chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: MASSIVE BLUNT FORCE TRAUMA; CAR ACCIDENT; BLEEDING PROBLEMS; FELT PUNK; POSITIVE COVID TEST/ CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned an 77year old male.  The patient's weight was 216 pounds, and height was 65 inches. The patient's concurrent conditions included pacemaker, and copd (Chronic obstructive pulmonary disease), and other pre-existing medical conditions included the patient was on respiratory medications and blood thinners. The patient was previously treated with warfarin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry :unknown) dose was not reported, 1 total, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not provided and has been requested. On an unspecified date in JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. The patient felt a little punk from the vaccine initially. On 18-MAY-2021, the patient was in a car accident. He was driving a truck and got T-boned by a car and pushed 40 feet into a ditch. He was hospitalized and had 2 negative rapid tests for COVID. He decompensated and was intubated. Upon intubation, another rapid COVID test was done and was positive. They did an additional test that was also positive. He passed away on 25-MAY-2021. An autopsy was performed on an unspecified date. It was reported that she believed the cause of death to be the massive blunt force trauma and bleeding problems. He tested positive for COVID with a 5 day test in JAN-2021. During that time, he had received the monoclonal infusion. She noted that he did not get ivermectin. He also got a physical examination done. Laboratory data included: COVID-19 virus test (NR: not provided) not reported, and SARS-CoV-2 rapid diagnostic test (NR: not provided) positive, positive. Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) negative, negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of massive blunt force trauma and bleeding problems on 25-MAY-2021, and the outcome of positive covid test/ confirmed covid-19 infection, car accident and felt punk was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210554454-COVID-19 VACCINE AD26.COV2.S. Massive blunt force trauma, bleeding problems, car accident. This events is considered unassessable. The events have an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: MASSIVE BLUNT FORCE TRAUMA; BLEEDING
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Bell's palsy, Guillain-Barre syndrome, Thrombosis
Clinical narrative: BELL'S PALSY; BLOOD CLOT; GUILLAIN BARRE SYNDROME; ANAPHYLAXIS; This spontaneous report received from a patient via a company representative (other manufacturer Pfizer ) concerned multiple patients. The patient height and weight was not reported .No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported)frequency one total , dose, start therapy date were not reported for prophylactic vaccination.The batch no was not reported ,The Company is unable to performed follow up to request batch /Lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced bell's palsy, blood clot, guillain barre syndrome, and anaphylaxis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bell's palsy, blood clot, guillain barre syndrome and anaphylaxis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210556206-COVID-19 VACCINE AD26.COV2.S. Bell's palsy, Blood clot, Guillain Barre syndrome. This events is considered unassessable. The events has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210556206-COVID-19 VACCINE AD26.COV2.S. Anaphylaxis. This event is labeled per RSI and is therefore considered potentially related.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Electrocution, Erythema, Feeling abnormal, Gait disturbance
Clinical narrative: BODY TREMBLING AND SHAKES; FEELING ELECTROCUTED; TINGLING ALL OVER THE BODY; INSOMNIA; BARELY ABLE TO WALK; REDNESS IN THE FACE; HEART FEELING WEIRD; WHOLE BODY ACHES; EXTREME  SORNESS OF LEGS; EXTREME WEAKNESS; HEADACHES; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included there was no past medical history. the patient was overall healthy prior to the side effects after receiving the vaccine. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body trembling and shakes. On APR-2021, the subject experienced feeling electrocuted. On APR-2021, the subject experienced tingling all over the body. On APR-2021, the subject experienced insomnia. On APR-2021, the subject experienced barely able to walk. On APR-2021, the subject experienced redness in the face. On APR-2021, the subject experienced heart feeling weird. On APR-2021, the subject experienced whole body aches. On APR-2021, the subject experienced extreme sorness of legs. On APR-2021, the subject experienced extreme weakness. On APR-2021, the subject experienced headaches. Laboratory data (dates unspecified) included: Scan (NR: not provided) No diagnosis, and X-ray (NR: not provided) No diagnosis. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from body trembling and shakes, tingling all over the body, insomnia, redness in the face, whole body aches, extreme sorness of legs, heart feeling weird, headaches, extreme weakness, and barely able to walk, and the outcome of feeling electrocuted was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: BODY TREMBLING AND SHAKES; FEELING ELECTROCUTED; TINGLING ALL OVER THE BODY; INSOMNIA; BARELY ABLE TO WALK; REDNESS IN THE FACE; HEART FEELING WEIRD; WHOLE BODY ACHES; EXTREME  SORNESS OF LEGS; EXTREME WEAKNESS; HEADACHES; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included there was no past medical history. the patient was overall healthy prior to the side effects after receiving the vaccine. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body trembling and shakes. On APR-2021, the subject experienced feeling electrocuted. On APR-2021, the subject experienced tingling all over the body. On APR-2021, the subject experienced insomnia. On APR-2021, the subject experienced barely able to walk. On APR-2021, the subject experienced redness in the face. On APR-2021, the subject experienced heart feeling weird. On APR-2021, the subject experienced whole body aches. On APR-2021, the subject experienced extreme sorness of legs. On APR-2021, the subject experienced extreme weakness. On APR-2021, the subject experienced headaches. Laboratory data (dates unspecified) included: Scan (NR: not provided) No diagnosis, and X-ray (NR: not provided) No diagnosis. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from body trembling and shakes, tingling all over the body, insomnia, redness in the face, whole body aches, extreme sorness of legs, heart feeling weird, headaches, extreme weakness, and barely able to walk, and the outcome of feeling electrocuted was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Scan, Tremor, X-ray
Clinical narrative: BODY TREMBLING AND SHAKES; FEELING ELECTROCUTED; TINGLING ALL OVER THE BODY; INSOMNIA; BARELY ABLE TO WALK; REDNESS IN THE FACE; HEART FEELING WEIRD; WHOLE BODY ACHES; EXTREME  SORNESS OF LEGS; EXTREME WEAKNESS; HEADACHES; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included there was no past medical history. the patient was overall healthy prior to the side effects after receiving the vaccine. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body trembling and shakes. On APR-2021, the subject experienced feeling electrocuted. On APR-2021, the subject experienced tingling all over the body. On APR-2021, the subject experienced insomnia. On APR-2021, the subject experienced barely able to walk. On APR-2021, the subject experienced redness in the face. On APR-2021, the subject experienced heart feeling weird. On APR-2021, the subject experienced whole body aches. On APR-2021, the subject experienced extreme sorness of legs. On APR-2021, the subject experienced extreme weakness. On APR-2021, the subject experienced headaches. Laboratory data (dates unspecified) included: Scan (NR: not provided) No diagnosis, and X-ray (NR: not provided) No diagnosis. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from body trembling and shakes, tingling all over the body, insomnia, redness in the face, whole body aches, extreme sorness of legs, heart feeling weird, headaches, extreme weakness, and barely able to walk, and the outcome of feeling electrocuted was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Investigation, Mitral valve incompetence, Pneumonia, Pulmonary oedema
Clinical narrative: MITRAL VALVE WORSENING; PNEUMONIA; WATER ON LUNG; This spontaneous report received from a patient concerned a 60-year-old male. The patient's weight was 116 pounds, and height was 64 inches. The patient's concurrent conditions included mitral valve leak, non-smoker, and abstains from alcohol, and other pre-existing medical conditions included no known allergies, no drug abuse or illicit drug usage, no recent history of exposure to a person with covid infection, no flu test performed, no recent infections and no other known laboratory examination and/or pathological finding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered at right arm on 14-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. The patient denied any concomitant medications.  Between 16-APR-2021 and 22-APR-2021, the patient experienced fever, pneumonia and water on lungs, the former two symptoms due to mitral valve worsening. Patient was hospitalized on 22-APR-2021. When the patient was hospitalized, laboratory data included: Body temperature 100.4 F (highest) and 99 F (lowest), COVID-19 virus test was Negative, an unspecified diagnostic procedure which was inconclusive for endocarditis. Treatment medications (dates unspecified) included: Lasix (Furosemide). Patient received an antibiotic for the pneumonia which started with letter "L" but declined Levaquin or levofloxacin. Patient stated that his mitral value condition deteriorated rapidly in the last 4 weeks and would eventually require a surgery.  Patient was hospitalized for 5 days and discharged on 26-Apr-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pneumonia, and water on lung, and had not recovered from mitral valve worsening. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210556507- covid-19 vaccine ad26.cov2.s-mitral valve worsening. 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: MEDICAL HISTORY 20210556507- covid-19 vaccine ad26.cov2.s-pneumonia, water on lung. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: MITRAL VALVE WORSENING; PNEUMONIA; WATER ON LUNG; This spontaneous report received from a patient concerned a 60-year-old male. The patient's weight was 116 pounds, and height was 64 inches. The patient's concurrent conditions included mitral valve leak, non-smoker, and abstains from alcohol, and other pre-existing medical conditions included no known allergies, no drug abuse or illicit drug usage, no recent history of exposure to a person with covid infection, no flu test performed, no recent infections and no other known laboratory examination and/or pathological finding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered at right arm on 14-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. The patient denied any concomitant medications.  Between 16-APR-2021 and 22-APR-2021, the patient experienced fever, pneumonia and water on lungs, the former two symptoms due to mitral valve worsening. Patient was hospitalized on 22-APR-2021. When the patient was hospitalized, laboratory data included: Body temperature 100.4 F (highest) and 99 F (lowest), COVID-19 virus test was Negative, an unspecified diagnostic procedure which was inconclusive for endocarditis. Treatment medications (dates unspecified) included: Lasix (Furosemide). Patient received an antibiotic for the pneumonia which started with letter "L" but declined Levaquin or levofloxacin. Patient stated that his mitral value condition deteriorated rapidly in the last 4 weeks and would eventually require a surgery.  Patient was hospitalized for 5 days and discharged on 26-Apr-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pneumonia, and water on lung, and had not recovered from mitral valve worsening. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210556507- covid-19 vaccine ad26.cov2.s-mitral valve worsening. 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: MEDICAL HISTORY 20210556507- covid-19 vaccine ad26.cov2.s-pneumonia, water on lung. 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: Abdominal pain, Gastric disorder, Pain in extremity, Thrombosis
Clinical narrative: BLOOD CLOT; BELLY BUTTON PAIN; LOWER LEG PAIN; STOMACH PROBLEMS; This spontaneous report received from a patient concerned a 57 year old white(Not Hispanic or Latino) female. The patient's height, and weight were not reported. No past medical history was reported. 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: 1805025,expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the patient experienced stomach problems(pain, cramping, bloating). On an unspecified date, the patient experienced blood clot, belly button pain, and lower leg pain. The patient did not made any changes to diet and no new medications took since getting the vaccine. The patient had tried yogurt and probiotic. Treatment medications (dates unspecified) included: bismuth subsalicylate for unknown indication. On 28-May-2021, she started taking turmeric, but so far nothing had resolved the issues. The patient had a tele visit with family doctor of medicine and would go next week wednesday. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot, and lower leg pain, and had not recovered from stomach problems, and belly button pain. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210556734.; Sender's Comments: V0 20210556510- COVID-19 VACCINE AD26.COV2.S- blood clot. 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: Vaccination failure
Clinical narrative: NOT ENOUGH PROTECTION (SUSPECTED VACCINATION FAILURE); This spontaneous report received from a physician via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported, 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, after five or six weeks of vaccine, it still looked like the old one from last time for the patient. According to her physician there was just not enough protection (suspected vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not enough protection (suspected vaccination failure) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210556690-COVID-19 VACCINE AD26.COV2.S- not enough protection (suspected 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: VAGINAL BLEEDING 5 DAYS AFTER  CYCLE HAS ENDED; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight was not reported and height was 66 inches. The patient's past medical history included spotting after cycle.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203a21a, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 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 ethinylestradiol/ferrous fumarate/norethisterone acetate, and venlafaxine hydrochloride. On 29-MAY-2021, the subject experienced vaginal bleeding 5 days after cycle has ended. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vaginal bleeding 5 days after cycle has ended. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: BODY ACHE; FEVER (103 F); This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no pertinent medical history. The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine (suspension for injection, intramuscular, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced body ache. On 05-MAR-2021, the subject experienced fever (103 F). Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from body ache, and fever (103 F) on 07-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210557887.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Body temperature decreased, Headache, Paraesthesia
Clinical narrative: ITCHING ON ANKLES/CALVES BOTH SIDES; PINS AND NEEDLES IN LOWER LEGS; WEAKNESS/LACK OF ENERGY; HEADACHE; BODY TEMPERATURE WOULD NOT GO UP (95.2 DEGREES PRESENTLY); 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 asthmatic, allergic to fragrances, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient had allergy to unspecified cholesterol medications and some diabetic medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced body temperature would not go up (95.2 degrees presently). Laboratory data included: Body temperature (NR: not provided) 95.2 deg. On 26-MAY-2021, the subject experienced itching on ankles/calves both sides. On 26-MAY-2021, the subject experienced pins and needles in lower legs. On 26-MAY-2021, the subject experienced weakness/lack of energy. On 26-MAY-2021, the subject experienced headache. On 28-MAY-2021, treatment medications included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from weakness/lack of energy, itching on ankles/calves both sides, and pins and needles in lower legs, and the outcome of headache and body temperature would not go up (95.2 degrees presently) was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: ITCHING ON ANKLES/CALVES BOTH SIDES; PINS AND NEEDLES IN LOWER LEGS; WEAKNESS/LACK OF ENERGY; HEADACHE; BODY TEMPERATURE WOULD NOT GO UP (95.2 DEGREES PRESENTLY); 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 asthmatic, allergic to fragrances, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient had allergy to unspecified cholesterol medications and some diabetic medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced body temperature would not go up (95.2 degrees presently). Laboratory data included: Body temperature (NR: not provided) 95.2 deg. On 26-MAY-2021, the subject experienced itching on ankles/calves both sides. On 26-MAY-2021, the subject experienced pins and needles in lower legs. On 26-MAY-2021, the subject experienced weakness/lack of energy. On 26-MAY-2021, the subject experienced headache. On 28-MAY-2021, treatment medications included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from weakness/lack of energy, itching on ankles/calves both sides, and pins and needles in lower legs, and the outcome of headache and body temperature would not go up (95.2 degrees presently) was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Fatigue, Feeling abnormal
Clinical narrative: ELEVATED BP; "SPACEY"; MUSCLE CRAMPS; SORE ARM; EXTREME CHILLS; TIRED; This spontaneous report received from a patient concerned a 74-year-old white and not-Hispanic or Latino female. The patient's weight was 150 pounds, and height was 61 inches. The patient's concurrent conditions included high blood pressure, allergy to formaldehyde, paint, nail polish, raspberries and pepper. Patient was non-smoker, and non-alcohol user. Patient had breast cancer 15 years ago. Patient had allergy to new carpeting with fire protection coating. Patient did not have any drug abuse or illicit drug use. The patient experienced drug allergy when treated with Tylenol, sulfa drugs, ibuprofen, loratadine, and hydrochlorothiazide/losartan potassium for drug used for unknown indication.  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 28-MAY-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-MAY-2021, couple hours later vaccination, patient was tired and spacey. At around 10:30 pm, she noted extreme chills and muscle spasms. She could not warm herself up, and kept getting colder and colder. She went ER (emergency room) at 1:30 am because her BP (blood pressure) was high (176/110 mmHg). She left the ER at 5 am it was 150/80 mmHg. At the hospital, they gave her Tylenol, which helped her within an hour. They noted to add some Advil with the Tylenol for relief, and to continue for another 48 hours. Her arm was little a sore. It sometimes cramps in the area about every 8 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spacey, and tired on 28-MAY-2021, was recovering from extreme chills, elevated blood pressure, and sore arm, and the outcome of muscle cramps was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210557834-COVID-19 VACCINE AD26.COV2.S-Elevated BP. 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: UNDERLYING DISEASE
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: ELEVATED BP; "SPACEY"; MUSCLE CRAMPS; SORE ARM; EXTREME CHILLS; TIRED; This spontaneous report received from a patient concerned a 74-year-old white and not-Hispanic or Latino female. The patient's weight was 150 pounds, and height was 61 inches. The patient's concurrent conditions included high blood pressure, allergy to formaldehyde, paint, nail polish, raspberries and pepper. Patient was non-smoker, and non-alcohol user. Patient had breast cancer 15 years ago. Patient had allergy to new carpeting with fire protection coating. Patient did not have any drug abuse or illicit drug use. The patient experienced drug allergy when treated with Tylenol, sulfa drugs, ibuprofen, loratadine, and hydrochlorothiazide/losartan potassium for drug used for unknown indication.  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 28-MAY-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-MAY-2021, couple hours later vaccination, patient was tired and spacey. At around 10:30 pm, she noted extreme chills and muscle spasms. She could not warm herself up, and kept getting colder and colder. She went ER (emergency room) at 1:30 am because her BP (blood pressure) was high (176/110 mmHg). She left the ER at 5 am it was 150/80 mmHg. At the hospital, they gave her Tylenol, which helped her within an hour. They noted to add some Advil with the Tylenol for relief, and to continue for another 48 hours. Her arm was little a sore. It sometimes cramps in the area about every 8 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spacey, and tired on 28-MAY-2021, was recovering from extreme chills, elevated blood pressure, and sore arm, and the outcome of muscle cramps was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210557834-COVID-19 VACCINE AD26.COV2.S-Elevated BP. 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: UNDERLYING DISEASE
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: DIZZINESS; LACK OF ENERGY; This spontaneous report received from a patient 69-year-old male white not Hispanic or white patient. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, nonsmoker, coronary artery disease (takes blood pressure meds, cholesterol meds, and OTC glucosamine/supplements), penicillin allergy, scallops allergy, and contrast media allergy. The patient had no known drug allergies and no drug abuse/illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose 1 total administered on 20-MAY-2021 for prophylactic vaccination. Concomitant medications included glucosamine for coronary artery disease. On 29-MAY-2021, he woke up with dizziness, light-headedness, and low energy. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from dizziness, and lack of energy. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Pneumonia
Clinical narrative: PNEUMONIA; INJECTION SITE ITCHINESS; RASH AT INJECTION SITE; This spontaneous report received from a consumer concerned a 97 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 was not reported, 1 total dose administered on 07-APR-2021 in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient developed an itchy rash at the site of the vaccine, 5 days after receiving the vaccine. Her husband did not said anything and it had started to dry up. Consumer said her husband picked up pneumonia about 3 weeks after the vaccine on 27-APR-2021 and was hospitalized. He was on antibiotics for a long time. might be 2 weeks or more. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pneumonia, injection site itchiness, and rash at injection site. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 - 20210557955-covid-19 vaccine ad26.cov2.s-Pneumonia. 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: Injection site pain, Pain, Rash, Rash pruritic, SARS-CoV-2 antibody test
Clinical narrative: MILD PAIN AT INJECTION SITE; RASH CAUSING PRICKLY PAIN; PINK RASH COVERING BOTH ARMS; DEVELOPED A RASH, PINK IN COLOR, THAT COVERED BOTH ARMS CAUSING CONTINUOUS PRICKLY PAIN AND ITCHINESS; 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced rash causing prickly pain. On MAY-2021, the subject experienced pink rash covering both arms. On MAY-2021, the subject experienced developed a rash, pink in color, that covered both arms causing continuous prickly pain and itchiness. On an unspecified date, the subject experienced mild pain at injection site. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Positive antibodies for Covid-19. The action taken with covid-19 vaccine was not applicable. The patient recovered from mild pain at injection site, and the outcome of pink rash covering both arms, rash causing prickly pain and developed a rash, pink in color, that covered both arms causing continuous prickly pain and itchiness was not reported. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Influenza like illness, Injection site pain, Migraine
Clinical narrative: SEVERE MIGRAINE; FLU LIKE SYMPTOMS; STOMACH PAIN; ARM SORENESS ON THE SURROUNDING TISSUE AROUND THE INJECTION; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, severe depressive disorder, generalized anxiety, alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. Concomitant medications included sertraline for antidepressant, ethinylestradiol/norgestimate for birth control, and salbutamol. On 25-MAY-2021, the subject experienced arm soreness on the surrounding tissue around the injection. On 26-MAY-2021, the subject experienced severe migraine. On 26-MAY-2021, the subject experienced flu like symptoms. On 26-MAY-2021, the subject experienced stomach pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe migraine on 26-MAY-2021, and flu like symptoms, stomach pain, and arm soreness on the surrounding tissue around the injection on 27-MAY-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS FOR 7 HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills for 7 hours. The action taken with covid-19 vaccine was not applicable. The outcome of chills for 7 hours was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: TINNITUS HAD BEEN CONSTANT SINCE ONSET; 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 (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced tinnitus had been constant since onset. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from tinnitus had been constant since onset. This report was non-serious. This case, from the same reporter is linked to 20210600421.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER OF 100.7; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced body aches, chills, and fever of 100.7. The action taken with covid-19 vaccine was not applicable. The outcome of the chills, body aches and fever of 100.7 was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Injection site bruising
Clinical narrative: INJECTION SITE BRUISE; CHILLS; GRADUALLY INCREASING HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-MAY-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 30-MAY-2021, the subject experienced injection site bruise. On 30-MAY-2021, the subject experienced chills. On 30-MAY-2021, the subject experienced gradually increasing headache. Laboratory data included: Body temperature (NR: not provided) 104 F. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from injection site bruise, and the outcome of gradually increasing headache and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Drug ineffective, Pyrexia
Clinical narrative: KICKING MY ASS; FELT SYMPTOMS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 MAY-2021, the subject experienced kicking my ass. On MAY-2021, the subject experienced felt symptoms. On MAY-2021, the subject experienced fever. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever on MAY-2021, and had not recovered from felt symptoms, and kicking my ass. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: SICK AS A SICK DOG; HIGH FEVER; NAUSEOUS; RAGING HEADACHE; TOTALLY EXHAUSTED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sick as a sick dog, high fever, nauseous, raging headache, and totally exhausted. The action taken with covid-19 vaccine was not applicable. The outcome of the sick as a sick dog, high fever, nauseous, raging headache and totally exhausted was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: VIOLENT CHILLS; PAIN IN ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-MAY-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 MAY-2021, the subject experienced pain in arm. On 29-MAY-2021, the subject experienced violent chills. The action taken with covid-19 vaccine was not applicable. The patient was recovering from violent chills, and the outcome of pain in arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 number.  No concomitant medications were reported. On an unspecified date, the subject experienced chills, and fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Epistaxis, Fatigue, Feeling abnormal, Headache
Clinical narrative: BLOODY NOSE; BODY DISCOMFORT; CHRONIC PAIN; FEELING A LITTLE OOGY; TIRED; BIT OF A HEADACHE; SORE ARM; PERIOD AFTER COUPLE OF MONTHS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included chronic pain, always tired, and not having a period for couple of months. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 28-MAY-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 MAY-2021, the subject experienced period after couple of months. On 28-MAY-2021, the subject experienced sore arm. On 29-MAY-2021, the subject experienced bloody nose. On 29-MAY-2021, the subject experienced body discomfort. On 29-MAY-2021, the subject experienced chronic pain. On 29-MAY-2021, the subject experienced feeling a little oogy. On 29-MAY-2021, the subject experienced tired. On 29-MAY-2021, the subject experienced bit of a headache. The action taken with covid-19 vaccine was not applicable. The outcome of the sore arm, bit of a headache, bloody nose, tired, body discomfort, feeling a little oogy, period after couple of months and chronic pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Pain, Pain in extremity
Clinical narrative: BLOODY NOSE; BODY DISCOMFORT; CHRONIC PAIN; FEELING A LITTLE OOGY; TIRED; BIT OF A HEADACHE; SORE ARM; PERIOD AFTER COUPLE OF MONTHS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included chronic pain, always tired, and not having a period for couple of months. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 28-MAY-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 MAY-2021, the subject experienced period after couple of months. On 28-MAY-2021, the subject experienced sore arm. On 29-MAY-2021, the subject experienced bloody nose. On 29-MAY-2021, the subject experienced body discomfort. On 29-MAY-2021, the subject experienced chronic pain. On 29-MAY-2021, the subject experienced feeling a little oogy. On 29-MAY-2021, the subject experienced tired. On 29-MAY-2021, the subject experienced bit of a headache. The action taken with covid-19 vaccine was not applicable. The outcome of the sore arm, bit of a headache, bloody nose, tired, body discomfort, feeling a little oogy, period after couple of months and chronic pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.