported, 1 total, administered at right arm on SEP-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported.  On an unspecified date in SEP-2021, on the same day of vaccination the patient experienced body soreness and temperature of 100.2 f the night after the vaccine. Laboratory data included: Body temperature (NR: not provided) 100.2 F.  On 20-DEC-2021, the patient woke up with a little bit of a cough, low grade fever, body aches a little bit and chest tightness, tired, drained and had no energy (suspected covid 19 infection). On same day, on 20-DEC-2021 he tested for Covid-19 at home, COVID-19 rapid POC test which was negative. On 20-DEC-2021, the patient experienced suspected clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body soreness the day of the vaccine, and temperature of 100.2 f the night after the vaccine, had not recovered from suspected covid 19 infection (little bit of a cough, low grade fever, body aches a little bit and chest tightness, tired, drained and no energy), and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000207839.  The suspected product quality complaint has been confirmed to be void-Y,this record describes adverse events (coughing, fever, body ache, chest tightness) but indicates a negative covid test. this report does not meet the definition of a product quality complaint or explicitly allege a potency issue. this record will be voided as no pqc.(void: yes) based on the RA evaluation/investigation performed.; Sender's Comments: V0:20211245146 covid-19 vaccine ad26.cov2.s - suspected clinical vaccination failure This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically:SPECIAL SITUATIONS
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION (LITTLE BIT OF A COUGH, LOW GRADE FEVER, BODY ACHES A LITTLE BIT AND CHEST TIGHTNESS, TIRED, DRAINED  AND NO ENERGY); BODY SORENESS THE DAY OF THE VACCINE; TEMPERATURE OF 100.2 F THE NIGHT AFTER THE VACCINE; This spontaneous report received from a patient concerned a 50 year old male The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and alcohol user one glass of wine at night and other pre-existing medical conditions included: patient did not have any known drug allergies and no medical history of chronic illness at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204AZ1A, expiry: unknown) dose was not reported, 1 total, administered at right arm on SEP-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported.  On an unspecified date in SEP-2021, on the same day of vaccination the patient experienced body soreness and temperature of 100.2 f the night after the vaccine. Laboratory data included: Body temperature (NR: not provided) 100.2 F.  On 20-DEC-2021, the patient woke up with a little bit of a cough, low grade fever, body aches a little bit and chest tightness, tired, drained and had no energy (suspected covid 19 infection). On same day, on 20-DEC-2021 he tested for Covid-19 at home, COVID-19 rapid POC test which was negative. On 20-DEC-2021, the patient experienced suspected clinical vaccination failure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body soreness the day of the vaccine, and temperature of 100.2 f the night after the vaccine, had not recovered from suspected covid 19 infection (little bit of a cough, low grade fever, body aches a little bit and chest tightness, tired, drained and no energy), and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000207839.  The suspected product quality complaint has been confirmed to be void-Y,this record describes adverse events (coughing, fever, body ache, chest tightness) but indicates a negative covid test. this report does not meet the definition of a product quality complaint or explicitly allege a potency issue. this record will be voided as no pqc.(void: yes) based on the RA evaluation/investigation performed.; Sender's Comments: V0:20211245146 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: Impaired work ability, Post concussion syndrome, Vertigo
Clinical narrative: SEVERE VERTIGO; POST CONCUSSED FEELING; COULD NOT WORK; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On an unspecified date, the patient experienced severe vertigo, post concussed feeling, and could not work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe vertigo, post concussed feeling and could not work was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: Suspected Clinical Vaccination Failure; Suspected COVID-19 Infection; This spontaneous report received from a patient concerned a 20 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: 201A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 04-SEP-2021 for prophylactic vaccination on right arm (dose number in series 1). No concomitant medications were reported.  On an unspecified date the patient experienced headache, feeling tired, chest felt tight and sinus problems. The patient tested positive for COVID-19 with two rapid tests twice. Laboratory data (dates unspecified) included: COVID-19 rapid POC (point-of-care) test (NR: not provided) Positive. On 22-DEC-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) (suspected clinical vaccination failure and suspected covid-19 infection).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection and sinus problems was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000208241.; Sender's Comments: V0: 20211250977-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: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer through a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: Unknown and expiry: Unknown) 1 total, dose (Dose number in series:1) and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced stroke. The consumer reported as "The lady I work for had a stroke after getting hers. She's in a wheelchair for the rest of her life." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211251043 and 20211251833.; Sender's Comments: V0: 20211251030 - Stroke This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a consumer 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 (dose number in series 1) (suspension for injection, route of administration not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Reporter stated that, on an unspecified date, reporter's friend's husband had a heart attack after the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211251030 and 20211251833.; Sender's Comments: V0:20211251043- COVID-19 VACCINE AD26.COV2.S- Heart attack. This event is considered Un assessable. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 48-year-old male. The patient's height, and weight were not reported. The patient's past medical history included: a lot of surgeries, and concurrent conditions included: autoimmune disease.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: UNKNOWN) 1 total, dose was not reported, administered on 09-JUN-2021 to left arm as prophylactic vaccination (Dose number in series 1). No concomitant medications were reported.  The patient then had an antibody test which showed that he had no antibodies. On 28-OCT-2021, SARS-Doz-2-nucleocapsid IgG test result was 0. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed immunological vaccination failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000208297.; Sender's Comments: V0:20211251085-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
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: REALLY SICK WITH COVID; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced really sick with covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of really sick with covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000208313, 90000208322.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: INCREASED HEART RATE; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; 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, and batch number were not reported, expiry: unknown) dose was not reported, dose number in series was 1, 1 total administered on 08-JUL-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Since the past weekend (19-DEC-2021) patient had been lethargic. It was reported that symptoms did not really hit till Monday (20-DEC-2021). Patient had increased heart rate, dry cough, really bad headache which has gotten better, a little bit of a runny nose. Patient tested at home with the BinaxNow rapid test and it came out positive (suspected covid-19 infection and suspected clinical vaccination failure). Patient tested with the same kit yesterday (21-Dec-2021) and it was negative. The doctor prescribed some medication. Dose number in series was 1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, increased heart rate, and suspected clinical vaccination failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000208377.; Sender's Comments: V0:20211251194-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Influenza
Clinical narrative: SLIGHT FLU/UNDER THE WEATHER/TIRED/EXHAUSTED; CROAKY; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included: anaphylaxis reactions, and pneumonia, and concurrent conditions included: asthma, chronic obstructive pulmonary disease, immunocompromised immune system, bad allergies, and high blood pressure. The patient experienced drug allergy when treated with silicon dioxide for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride for anaphylaxis reactions. On 30-APR-2021, the patient experienced slight flu/under the weather/tired/exhausted, and croaky. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight flu/under the weather/tired/exhausted, and croaky on MAY-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death, Suspected COVID-19, Vaccination failure
Clinical narrative: DEATH; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. Dose number in series was 1. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection, suspected clinical vaccination failure and was dead (dose number in series was 1). The consumer reported as "my friend got covid after getting the vaccine and passed away". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died (unknown cause) on an unspecified date, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with a product quality complaint: 90000208523. This case, from the same reporter is linked to 20211251030 and 20211251043.; Sender's Comments: V0: 20211251833 - death. 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).  20211251833 -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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pyrexia, Throat irritation, Tinnitus
Clinical narrative: COUGHING; BUZZ TO THE LEFT EAR; FEVER; SCRATCHY THROAT; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 14-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-DEC-2021, the patient experienced scratchy throat. On 22-DEC-2021, the patient experienced coughing, buzz to the left ear, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the scratchy throat, coughing, buzz to the left ear and fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; WAS IN BED ALL DAY; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced body aches, was in bed all day, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, body aches and was in bed all day was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Muscle atrophy, Muscle swelling, Pain in extremity, Vasodilatation
Clinical narrative: 3 MONTHS AFTER THE SHOT VEINS STARTED SWELLING; MUSCLES STARTED SWELLING; VEINS STARTED COLLAPSING; MUSCLES STARTED COLLAPSING; PAINFUL ARMS HANDS AND LEGS; PAIN IN BACK OF HEAD; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced 3 months after the shot veins started swelling, muscles started swelling, veins started collapsing, muscles started collapsing, painful arms hands and legs, and pain in back of head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 3 months after the shot veins started swelling, pain in back of head, painful arms hands and legs, muscles started swelling, veins started collapsing and muscles started collapsing was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vein collapse
Clinical narrative: 3 MONTHS AFTER THE SHOT VEINS STARTED SWELLING; MUSCLES STARTED SWELLING; VEINS STARTED COLLAPSING; MUSCLES STARTED COLLAPSING; PAINFUL ARMS HANDS AND LEGS; PAIN IN BACK OF HEAD; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced 3 months after the shot veins started swelling, muscles started swelling, veins started collapsing, muscles started collapsing, painful arms hands and legs, and pain in back of head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 3 months after the shot veins started swelling, pain in back of head, painful arms hands and legs, muscles started swelling, veins started collapsing and muscles started collapsing was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Fatigue, Headache
Clinical narrative: BACK PAIN STEADILY GETTING WORSE; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, back pain, latex allergy, nickel allergy, non alcohol user, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 26-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-DEC-2021, the patient experienced back pain steadily getting worse, headache, and fatigue. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. Treatment medications (dates unspecified) included: oxycodone hydrochloride/paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain steadily getting worse, headache, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Illness
Clinical narrative: STOMACH ACHE; REALLY SICK; LOWER BACK PAIN IN THE KIDNEY AREA; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced stomach ache, really sick, and lower back pain in the kidney area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach ache, really sick and lower back pain in the kidney area was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: TERRIBLY SICK AFTER THE JAB AND WERE STILL NOT OVER IT; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced terribly sick after the jab and were still not over it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from terribly sick after the jab and were still not over it. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED A JANSSEN COVID-19 VACCINE PAST EXPIRATION DATE; This spontaneous report received from a pharmacist 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: 212A21A, and expiry: 21-DEC-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced patient received a janssen covid-19 vaccine past expiration date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient received a janssen covid-19 vaccine past expiration date was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF ONE DOSE OF THE JANSSEN COVID-19 VACCINE EXPIRED BY ONE DAY; This spontaneous report received from a pharmacist 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: 212A21A, expiry: 21-DEC-2021) dose was not reported, administered on 22-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-DEC-2021, the patient experienced administration of one dose of the janssen covid-19 vaccine expired by one day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of one dose of the janssen covid-19 vaccine expired by one day was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: TINNITUS; HEADACHE; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 17-AUG-2021 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 patient experienced tinnitus, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE (FIRST INCIDENCE- MAX 56.1 F, MIN 48.2 F, SECOND INCIDENCE MAX 35.2 F MIN 30.1 F); This spontaneous report received from a pharmacist 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: 1822809, expiry: 07-MAR-2022) dose was not reported, administered on 18-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-OCT-2021, the patient experienced out of specification product use, and incorrect product storage (first incidence- max 56.1 f, min 48.2 f, second incidence max 35.2 f min 30.1 f). 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 (first incidence- max 56.1 f, min 48.2 f, second incidence max 35.2 f min 30.1 f) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Illness
Clinical narrative: REALLY SICK FOR 2 DAYS; SEVERE BACK PAIN; CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced really sick for 2 days, severe back pain, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really sick for 2 days, and the outcome of severe back pain, chills and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20211254498.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT NOS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious. This case, from the same reporter is linked to 20211254439.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Blood test, Vaccination site pain
Clinical narrative: Soreness in his arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness in his arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 032L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in his arm). At the time of the report, VACCINATION SITE PAIN (Soreness in his arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Antibody test: 110 (Low) S test showing a count of 110. In December 2021, Antibody test: 83.9 (Low) S antibody count dropped to 83.9.. In December 2021, Blood test: not reported Results were not reported. On 18-Dec-2021, Antibody test: not reported Anti SARS CoV N and S tests Results were not reported.. On an unknown date, Antibody test: 85 Retested and count was 85.         No concomitant information was reported. No treatment information was reported.  Patient stated that he was not sure whether it was possible that the booster created absolutely no S antibodies and failed to trigger an immune response in the patient.  Patient was enrolled in an antibody study undertaken by [school] by utilizing (unspecified) tests.These tests were done by a Laboratory.   This case was linked to MOD-2021-417990 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2021: Added reporter occupation as other health professional, Lab tests, event outcome as recovered. On 23-Dec-2021: Updated reporter occupation as patient and Updated lab data- Antibody count updated
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 12-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste in his mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in his mouth) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced DYSGEUSIA (metallic taste in his mouth). At the time of the report, DYSGEUSIA (metallic taste in his mouth) had not resolved.            The patient experienced metallic taste in his mouth after his second dose.   No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-420720 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Follow up received and updated patient demographics, product details and event onset date. On 21-Dec-2021: Follow up received contains non significant information.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Palpitations, SARS-CoV-2 test
Clinical narrative: Heart palpitation after the 2nd shot; May have been anxiety; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitation after the 2nd shot) and ANXIETY (May have been anxiety) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced PALPITATIONS (Heart palpitation after the 2nd shot) and ANXIETY (May have been anxiety). On 04-May-2021, PALPITATIONS (Heart palpitation after the 2nd shot) and ANXIETY (May have been anxiety) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Patient never had COVID disease nor a positive test..         Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Patient wife reported that patient had heart palpitation. Patient did not see a doctor and the heart palpitation went away by itself. He had been around people with COVID Disease but he never had COVID-Disease nor a positive test. His medical history was clear and healthy. Wife also stated, At that time, we thought it may had been anxiety, since it was not listed as a side effect..
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose yesterday 20Dec2021/1st dose on 14Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose yesterday 20Dec2021/1st dose on 14Oct2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose yesterday 20Dec2021/1st dose on 14Oct2021). On 20-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose yesterday 20Dec2021/1st dose on 14Oct2021) had resolved.            Concomitant products was not provided. Treatment medication was not reported.   This case was linked to MOD-2021-406165 (Patient Link).