chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: FROZEN VACCINE WAS THAWED AND GIVEN TO PATIENT; This spontaneous report received from a pharmacist concerned a 71 year old male. The patient's weight was not reported and height was 71 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, frequency one total, administered on 18-JUN-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced frozen vaccine was thawed and given to subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of frozen vaccine was thawed and given to patient was not reported. This report was serious (Other Medically Important Condition).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Gingival bleeding, Pain in extremity, Vision blurred
Clinical narrative: EYESIGHT IS A LITTLE BLURRY; BLEEDING GUMS WHEN BRUSHING TEETH; LIKE A BLISTER; PAIN IN LEG; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient was healthy and fit. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prevention of covid-19 vaccine. No concomitant medications were reported. On APR-2021, the subject experienced like a blister. On APR-2021, the subject experienced pain in leg. On an unspecified date, the subject experienced eyesight is a little blurry, and bleeding gums when brushing teeth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in leg, eyesight is a little blurry, bleeding gums when brushing teeth, and like a blister. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Skin odour abnormal
Clinical narrative: BAD BODY ODOR; This spontaneous report received from a patient concerned a 36 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.. No concomitant medications were reported.  On an unspecified date, the subject experienced bad body odor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad body odor. This report was non-serious. This case, from the same reporter is linked to 20210660241.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, COVID-19, Fatigue, Hypoaesthesia
Clinical narrative: WHOLE BODY NUMBNESS; SLUGGISHNESS; MUSCLE SPASMS IN BACK AND NECK IN BOTH THE BACK AND FRONT AND UP AND DOWN ALSO; SEVERE CRAMPING TO BOTH UPPER  EXTREMITIES, ESPECIALLY HANDS, WRISTS, FINGERS; UNABLE TO MOVE WHOLE BODY; FEELING UNWELL; GENERALIZED WEAKNESS; BEAT UP, WASHED OUT FEELING; FEVER UPTO 100F-104.5F; THE PATIENT WAS IN TEARS; This spontaneous report received from a parent concerned a 22 year old male. The patient's weight was 160 pounds, and height was 69 inches. The patient's past medical history included covid-19, and concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUN-2021, the subject experienced whole body numbness. On 22-JUN-2021, the subject experienced sluggishness. On 22-JUN-2021, the subject experienced muscle spasms in back and neck in both the back and front and up and down also. On 22-JUN-2021, the subject experienced severe cramping to both upper extremities, especially hands, wrists, fingers. On 22-JUN-2021, the subject experienced unable to move whole body. On 22-JUN-2021, the subject experienced feeling unwell. On 22-JUN-2021, the subject experienced generalized weakness. On 22-JUN-2021, the subject experienced beat up, washed out feeling. On 22-JUN-2021, the subject experienced fever upto 100f-104.5f. On 22-JUN-2021, the subject experienced the subject was in tears. Laboratory data included: Body temperature (NR: not provided) 104.5 F, 103 F, 102 F. On 23-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. Laboratory data (dates unspecified) included: COVID-19 (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body numbness, severe cramping to both upper extremities, especially hands, wrists, fingers, and unable to move whole body on 22-JUN-2021, was recovering from fever upto 100f-104.5f, muscle spasms in back and neck in both the back and front and up and down also, beat up, washed out feeling, feeling unwell, and the patient was in tears, and the outcome of sluggishness and generalized weakness was not reported. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Movement disorder, Muscle spasms, Pyrexia, Sluggishness
Clinical narrative: WHOLE BODY NUMBNESS; SLUGGISHNESS; MUSCLE SPASMS IN BACK AND NECK IN BOTH THE BACK AND FRONT AND UP AND DOWN ALSO; SEVERE CRAMPING TO BOTH UPPER  EXTREMITIES, ESPECIALLY HANDS, WRISTS, FINGERS; UNABLE TO MOVE WHOLE BODY; FEELING UNWELL; GENERALIZED WEAKNESS; BEAT UP, WASHED OUT FEELING; FEVER UPTO 100F-104.5F; THE PATIENT WAS IN TEARS; This spontaneous report received from a parent concerned a 22 year old male. The patient's weight was 160 pounds, and height was 69 inches. The patient's past medical history included covid-19, and concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUN-2021, the subject experienced whole body numbness. On 22-JUN-2021, the subject experienced sluggishness. On 22-JUN-2021, the subject experienced muscle spasms in back and neck in both the back and front and up and down also. On 22-JUN-2021, the subject experienced severe cramping to both upper extremities, especially hands, wrists, fingers. On 22-JUN-2021, the subject experienced unable to move whole body. On 22-JUN-2021, the subject experienced feeling unwell. On 22-JUN-2021, the subject experienced generalized weakness. On 22-JUN-2021, the subject experienced beat up, washed out feeling. On 22-JUN-2021, the subject experienced fever upto 100f-104.5f. On 22-JUN-2021, the subject experienced the subject was in tears. Laboratory data included: Body temperature (NR: not provided) 104.5 F, 103 F, 102 F. On 23-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. Laboratory data (dates unspecified) included: COVID-19 (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body numbness, severe cramping to both upper extremities, especially hands, wrists, fingers, and unable to move whole body on 22-JUN-2021, was recovering from fever upto 100f-104.5f, muscle spasms in back and neck in both the back and front and up and down also, beat up, washed out feeling, feeling unwell, and the patient was in tears, and the outcome of sluggishness and generalized weakness was not reported. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Tearfulness
Clinical narrative: WHOLE BODY NUMBNESS; SLUGGISHNESS; MUSCLE SPASMS IN BACK AND NECK IN BOTH THE BACK AND FRONT AND UP AND DOWN ALSO; SEVERE CRAMPING TO BOTH UPPER  EXTREMITIES, ESPECIALLY HANDS, WRISTS, FINGERS; UNABLE TO MOVE WHOLE BODY; FEELING UNWELL; GENERALIZED WEAKNESS; BEAT UP, WASHED OUT FEELING; FEVER UPTO 100F-104.5F; THE PATIENT WAS IN TEARS; This spontaneous report received from a parent concerned a 22 year old male. The patient's weight was 160 pounds, and height was 69 inches. The patient's past medical history included covid-19, and concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUN-2021, the subject experienced whole body numbness. On 22-JUN-2021, the subject experienced sluggishness. On 22-JUN-2021, the subject experienced muscle spasms in back and neck in both the back and front and up and down also. On 22-JUN-2021, the subject experienced severe cramping to both upper extremities, especially hands, wrists, fingers. On 22-JUN-2021, the subject experienced unable to move whole body. On 22-JUN-2021, the subject experienced feeling unwell. On 22-JUN-2021, the subject experienced generalized weakness. On 22-JUN-2021, the subject experienced beat up, washed out feeling. On 22-JUN-2021, the subject experienced fever upto 100f-104.5f. On 22-JUN-2021, the subject experienced the subject was in tears. Laboratory data included: Body temperature (NR: not provided) 104.5 F, 103 F, 102 F. On 23-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. Laboratory data (dates unspecified) included: COVID-19 (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body numbness, severe cramping to both upper extremities, especially hands, wrists, fingers, and unable to move whole body on 22-JUN-2021, was recovering from fever upto 100f-104.5f, muscle spasms in back and neck in both the back and front and up and down also, beat up, washed out feeling, feeling unwell, and the patient was in tears, and the outcome of sluggishness and generalized weakness was not reported. This report was non-serious.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Off label use
Clinical narrative: REVACCINATED/PATIENT RECEIVED 2 DOSES OF THE JANSSEN COVID19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 50 year old of unspecified 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: 202A21A, expiry: UNKNOWN) dose was not reported, administered on APR-2021, and dose was not reported, administered on 25-JUN-2021 13:15 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced revaccinated/subject received 2 doses of the janssen covid19 vaccine. On 25-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the revaccinated/patient received 2 doses of the janssen covid19 vaccine and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: PATIENT GIVEN A SYRINGE THAT PASSED THE 6 HOUR WINDOW IN THE REFRIGERATOR; This spontaneous report received from a health care professional 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced subject given a syringe that passed the 6 hour window in the refrigerator. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient given a syringe that passed the 6 hour window in the refrigerator was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Tremor
Clinical narrative: FINGERS NUMB; SHAKING LIKE A RABBIT; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 27-JUN-2021, the subject experienced fingers numb. On 27-JUN-2021, the subject experienced shaking like a rabbit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fingers numb, and shaking like a rabbit. This report was non-serious. This case, from the same reporter is linked to 20210660727.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Impaired work ability, Lymphadenopathy
Clinical narrative: SWOLLEN LYMPH NODE IN NECK; FREAKED OUT; CALL OUT OF WORK 2 DAYS; EXTREME FATIGUE FOR A WEEK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced swollen lymph node in neck, freaked out, call out of work 2 days, and extreme fatigue for a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen lymph node in neck, freaked out, call out of work 2 days, and extreme fatigue for a week. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging
Clinical narrative: PERSISTENT HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included headaches, and other pre-existing medical conditions included the patient had no known allergies. The patient's family history included twin sister experienced a pulmonary embolism in the past. The physician suggested for testing done because patient's familial history predisposes her to a greater risk of getting a blood clot from vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Magnetic resonance imaging (NR: not provided) No blood clots present. On 02-APR-2021, the subject experienced persistent headache.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from persistent headache on APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: LOTS OF PAIN IN BACK KNEE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included slight back knee pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced lots of pain in back knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lots of pain in back knee was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: OUT OF SPECIFICATION PRODUCT USED; This spontaneous report received from a health care professional 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: 206A21A expiry: 07-AUG-2021) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced out of specification product used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of specification product used was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, SARS-CoV-2 antibody test, Stress, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; ANXIOUS; STRESS; This spontaneous report received from a physician concerned a 73 year old female. Initial information was processed along with the additional information received from central complaint vigilance on 01-JUL-2021 The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient's concomitant medications included unspecified medications for blood pressure. It was reported that, the patient's partner was not using mask and going out to multiple high risk areas and this was causing a lot of tension and stress for the patient. On an unspecified date, the patient was tested negative for SARS-CoV-2 IgG antibody test spike, Semi QN (SARS-CoV-2 IgG) antibody test, and regular antibodies SARS CoV 2 SEROLOGY (COVID19) AB (IgG, IgM) SARS-CoV-2 IgM (IA SARS CoV 2 AB) antibody test (suspected immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anxious, stress and suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000184427. The suspected product quality complaint has been confirmed to be voided (does not meet criteria) based on the evaluation/investigation performed.; Sender's Comments: V0: 20210665609- COVID-19 VACCINE AD26.COV2.S- Suspected immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. 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: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested.   On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on MAR-2021. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Magnetic resonance imaging, Musculoskeletal stiffness
Clinical narrative: LOWER BACK STIFFNESS; SEVERE KNEE PAIN ON BOTH KNEES; JOINT PAIN; This spontaneous report received from a consumer concerned a 56 year old male. The patient's weight was 170 pounds, and height was 69 inches. The patient's concurrent conditions included seasonal allergy, non-smoker, and no alcohol consumption, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 24-JUL-2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced lower back stiffness. On APR-2021, the subject experienced severe knee pain on both knees. On APR-2021, the subject experienced joint pain. On 15-JUN-2021, treatment medications included: meloxicam. On 26-JUN-2021, Laboratory data included: Magnetic resonance imaging (NR: not provided) unspecified. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe knee pain on both knees, joint pain, and lower back stiffness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced suspected covid-19 infection. Laboratory data included: COVID-19 virus test (NR: not provided) Positive, Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This case, from the same reporter is linked to 20210700575.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Pain, Taste disorder
Clinical narrative: FELT TASTE OF BLOOD IN MOUTH; FELT SORENESS; FEELING OF PAIN IN CHEST; NO ENERGY; DIZZINESS; This spontaneous report received from a consumer concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and gout, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced dizziness. On 25-JUN-2021, the subject experienced no energy. On 26-JUN-2021, treatment medications included: paracetamol. On 27-JUN-2021, the subject experienced felt soreness. On 27-JUN-2021, the subject experienced feeling of pain in chest. On 29-JUN-2021, the subject experienced felt taste of blood in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and no energy, and the outcome of felt soreness, feeling of pain in chest and felt taste of blood in mouth was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, Petechiae
Clinical narrative: MILD PETECHIAE; DRUG EXPOSURE DURING BREASTFEEDING; This spontaneous report received from a consumer concerned a 6 week 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, transmammary, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced mild petechiae, and drug exposure during breastfeeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild petechiae, and drug exposure during breastfeeding. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: Suspected Immunological Vaccine Failure; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose not reported, 01 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, Laboratory data included: COVID-19 antibody test (NR: not provided), results: no antibodies to COVID-19 disease. The patient experienced suspected immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210666824-covid-19 vaccine ad26.cov2.s -suspected immunological vaccine 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER OF 102F; This spontaneous report received from a parent concerned a 29 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, intramuscular, batch number: Unknown) dose was not reported, administered on 29-JUN-2021 11:00 for prophylactic vaccination .The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Thrombosis, Vaccination complication
Clinical narrative: CLOTS; ODD REACTIONS; This spontaneous report was received from a patient of unspecified age, sex, race, and ethnic origin  via a company representative. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 11-APR-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, in APR-2021, the patient developed clots and other odd reactions (not specified). Laboratory data included: Blood test (result unknown). The patient spent 10 days waiting for the blood test, wondering if the clot would kill. The action taken with covid-19 vaccine was not applicable. The outcome of the clots and odd reactions was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210667066-COVID-19 VACCINE -Clots. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: ENTIRE BODY FEELING HOT AND FELT LIKE ON FIRE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was not reported and height was 64 centimeters. The patient's past medical history included difficulty breathing, and hurting around heart, and concurrent conditions included alcoholic (40s per day beer), and smoker, and other pre-existing medical conditions included the patient did not have any known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUN-2021, the subject experienced entire body feeling hot and felt like on fire. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of entire body feeling hot and felt like on fire was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Critical illness
Clinical narrative: CRITICAL CONDITION; This spontaneous report received from a consumer via other company Pfizer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported, one total, 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 critical condition. The reporter narrated that he knew a person who was in critical condition after taking the Johnson and Johnson vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of critical condition was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210667676-COVID-19 VACCINE AD26.COV2.S-Critical Condition. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: A RASH OVER LEFT CHEST, TOP BOTTOM LIP, AND RIGHT SIDE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 325 pounds, and height was 67 inches. The patient's past medical history included a rash of the same type, and concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced a rash over left chest, top bottom lip, and right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from a rash over left chest, top bottom lip, and right side. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pain, Pyrexia
Clinical narrative: A SMALL PATCH OF BLISTERS BEGAN ON HER  LOWER RIGHT ARM, , LEFT HAND.; BODY ACHE; FEVER; This spontaneous report received from a patient concerned a 54 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, intramuscular, batch number: 204A21A, and batch number: 204A21A expiry: /JUN/2021) .5 ml, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced body ache. On 14-JUN-2021, the subject experienced fever. On 28-JUN-2021, the subject experienced a small patch of blisters began on her lower right arm, left hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fever on 15-JUN-2021, and had not recovered from a small patch of blisters began on her lower right arm, left hand. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: BAD HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: A BIT OF A 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced a bit of a fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a bit of a fever was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nightmare, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: TREMBLING; BODY ACHES; NIGHTMARES; SEVERE CHILLS; SORE / PAINFUL ARM; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, and other pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 28-JUN-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) Negative. On 28-JUN-2021, the subject experienced sore / painful arm. On 29-JUN-2021, the subject experienced trembling. On 29-JUN-2021, the subject experienced body aches. On 29-JUN-2021, the subject experienced nightmares. On 29-JUN-2021, the subject experienced severe chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trembling, nightmares, and severe chills on 29-JUN-2021, and body aches on 30-JUN-2021, and had not recovered from sore / painful arm. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: TREMBLING; BODY ACHES; NIGHTMARES; SEVERE CHILLS; SORE / PAINFUL ARM; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, and other pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 28-JUN-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, Laboratory data included: COVID-19 antigen test (NR: not provided) Negative. On 28-JUN-2021, the subject experienced sore / painful arm. On 29-JUN-2021, the subject experienced trembling. On 29-JUN-2021, the subject experienced body aches. On 29-JUN-2021, the subject experienced nightmares. On 29-JUN-2021, the subject experienced severe chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trembling, nightmares, and severe chills on 29-JUN-2021, and body aches on 30-JUN-2021, and had not recovered from sore / painful arm. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Headache
Clinical narrative: Dizzyness, headache for 4 days now.  Eversince 2nd shot.. it happened like 4 times now.. i never had that happen to me..
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Urticaria
Clinical narrative: Hives, went to med center on May 9, Given Prednisone 20mg Decreasing Dose, CompletedDose Hives, went to med center on May 23, Given Prednisone 20m Decreasing Dose, Completed Dose Hives, went to PCP,May 19, Did blood work for respiratory and food allergies and referred to Allergist. Told to start Clairton as well as Benadryl.   Saw Allergist on June 9.  Told to start Clariton 24hr in morning and Benadryl 25mg before bed for 3 months. Talked to nurse for allergist July 1. Hives worsening.  Told to take Benadryl two X's day and continue with Claritin 24 hr daily.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chest discomfort, Chest pain, Diarrhoea
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Mild
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Headache, Hyperhidrosis
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Mild
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lethargy, Nausea, Pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Mild
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Mild
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Ear discomfort, Erythema, Headache
Clinical narrative: REDNESS; SWELLING AT SITE; CHILLS; HIGH TEMPERATURE; NAUSEA; HEADACHE; COUGHING; SNEEZING; PRESSURE IN EARS; SORE THROAT; RUNNY NOSE; This spontaneous report received from a patient concerned a 72 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: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced sneezing. On MAY-2021, the subject experienced coughing. On MAY-2021, the subject experienced pressure in ears. On MAY-2021, the subject experienced sore throat. On MAY-2021, the subject experienced runny nose. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced high temperature. On MAY-2021, the subject experienced nausea. On MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced redness. On 15-MAY-2021, the subject experienced swelling at site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pressure in ears on 23-JUN-2021, redness on 16-MAY-2021, and swelling at site, chills, nausea, and headache, was recovering from sneezing, and runny nose, had not recovered from coughing, and the outcome of sore throat and high temperature was not reported. This report was non-serious. This case, from the same reporter is linked to 20210643478.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: REDNESS; SWELLING AT SITE; CHILLS; HIGH TEMPERATURE; NAUSEA; HEADACHE; COUGHING; SNEEZING; PRESSURE IN EARS; SORE THROAT; RUNNY NOSE; This spontaneous report received from a patient concerned a 72 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: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced sneezing. On MAY-2021, the subject experienced coughing. On MAY-2021, the subject experienced pressure in ears. On MAY-2021, the subject experienced sore throat. On MAY-2021, the subject experienced runny nose. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced high temperature. On MAY-2021, the subject experienced nausea. On MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced redness. On 15-MAY-2021, the subject experienced swelling at site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pressure in ears on 23-JUN-2021, redness on 16-MAY-2021, and swelling at site, chills, nausea, and headache, was recovering from sneezing, and runny nose, had not recovered from coughing, and the outcome of sore throat and high temperature was not reported. This report was non-serious. This case, from the same reporter is linked to 20210643478.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: REDNESS; SWELLING AT SITE; CHILLS; HIGH TEMPERATURE; NAUSEA; HEADACHE; COUGHING; SNEEZING; PRESSURE IN EARS; SORE THROAT; RUNNY NOSE; This spontaneous report received from a patient concerned a 72 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: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced sneezing. On MAY-2021, the subject experienced coughing. On MAY-2021, the subject experienced pressure in ears. On MAY-2021, the subject experienced sore throat. On MAY-2021, the subject experienced runny nose. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced high temperature. On MAY-2021, the subject experienced nausea. On MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced redness. On 15-MAY-2021, the subject experienced swelling at site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pressure in ears on 23-JUN-2021, redness on 16-MAY-2021, and swelling at site, chills, nausea, and headache, was recovering from sneezing, and runny nose, had not recovered from coughing, and the outcome of sore throat and high temperature was not reported. This report was non-serious. This case, from the same reporter is linked to 20210643478.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Hypoaesthesia, Palpitations
Clinical narrative: Patient began feeling chest pains and numbness to right arm. Patient also complained of palpitations. Patient instructed on breathing techniques. EMS called over. Vitals taken. Patient's symptoms subsided. Pulse back in range. Normal sinus rhythm per EMS.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Flushing
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: Followed up with patient 3 days after the inital reaction and the patient still said was having issues with her arm having pain/soreness and if she moved her arm too far she would become dizzy.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site pain, Lethargy, Nausea, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: Followed up with patient 3 days after the inital reaction and the patient still said was having issues with her arm having pain/soreness and if she moved her arm too far she would become dizzy.