chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Tinnitus, Vision blurred
Clinical narrative: FLU-LIKE SYMPTOMS (CHILLS, GENERAL ACHES, HEADACHES); EARS RINGING; BLURRED VISION; This spontaneous report received from a patient concerned a 63 year old female patient of an unspecified race and ethnic origin. The patient's weight was 140 pounds, and height was 66 inches. The patient's concurrent conditions included: penicilline allergy, and also had drug allergy with codeine, and gabapentin.  On an unspecified date, the patient received bnt 162 (Pfizer vaccine), (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, ( Dose number in series 1) for prophylactic vaccination.  On an unspecified date, following vaccination with Pfizer vaccine, the patient experienced severe allergic reaction ( Dose number in series 1).   The patient received additional company suspect vaccine covid-19 vaccine ad26.cov2.s, (suspension for injection, route of administration not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, 01 total, administered on 06-DEC-2021 on left arm ( Dose number in series 2) for prophylactic vaccination. No concomitant medications were reported.  On 06-DEC-2021, the patient experienced blurred vision and ears ringing which came on rather quickly, like within 30 minutes of injection. The patient also stated that the ringing had gone but the blurry vision was still there on 07-DEC-2021. On 07-DEC-2021, the patient experienced flu-like symptoms (chills, general aches, headaches) (Dose number in series 2).  she contacted her health care professional and was referred to an ophthalmologist. On 07-DEC-2021, laboratory data included: Body temperature was 97.1 Fahrenheit showed no fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ears ringing (on unspecified date) in DEC-2021, had not recovered from blurred vision and outcome for flu-like symptoms (chills, general aches, headaches) was unknown. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Osteoporosis, Vaccination site pain
Clinical narrative: OSTEOPOROSIS; Vaccination site pain; This spontaneous report received from a patient concerned a 63 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, and other pre-existing medical conditions included: The patient had no known allergies. The patient previously received covid-19 vaccine ad26. cov2. s. (suspension for injection, intramuscular, batch number: Unknown, expiry :unknown) dose was not reported, 1 in total, administered on 9-APR-2021 for prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse events. Non-company suspect drugs included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: unknown) dose was not reported, 1 in total, administered on 29-NOV-2021 for prophylactic vaccination (dose number in series 2). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced osteoporosis. On 29-NOV-2021, the patient experienced vaccination site pain (sore arm after booster shot). (Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vaccination site pain, and had not recovered from osteoporosis. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nerve injury
Clinical narrative: NEUROLOGICAL DAMAGE IN ONE ARM; This spontaneous report received from a consumer by a Business partner on 07-DEC-2021 was received on 08-DEC-2021 and 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, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 07-DEC-2021, the patient experienced neurological damage in one arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neurological damage in one arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20211221968-covid-19 vaccine ad26.cov2.s -Neurological damage in one arm. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Wrong product administered
Clinical narrative: TINGLING IN LEGS; WRONG DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned an 89 year old white female of unspecified ethnicity The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received 2 doses of non-company vaccines included: MRNA 1273 (Moderna) (form of admin, route of admin, and batch number were not reported),1 in total, dose was not reported (dose number in series was 1), administered on JAN-2021 and MAR-2021 for prophylactic vaccination and it was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 060H21A, and expiry: UNKNOWN), dose was not reported,1 total, (dose number in series was 2) administered on 09-DEC-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 09-DEC-2021, the patient requested a booster dose of the moderna vaccine but accidentally received booster dose of the Janssen Covid-19 vaccine (RRT: wrong dose of vaccine administered, LLT: Medication Error). On 09-DEC-2021, after 5 minutes of receiving the vaccine, patient had tingling in legs (dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling in legs and wrong dose of vaccine administered was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: FLU LIKE SYMPTOMS; SORE LEFT ARM; ACHING MUSCLES; CHILLS; FEVER; This spontaneous report received from a patient concerned a 74-year-old female of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine (manufacturer unknown) (suspension for injection, route of admin not reported) 1 total, dose was not reported administered on unspecified days for prophylactic vaccination (dose series 1). It was unknown whether patient had any adverse event following vaccination with series 1 vaccine.  The patient received booster dose covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A and expiry: 11-DEC-2021) dose was not reported, 1 total administered left arm on 04-NOV-2021 for prophylactic vaccination (dose series 2). No concomitant medications were reported. On 04-NOV-2021, at bed time the patient experienced chills and fever. On 06-NOV-2021, the patient experienced flu like symptoms, aching muscles and sore left arm. It was reported that, the patient experience fever and chills at bed time which lasted two days. After aching muscles, sore left arm and flu like symptoms which lasted for five day(dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills and fever on 06-NOV-2021 and flu like symptoms, aching muscles, and sore left arm on 11-NOV-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FEELING SPACY; This spontaneous report received from a consumer concerned a female 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 previously received covid-19 vaccine ad26. cov2 s (unspecified manufacturer) (suspension for injection, route of admin was not reported, and batch number: unknown ,expiry: unknown) frequency one total, dose was not reported for prophylactic vaccination. It was unknown whether the patient had any adverse events. (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, and batch number: unknown ,expiry :unknown) frequency one total, dose was not reported, administered on 02-DEC-2021 for prophylactic vaccination (Dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-DEC-2021, the patient experienced feeling spacy.  reporter stated that after vaccination of booster dose patient felt little spacy at night, at the time of reporting she was better. (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling spacy on DEC-2021. This report was non-serious. This case, from the same reporter is linked to 20211222743.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: NOT FEELING TOO WELL; This spontaneous report received from a consumer concerned a female 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. On an unspecified date, the patient previously received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number were not reported), 1 in total, dose was not reported, for prophylactic vaccination. It was unknown whether patient had any adverse event following covid-19 vaccine from unspecified manufacturer. (Dose series in number 1). 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, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. (Dose series in number 2) On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced not feeling too well. (Dose series in number 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling too well was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Arthralgia, Fatigue, Therapeutic response unexpected
Clinical narrative: JOINT PAIN; FATIGUE; NEGATIVE SIDE AFFECTS; JOINT PAIN, FATIGUE AND HEADACHE WENT AWAY (UNEXPECTED BENEFICIAL EFFECTS); 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 concurrent conditions included: joint pain, headache, and fatigue. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAR-2021, the patient experienced negative side affects for less than 24 hours but felt great after that. On an unspecified date in MAR-2021, after receiving vaccine, the patient's joint pain, fatigue and headache went away (coded as Unexpected beneficial therapeutic response). On an unspecified date in NOV-2021, the patient joint pain, and fatigue came back (all events dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from negative side affects. The events joint pain, and fatigue, and the outcome of joint pain, fatigue and headache went away (unexpected beneficial effects) was not reported. This report was non-serious. This case, involving the same patient is linked to 20211226128.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: mild headache. The patient was previously received covid-19 vaccine (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) does not reported,1 in total administrated on MAR-2021 for prophylactic vaccination. On an unspecified date, following vaccination the patient had negative side effects for less than 24 hours (dose number in series 1), but felt great after that. It was reported that after receiving the first dose of vaccine the fatigue, joint pain, mild headache went away (unexpected therapeutic benefit) (dose number in series 1). On an unspecified date, a month ago the patient had fatigue and joint pain again. The patient received covid-19 vaccine (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administrated for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, after booster dose all pain went away (unexpected therapeutic benefit) (dose number in series 2). The action taken with covid-19 vaccine was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious. This case, involving the same patient is linked to 20211226110.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pyrexia
Clinical narrative: KNOCKED OUT; CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced chills, fever and was knocked out for 12 hours straight after first J and J vaccine. (Dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and knocked out was not reported. This report was non-serious. This case, involving the same patient is linked to 20211227884 (Dose number in series 2 case).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM PAIN; This spontaneous report received from a patient by concerned a 7 decade old female. The patient's weight was 99.1 kilograms, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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. Concomitant medications included diphenhydramine hydrochloride, and riociguat. On an unspecified date, the patient experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm pain was not reported. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and seasonal allergy. 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 10-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-DEC-2021, the patient experienced confirmed covid-19 infection. On 12-DEC-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was non-serious. This report was associated with a product quality complaint: 90000206767.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative via media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  The reporter stated that, "the patient died 30 minutes after vaccination." On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to unknown cause of death. This report was serious (Death). This case, from the same reporter is linked to 20211229952.; Sender's Comments: V0: 20211230647 -COVID-19 VACCINE AD26.COV2.S- Died .This event(s) is considered unassessable .The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Gait inability, Insomnia
Clinical narrative: COULD NOT WALK FOR A PERIOD OF TIME; CAN'T SLEEP; INTENSE BURNING IN BACK AND IT ALL WENT TO FINGERS; TERRIBLE SHOULDER PAIN; 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 not reported, batch number: Unk) dose was not reported, administered on 15-OCT-2021 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 could not walk for a period of time, can't sleep, intense burning in back and it all went to fingers, and terrible shoulder pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from terrible shoulder pain, and can't sleep, and the outcome of could not walk for a period of time and intense burning in back and it all went to fingers was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; JOINT PAIN; This spontaneous report received from a consumer concerned a 31 year female. Initial information was processed along with the additional information received on 14-DEC-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 034A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 03-APR-2021 for prophylactic vaccination. (Dose number in series was 1). No concomitant medications were reported. On 05-DEC-2021, the patient experienced unspecified symptoms and on 06-DEC-2021, the patient had confirmed covid-19 infection (confirmed clinical vaccination failure). On 06-DEC-2021, Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) positive. On 07-DEC-2021, the patient had experienced fever and body temperature was 103.6 F (Fahrenheit). After 1 or 2 days, patient experienced runny nose, headache, joint pain, chills, itchy throat and coughing. After 3 days, patient experienced almost like a cold or a flu, really tired and severe diarrhea which was over at the time of reporting. (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 confirmed covid-19 infection, joint pain and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority: 90000206740. This case, from the same reporter is linked to 20211229762 and 20211232501.; Sender's Comments: V0:20211230837-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Basedow's disease
Clinical narrative: GRAVES' DISEASE; This spontaneous report received from a parent via social media via 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 Janssen series 1 (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient was diagnosed with graves' disease. The parent reported that patient on life time medication and had bought encyclopedia of herbs to try first and sea moss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of graves' disease was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20211230855-covid-19 vaccine ad26.cov2.s -Graves' disease. 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: COVID-19, Pain in extremity, SARS-CoV-2 test
Clinical narrative: ARM PAIN; COVID POST VACCINATION; This spontaneous report received from a patient concerned an adult 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: 041A21A expiry: UNKNOWN) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-DEC-2021, the patient experienced covid post vaccination. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On an unspecified date, the patient experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid post vaccination and arm pain was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 25-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On OCT-2021, the patient experienced arm swelled under armpit really large. On 25-OCT-2021, the patient experienced as soon as got the shot immediately felt it went from arm to chest, then through sinuses and down legs and felt weird the entire night. On 25-OCT-2021, the patient experienced felt like going to pass out and had frequent days where dizzy. On 26-OCT-2021, the patient experienced cannot see straight for no apparent reason, so left work early and laid down. On 26-OCT-2021, the patient experienced had a headache. On 27-OCT-2021, the patient experienced woken by stabbing pain in left leg, feet and hands are in pain all the time. On 27-OCT-2021, the patient experienced numbness in both feet and hands and right arm went completely numb. On 28-OCT-2021, the patient experienced had nonstop severe chest pains. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from as soon as got the shot immediately felt it went from arm to chest, then through sinuses and down legs and felt weird the entire night, felt like going to pass out and had frequent days where dizzy, had a headache, woken by stabbing pain in left leg, feet and hands are in pain all the time, had nonstop severe chest pains, arm swelled under armpit really large, cannot see straight for no apparent reason, so left work early and laid down, and numbness in both feet and hands and right arm went completely numb. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Visual impairment
Clinical narrative: 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 25-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On OCT-2021, the patient experienced arm swelled under armpit really large. On 25-OCT-2021, the patient experienced as soon as got the shot immediately felt it went from arm to chest, then through sinuses and down legs and felt weird the entire night. On 25-OCT-2021, the patient experienced felt like going to pass out and had frequent days where dizzy. On 26-OCT-2021, the patient experienced cannot see straight for no apparent reason, so left work early and laid down. On 26-OCT-2021, the patient experienced had a headache. On 27-OCT-2021, the patient experienced woken by stabbing pain in left leg, feet and hands are in pain all the time. On 27-OCT-2021, the patient experienced numbness in both feet and hands and right arm went completely numb. On 28-OCT-2021, the patient experienced had nonstop severe chest pains. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from as soon as got the shot immediately felt it went from arm to chest, then through sinuses and down legs and felt weird the entire night, felt like going to pass out and had frequent days where dizzy, had a headache, woken by stabbing pain in left leg, feet and hands are in pain all the time, had nonstop severe chest pains, arm swelled under armpit really large, cannot see straight for no apparent reason, so left work early and laid down, and numbness in both feet and hands and right arm went completely numb. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 28 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 (dose number in series 1) (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-DEC-2021, the patient tested positive for coronavirus disease (Covid-19) and had confirmed clinical vaccination failure. On the same date, he experienced fatigue, chills, fever, sore throat and leg muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. This case, from the same reporter is linked to 20211232994.; Sender's Comments: V0:20211232714-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Pain, Thrombosis
Clinical narrative: FILLED WITH BLOOD CLOTS; DAMAGE TO HEART; CONSTANT PAIN; This spontaneous report received from a patient via media via a company representative concerned a patient of unspecified age and sex with unspecified race and ethnicity.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination (dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced filled with blood clots, damage to heart, and constant pain. Reporter stated that" cases like me who have damage to our hearts and are filled with blood clots. I have been in constant pain for weeks now". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant pain, and the outcome of damage to heart and filled with blood clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211232200.; Sender's Comments: V0: 20211232808-COVID-19 VACCINE AD26.COV2.S- filled with blood clots and damage to heart. This event(s) is considered unassessable. The event(s) 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(s).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pain, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: DISCOMFORT RIGHT AWAY AT THE INJECTION SITE; INJECTION SITE PAIN; HIS ARM STARTED SWOLLEN; HIS ARM STARTED TO HURT AGAIN AND TENDER ARM PAIN THAT CAME BACK/HURT TO THE TOUCH, HURTS TO SLEEP ON IT; This spontaneous report received from a patient concerned a 44 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: 1855191, and expiry: 11-APR-2022) dose was not reported, administered on 02-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2021, the patient experienced his arm started swollen. On DEC-2021, the patient experienced his arm started to hurt again and tender arm pain that came back/hurt to the touch, hurts to sleep on it. Laboratory data included: COVID-19 virus test (NR: not provided) NOT REPORTED. On 02-DEC-2021, the patient experienced discomfort right away at the injection site. On 02-DEC-2021, the patient experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, discomfort right away at the injection site, his arm started to hurt again and tender arm pain that came back/hurt to the touch, hurts to sleep on it, and his arm started swollen. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Muscle spasms
Clinical narrative: LEFT EYE STARTED GETTING MUSCLE SPASMS; KEPT UP AT NIGHT; 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 left eye started getting muscle spasms, and kept up at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left eye started getting muscle spasms and kept up at night was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Tremor
Clinical narrative: SHAKING; CHILLING; INJECTION BURNED IMMENSELY AS IT WAS INJECTED; HEADACHE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included: radiofrequency ablation, and cryoablation. 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 MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced chilling, shaking, injection burned immensely as it was injected, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and the outcome of chilling, shaking and injection burned immensely as it was injected was not reported. This report was non-serious. This case, from the same reporter is linked to 20211233591. This report was associated with a product quality complaint:90000207187.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: VIOLENTLY ILL THE WHOLE NEXT DAY, COULD NOT GO TO WORK; 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 (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 was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced violently ill the whole next day, could not go to work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of violently ill the whole next day, could not go to work was not reported. This report was non-serious. This case, from the same reporter is linked to 20211222865.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE BURNING/SORENESS AT INJECTION SITE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced injection site burning/soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site burning/soreness at injection site was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000207191. This case, from the same reporter is linked to 20211233549.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hyperhidrosis
Clinical narrative: MADE ME FEEL BAD OVERNIGHT; SWEATS; CHILLS; 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 made me feel bad overnight, sweats, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the made me feel bad overnight, sweats and chills was not reported. This report was non-serious. This case, involving the same patient is linked to 20211232327.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: I DON'T LIKE THE SIDE EFFECTS I GOT; 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 was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced i don't like the side effects i got. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of i don't like the side effects i got was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Ear pain, Headache, Oropharyngeal pain
Clinical narrative: THROAT PAIN; EAR PAIN; COUGH; CHEST PAIN WHEN COUGHING; HEADACHE; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A and expiry: UNKNOWN) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-DEC-2021, the patient experienced throat pain. On 14-DEC-2021, the patient experienced ear pain. On 14-DEC-2021, the patient experienced cough. On 14-DEC-2021, the patient experienced chest pain when coughing. On 14-DEC-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throat pain, ear pain, headache, cough, and chest pain when coughing. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot, Hyperhidrosis, Muscle spasms, Myalgia
Clinical narrative: CHARLEY HORSE IN CALVES; CLOTHES FELT WET WHEN THEY TOUCH BODY; FEELS WARM/CANNOT FEEL THE COLDNESS; LEGS FEEL FUNNY; MUSCLE ACHES; BURNING SENSATION; This spontaneous report received from a patient concerned a 50 year old male. The patient's weight was 210 pounds, and height was 67 inches. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-OCT-2021, the patient experienced burning sensation. On an unspecified date, the patient experienced charley horse in calves, clothes felt wet when they touch body, feels warm/cannot feel the coldness, legs feel funny, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation, and the outcome of muscle aches, charley horse in calves, clothes felt wet when they touch body, feels warm/cannot feel the coldness and legs feel funny was not reported. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: CHARLEY HORSE IN CALVES; CLOTHES FELT WET WHEN THEY TOUCH BODY; FEELS WARM/CANNOT FEEL THE COLDNESS; LEGS FEEL FUNNY; MUSCLE ACHES; BURNING SENSATION; This spontaneous report received from a patient concerned a 50 year old male. The patient's weight was 210 pounds, and height was 67 inches. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-OCT-2021, the patient experienced burning sensation. On an unspecified date, the patient experienced charley horse in calves, clothes felt wet when they touch body, feels warm/cannot feel the coldness, legs feel funny, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation, and the outcome of muscle aches, charley horse in calves, clothes felt wet when they touch body, feels warm/cannot feel the coldness and legs feel funny was not reported. This report was non-serious.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: DULL STOMACH PAIN; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, non alcohol user, and other pre-existing medical conditions included: Patient did not have any drug abuse or illicit drug usage. Patient weight was normal. The patient experienced allergic reaction to polyethylene glycol when treated with mrna 1273, and drug allergy when treated with lidocaine. 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 09-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-DEC-2021, the patient experienced dull stomach pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dull stomach pain. This report was non-serious.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Fatigue, Laboratory test, Myalgia, Platelet count
Clinical narrative: MUSCLE PAIN; FATIGUE; BURNING IN TOP OF ESOPHAGUS THAT WENT ON DOWN, BUT TOOK A WHILE, GRADUALLY TO STOMACH; This spontaneous report received from a patient concerned an 83 year old female. The patient's height, and weight were not reported. The patient's past medical history included: esophageal spasm, and concurrent conditions included: highly allergic to iv contrast dye. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: 23-AUG-2021) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Laboratory test (NR: not provided) not reported, and Platelet count (NR: not provided) not reported. On 07-MAR-2021, the patient experienced burning in top of esophagus that went on down, but took a while, gradually to stomach. On 08-MAR-2021, the patient experienced muscle pain. On 08-MAR-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning in top of esophagus that went on down, but took a while, gradually to stomach on 07-MAR-2021, and muscle pain, and fatigue on 08-MAR-2021. This report was non-serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: MUSCLE ACHES; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-DEC-2021, the patient experienced muscle aches. On 15-DEC-2021, the patient experienced fatigue. On 15-DEC-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, fatigue, and headache. This report was non-serious.