chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: RISE IN TEMPERATURE; 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 rise in temperature. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Raised. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rise in temperature was not reported. This report was non-serious. This case, from the same reporter is linked to 20210847388.
Sex: U
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex, unknown race, and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 23-AUG-2021, the patient had just come back from the doctor and the doctor had drawn the patient's blood to see where the patient's antibodies level was to see if the patient needed a booster. The patient's IgG (Immunoglobulin G), and IgM (Immunoglobulin M) were both negative. When the patient told the doctor that the patient received the Johnson and Johnson vaccine, the doctor said that he was prohibited from giving the patient a booster and that they had to wait to see what the CDC (Centers for Disease Control and Prevention) said. The patient asked about getting another brand of vaccine and the doctor said said that he would have done it, but he needed orders from a Johnson and Johnson doctor sent to him. The patient did not know how to get that. The patient stated that he was walking around without any immunity and he was told that the protection would last 8 months. The patient was planning to get a vaccine in November again, but without any antibodies, the patient felt that he needed a vaccine. 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). This report was associated with product quality complaint number: 90000190615.; Sender's Comments: V0: 20210846539-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: U
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned 2 patients of unspecified sex, age, race and ethnicity. No past medical histories or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A, expiry: unknown) dose was not reported, 1 total administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported that the 2 patients had a polymerase chain reaction (PCR) based corona virus disease (COVID) test which came back positive. Both had fever, headaches, nasal congestion, and diarrhea. The patients experienced confirmed COVID-19 infection, and confirmed clinical vaccination failure. The patients were still recovering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering 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 case, from the same reporter is linked to 20210846435.; Sender's Comments: V0. 20210846649-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
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Body temperature, Fatigue, Feeling cold, Headache
Clinical narrative: FATIGUE(TIREDNESS); PAIN AT INJECTION SITE/ARM; NAUSEA; FEVER/CHILLS,FEVER OF 100.8F; SEVERE HEADACHE; FEELS BLOATED WITH ABDOMINAL DISTENTION; SHAKING/TREMBLING; FEELING COLD; FEELING SICK ,UNWELL,DID NOT FEEL WELL, GENERAL MALAISE; VOMITING,RETCHING; ARM WAS VERY PAINFUL; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 120 pounds, and height was 65 inches. The patient's concurrent conditions included: occasional migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 14-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced arm was very painful. On 14-AUG-2021, the patient experienced feels bloated with abdominal distention. On 14-AUG-2021, the patient experienced shaking/trembling. On 14-AUG-2021, the patient experienced feeling cold. On 14-AUG-2021, the patient experienced feeling sick, unwell, did not feel well, general malaise. On 14-AUG-2021, the patient experienced vomiting, retching. On 14-AUG-2021, the patient experienced nausea. On 14-AUG-2021, the patient experienced fever/chills, fever of 100.8f. On 14-AUG-2021, the patient experienced severe headache. On 14-AUG-2021, the patient experienced pain at injection site/arm. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 15-AUG-2021, the patient experienced fatigue (tiredness). Treatment medications (dates unspecified) included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking/trembling, feeling cold, vomiting,retching, nausea, fever/chills,fever of 100.8f, and severe headache on 15-AUG-2021, and arm was very painful, and pain at injection site/arm on AUG-2021, and had not recovered from fatigue(tiredness), feeling sick ,unwell,did not feel well, general malaise, and feels bloated with abdominal distention. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Nausea, Pain in extremity, Pyrexia
Clinical narrative: FATIGUE(TIREDNESS); PAIN AT INJECTION SITE/ARM; NAUSEA; FEVER/CHILLS,FEVER OF 100.8F; SEVERE HEADACHE; FEELS BLOATED WITH ABDOMINAL DISTENTION; SHAKING/TREMBLING; FEELING COLD; FEELING SICK ,UNWELL,DID NOT FEEL WELL, GENERAL MALAISE; VOMITING,RETCHING; ARM WAS VERY PAINFUL; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 120 pounds, and height was 65 inches. The patient's concurrent conditions included: occasional migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 14-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced arm was very painful. On 14-AUG-2021, the patient experienced feels bloated with abdominal distention. On 14-AUG-2021, the patient experienced shaking/trembling. On 14-AUG-2021, the patient experienced feeling cold. On 14-AUG-2021, the patient experienced feeling sick, unwell, did not feel well, general malaise. On 14-AUG-2021, the patient experienced vomiting, retching. On 14-AUG-2021, the patient experienced nausea. On 14-AUG-2021, the patient experienced fever/chills, fever of 100.8f. On 14-AUG-2021, the patient experienced severe headache. On 14-AUG-2021, the patient experienced pain at injection site/arm. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 15-AUG-2021, the patient experienced fatigue (tiredness). Treatment medications (dates unspecified) included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking/trembling, feeling cold, vomiting,retching, nausea, fever/chills,fever of 100.8f, and severe headache on 15-AUG-2021, and arm was very painful, and pain at injection site/arm on AUG-2021, and had not recovered from fatigue(tiredness), feeling sick ,unwell,did not feel well, general malaise, and feels bloated with abdominal distention. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: FATIGUE(TIREDNESS); PAIN AT INJECTION SITE/ARM; NAUSEA; FEVER/CHILLS,FEVER OF 100.8F; SEVERE HEADACHE; FEELS BLOATED WITH ABDOMINAL DISTENTION; SHAKING/TREMBLING; FEELING COLD; FEELING SICK ,UNWELL,DID NOT FEEL WELL, GENERAL MALAISE; VOMITING,RETCHING; ARM WAS VERY PAINFUL; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 120 pounds, and height was 65 inches. The patient's concurrent conditions included: occasional migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 14-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced arm was very painful. On 14-AUG-2021, the patient experienced feels bloated with abdominal distention. On 14-AUG-2021, the patient experienced shaking/trembling. On 14-AUG-2021, the patient experienced feeling cold. On 14-AUG-2021, the patient experienced feeling sick, unwell, did not feel well, general malaise. On 14-AUG-2021, the patient experienced vomiting, retching. On 14-AUG-2021, the patient experienced nausea. On 14-AUG-2021, the patient experienced fever/chills, fever of 100.8f. On 14-AUG-2021, the patient experienced severe headache. On 14-AUG-2021, the patient experienced pain at injection site/arm. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 15-AUG-2021, the patient experienced fatigue (tiredness). Treatment medications (dates unspecified) included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking/trembling, feeling cold, vomiting,retching, nausea, fever/chills,fever of 100.8f, and severe headache on 15-AUG-2021, and arm was very painful, and pain at injection site/arm on AUG-2021, and had not recovered from fatigue(tiredness), feeling sick ,unwell,did not feel well, general malaise, and feels bloated with abdominal distention. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 61.4 kilograms, and height was not reported. The patient's concurrent conditions included: primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included sildenafil citrate. On an unspecified date, the patient experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea. This report was non-serious. This case, involving the same patient is linked to 20210818697.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia, Migraine, Parosmia, Visual impairment
Clinical narrative: VISION TROUBLE; UNCOMFORTABLE SLEEP; I THOUGHT I WAS HAVING A STROKE/FELT VERY BAD JUST ODD AND STRANGE; SMELLING SMOKE; PAIN AT THE TOP OF HER HEAD/INSTANT WORSE MIGRAINE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's past medical history included: stroke. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-MAR-2021, the patient experienced pain at the top of her head/instant worse migraine. On an unspecified date, the patient experienced vision trouble, uncomfortable sleep, i thought i was having a stroke/felt very bad just odd and strange, and smelling smoke. The action taken with covid-19 vaccine was not applicable. The patient recovered from pain at the top of her head/instant worse migraine, vision trouble, uncomfortable sleep, and smelling smoke, and the outcome of i thought i was having a stroke/felt very bad just odd and strange was not reported. This report was non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 73 year male. The patient's height, and weight were not reported. The patient's concurrent conditions included: insulin dependent. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: unknown) dose was not reported, 1 total, administered on 10-APR-2021 in right arm in the morning for prophylactic vaccination. No concomitant medications were reported.  On 18-AUG-2021, the patient experienced confirmed immunological vaccine failure. The patient underwent a Immunoglobulin G/Immunoglobulin M (IgG/IgM) COVID-19 combination antibody test, which resulted into negative antibodies (Ab).  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: V0: 20210847388-covid-19 vaccine ad26.cov2.s-Confirmed 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: U
Vaccine: COVID19
Symptoms: Chest discomfort, Influenza like illness
Clinical narrative: HEAVY FEELING IN CHEST; FLU-LIKE SYMPTOMS(FELT FEVERISH, HACKING COUGH, SUDDEN TIREDNESS, HEADACHES, MUSCLE ACHES); 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 not reported, batch number: unknown) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-JUL-2021, the patient experienced heavy feeling in chest. On 27-JUL-2021, the patient experienced flu-like symptoms (felt feverish, hacking cough, sudden tiredness, headaches, muscle aches). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heavy feeling in chest, and flu-like symptoms (felt feverish, hacking cough, sudden tiredness, headaches, muscle aches). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash. This report was non-serious. This case, from the same reporter is linked to 20210846321.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Middle insomnia, Muscle spasms
Clinical narrative: NIGHTMARES; WAKING UP EVERY HOUR IN PAIN; EXTREME MUSCLE CRAMPS; STOMACH PAIN; DIARRHEA; HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, treatment medications included: acetylsalicylic acid, and ibuprofen. On 17-AUG-2021, the patient experienced nightmares. On 17-AUG-2021, the patient experienced waking up every hour in pain. On 17-AUG-2021, the patient experienced extreme muscle cramps. On 17-AUG-2021, the patient experienced stomach pain. On 17-AUG-2021, the patient experienced diarrhea. On 17-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, diarrhea, nightmares, waking up every hour in pain, extreme muscle cramps, and stomach pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nightmare
Clinical narrative: NIGHTMARES; WAKING UP EVERY HOUR IN PAIN; EXTREME MUSCLE CRAMPS; STOMACH PAIN; DIARRHEA; HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, treatment medications included: acetylsalicylic acid, and ibuprofen. On 17-AUG-2021, the patient experienced nightmares. On 17-AUG-2021, the patient experienced waking up every hour in pain. On 17-AUG-2021, the patient experienced extreme muscle cramps. On 17-AUG-2021, the patient experienced stomach pain. On 17-AUG-2021, the patient experienced diarrhea. On 17-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, diarrhea, nightmares, waking up every hour in pain, extreme muscle cramps, and stomach pain. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Malaise, Muscle spasms
Clinical narrative: PARANOID THAT PATIENT HAD SARS SYNDROME; MUSCLE SPASMS IN FINGERS, TOES, AND BUTTOCKS; DISTURBING DREAMS AS IF PATIENT WAS IN A BARBER CHAIR AND SOMEONE WAS SPINNING PATIENT; SPINNING SENSATION DURING DREAMS AND WHEN AWAKE; FELT OFF/FELT LIKE HIT BY A TRUCK; FELT ILL; FEELING SUPER DUPER TIRED AND FATIGUE; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies, no known previous medical conditions, and no current medication usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced felt off/felt like hit by a truck. On 30-JUL-2021, the patient experienced felt ill. On 30-JUL-2021, the patient experienced feeling super duper tired and fatigue. On 30-JUL-2021, the patient experienced fever. On 30-JUL-2021, the patient experienced nausea. On 30-JUL-2021, the patient experienced headache. On 01-AUG-2021, the patient experienced disturbing dreams as if patient was in a barber chair and someone was spinning patient. On 01-AUG-2021, the patient experienced spinning sensation during dreams and when awake. On 08-AUG-2021, the patient experienced muscle spasms in fingers, toes, and buttocks. On an unspecified date, the patient experienced paranoid that patient had sars syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt off/felt like hit by a truck, felt ill, feeling super duper tired and fatigue, fever, nausea, and headache, and disturbing dreams as if patient was in a barber chair and someone was spinning patient, spinning sensation during dreams and when awake, and muscle spasms in fingers, toes, and buttocks on AUG-2021, and the outcome of paranoid that patient had sars syndrome was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nightmare, Paranoia, Pyrexia, Vertigo
Clinical narrative: PARANOID THAT PATIENT HAD SARS SYNDROME; MUSCLE SPASMS IN FINGERS, TOES, AND BUTTOCKS; DISTURBING DREAMS AS IF PATIENT WAS IN A BARBER CHAIR AND SOMEONE WAS SPINNING PATIENT; SPINNING SENSATION DURING DREAMS AND WHEN AWAKE; FELT OFF/FELT LIKE HIT BY A TRUCK; FELT ILL; FEELING SUPER DUPER TIRED AND FATIGUE; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies, no known previous medical conditions, and no current medication usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced felt off/felt like hit by a truck. On 30-JUL-2021, the patient experienced felt ill. On 30-JUL-2021, the patient experienced feeling super duper tired and fatigue. On 30-JUL-2021, the patient experienced fever. On 30-JUL-2021, the patient experienced nausea. On 30-JUL-2021, the patient experienced headache. On 01-AUG-2021, the patient experienced disturbing dreams as if patient was in a barber chair and someone was spinning patient. On 01-AUG-2021, the patient experienced spinning sensation during dreams and when awake. On 08-AUG-2021, the patient experienced muscle spasms in fingers, toes, and buttocks. On an unspecified date, the patient experienced paranoid that patient had sars syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt off/felt like hit by a truck, felt ill, feeling super duper tired and fatigue, fever, nausea, and headache, and disturbing dreams as if patient was in a barber chair and someone was spinning patient, spinning sensation during dreams and when awake, and muscle spasms in fingers, toes, and buttocks on AUG-2021, and the outcome of paranoid that patient had sars syndrome was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: CRAMPS IN BOTH LEGS FROM KNEE TO ANKLE; SEVERE ARM PAIN THAT RADIATES FROM SHOULDER TO ELBOW LIKE HAD SURGERY ON IT; This spontaneous report received from a patient concerned a 37 year old female. The patient's weight was not reported and height was 61 inches. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: Patient had no any seasonal allergies, medications and previous medical history, no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 23-AUG-2021 11:30 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 24-AUG-2021, the patient experienced cramps in both legs from knee to ankle. On 24-AUG-2021, the patient experienced severe arm pain that radiates from shoulder to elbow like had surgery on it. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe arm pain that radiates from shoulder to elbow like had surgery on it, and cramps in both legs from knee to ankle. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Headache, Pain in extremity
Clinical narrative: THE FOLLOWING WEEK HAD ABOUT TEN DIME SIZE BRUISES ON ARMS AND LEGS; SEVERE CHILLS; SORE ARM; HEADACHE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes( controlled with diet), hashimoto, sjogrens, celiac, and crohns. 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 APR-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 the following week had about ten dime size bruises on arms and legs, severe chills, sore arm, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe chills, and sore arm, and the outcome of headache and the following week had about ten dime size bruises on arms and legs was not reported. This report was non-serious.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood disorder, Body temperature, Burning sensation, Echocardiogram
Clinical narrative: BODY IS ON FIRE, HEAD TO TOE/SKIN IS ON FIRE; BLOOD PROBLEM/HEMATOLOGY PROBLEM; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's past medical history included: sinus infections. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced body is on fire, head to toe/skin is on fire, and blood problem/hematology problem. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97-98 (normal), and Echocardiogram (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body is on fire, head to toe/skin is on fire and blood problem/hematology problem was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: BODY ACHES; SORE ARM; HEADACHES; FEVER OF 101.1F; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 23-AUG-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced body aches. On 24-AUG-2021, the patient experienced sore arm. On 24-AUG-2021, the patient experienced headaches. On 24-AUG-2021, the patient experienced fever of 101.1f. Laboratory data included: Body temperature (NR: not provided) 101.1 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 24-AUG-2021, and was recovering from headaches, sore arm, and fever of 101.1f. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fibromyalgia
Clinical narrative: FIBROMYALGIA; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the patient experienced fibromyalgia. Laboratory data (dates unspecified) included: Blood test (NR: not provided) No significant findings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fibromyalgia. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphonia, Headache, Nasal congestion, Pain
Clinical narrative: VOICE SOUNDS LIKE A FROG; STUFFED UP IN NOSE AREA; BODY ACHES FROM HEAD TO TOE; CHILLS; HEADACHE; SORENESS IN ARM; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: UNKNOWN) dose was not reported, administered on 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-AUG-2021, the patient experienced soreness in arm. On 24-AUG-2021, the patient experienced voice sounds like a frog. On 24-AUG-2021, the patient experienced stuffed up in nose area. On 24-AUG-2021, the patient experienced body aches from head to toe. On 24-AUG-2021, the patient experienced chills. On 24-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in arm, was recovering from chills, and had not recovered from body aches from head to toe, stuffed up in nose area, voice sounds like a frog, and headache. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: VOICE SOUNDS LIKE A FROG; STUFFED UP IN NOSE AREA; BODY ACHES FROM HEAD TO TOE; CHILLS; HEADACHE; SORENESS IN ARM; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, and expiry: UNKNOWN) dose was not reported, administered on 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-AUG-2021, the patient experienced soreness in arm. On 24-AUG-2021, the patient experienced voice sounds like a frog. On 24-AUG-2021, the patient experienced stuffed up in nose area. On 24-AUG-2021, the patient experienced body aches from head to toe. On 24-AUG-2021, the patient experienced chills. On 24-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in arm, was recovering from chills, and had not recovered from body aches from head to toe, stuffed up in nose area, voice sounds like a frog, and headache. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Disorientation, Head discomfort, Malaise
Clinical narrative: HEAVINESS IN HEAD; FELT DISORIENTED; CHILLS; NOT FEELING GOOD; FEVER; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's past medical history included: mild covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: 02-OCT-2021) dose was not reported, administered on 18-AUG-2021 19:00 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021, the patient experienced heaviness in head. On 19-AUG-2021, the patient experienced felt disoriented. On 19-AUG-2021, the patient experienced chills. On 19-AUG-2021, the patient experienced not feeling good. On 19-AUG-2021, the patient experienced fever. On 20-AUG-2021, Laboratory data included: Body temperature (NR: not provided) 100.5 F. Treatment medications included: ibuprofen. On 21-AUG-2021, treatment medications included: paracetamol. On 23-AUG-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 20-AUG-2021, had not recovered from heaviness in head, and felt disoriented, and the outcome of not feeling good was not reported. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HEAVINESS IN HEAD; FELT DISORIENTED; CHILLS; NOT FEELING GOOD; FEVER; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's past medical history included: mild covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: 02-OCT-2021) dose was not reported, administered on 18-AUG-2021 19:00 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021, the patient experienced heaviness in head. On 19-AUG-2021, the patient experienced felt disoriented. On 19-AUG-2021, the patient experienced chills. On 19-AUG-2021, the patient experienced not feeling good. On 19-AUG-2021, the patient experienced fever. On 20-AUG-2021, Laboratory data included: Body temperature (NR: not provided) 100.5 F. Treatment medications included: ibuprofen. On 21-AUG-2021, treatment medications included: paracetamol. On 23-AUG-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 20-AUG-2021, had not recovered from heaviness in head, and felt disoriented, and the outcome of not feeling good was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia, Taste disorder
Clinical narrative: LOSS/ALTERED SENSE OF TASTE; LOSS/ALTERED SENSE OF SMELL; EVERYTHING TASTE LIKE NICKELS; This spontaneous report received from a patient concerned a 21 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 not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced loss/altered sense of taste. On 13-MAR-2021, the patient experienced loss/altered sense of smell. On 13-MAR-2021, the patient experienced everything taste like nickels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss/altered sense of taste, loss/altered sense of smell, and everything taste like nickels. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Peripheral swelling
Clinical narrative: KNEES HURTED; SWOLLEN  ANKLES; SWOLLEN KNEES; SWOLLEN FEET; This spontaneous report received from a patient concerned a 57 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: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced swollen ankles. On APR-2021, the patient experienced swollen knees. On APR-2021, the patient experienced swollen feet. On an unspecified date, the patient experienced knees hurted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen ankles, swollen knees, knees hurted and swollen feet was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Gastroenteritis viral
Clinical narrative: PROBABLE STOMACH FLU; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced probable stomach flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of probable stomach flu was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Blood test, Fatigue, Heart rate, Heart rate increased
Clinical narrative: MENSTRUAL CHANGES; ACNE; NUMBNESS IN LEGS; ACHINESS AND PAIN IN HER LEGS; FATIGUE; MIGRAINES; HIGH PULSE RATE; SWEATING; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's past medical history included: reaction to flu vaccine, and concurrent conditions included: low pulse rate, non-alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and cyanocobalamin. On 07-JUN-2021, the patient experienced high pulse rate. Laboratory data included: Pulse rate (NR: not provided) over 150 bpm. On 07-JUN-2021, the patient experienced sweating. On 07-JUN-2021, the patient experienced migraines. On 07-JUN-2021, the patient experienced fatigue. On 08-JUN-2021, the patient experienced numbness in legs. On 08-JUN-2021, the patient experienced achiness and pain in her legs. On 24-JUN-2021, the patient experienced menstrual changes. On 24-JUN-2021, the patient experienced acne. On 02-JUL-2021, Laboratory data included: X-ray (NR: not provided) Unknown. Laboratory data (dates unspecified) included: Blood test (NR: not provided) exact tests and results were not accessible, and Diagnostic ultrasound (NR: not provided) could not see anything. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraines on 11-JUL-2021, was recovering from fatigue, high pulse rate, and menstrual changes, and the outcome of sweating, numbness in legs, acne and achiness and pain in her legs was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Menstrual disorder, Migraine, Pain in extremity
Clinical narrative: MENSTRUAL CHANGES; ACNE; NUMBNESS IN LEGS; ACHINESS AND PAIN IN HER LEGS; FATIGUE; MIGRAINES; HIGH PULSE RATE; SWEATING; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's past medical history included: reaction to flu vaccine, and concurrent conditions included: low pulse rate, non-alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and cyanocobalamin. On 07-JUN-2021, the patient experienced high pulse rate. Laboratory data included: Pulse rate (NR: not provided) over 150 bpm. On 07-JUN-2021, the patient experienced sweating. On 07-JUN-2021, the patient experienced migraines. On 07-JUN-2021, the patient experienced fatigue. On 08-JUN-2021, the patient experienced numbness in legs. On 08-JUN-2021, the patient experienced achiness and pain in her legs. On 24-JUN-2021, the patient experienced menstrual changes. On 24-JUN-2021, the patient experienced acne. On 02-JUL-2021, Laboratory data included: X-ray (NR: not provided) Unknown. Laboratory data (dates unspecified) included: Blood test (NR: not provided) exact tests and results were not accessible, and Diagnostic ultrasound (NR: not provided) could not see anything. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraines on 11-JUL-2021, was recovering from fatigue, high pulse rate, and menstrual changes, and the outcome of sweating, numbness in legs, acne and achiness and pain in her legs was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, X-ray
Clinical narrative: MENSTRUAL CHANGES; ACNE; NUMBNESS IN LEGS; ACHINESS AND PAIN IN HER LEGS; FATIGUE; MIGRAINES; HIGH PULSE RATE; SWEATING; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's past medical history included: reaction to flu vaccine, and concurrent conditions included: low pulse rate, non-alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid, and cyanocobalamin. On 07-JUN-2021, the patient experienced high pulse rate. Laboratory data included: Pulse rate (NR: not provided) over 150 bpm. On 07-JUN-2021, the patient experienced sweating. On 07-JUN-2021, the patient experienced migraines. On 07-JUN-2021, the patient experienced fatigue. On 08-JUN-2021, the patient experienced numbness in legs. On 08-JUN-2021, the patient experienced achiness and pain in her legs. On 24-JUN-2021, the patient experienced menstrual changes. On 24-JUN-2021, the patient experienced acne. On 02-JUL-2021, Laboratory data included: X-ray (NR: not provided) Unknown. Laboratory data (dates unspecified) included: Blood test (NR: not provided) exact tests and results were not accessible, and Diagnostic ultrasound (NR: not provided) could not see anything. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraines on 11-JUL-2021, was recovering from fatigue, high pulse rate, and menstrual changes, and the outcome of sweating, numbness in legs, acne and achiness and pain in her legs was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Limb discomfort, Pain in extremity, Paraesthesia
Clinical narrative: DIFFICULTY WALKING DUE TO THE PAIN; TINGLING IN LEG THAT GOES UP AND DOWN SOMETIMES INVOLVES TOES; DULL ACHE/PAIN IN LEFT LEG; HEAVINESS IN LEFT LEG; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 23-AUG-2021) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient experienced heaviness in left leg. On 17-MAR-2021, the patient experienced dull ache/pain in left leg. On 20-JUN-2021, the patient experienced difficulty walking due to the pain. On 20-JUN-2021, the patient experienced tingling in leg that goes up and down sometimes involves toes. Treatment medications (dates unspecified) included: diclofenac sodium, and meloxicam. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dull ache/pain in left leg, and the outcome of tingling in leg that goes up and down sometimes involves toes, heaviness in left leg and difficulty walking due to the pain was not reported. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: SWOLLEN FACE; This spontaneous report received from a consumer concerned a 56 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: 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 swollen face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swollen face was not reported. This report was non-serious.