chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: SHOULDER PAIN; MUSCLE ACHES; 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 pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced shoulder pain. On 01-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shoulder pain, and muscle aches. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Cerebrovascular accident
Clinical narrative: STROKE; LITTLE BIT OF JOINT PAIN ON LEGS; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, and psoriasis. The patient received guselkumab (solution for injection, subcutaneous, batch number was not reported) 100 mg, 1 time every 8 weeks, strength 100 milligram per milliliter from 2020 for psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included vedolizumab for ulcerative colitis.  On an unspecified date, (13 days after vaccination), the patient had stroke. In APR-2021 (recent to this report), the patient had a little bit of joint pain on legs especially after exercising. The action taken with covid-19 vaccine ad26.cov2.s, and guselkumab was not applicable. The outcome of the stroke and little bit of joint pain on legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210438989-covid-19 vaccine ad26.cov2.s-stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210438989-guselkumab-stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the subject experienced vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure during pregnancy was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure since case is assessed as non serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cervical radiculopathy
Clinical narrative: CERVICAL RADICULOPATHY IN LEFT ARM; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: unknown) dose was not reported, 1 total, administered on 12-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in 2021, the patient experienced severe pain in the shoulder where he got the injection, later diagnosed as cervical radiculopathy in left arm, and was hospitalized for 3 weeks (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cervical radiculopathy in left arm. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- covid-19 vaccine ad26.cov2.s -Cervical Radiculopathy. 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: Hypokinesia, Injection site pain, Lymphadenopathy, Neck pain, Pain in extremity
Clinical narrative: PAIN IN RIGHT NECK; PAINFUL ARM, PAIN IN ARM/PAIN IN UNDERARM, EXTREME SORENESS ON RIGHT ARM; HURTS TO MOVE RIGHT HAND; SWOLLEN LYMPH NODES ON RIGHT ARM, RIGHT ARMPIT AND NECK; PAIN ON INJECTION SITE INTO SHOULDER; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies to narcotics, and other pre-existing medical conditions included sensitivity to most western medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced pain on injection site into shoulder. On 12-APR-2021, the subject experienced swollen lymph nodes on right arm, right armpit and neck. On 12-APR-2021, the subject experienced hurts to move right hand. On 18-APR-2021, the subject experienced pain in right neck. On 18-APR-2021, the subject experienced painful arm, pain in arm/pain in underarm, extreme soreness on right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen lymph nodes on right arm, right armpit and neck, painful arm, pain in arm/pain in underarm, extreme soreness on right arm, pain in right neck, and hurts to move right hand, and the outcome of pain on injection site into shoulder was not reported. This report was non-serious.; Sender's Comments: V0:As per standard protocol,  comment is not required for nonserious case.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Concussion, Disorientation, Epistaxis, Head injury
Clinical narrative: BLACKED OUT; HIT HER HEAD; BLEEDING NOSE; Concussion; SWEATING ALL OVER BODY; DISORIENTATION; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a female of unspecified age.  The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered to left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced headache, nausea, sweating, disorientation and fever. She had a black out and hit her head, woke up from the floor and was still feverish and she noticed blood in her nose. She then called her mom to help her because the headache did not go away. 2 days later she called health department and they directed her to emergency room. Computerized tomography scan and a dye scan was done and it was found out that she had a concussion. She hit her head in 2 places. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, sweating all over body, fever, disorientation, blacked out, bleeding nose, concussion and hit her head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210441012 - Blacked out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Loss of consciousness, Nausea, Pyrexia
Clinical narrative: BLACKED OUT; HIT HER HEAD; BLEEDING NOSE; Concussion; SWEATING ALL OVER BODY; DISORIENTATION; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a female of unspecified age.  The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered to left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced headache, nausea, sweating, disorientation and fever. She had a black out and hit her head, woke up from the floor and was still feverish and she noticed blood in her nose. She then called her mom to help her because the headache did not go away. 2 days later she called health department and they directed her to emergency room. Computerized tomography scan and a dye scan was done and it was found out that she had a concussion. She hit her head in 2 places. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, sweating all over body, fever, disorientation, blacked out, bleeding nose, concussion and hit her head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210441012 - Blacked out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast
Clinical narrative: BLACKED OUT; HIT HER HEAD; BLEEDING NOSE; Concussion; SWEATING ALL OVER BODY; DISORIENTATION; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a female of unspecified age.  The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered to left arm on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced headache, nausea, sweating, disorientation and fever. She had a black out and hit her head, woke up from the floor and was still feverish and she noticed blood in her nose. She then called her mom to help her because the headache did not go away. 2 days later she called health department and they directed her to emergency room. Computerized tomography scan and a dye scan was done and it was found out that she had a concussion. She hit her head in 2 places. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, nausea, sweating all over body, fever, disorientation, blacked out, bleeding nose, concussion and hit her head was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210441012 - Blacked out. 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Thrombosis
Clinical narrative: BLOOD CLOT IN ARM; FEELING SICK; This spontaneous report received from a patient via a company representative concerned a 47 year old female. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of report The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient experienced burning sensation in arm, tenderness of arm, and pronounced veins on arm; also she was feeling sick. She saw the healthcare professional (HCP) after these symptoms. She was told about a blood clot (tenderness / burning sensation/ pronounced veins) in the arm. HCP recommended her taking aspirin and applying heat to the arm. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in arm, and the outcome of feeling sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments:  This 47-year-old female patient reported burning sensation and tenderness in arm, pronounced veins in arm, and feeling sick after an unspecified duration from receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection.  HCP was consulted and was "told" about a blood clot and prescribed aspirin with advice to apply her to the arm.  No other details reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information was requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Depression, Facial paralysis, Fibromyalgia
Clinical narrative: MAJOR FACIAL DROPPING; ANXIETY; DEPRESSION; FIBROMYALGIA; BODY WEAKNESS; This spontaneous report received from a patient via media concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total 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, after the vaccination, the patient had a bad reaction after which she was rushed to the hospital. When at the hospital, her medical records showed she was diagnosed with body weakness, anxiety, depression, major facial dropping and fibromyalgia. After being in intensive care, she was taken to patient care for the following two weeks where she received occupational, physical and speech therapy.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the events of body weakness, anxiety, depression, major facial dropping and fibromyalgia was unknown. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: This report was obtained  from media and concerned a female patient, unspecified age who, on an unspecified number of days, was rushed to the hospital, where she was noted with h body weakness, anxiety, depression, major facial dropping and fibromyalgia. She was initially brought to intensive care then taken to patient care for the following two weeks where she received occupational, physical and speech therapy. The patient's weight, height, and medical history were not reported. The information provided precludes and meaningful medical assessment. More information will be sought when contact information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 15-MAR-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 an unspecified date in APR-2021, the patient experienced suspected immunological vaccine failure. She did a blood test (nucleocapsid protein IgG antibody test) which was negative. No additional information was provided. Laboratory data included: Antibody test (NR: not provided) Negative. 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- 20210444312;-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
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: PASSED AWAY/ DEATH; This spontaneous report received from a consumer via company representative concerned a 70 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: 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 number. No concomitant medications were reported.  On an unspecified date, the patient passed away after receiving the vaccine. The patient died from an unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:-covid-19 vaccine ad26.cov2.s-death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count decreased, Platelet factor 4
Clinical narrative: IDIOPATHIC THROMBOCYTOPENIC PURPURA; This spontaneous report received from a company representative concerned a 60 year old  female. Initial information was processed with additional information received from the patient's physician, in response to telephone follow-up, on 26-APR-2021.  The patient's weight and weight were not reported. The patient's concurrent conditions included hypertension, hyperlipidemia, and obesity. She was a non-smoker and had no history of acute illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included blood pressure medication, vitamins, and a statin (all unspecified). On 21-APR-2021, the patient experienced Idiopathic thrombocytopenic purpura and was in critical condition. The patient presented with petechiae on her legs. Her platelet count was low, less than 9000 and all other labs were normal. The patient was hospitalized on 21-APR-2021 and the duration of hospitalization was not reported. The patient did not have any clots and she was treated with decadron and Intravenous immunoglobulin. On 22-APR-2021, the patient's and improved the next day with platelet of 30,000 and she was discharged same day. on an unspecified date anti-PF 4 antibodies were performed and were normal. Fibrin D-dimer tests were not performed. The reporter stated the discharge diagnosis was Idiopathic thrombocytopenic purpura which could have been related to recent vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from  Idiopathic thrombocytopenic purpura. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0:  This 60-year-old female was hospitalized for immune thrombocytopenia 25 days after receiving the Janssen Covid-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  Concurrent conditions included hypertension, hyperlipidemia, and obesity. She was a non-smoker and had no history of acute illness.  Concomitant medications included unspecified blood pressure medication, a statin, and vitamins.  Twenty-five days post-vaccination, she developed petechiae on her legs and was found to have a platelet count of 9000; all other labs were normal including anti-platelet factor 4. She did not have clots. She was admitted to the hospital the same day and was treated with dexamethasone and iv immunoglobulin. The next day, her platelet count improved to 30,000 and was discharged. Based on the available information, the relationship with Janssen Covid-19 vaccine is considered indeterminate. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Injection site rash, Muscle spasms
Clinical narrative: SPASMS TO LEFT HAND AND FINGERS; BUMP SIZE, PENNY SIZE TO LEFT  UPPER ARM (INJECTION SITE); TENDENTIOUS/ LEFT ARM WITH RADIATING PAIN TO LEFT HAND AND FINGERS/ LEFT HAND THROB; SOME FATIGUE; HEADACHE RADIATING TO NECK, FRONT HEAD AND LEFT SHOULDER; UNABLE TO WORK; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight was 175 pounds, and height was 63 inches. The patient's concurrent conditions included fatty liver disease, blood pressure, alcoholic, non smoker, and muscular skeletal pain in left arm, and other pre-existing medical conditions included the patient had no known drug allergy and did not have 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included valsartan for blood pressure, and tizanidine for muscular skeletal pain in left arm. On APR-2021, the subject experienced unable to work. On 09-APR-2021, the subject experienced tendentious/ left arm with radiating pain to left hand and fingers/ left hand throb. On 09-APR-2021, the subject experienced some fatigue. On 09-APR-2021, the subject experienced headache radiating to neck, front head and left shoulder. On 11-APR-2021, the subject experienced bump size, penny size to left upper arm (injection site). On 19-APR-2021, the subject experienced spasms to left hand and fingers. On 20-APR-2021, treatment medications included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from some fatigue, had not recovered from headache radiating to neck, front head and left shoulder, bump size, penny size to left upper arm (injection site), and tendentious/ left arm with radiating pain to left hand and fingers/ left hand throb, and the outcome of spasms to left hand and fingers and unable to work was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tendonitis
Clinical narrative: SPASMS TO LEFT HAND AND FINGERS; BUMP SIZE, PENNY SIZE TO LEFT  UPPER ARM (INJECTION SITE); TENDENTIOUS/ LEFT ARM WITH RADIATING PAIN TO LEFT HAND AND FINGERS/ LEFT HAND THROB; SOME FATIGUE; HEADACHE RADIATING TO NECK, FRONT HEAD AND LEFT SHOULDER; UNABLE TO WORK; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight was 175 pounds, and height was 63 inches. The patient's concurrent conditions included fatty liver disease, blood pressure, alcoholic, non smoker, and muscular skeletal pain in left arm, and other pre-existing medical conditions included the patient had no known drug allergy and did not have 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included valsartan for blood pressure, and tizanidine for muscular skeletal pain in left arm. On APR-2021, the subject experienced unable to work. On 09-APR-2021, the subject experienced tendentious/ left arm with radiating pain to left hand and fingers/ left hand throb. On 09-APR-2021, the subject experienced some fatigue. On 09-APR-2021, the subject experienced headache radiating to neck, front head and left shoulder. On 11-APR-2021, the subject experienced bump size, penny size to left upper arm (injection site). On 19-APR-2021, the subject experienced spasms to left hand and fingers. On 20-APR-2021, treatment medications included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from some fatigue, had not recovered from headache radiating to neck, front head and left shoulder, bump size, penny size to left upper arm (injection site), and tendentious/ left arm with radiating pain to left hand and fingers/ left hand throb, and the outcome of spasms to left hand and fingers and unable to work was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on left arm on15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient received the Janssen COVID 19 Vaccine on 15-MAR-2021, He didn't have any side effects after vaccination. On 19-APR-2021, he went to get tested for COVID 19 antibodies. On 21-APR-2021, The test results came back negative for SARS-COV2 antibodies (coded as confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210446599-Covid-19 vaccine ad26.cov2.s- Confirmed 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: F
Vaccine: COVID19
Symptoms: Dyspnoea, Musculoskeletal stiffness, Neck pain, Sinusitis
Clinical narrative: SHORTNESS OF BREATH; TERRIBLE PAIN IN NECK ON LEFT SIDE; STIFF NECK IN THE SAME SIDE AS  INJECTION - LEFT SIDE; SUSPECTED SINUS INFECTION; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure abnormal, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced nausea and vomiting when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 10:00 for prophylactic vaccination. Concomitant medications included amlodipine for blood pressure abnormal.  On APR-2021, the subject experienced suspected sinus infection. On 14-APR-2021, the subject experienced terrible pain in neck on left side. On 14-APR-2021, the subject experienced stiff neck in the same side as injection - left side. On 20-APR-2021, treatment medications included: doxycycline. On an unspecified date, the subject experienced shortness of breath. Additional treatment medications (dates unspecified) included: camphor/menthol/methyl salicylate/tocopheryl acetate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiff neck in the same side as injection - left side, had not recovered from terrible pain in neck on left side, and the outcome of suspected sinus infection and shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Pain
Clinical narrative: BLOOD CLOTS IN THE BRAIN; EXTRAORDINARY PAIN; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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.  On an unspecified date in APR-2021, the patient had clots in the brain. The patient was flown to the hospital and had been in Intensive Care Unit (ICU) for the past 2 weeks from the report.  The patient underwent multiple procedures for it, and was in extraordinary pain. The patient was currently receiving plasmapheresis. The number of days of hospitalization was not specified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in the brain, and extraordinary pain. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0:  This female patient of unspecified age and ethnicity was reported to have been admitted in ICU for clots in the brain after an unspecified duration of receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection.  The patient underwent multiple unspecified procedures and currently undergoing plasmapheresis.  No other details reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information was requested.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: BECAME VERY ILL; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021 after vaccination, the patient became very ill. The patient was hospitalized on an unspecified date, The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling very ill was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210449330--BECAME VERY ILL. This event is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Exposure during pregnancy
Clinical narrative: VACCINE EXPOSURE DURING PREGNANCY; ANXIETY; This spontaneous pregnancy report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced anxiety. On 12-APR-2021, the subject experienced vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine exposure during pregnancy and anxiety was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Decreased appetite, Fatigue
Clinical narrative: HEADACHES; PAIN AT INJECTION SITE; COUGH; LACK OF APPETITE; JOINT AND NECK PAIN; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 45 year old female. he patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroid, non smoker, and non alcohol user, and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  Concomitant medications included levothyroxine for hypothyroid.  On 06-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE (units unspecified), and COVID-19 virus test negative (NR: not provided) NEGATIVE (units unspecified). On 08-APR-2021, the subject experienced joint and neck pain. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced cough. On 09-APR-2021, the subject experienced lack of appetite. On 09-APR-2021, the subject experienced pain at injection site. On 15-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough on 11-APR-2021, lack of appetite on 12-APR-2021, joint and neck pain, and fatigue on 09-APR-2021, chills, and fever on 08-APR-2021, headaches on 18-APR-2021, and pain at injection site on 14-APR-2021. This report was non-serious. This case, from the same reporter is linked to.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test negative
Clinical narrative: HEADACHES; PAIN AT INJECTION SITE; COUGH; LACK OF APPETITE; JOINT AND NECK PAIN; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 45 year old female. he patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroid, non smoker, and non alcohol user, and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  Concomitant medications included levothyroxine for hypothyroid.  On 06-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE (units unspecified), and COVID-19 virus test negative (NR: not provided) NEGATIVE (units unspecified). On 08-APR-2021, the subject experienced joint and neck pain. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced cough. On 09-APR-2021, the subject experienced lack of appetite. On 09-APR-2021, the subject experienced pain at injection site. On 15-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough on 11-APR-2021, lack of appetite on 12-APR-2021, joint and neck pain, and fatigue on 09-APR-2021, chills, and fever on 08-APR-2021, headaches on 18-APR-2021, and pain at injection site on 14-APR-2021. This report was non-serious. This case, from the same reporter is linked to.
Sex: U
Vaccine: COVID19
Symptoms: Increased bronchial secretion
Clinical narrative: MUCOUS SINCE PROBABLY AFTER TWO WEEKS GETTING THE SHOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced mucous since probably after two weeks getting the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mucous since probably after two weeks getting the shot. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Rash
Clinical narrative: BODY ACHES; CHILLS; RASH; HIVES; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 36 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced body aches, chills, rash, hives, headache, nausea.  Treatment medications (dates unspecified) included: epinephrine, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and nausea on 02-APR-2021, and had not recovered from hives, headache, and rash. This report was non-serious.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: BODY ACHES; CHILLS; RASH; HIVES; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 36 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced body aches, chills, rash, hives, headache, nausea.  Treatment medications (dates unspecified) included: epinephrine, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and nausea on 02-APR-2021, and had not recovered from hives, headache, and rash. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Fatigue, Pyrexia
Clinical narrative: PERSISTENT FEVER OF 99-100 DEGREES FARENHEIT; TIREDNESS; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune issues. 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 10-APR-2021 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. On APR-2021, Laboratory data included: Blood test (NR: not provided) 98-100 F. On an unspecified date, the subject experienced persistent fever of 99-100 f, and tiredness. Treatment medications (dates unspecified) included: Tylenol (paracetamol), and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the persistent fever of 99-100 f and tiredness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a pharmacist concerned a male of an unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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.  On an unspecified date, the patient who received the JANSSEN COVID-19 vaccine and passed away a few weeks later. It was not sure whether his other medical issues contributed to his death. The patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: - COVID-19 VACCINE AD26.COV2.S - Death, 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Hunger
Clinical narrative: HIGH  BLOOD SUGAR; FEELING HUNGRY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 semaglutide.  On an unspecified date, the subject experienced high blood sugar, and feeling hungry. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high blood sugar and feeling hungry was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: BREAK OUT IN HIVES ON BACK AND STOMACH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy, and other pre-existing medical conditions included the patient did not have any other allergy.  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 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the patient experienced hives on back and subtle small pink dry patches on stomach shoulder and neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives on back and subtle small pink dry patches on stomach shoulder and neck. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: SEVERE PAIN IN LEFT ARM; SORE TO TOUCH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number :Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced sore to touch. On 06-APR-2021, the subject experienced severe pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore to touch, and the outcome of severe pain in left arm was not reported. This report was non-serious. This case, from the same reporter is linked to.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: HEADACHE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced pain at injection site. On 11-APR-2021, the subject experienced headache. On 26-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 12-APR-2021, and had not recovered from headache. This report was non-serious.