chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Chest pain, Discomfort, Emotional distress, Exposure to toxic agent
Clinical narrative: DECREASED IN VISION; DECREASE IN MEMORY; DECREASE IN HEARING; DECLINE IN HEALTH AND HYGIENE; BLURRY EYES; TEMPLE PAIN; NECK PAIN; CHEST PAIN; OPPRESSION; FEELING STALKED, MONITORED, HARASSED; TRAUMATIZED; OVERWHELMED; EXPOSURE TO ELEMENTS; SWOLLEN ANKLES; MENTAL STRESSED; UNCOMFORTABILITY; This spontaneous report received from a patient concerned a female patient (age, race and ethnicity not reported). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) on an unspecified date for prophylactic vaccination. No concomitant medications were reported.  The patient filed a complaint in the  Court on 20-APR-2021. Federal statutory rights including retaliation, abuse of power, discrimination, and persecution were reported as violated. She listed defendants.  Place of occurrences. Dates of occurrences were between 11-APR-2021 and 16-APR-2021.  Injuries were reported as: decreased in vision, memory, hearing, decline in health and hygiene,  blurry eyes,  temple pain,  neck pain, chest pain,  blocked path to housing and food, oppression, feeling stalked, monitored, traumatized, overwhelmed,  exposure to elements, swollen ankles, re-worn dirty clothes, harassed, mental stressed, and uncomfortability. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the decreased in vision, decrease in memory, decrease in hearing, decline in health and hygiene, blurry eyes, temple pain, neck pain, chest pain, oppression, feeling stalked, monitored, traumatized, overwhelmed, exposure to elements, swollen ankles, felt harassed, mental stressed and uncomfortability was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient concerned a female patient (age, race and ethnicity not reported) who experienced the below complaints unspecified time after vaccine. No past medical history was reported. No concomitant medications were reported. The patient filed a complaint in the Court . Federal statutory rights including retaliation, abuse of power, discrimination, and persecution were reported as violated. She listed defendants. Injuries were reported as: decreased in vision, memory, hearing, decline in health and hygiene, blurry eyes, temple pain, neck pain, chest pain, blocked path to housing and food, oppression, feeling stalked, monitored, traumatized, overwhelmed, exposure to elements, swollen ankles, re-worn dirty clothes, harassed, mental stressed, and uncomfortability. A meaningful medical assessment can not be made of this legal case, although the events are unlikely to be related to vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, General physical health deterioration, Headache, Hypoacusis, Injury
Clinical narrative: DECREASED IN VISION; DECREASE IN MEMORY; DECREASE IN HEARING; DECLINE IN HEALTH AND HYGIENE; BLURRY EYES; TEMPLE PAIN; NECK PAIN; CHEST PAIN; OPPRESSION; FEELING STALKED, MONITORED, HARASSED; TRAUMATIZED; OVERWHELMED; EXPOSURE TO ELEMENTS; SWOLLEN ANKLES; MENTAL STRESSED; UNCOMFORTABILITY; This spontaneous report received from a patient concerned a female patient (age, race and ethnicity not reported). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) on an unspecified date for prophylactic vaccination. No concomitant medications were reported.  The patient filed a complaint in the  Court on 20-APR-2021. Federal statutory rights including retaliation, abuse of power, discrimination, and persecution were reported as violated. She listed defendants.  Place of occurrences. Dates of occurrences were between 11-APR-2021 and 16-APR-2021.  Injuries were reported as: decreased in vision, memory, hearing, decline in health and hygiene,  blurry eyes,  temple pain,  neck pain, chest pain,  blocked path to housing and food, oppression, feeling stalked, monitored, traumatized, overwhelmed,  exposure to elements, swollen ankles, re-worn dirty clothes, harassed, mental stressed, and uncomfortability. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the decreased in vision, decrease in memory, decrease in hearing, decline in health and hygiene, blurry eyes, temple pain, neck pain, chest pain, oppression, feeling stalked, monitored, traumatized, overwhelmed, exposure to elements, swollen ankles, felt harassed, mental stressed and uncomfortability was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient concerned a female patient (age, race and ethnicity not reported) who experienced the below complaints unspecified time after vaccine. No past medical history was reported. No concomitant medications were reported. The patient filed a complaint in the Court . Federal statutory rights including retaliation, abuse of power, discrimination, and persecution were reported as violated. She listed defendants. Injuries were reported as: decreased in vision, memory, hearing, decline in health and hygiene, blurry eyes, temple pain, neck pain, chest pain, blocked path to housing and food, oppression, feeling stalked, monitored, traumatized, overwhelmed, exposure to elements, swollen ankles, re-worn dirty clothes, harassed, mental stressed, and uncomfortability. A meaningful medical assessment can not be made of this legal case, although the events are unlikely to be related to vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Neck pain, Paranoia, Sense of oppression, Vision blurred
Clinical narrative: DECREASED IN VISION; DECREASE IN MEMORY; DECREASE IN HEARING; DECLINE IN HEALTH AND HYGIENE; BLURRY EYES; TEMPLE PAIN; NECK PAIN; CHEST PAIN; OPPRESSION; FEELING STALKED, MONITORED, HARASSED; TRAUMATIZED; OVERWHELMED; EXPOSURE TO ELEMENTS; SWOLLEN ANKLES; MENTAL STRESSED; UNCOMFORTABILITY; This spontaneous report received from a patient concerned a female patient (age, race and ethnicity not reported). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) on an unspecified date for prophylactic vaccination. No concomitant medications were reported.  The patient filed a complaint in the  Court on 20-APR-2021. Federal statutory rights including retaliation, abuse of power, discrimination, and persecution were reported as violated. She listed defendants.  Place of occurrences. Dates of occurrences were between 11-APR-2021 and 16-APR-2021.  Injuries were reported as: decreased in vision, memory, hearing, decline in health and hygiene,  blurry eyes,  temple pain,  neck pain, chest pain,  blocked path to housing and food, oppression, feeling stalked, monitored, traumatized, overwhelmed,  exposure to elements, swollen ankles, re-worn dirty clothes, harassed, mental stressed, and uncomfortability. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the decreased in vision, decrease in memory, decrease in hearing, decline in health and hygiene, blurry eyes, temple pain, neck pain, chest pain, oppression, feeling stalked, monitored, traumatized, overwhelmed, exposure to elements, swollen ankles, felt harassed, mental stressed and uncomfortability was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient concerned a female patient (age, race and ethnicity not reported) who experienced the below complaints unspecified time after vaccine. No past medical history was reported. No concomitant medications were reported. The patient filed a complaint in the Court . Federal statutory rights including retaliation, abuse of power, discrimination, and persecution were reported as violated. She listed defendants. Injuries were reported as: decreased in vision, memory, hearing, decline in health and hygiene, blurry eyes, temple pain, neck pain, chest pain, blocked path to housing and food, oppression, feeling stalked, monitored, traumatized, overwhelmed, exposure to elements, swollen ankles, re-worn dirty clothes, harassed, mental stressed, and uncomfortability. A meaningful medical assessment can not be made of this legal case, although the events are unlikely to be related to vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: DECREASED IN VISION; DECREASE IN MEMORY; DECREASE IN HEARING; DECLINE IN HEALTH AND HYGIENE; BLURRY EYES; TEMPLE PAIN; NECK PAIN; CHEST PAIN; OPPRESSION; FEELING STALKED, MONITORED, HARASSED; TRAUMATIZED; OVERWHELMED; EXPOSURE TO ELEMENTS; SWOLLEN ANKLES; MENTAL STRESSED; UNCOMFORTABILITY; This spontaneous report received from a patient concerned a female patient (age, race and ethnicity not reported). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) on an unspecified date for prophylactic vaccination. No concomitant medications were reported.  The patient filed a complaint in the  Court on 20-APR-2021. Federal statutory rights including retaliation, abuse of power, discrimination, and persecution were reported as violated. She listed defendants.  Place of occurrences. Dates of occurrences were between 11-APR-2021 and 16-APR-2021.  Injuries were reported as: decreased in vision, memory, hearing, decline in health and hygiene,  blurry eyes,  temple pain,  neck pain, chest pain,  blocked path to housing and food, oppression, feeling stalked, monitored, traumatized, overwhelmed,  exposure to elements, swollen ankles, re-worn dirty clothes, harassed, mental stressed, and uncomfortability. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the decreased in vision, decrease in memory, decrease in hearing, decline in health and hygiene, blurry eyes, temple pain, neck pain, chest pain, oppression, feeling stalked, monitored, traumatized, overwhelmed, exposure to elements, swollen ankles, felt harassed, mental stressed and uncomfortability was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient concerned a female patient (age, race and ethnicity not reported) who experienced the below complaints unspecified time after vaccine. No past medical history was reported. No concomitant medications were reported. The patient filed a complaint in the Court . Federal statutory rights including retaliation, abuse of power, discrimination, and persecution were reported as violated. She listed defendants. Injuries were reported as: decreased in vision, memory, hearing, decline in health and hygiene, blurry eyes, temple pain, neck pain, chest pain, blocked path to housing and food, oppression, feeling stalked, monitored, traumatized, overwhelmed, exposure to elements, swollen ankles, re-worn dirty clothes, harassed, mental stressed, and uncomfortability. A meaningful medical assessment can not be made of this legal case, although the events are unlikely to be related to vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FEELING UNWELL (A LITTLE BIT UNDER THE WEATHER); This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced feeling unwell (a little bit under the weather). The action taken with covid-19 vaccine  was not applicable. The patient recovered from feeling unwell (a little bit under the weather). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included healthy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total 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 2021, the patient experienced confirmed immunological vaccine failure.  Dr. had provided antibody test 4-6 weeks after receiving the Janssen COVID-19 vaccine of all office staff and immunosuppressed patients. This antibody test named as Quest. Laboratory data (dates unspecified) included: Quest antibody test (NR: not provided) NEGATIVE and showed 0 antibodies (negative test, healthy patient). The patient received the vaccination at the Stadium close to the place where the manufacturing blip occurred. MD told all of these patients to function as if they never got the vaccine at all. He suspected that those people got vaccines that were in prefilled syringes and kept out of the refrigerator for more than 2 hours, thus rendering them useless. He would like a medical director from JnJ to call  him to discuss this and have already called the CDC. According to MD patients who received Pfizer and Moderna produced strong results. Dr. had requested a medical director to reach out to him, directly regarding to those tests.  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: 20210545141-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Dyspnoea exertional, Fatigue
Clinical narrative: HEAD "FEELS LIKE IT IS SWIMMING"; WEAKNESS; FATIGUE; FEELING LIKE PASSED-OUT; ACCELERATION OF BREATHING DURING WALKING OR MOVING; UNSTEADY; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type ii diabetic, and hiatal hernia, and other pre-existing medical conditions included patient had no known allergies. patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included darunavir/cobicistat non-company. On 10-MAY-2021, the subject experienced feeling like passed-out. On 10-MAY-2021, the subject experienced acceleration of breathing during walking or moving. On 10-MAY-2021, the subject experienced unsteady. On 10-MAY-2021, the subject experienced weakness. On 10-MAY-2021, the subject experienced fatigue. On an unspecified date, the subject experienced head "feels like it is swimming". The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from weakness, fatigue, feeling like passed-out, acceleration of breathing during walking or moving, and unsteady, and the outcome of head "feels like it is swimming" was not reported. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort
Clinical narrative: HEAD "FEELS LIKE IT IS SWIMMING"; WEAKNESS; FATIGUE; FEELING LIKE PASSED-OUT; ACCELERATION OF BREATHING DURING WALKING OR MOVING; UNSTEADY; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type ii diabetic, and hiatal hernia, and other pre-existing medical conditions included patient had no known allergies. patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included darunavir/cobicistat non-company. On 10-MAY-2021, the subject experienced feeling like passed-out. On 10-MAY-2021, the subject experienced acceleration of breathing during walking or moving. On 10-MAY-2021, the subject experienced unsteady. On 10-MAY-2021, the subject experienced weakness. On 10-MAY-2021, the subject experienced fatigue. On an unspecified date, the subject experienced head "feels like it is swimming". The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from weakness, fatigue, feeling like passed-out, acceleration of breathing during walking or moving, and unsteady, and the outcome of head "feels like it is swimming" was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 3 DOTS UNDER FOREARM; 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 not reported, batch number: 206821A expiry: UNIKNOWN) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced 3 dots under forearm. The action taken with covid-19 vaccine was not applicable. The outcome of 3 dots under forearm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Seizure
Clinical narrative: SEIZURE (PASSED OUT); WEAK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-May-2021, the patient got the vaccine and passed out, patient had 2 seizures. patient had not eaten much during day so patient might have been weak.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure (passed out) and weak was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: covid-19 vaccine ad26.cov2.s-seizure (passed out). 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: U
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: SWEATING OVERNIGHT; BODY ACHES; CHILLS; HEADACHE; SUDDEN SUPER NAUSEOUS; 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. No concomitant medications were reported.  On an unspecified date, the subject experienced sweating overnight, body aches, chills, headache, and sudden super nauseous. The action taken with covid-19 vaccinewas not applicable. The patient recovered from sweating overnight, body aches, chills, headache, and sudden super nauseous. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: POSSIBLE POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a pharmacist 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 and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced possible poor quality vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of possible poor quality vaccine administered was not reported. This report was non-serious. This report was associated with product quality complaint: 90000180575. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Fibrin D dimer normal, Heart rate irregular, Injection site erythema
Clinical narrative: BLISTERS AT INJECTION SITE; INJECTION SITE ITCHINESS; LOW PLATELET COUNT; PREMATURE VENTRICULAR CONTRACTIONS; MIGRAINE; SWOLLEN ARM; FEELING HOT AT THE INJECTION SITE; CHILLS; FEELING TIRED; REDNESS AT INJECTION SITE; FEELING FEVERISH; FEELING NAUSEOUS; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 145 kilograms, and height was 60 inches. The patient's past medical history included history of four heart attacks, thrombocytopenia, and colon cancer, and concurrent conditions included smoker, and food allergy, and other pre-existing medical conditions included patient is allergic to bees, honey, sulfa, cephalosporins, moderna vaccine, fish, seafood. patient tends to run at 142,000 which was the result when a test was done in march. she stated that previously she did get the moderna vaccine at the end of april and had an anaphylactic reaction. The patient experienced drug allergy when treated with cefaclor, erythromycin, cefalexin, nitrofurantoin, penicillin nos, and azithromycin. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Heartbeats irregular (NR: not provided) not reported, and Platelet count (NR: not provided) 94, 000. On 21-MAY-2021, the subject experienced swollen arm. On 21-MAY-2021, the subject experienced feeling hot at the injection site. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced feeling tired. On 21-MAY-2021, the subject experienced redness at injection site. On 21-MAY-2021, the subject experienced feeling feverish. On 21-MAY-2021, the subject experienced feeling nauseous. On 23-MAY-2021, the subject experienced low platelet count. On 23-MAY-2021, the subject experienced premature ventricular contractions. On 23-MAY-2021, the subject experienced migraine. On 24-MAY-2021, the subject experienced blisters at injection site. On 24-MAY-2021, the subject experienced injection site itchiness. Laboratory data (dates unspecified) included: Fibrin D dimer normal (NR: not provided) 0.5. The action taken with covid-19 vaccine  was not applicable. The patient recovered from premature ventricular contractions, and migraine on 24-MAY-2021, chills, and feeling nauseous on 22-MAY-2021, and feeling tired, and feeling feverish on 23-MAY-2021, and had not recovered from low platelet count, swollen arm, redness at injection site, feeling hot at the injection site, blisters at injection site, and injection site itchiness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site reaction, Injection site vesicles, Migraine, Nausea
Clinical narrative: BLISTERS AT INJECTION SITE; INJECTION SITE ITCHINESS; LOW PLATELET COUNT; PREMATURE VENTRICULAR CONTRACTIONS; MIGRAINE; SWOLLEN ARM; FEELING HOT AT THE INJECTION SITE; CHILLS; FEELING TIRED; REDNESS AT INJECTION SITE; FEELING FEVERISH; FEELING NAUSEOUS; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 145 kilograms, and height was 60 inches. The patient's past medical history included history of four heart attacks, thrombocytopenia, and colon cancer, and concurrent conditions included smoker, and food allergy, and other pre-existing medical conditions included patient is allergic to bees, honey, sulfa, cephalosporins, moderna vaccine, fish, seafood. patient tends to run at 142,000 which was the result when a test was done in march. she stated that previously she did get the moderna vaccine at the end of april and had an anaphylactic reaction. The patient experienced drug allergy when treated with cefaclor, erythromycin, cefalexin, nitrofurantoin, penicillin nos, and azithromycin. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Heartbeats irregular (NR: not provided) not reported, and Platelet count (NR: not provided) 94, 000. On 21-MAY-2021, the subject experienced swollen arm. On 21-MAY-2021, the subject experienced feeling hot at the injection site. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced feeling tired. On 21-MAY-2021, the subject experienced redness at injection site. On 21-MAY-2021, the subject experienced feeling feverish. On 21-MAY-2021, the subject experienced feeling nauseous. On 23-MAY-2021, the subject experienced low platelet count. On 23-MAY-2021, the subject experienced premature ventricular contractions. On 23-MAY-2021, the subject experienced migraine. On 24-MAY-2021, the subject experienced blisters at injection site. On 24-MAY-2021, the subject experienced injection site itchiness. Laboratory data (dates unspecified) included: Fibrin D dimer normal (NR: not provided) 0.5. The action taken with covid-19 vaccine  was not applicable. The patient recovered from premature ventricular contractions, and migraine on 24-MAY-2021, chills, and feeling nauseous on 22-MAY-2021, and feeling tired, and feeling feverish on 23-MAY-2021, and had not recovered from low platelet count, swollen arm, redness at injection site, feeling hot at the injection site, blisters at injection site, and injection site itchiness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Platelet count, Platelet count decreased, Pyrexia, Ventricular extrasystoles
Clinical narrative: BLISTERS AT INJECTION SITE; INJECTION SITE ITCHINESS; LOW PLATELET COUNT; PREMATURE VENTRICULAR CONTRACTIONS; MIGRAINE; SWOLLEN ARM; FEELING HOT AT THE INJECTION SITE; CHILLS; FEELING TIRED; REDNESS AT INJECTION SITE; FEELING FEVERISH; FEELING NAUSEOUS; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight was 145 kilograms, and height was 60 inches. The patient's past medical history included history of four heart attacks, thrombocytopenia, and colon cancer, and concurrent conditions included smoker, and food allergy, and other pre-existing medical conditions included patient is allergic to bees, honey, sulfa, cephalosporins, moderna vaccine, fish, seafood. patient tends to run at 142,000 which was the result when a test was done in march. she stated that previously she did get the moderna vaccine at the end of april and had an anaphylactic reaction. The patient experienced drug allergy when treated with cefaclor, erythromycin, cefalexin, nitrofurantoin, penicillin nos, and azithromycin. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Heartbeats irregular (NR: not provided) not reported, and Platelet count (NR: not provided) 94, 000. On 21-MAY-2021, the subject experienced swollen arm. On 21-MAY-2021, the subject experienced feeling hot at the injection site. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced feeling tired. On 21-MAY-2021, the subject experienced redness at injection site. On 21-MAY-2021, the subject experienced feeling feverish. On 21-MAY-2021, the subject experienced feeling nauseous. On 23-MAY-2021, the subject experienced low platelet count. On 23-MAY-2021, the subject experienced premature ventricular contractions. On 23-MAY-2021, the subject experienced migraine. On 24-MAY-2021, the subject experienced blisters at injection site. On 24-MAY-2021, the subject experienced injection site itchiness. Laboratory data (dates unspecified) included: Fibrin D dimer normal (NR: not provided) 0.5. The action taken with covid-19 vaccine  was not applicable. The patient recovered from premature ventricular contractions, and migraine on 24-MAY-2021, chills, and feeling nauseous on 22-MAY-2021, and feeling tired, and feeling feverish on 23-MAY-2021, and had not recovered from low platelet count, swollen arm, redness at injection site, feeling hot at the injection site, blisters at injection site, and injection site itchiness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Feeling abnormal, Headache, Insomnia
Clinical narrative: BODY ACHES; COLD SWEATS; COULD NOT SLEEP; FELT BAD; CHILLS; DEBILITATING 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, start therapy date were not reported for prophylactic vaccination. 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, cold sweats, could not sleep, felt bad, chills, and debilitating headache. The action taken with covid-19 vaccine was not applicable. The outcome of the chills, cold sweats, body aches, debilitating headache, could not sleep and felt bad was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY ACHES; COLD SWEATS; COULD NOT SLEEP; FELT BAD; CHILLS; DEBILITATING 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, start therapy date were not reported for prophylactic vaccination. 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, cold sweats, could not sleep, felt bad, chills, and debilitating headache. The action taken with covid-19 vaccine was not applicable. The outcome of the chills, cold sweats, body aches, debilitating headache, could not sleep and felt bad was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Gingival pain, Headache, Stomatitis
Clinical narrative: GUM SORES; MOUTH SORES; SEVERAL DAYS OF BAD HEADACHES; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (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 gum sores, mouth sores, and several days of bad headaches. The action taken with covid-19 vaccine was not applicable. The outcome of the several days of bad headaches, gum sores and mouth sores was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Injection site swelling, Photophobia, Swelling
Clinical narrative: MODERATE SWELLING AROUND FACE; EXHAUSTION; SWELLING AROUND INJECTION SITE; EYES HURT REALLY BAD; SWOLLEN EYELIDS; SWELLING ALL OVER BODY FROM HEAD TO TOE; LIGHT SENSITIVITY WHEN EXPOSED TO DIRECT SUN LIGHT; BLURRY VISION  WHEN EXPOSED TO DIRECT SUN LIGHT; 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced swelling all over body from head to toe. On 21-MAY-2021, the subject experienced light sensitivity when exposed to direct sun light. On 21-MAY-2021, the subject experienced blurry vision when exposed to direct sun light. On 23-MAY-2021, the subject experienced eyes hurt really bad. On 23-MAY-2021, the subject experienced swollen eyelids. On 24-MAY-2021, the subject experienced moderate swelling around face. On 24-MAY-2021, the subject experienced exhaustion. On 24-MAY-2021, the subject experienced swelling around injection site. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from swelling all over body from head to toe, and blurry vision when exposed to direct sun light on 23-MAY-2021, was recovering from light sensitivity when exposed to direct sun light, had not recovered from exhaustion, swelling around injection site, and moderate swelling around face, and the outcome of swollen eyelids and eyes hurt really bad was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Swelling face, Swelling of eyelid, Vision blurred
Clinical narrative: MODERATE SWELLING AROUND FACE; EXHAUSTION; SWELLING AROUND INJECTION SITE; EYES HURT REALLY BAD; SWOLLEN EYELIDS; SWELLING ALL OVER BODY FROM HEAD TO TOE; LIGHT SENSITIVITY WHEN EXPOSED TO DIRECT SUN LIGHT; BLURRY VISION  WHEN EXPOSED TO DIRECT SUN LIGHT; 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced swelling all over body from head to toe. On 21-MAY-2021, the subject experienced light sensitivity when exposed to direct sun light. On 21-MAY-2021, the subject experienced blurry vision when exposed to direct sun light. On 23-MAY-2021, the subject experienced eyes hurt really bad. On 23-MAY-2021, the subject experienced swollen eyelids. On 24-MAY-2021, the subject experienced moderate swelling around face. On 24-MAY-2021, the subject experienced exhaustion. On 24-MAY-2021, the subject experienced swelling around injection site. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from swelling all over body from head to toe, and blurry vision when exposed to direct sun light on 23-MAY-2021, was recovering from light sensitivity when exposed to direct sun light, had not recovered from exhaustion, swelling around injection site, and moderate swelling around face, and the outcome of swollen eyelids and eyes hurt really bad was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: PATIENT RECEIVED EXPIRED AND BEYOND USE VACCINE; VACCINE WAS STORED IN FRIDGE FOR 24 HOURS (VIAL PUNCTURED 24 HOURS PRIOR TO GIVING VACCINE); This spontaneous report received from a pharmacist 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: 1808986, expiry: 20-MAY-2021) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-MAY-2021, the subject experienced subject received expired and beyond use vaccine. On 21-MAY-2021, the subject experienced vaccine was stored in fridge for 24 hours (vial punctured 24 hours prior to giving vaccine). The action taken with covid-19 vaccine  was not applicable. The outcome of the patient received expired and beyond use vaccine and vaccine was stored in fridge for 24 hours (vial punctured 24 hours prior to giving vaccine) was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tremor
Clinical narrative: SHAKING; MILD HEADACHE; This spontaneous report received from a consumer concerned a 53 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced shaking. On 2021, the subject experienced mild headache. The action taken with covid-19 vaccine  mild headache on 2021. This report was non-serious.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product use issue
Clinical narrative: 13 YO MALE PATIENT GOT THE  VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 13 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25/MAY/2021) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced 13 yo male subject got the vaccine. On 22-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 13 yo male patient got the vaccine and off label use was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vision blurred
Clinical narrative: BLURRED VISION; HEADACHE; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, non alcohol user, sensitive to latex, and bees venom, and other pre-existing medical conditions included the patient had no illicit drug use. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203a21a, expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced blurred vision. On 23-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from blurred vision, and headache. This report was non-serious. This report was associated with product quality complaint: 90000180537 The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/ investigation performed.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE WAS ADMINISTERED  MORE THAN 6 HOURS FROM VIAL  PUNCTURE IN THE FRIDGE; This spontaneous report received from a pharmacist concerned a 31 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.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 24-MAY-2021 09:45 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced vaccine was administered more than 6 hours from puncture in the fridge. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was administered more than 6 hours from puncture in the fridge was not reported. This report was non-serious. This case, from the same reporter is linked to 20210547709.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: TERRIBLE ACHES; FELT ROPEY; FEVER FROM HELL; 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced terrible aches, feeling ropey, and fever from hell. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from feeling ropey, and the outcome of terrible aches and fever from hell was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LEFT ARM SORENESS; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced left arm soreness. The action taken with covid-19 vaccine was not applicable. The outcome of left arm soreness was not reported. This report was non-serious. This case involving the same patient is linked to 20201252495.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; 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 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 or lot numbers  No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine  was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210548212 and 20210548262.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mobility decreased, Muscle spasms, Muscle tightness, Neck pain
Clinical narrative: TRAP MUSCLE AND NECK MUSCLES LOCKED UP; MUSCLE CRAMPS; COULDN'T MOVE NECK AND NOT EVEN ABLE TO LIFT UP ARM; NECK PAIN OFF AND ON; SORE ARM; SEVERE HEADACHE/ OFF AND ON HEADACHE; 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, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced neck pain off and on. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced severe headache/ off and on headache. On 25-MAR-2021, the subject experienced trap muscle and neck muscles locked up. On 25-MAR-2021, the subject experienced muscle cramps. On 25-MAR-2021, the subject experienced couldn't move neck and not even able to lift up arm. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and severe headache/ off and on headache on APR-2021, and had not recovered from trap muscle and neck muscles locked up, muscle cramps, couldn't move neck and not even able to lift up arm, and neck pain off and on. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: TRAP MUSCLE AND NECK MUSCLES LOCKED UP; MUSCLE CRAMPS; COULDN'T MOVE NECK AND NOT EVEN ABLE TO LIFT UP ARM; NECK PAIN OFF AND ON; SORE ARM; SEVERE HEADACHE/ OFF AND ON HEADACHE; 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, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced neck pain off and on. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced severe headache/ off and on headache. On 25-MAR-2021, the subject experienced trap muscle and neck muscles locked up. On 25-MAR-2021, the subject experienced muscle cramps. On 25-MAR-2021, the subject experienced couldn't move neck and not even able to lift up arm. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and severe headache/ off and on headache on APR-2021, and had not recovered from trap muscle and neck muscles locked up, muscle cramps, couldn't move neck and not even able to lift up arm, and neck pain off and on. This report was non-serious.