chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a 29 year old male patient / inadvertently received the Shingrix vaccine; patient inadvertently received the Shingrix vaccine, the intended vaccine was the Moderna Covid-19; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 29-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th June 2021, the patient received Shingrix. On 15th June 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.  Additional details were provided as follows: The pharmacist reported that, the 29 year old male patient inadvertently received the Shingrix vaccine, the intended vaccine was the Moderna Covid-19, which led to inappropriate age at vaccine administration and wrong vaccine administered. No further information was reported.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administrated with and expired dose / vaccine expired on March 5 2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received HBV (Engerix B) (batch number unknown, expiry date 5th March 2021) for prophylaxis.   On 15th June 2021, the patient received Engerix B. On 15th June 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The physician assistance reported that, the patient received expired dose of Engerix B, which led to expired vaccine used No adverse event was reported .  The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose of Shingrix / second dose six weeks after that.; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 63-year-old patient who received Herpes zoster (Shingrix) (batch number DS754, expiry date 18th December 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, less than the recommended interval, which led to shortening of vaccination schedule. The patient received 2nd dose 6 weeks after the 1st dose. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Rash, Swelling, Tenderness
Clinical narrative: swelling; rash; redness; tenderness; pain; This case was reported by a physician via call center representative and described the occurrence of swelling in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 20th May 2021, less than a day after receiving Shingrix, the patient experienced swelling, rash, erythema, tenderness and pain. On an unknown date, the outcome of the swelling, rash, erythema, tenderness and pain were recovered/resolved.   It was unknown if the reporter considered the swelling, rash, erythema, tenderness and pain to be related to Shingrix.  Additional details were provided as follows: The patient received first Shingrix shot and experienced swelling, rash, redness, tenderness, pain of which have now resolved.   The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose 1 of shingrix in 2019 never got the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No other details of patient / vaccine/ health care professional was provided. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On 11Mar2018/ received the first dose/ 20Oct2019/ receive the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th March 2018).   On 20th October 2019, the patient received the 2nd dose of Shingrix. On 20th October 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received second dose of Shingrix exceeding the recommending dosing schedule, which led to lengthening of vaccine schedule. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix on 2019 / has not received the second dose yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consent to follow up.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Feeling of body temperature change, Hyperhidrosis, Pain
Clinical narrative: SHAKING; CAN NOT STAND; DIZZY; SWEATING; HOT AND COLD; PAIN ALL IN BODY; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight was 200 pounds, and height was not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced shaking. On 05-JUN-2021, the subject experienced can not stand. On 05-JUN-2021, the subject experienced dizzy. On 05-JUN-2021, the subject experienced sweating. On 05-JUN-2021, the subject experienced hot and cold. On 05-JUN-2021, the subject experienced pain all in body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking, can not stand, dizzy, sweating, hot and cold, and pain all in body. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: SHAKING; CAN NOT STAND; DIZZY; SWEATING; HOT AND COLD; PAIN ALL IN BODY; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight was 200 pounds, and height was not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced shaking. On 05-JUN-2021, the subject experienced can not stand. On 05-JUN-2021, the subject experienced dizzy. On 05-JUN-2021, the subject experienced sweating. On 05-JUN-2021, the subject experienced hot and cold. On 05-JUN-2021, the subject experienced pain all in body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking, can not stand, dizzy, sweating, hot and cold, and pain all in body. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Haematocrit, Haematocrit abnormal, Haemoglobin, Haemoglobin abnormal
Clinical narrative: PLATELET COUNT INCREASED; MIGRAINE; RED BLOOD CELL COUNT ABNORMAL; HAEMOGLOBIN ABNORMAL; HAEMATOCRIT ABNORMAL; MALAISE; FATIGUE; This spontaneous report received from a physician concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included polycythaemia vera. The patient was previously treated with hydroxycarbamide for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: ruxolitinib phosphate (tablet, oral, batch number was not reported) 10 mg, 2 times every 1 day, therapy dates were not reported, for polycythaemia vera. Concomitant medications included acetylsalicylic acid, ascorbic acid, oenothera biennis oil, sulfamethoxazole/trimethoprim, topiramate, and vitamin e nos.  On an unspecified date, the platelets went to a critical level/had 800 000/uL platelets/platelets levels so high/ platelets went up/ platelets have been all over the map/ went up in to the 800s/plateIets going up (Platelet count increased). The patient was not feeling well (Malaise), Migraine headaches/ having migraines more often (Migraine), some issues with her red blood counts levels/ RBC 12/8 4.04, 1/5/21 4.15, 2117/21 4.34/4/20/21 4.40 (Red blood cell count abnormal), H/H 12/8 12.3/36.7, 115/21 12.1/36.9, 2/17/21 12.8/39.6 (Haemoglobin abnormal), I-UH 12/8 12.3/36.7, 1/5/21 12.1/36.9, 2/17/21 12.8/39.6 (Haematocrit abnormal). The patient had been feeling a little bit more tired (Fatigue) coincident with Jakafi (ruxolitinib). The reporting physician considered the events platelet count increased, malaise, migraine, and red blood cell count abnormal as not related to Jakafi. The events were considered related to stopping Hydroxyurea suddenly instead of weaning off while starting Jakafi. The units were not provided for all laboratory values.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ruxolitinib phosphate was not changed. The patient had not recovered from platelet count increased, migraine, and fatigue, and the outcome of malaise, red blood cell count abnormal, haemoglobin abnormal and haematocrit abnormal was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210617549-COVID-19 VACCINE AD26.COV2.S- Platelet count increased. 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise, Migraine, Platelet count, Platelet count increased, Red blood cell count
Clinical narrative: PLATELET COUNT INCREASED; MIGRAINE; RED BLOOD CELL COUNT ABNORMAL; HAEMOGLOBIN ABNORMAL; HAEMATOCRIT ABNORMAL; MALAISE; FATIGUE; This spontaneous report received from a physician concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included polycythaemia vera. The patient was previously treated with hydroxycarbamide for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: ruxolitinib phosphate (tablet, oral, batch number was not reported) 10 mg, 2 times every 1 day, therapy dates were not reported, for polycythaemia vera. Concomitant medications included acetylsalicylic acid, ascorbic acid, oenothera biennis oil, sulfamethoxazole/trimethoprim, topiramate, and vitamin e nos.  On an unspecified date, the platelets went to a critical level/had 800 000/uL platelets/platelets levels so high/ platelets went up/ platelets have been all over the map/ went up in to the 800s/plateIets going up (Platelet count increased). The patient was not feeling well (Malaise), Migraine headaches/ having migraines more often (Migraine), some issues with her red blood counts levels/ RBC 12/8 4.04, 1/5/21 4.15, 2117/21 4.34/4/20/21 4.40 (Red blood cell count abnormal), H/H 12/8 12.3/36.7, 115/21 12.1/36.9, 2/17/21 12.8/39.6 (Haemoglobin abnormal), I-UH 12/8 12.3/36.7, 1/5/21 12.1/36.9, 2/17/21 12.8/39.6 (Haematocrit abnormal). The patient had been feeling a little bit more tired (Fatigue) coincident with Jakafi (ruxolitinib). The reporting physician considered the events platelet count increased, malaise, migraine, and red blood cell count abnormal as not related to Jakafi. The events were considered related to stopping Hydroxyurea suddenly instead of weaning off while starting Jakafi. The units were not provided for all laboratory values.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ruxolitinib phosphate was not changed. The patient had not recovered from platelet count increased, migraine, and fatigue, and the outcome of malaise, red blood cell count abnormal, haemoglobin abnormal and haematocrit abnormal was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210617549-COVID-19 VACCINE AD26.COV2.S- Platelet count increased. 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Red blood cell count abnormal
Clinical narrative: PLATELET COUNT INCREASED; MIGRAINE; RED BLOOD CELL COUNT ABNORMAL; HAEMOGLOBIN ABNORMAL; HAEMATOCRIT ABNORMAL; MALAISE; FATIGUE; This spontaneous report received from a physician concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included polycythaemia vera. The patient was previously treated with hydroxycarbamide for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: ruxolitinib phosphate (tablet, oral, batch number was not reported) 10 mg, 2 times every 1 day, therapy dates were not reported, for polycythaemia vera. Concomitant medications included acetylsalicylic acid, ascorbic acid, oenothera biennis oil, sulfamethoxazole/trimethoprim, topiramate, and vitamin e nos.  On an unspecified date, the platelets went to a critical level/had 800 000/uL platelets/platelets levels so high/ platelets went up/ platelets have been all over the map/ went up in to the 800s/plateIets going up (Platelet count increased). The patient was not feeling well (Malaise), Migraine headaches/ having migraines more often (Migraine), some issues with her red blood counts levels/ RBC 12/8 4.04, 1/5/21 4.15, 2117/21 4.34/4/20/21 4.40 (Red blood cell count abnormal), H/H 12/8 12.3/36.7, 115/21 12.1/36.9, 2/17/21 12.8/39.6 (Haemoglobin abnormal), I-UH 12/8 12.3/36.7, 1/5/21 12.1/36.9, 2/17/21 12.8/39.6 (Haematocrit abnormal). The patient had been feeling a little bit more tired (Fatigue) coincident with Jakafi (ruxolitinib). The reporting physician considered the events platelet count increased, malaise, migraine, and red blood cell count abnormal as not related to Jakafi. The events were considered related to stopping Hydroxyurea suddenly instead of weaning off while starting Jakafi. The units were not provided for all laboratory values.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ruxolitinib phosphate was not changed. The patient had not recovered from platelet count increased, migraine, and fatigue, and the outcome of malaise, red blood cell count abnormal, haemoglobin abnormal and haematocrit abnormal was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210617549-COVID-19 VACCINE AD26.COV2.S- Platelet count increased. 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.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE TO ONE PATIENT; LEFT LONGER THAN 2 HOURS OUTSIDE THE FRIDGE; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-JUN-2021, the subject experienced administration of expired vaccine to one subject. On 01-JUN-2021, the subject experienced left longer than 2 hours outside the fridge. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine to one patient and left longer than 2 hours outside the fridge was not reported. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Heart rate, Heart rate irregular
Clinical narrative: ERRATIC HEARTBEAT AND PULSE, PULSE RATE VARIED; LOOSE BOWELS LIKE WATER, DIARRHEA; TIRED; This spontaneous report received from a consumer concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included loose bowels. Patient had no gallbladder and no known allergies The patient received covid-19 vaccine ad26.cov2.s by 2 paramedics (suspension for injection, route of admin not reported, batch number: 20SA61A and expiry: Unknown) dose was not reported, 1 total administered on 18-MAY-2021 14:00 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021 (after the vaccination), the patient felt tired. Patient always had loose bowels, now on 26-MAY-2021, the patient could not make it to the toilet, diarrhea and it came out like water. This had been ongoing for two weeks. On 08-JUN-2021, the patient had erratic heartbeat and on the same day at 12:45 pulse rate had been varied (erratic pulse). Patient could not keep anything in her. It was reported that nurse was in last week and informed loose bowels could be probably due to food. Patient did not had any medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 20-MAY-2021, and had not recovered from erratic heartbeat and pulse, pulse rate varied, and loose bowels like water, diarrhea. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood pressure measurement, Dizziness, Gait disturbance, Hypotension
Clinical narrative: NEEDING TO HOLD ON TO THE WALL WHEN WALKED; BLOOD PRESSURE WAS LOW AT FIRST; FELT FAINT/DIZZY; 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 concurrent conditions included allergies to bees, and other pre-existing medical conditions included the first symptom patient had as a rare allergic reaction was an intense headache. The patient felt numbness in lips and it spread, symmetrically from the center. The tip of tongue began growing numb. The patient felt some swelling in mouth. That slow ramp up was not typical of an allergic response, but it was precisely what happened the last time the patient was stung by an itsy bitsy baby bee hiding in a bushel of plums and the patient was in the emergency room. The patient experienced rare allergic reaction when treated with bnt 162 for drug used for unknown indication, and terrifying side effects when treated with tetanus vaccine for drug used for unknown indication. The patient received benadryl unspecified (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported 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, 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 needing to hold on to the wall when walked, blood pressure was low at first, and felt faint/dizzy. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with benadryl unspecified was not reported. The outcome of the blood pressure was low at first, felt faint/dizzy and needing to hold on to the wall when walked was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: GOT AN ENERGY BOOST FROM THE SHOT; This spontaneous report received from a patient concerned an 8 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fatigue.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 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 got an energy boost from the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got an energy boost from the shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20210621123.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a health care professional concerned a 4 decade old female of unknown race and ethnicity. The patient's height, and weight were not reported.  The patient's concurrent conditions included multiple medical issues.  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 an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had a negative antibody test, suspected immunological vaccination failure. It was reported that patient felt that the medical personnel during the vaccine clinic might have administered a partial dose to the patient possibly due to a drop of liquid coming out during administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with PQC number: 90000182451 The suspected product quality complaint has been confirmed to be void does not apply to this PQC error based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210622043-covid-19 vaccine ad26.cov2.s-suspected immunological vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Tonsillar hypertrophy
Clinical narrative: SWELLING IN BACK OF THROAT; SWELLING AROUND TONSILS; 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 07-JUN-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 10-JUN-2021, the subject experienced swelling in back of throat. On 10-JUN-2021, the subject experienced swelling around tonsils. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling in back of throat and swelling around tonsils was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Injection site pain, Insomnia, Nausea
Clinical narrative: VOMITING; BODY ACHES WHICH FELT LIKE AFTER A VERY HARD WORKOUT; PAIN IN STOMACH LIKE CRAMPING; HEART POUNDING IT FELT LIKE BLOOD RUSHING THROUGH THE  BODY VERY QUICKLY; UNABLE TO SLEEP; HEADACHE ALL THE TOP OF THE HEAD; NAUSEA; ARM HURTS WHEN IT MOVES; SORE ARM IN INJECTION SITE AREA THAT IS CANNOT BE TOUCHED OR LAY ON IT; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient has not had covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-JUN-2021, the subject experienced arm hurts when it moves. On 08-JUN-2021, the subject experienced sore arm in injection site area that is cannot be touched or lay on it. On 08-JUN-2021, the subject experienced nausea. Laboratory data included: Pain scale (NR: not provided) 6. On 09-JUN-2021, the subject experienced vomiting. On 09-JUN-2021, the subject experienced body aches which felt like after a very hard workout. On 09-JUN-2021, the subject experienced pain in stomach like cramping. On 09-JUN-2021, the subject experienced heart pounding it felt like blood rushing through the body very quickly. On 09-JUN-2021, the subject experienced unable to sleep. On 09-JUN-2021, the subject experienced headache all the top of the head. Laboratory data included: Pain scale (NR: not provided) 6-7. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative.  Treatment medications (dates unspecified) included: ondansetron, acetylsalicylic acid/caffeine/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm in injection site area that is cannot be touched or lay on it, nausea, vomiting, body aches which felt like after a very hard workout, pain in stomach like cramping, heart pounding it felt like blood rushing through the body very quickly, unable to sleep, and headache all the top of the head, and the outcome of arm hurts when it moves was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain assessment, Pain in extremity, Palpitations, SARS-CoV-2 test
Clinical narrative: VOMITING; BODY ACHES WHICH FELT LIKE AFTER A VERY HARD WORKOUT; PAIN IN STOMACH LIKE CRAMPING; HEART POUNDING IT FELT LIKE BLOOD RUSHING THROUGH THE  BODY VERY QUICKLY; UNABLE TO SLEEP; HEADACHE ALL THE TOP OF THE HEAD; NAUSEA; ARM HURTS WHEN IT MOVES; SORE ARM IN INJECTION SITE AREA THAT IS CANNOT BE TOUCHED OR LAY ON IT; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient has not had covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-JUN-2021, the subject experienced arm hurts when it moves. On 08-JUN-2021, the subject experienced sore arm in injection site area that is cannot be touched or lay on it. On 08-JUN-2021, the subject experienced nausea. Laboratory data included: Pain scale (NR: not provided) 6. On 09-JUN-2021, the subject experienced vomiting. On 09-JUN-2021, the subject experienced body aches which felt like after a very hard workout. On 09-JUN-2021, the subject experienced pain in stomach like cramping. On 09-JUN-2021, the subject experienced heart pounding it felt like blood rushing through the body very quickly. On 09-JUN-2021, the subject experienced unable to sleep. On 09-JUN-2021, the subject experienced headache all the top of the head. Laboratory data included: Pain scale (NR: not provided) 6-7. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative.  Treatment medications (dates unspecified) included: ondansetron, acetylsalicylic acid/caffeine/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm in injection site area that is cannot be touched or lay on it, nausea, vomiting, body aches which felt like after a very hard workout, pain in stomach like cramping, heart pounding it felt like blood rushing through the body very quickly, unable to sleep, and headache all the top of the head, and the outcome of arm hurts when it moves was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; BODY ACHES WHICH FELT LIKE AFTER A VERY HARD WORKOUT; PAIN IN STOMACH LIKE CRAMPING; HEART POUNDING IT FELT LIKE BLOOD RUSHING THROUGH THE  BODY VERY QUICKLY; UNABLE TO SLEEP; HEADACHE ALL THE TOP OF THE HEAD; NAUSEA; ARM HURTS WHEN IT MOVES; SORE ARM IN INJECTION SITE AREA THAT IS CANNOT BE TOUCHED OR LAY ON IT; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient has not had covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-JUN-2021, the subject experienced arm hurts when it moves. On 08-JUN-2021, the subject experienced sore arm in injection site area that is cannot be touched or lay on it. On 08-JUN-2021, the subject experienced nausea. Laboratory data included: Pain scale (NR: not provided) 6. On 09-JUN-2021, the subject experienced vomiting. On 09-JUN-2021, the subject experienced body aches which felt like after a very hard workout. On 09-JUN-2021, the subject experienced pain in stomach like cramping. On 09-JUN-2021, the subject experienced heart pounding it felt like blood rushing through the body very quickly. On 09-JUN-2021, the subject experienced unable to sleep. On 09-JUN-2021, the subject experienced headache all the top of the head. Laboratory data included: Pain scale (NR: not provided) 6-7. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative.  Treatment medications (dates unspecified) included: ondansetron, acetylsalicylic acid/caffeine/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm in injection site area that is cannot be touched or lay on it, nausea, vomiting, body aches which felt like after a very hard workout, pain in stomach like cramping, heart pounding it felt like blood rushing through the body very quickly, unable to sleep, and headache all the top of the head, and the outcome of arm hurts when it moves was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Muscle twitching
Clinical narrative: MIGRAINE HEADACHES; TWITCHING OF FACE; This spontaneous report received from a patient via a company representative concerned a 21 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 migraine headaches, and twitching of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine headaches and twitching of face was not reported. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pain in extremity
Clinical narrative: HUGE BLISTERS ALL OVER TOES AND FEET; FEET HURTING; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included elevated heart rate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. Concomitant medications included losartan for elevated heart rate, and metoprolol for elevated heart rate. On 05-JUN-2021, the subject experienced feet hurting. On 06-JUN-2021, the subject experienced huge blisters all over toes and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feet hurting, and huge blisters all over toes and feet. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: LUMP AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included none, and other 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: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced lump at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump at site of injection. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Injection site pain, Injection site pruritus, Neuralgia
Clinical narrative: NEUROLOGICAL PAIN; SHINGLES; INJECTION SITE ITCHING; LEFT SIDE INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy, oak allergy, and sumac allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A121A, expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced left side injection site pain. On 01-JUN-2021, the subject experienced injection site itching. On 02-JUN-2021, the subject experienced shingles. On an unspecified date, the subject experienced neurological pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left side injection site pain on 22-MAY-2021, had not recovered from shingles, and injection site itching, and the outcome of neurological pain was not reported. This report was non-serious.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Gait inability, Hypertension, Illness, Malaise
Clinical narrative: HIGH BLOOD PRESSURE; COULDN'T WALK; COULDN'T DO ANYTHING; SO SICK; NOT FEELING WELL; VERTIGO; VOMITING; NAUSEA; This spontaneous report received from a patient concerned a 96 year old female. The patient's weight was 128 pounds, and height was not reported. The patient's concurrent conditions included arthritis, neuropathy, thyroid issue, non smoker, non alcohol user, diabetes, and cannot walk without a walker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced vomiting. On MAR-2021, the subject experienced nausea. On 31-MAR-2021, the subject experienced vertigo. On an unspecified date, the subject experienced high blood pressure, couldn't walk, couldn't do anything, so sick, and not feeling well. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 200 over something. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vertigo, high blood pressure, not feeling well, couldn't walk, couldn't do anything, and so sick, and the outcome of nausea and vomiting was not reported. This report was non-serious.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Unevaluable event, Vertigo, Vomiting
Clinical narrative: HIGH BLOOD PRESSURE; COULDN'T WALK; COULDN'T DO ANYTHING; SO SICK; NOT FEELING WELL; VERTIGO; VOMITING; NAUSEA; This spontaneous report received from a patient concerned a 96 year old female. The patient's weight was 128 pounds, and height was not reported. The patient's concurrent conditions included arthritis, neuropathy, thyroid issue, non smoker, non alcohol user, diabetes, and cannot walk without a walker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced vomiting. On MAR-2021, the subject experienced nausea. On 31-MAR-2021, the subject experienced vertigo. On an unspecified date, the subject experienced high blood pressure, couldn't walk, couldn't do anything, so sick, and not feeling well. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 200 over something. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vertigo, high blood pressure, not feeling well, couldn't walk, couldn't do anything, and so sick, and the outcome of nausea and vomiting was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Decreased appetite, Dizziness
Clinical narrative: This spontaneous report received from a patient concerned a patient of unspecified age and sex.The patient's height, and weight were not reported. The patient's concurrent conditions included graves disease, and issue with heart. 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 09-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced loss of appetite. On JUN-2021, the subject experienced dizzy. On JUN-2021, the subject experienced weak. On 11-JUN-2021, the subject experienced chest feels tight. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of appetite, dizzy, weak and chest feels tight was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. 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 headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210624187.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included stent placement, and concurrent conditions included diabetic. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced swelling of left ankle. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of left ankle. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: 101 FEVER; HEADACHE; MUSCLE ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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 101 fever, headache, and muscle aches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 101 fever, headache and muscle aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Thyroiditis
Clinical narrative: THYROIDITIS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-MAY-2021 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 thyroiditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thyroiditis. 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, UNK
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This solicited report received from a consumer via PPSCVM000808: Janssen CarePath for XARELTO concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient was treated with rivaroxaban (film-coated tablet, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported,  1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced blood clots and not sure what was causing it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with rivaroxaban was not reported. The outcome of blood clots was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clots was not related; and between rivaroxaban, and blood clots was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210627971- covid-19 vaccine ad26.cov2.s-Blood Clots-This event is considered un-assessable. This event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.