chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Bradykinesia, Feeling abnormal, Joint stiffness
Clinical narrative: increased pain in RA flareups; Brainfog; anxiety; sleep deprivation; shortness of memory; stiff and burning sensation in joints; stiff and burning sensation in joints; mouth sores; moving slower much slower; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955), first dose via an unspecified route of administration, administered in Arm Left on 20Mar2021 (reported as 10:30) (at the age of 59 years old, not pregnant), single dose for covid-19 immunization. Medical history included rheumatoid arthritis, fibromyalgia, known allergies: Sulfa and tetracycline, from an unknown date. Concomitant medications included hydroxychloroquine; indometacin sodium (INDOCIN); methotrexate. On 20Mar2021, patient experienced Brainfog, anxiety, sleep deprivation, shortness of memory, increased pain in RA flareups, stiff and burning sensation in joints, mouth sores,moving slower much slower. The outcome of the events was not recovered. No treatment for the adverse events. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information related to batch/Lot no. was requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Rheumatoid arthritis, Sleep deficit, Stomatitis
Clinical narrative: increased pain in RA flareups; Brainfog; anxiety; sleep deprivation; shortness of memory; stiff and burning sensation in joints; stiff and burning sensation in joints; mouth sores; moving slower much slower; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955), first dose via an unspecified route of administration, administered in Arm Left on 20Mar2021 (reported as 10:30) (at the age of 59 years old, not pregnant), single dose for covid-19 immunization. Medical history included rheumatoid arthritis, fibromyalgia, known allergies: Sulfa and tetracycline, from an unknown date. Concomitant medications included hydroxychloroquine; indometacin sodium (INDOCIN); methotrexate. On 20Mar2021, patient experienced Brainfog, anxiety, sleep deprivation, shortness of memory, increased pain in RA flareups, stiff and burning sensation in joints, mouth sores,moving slower much slower. The outcome of the events was not recovered. No treatment for the adverse events. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information related to batch/Lot no. was requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Disorganised speech, Dizziness, Feeling cold, Headache
Clinical narrative: Body Tremors/tremors get worse when I feel cold; dizziness; headaches; balance issue; tremors get worse when I feel cold; I blurt out words for no reason; Eyes can't focus, when trying to read the words seem to be shaking; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm right on 11Jan2021 (Batch/Lot Number: EH9899) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 21Dec2020 (lot number: EH9899) for covid-19 immunisation. The patient experienced body tremors, dizziness, headaches, balance issue, tremors get worse when she feel cold, she blurt out words for no reason, eyes can't focus, when trying to read the words seem to be shaking on 18Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Dec2020, sars-cov-2 test: negative on 27Feb2021. There were no treatment received for the events. The patient did not recover from the events.; Sender's Comments: Based on the available information, causality between reported events and BNT162B2  (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor, Vision blurred
Clinical narrative: Body Tremors/tremors get worse when I feel cold; dizziness; headaches; balance issue; tremors get worse when I feel cold; I blurt out words for no reason; Eyes can't focus, when trying to read the words seem to be shaking; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm right on 11Jan2021 (Batch/Lot Number: EH9899) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 21Dec2020 (lot number: EH9899) for covid-19 immunisation. The patient experienced body tremors, dizziness, headaches, balance issue, tremors get worse when she feel cold, she blurt out words for no reason, eyes can't focus, when trying to read the words seem to be shaking on 18Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Dec2020, sars-cov-2 test: negative on 27Feb2021. There were no treatment received for the events. The patient did not recover from the events.; Sender's Comments: Based on the available information, causality between reported events and BNT162B2  (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Dizziness postural, Fall, Loss of consciousness, Seizure
Clinical narrative: Unconscious; Stood up and became very dizzy; Fell to the floor; Legs and arms were seizing; Legs and arms were seizing; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0150), via an unspecified route of administration, on 02Apr2021, at a single dose, for COVID-19 immunization. The patient's medical history included seizures (but they are rare). The patient had unspecified concomitant medications. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 03Apr2021 at 10:30 AM, the patient stood up and became very dizzy, she fell to the floor and was unconscious. When she came to a few moments after (unknown time), her legs and arms were seizing. The patient did have a history with seizures, but they are rare. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.
Sex: F
Vaccine: PPV
Symptoms: Induration, Injection site erythema, Injection site swelling, Peripheral swelling, Pruritus
Clinical narrative: Her arm was warm; Her arm was warm and had a knot; her arm started itching; the injection site was as big as a saucer and red and swollen and puffy; her left arm swelled up/injection site was as big as a saucer and reda nd swollen and puffy.; This spontaneous report was received from a currently 67-year-old Caucasian female patient referring to herself via Pfizer. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (reported as pneumonia vaccine) into an unspecified arm (exact dose, route of administration, lot # and expiration date were not provided) for prophylaxis.   On an unknown date, 10 days after the vaccination, her left arm swelled up, started itching and she was not scratching it. Her arm was warm and had a knot. She went to the bathroom to look at her arm and the injection site was as big as a saucer and red and swollen and puffy. She did not have a fever though. She called the pharmacy where she got the vaccine and spoke to the pharmacist about it and the pharmacist told her it was unusual to have a reaction 10 days after the pneumonia vaccine. The outcome of the events was not reported.  The relatedness between the events and the suspect vaccine was not provided.
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Her arm was warm; Her arm was warm and had a knot; her arm started itching; the injection site was as big as a saucer and red and swollen and puffy; her left arm swelled up/injection site was as big as a saucer and reda nd swollen and puffy.; This spontaneous report was received from a currently 67-year-old Caucasian female patient referring to herself via Pfizer. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (reported as pneumonia vaccine) into an unspecified arm (exact dose, route of administration, lot # and expiration date were not provided) for prophylaxis.   On an unknown date, 10 days after the vaccination, her left arm swelled up, started itching and she was not scratching it. Her arm was warm and had a knot. She went to the bathroom to look at her arm and the injection site was as big as a saucer and red and swollen and puffy. She did not have a fever though. She called the pharmacy where she got the vaccine and spoke to the pharmacist about it and the pharmacist told her it was unusual to have a reaction 10 days after the pneumonia vaccine. The outcome of the events was not reported.  The relatedness between the events and the suspect vaccine was not provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes virus infection, Injection site rash
Clinical narrative: breaking out with herpes again; a rash on my arm where I got the shot; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's concurrent conditions included herpes. Concomitant medications were not reported.  On an unknown date in 2006, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. It was reported that zoster vaccine live (ZOSTAVAX) "worked great" for the patient. On and unknown date, reported as "recently", the patient received zoster rge vaccine (mammalian) (SHINGRIX) into an arm (dose, route of administration, lot # and expiration date were not reported), because she "needed a booster".   On an unknown date, reported as "after a while", the patient started breaking out with herpes again and she had a rash on her arm where she got the shot.  The outcome of the event and the relatedness between the event and the suspect vaccines were not reported.
Sex: F
Vaccine: MMR
Symptoms: Anaphylactic reaction, Gastrointestinal disorder
Clinical narrative: she does have anaphylaxis to eggs, soy, Aspirin, and MMR vaccine; has gut issues; This spontaneous report was received from a consumer, referring to herself a female patient of unknown age. The patient's historical conditions included anaphylactic reaction. Her historical drugs included aspirin. The patient's concurrent conditions included anaphylactic reactions, food allergies and pharyngeal swelling. Her concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection (dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported) as prophylaxis.   On an unspecified date, the patient experienced anaphylaxis to measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (anaphylactic reaction). As treatment she had "six shots or something", she doesn't recall the reaction as it was too many years ago when she was a child. Also, the patient mentioned that she has gut issues (gastrointestinal disorder).   The outcome of the event anaphylactic reaction was not reported, and the gastrointestinal disorder was not resolved by the reporting time. The reporter considered the event anaphylactic reaction to be related to measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II). The causality assessment for the event gastrointestinal disorder and the suspect therapy was not provided.   Upon internal review, the event anaphylactic reaction was determined to be medically significant.
Age: 49.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthritis reactive, Product administered to patient of inappropriate age
Clinical narrative: reactive arthritis; first dose of Shingrix on 12/17/2019 at the age of 49; This case was reported by a consumer and described the occurrence of reactive arthritis in a 49-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced reactive arthritis (serious criteria GSK medically significant) and inappropriate age at vaccine administration. The patient was treated with adalimumab (Humira). On an unknown date, the outcome of the reactive arthritis and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the reactive arthritis to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not applicable for 2nd dose. The patient received first dose of Shingrix at the age of 49, which led to inappropriate age at vaccine administration. The patient has been taking Humira for reactive arthritis. The patient did not receive the second dose. The patient asked should he/she get 2 doses since it had been over 16 months or should he/she just get second dose.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Accidental overdose, Headache, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Her forehead hurts; 7 year old patient / given an adult Hepatitis-A vaccine / was given an adult dose of the vaccine; 7 year old patient / given an adult Hepatitis-A vaccine / was given an adult dose of the vaccine; This case was reported by a nurse via call center representative and described the occurrence of forehead headache in a 7-year-old female patient who received HAV (Havrix adult) (batch number Y29KL, expiry date 21st February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st March 2021, the patient received Havrix adult (intramuscular) and Havrix Pre-Filled Syringe Device. On 31st March 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the patient experienced forehead headache. On an unknown date, the outcome of the forehead headache, overdose and adult product administered to child were unknown.   It was unknown if the reporter considered the forehead headache to be related to Havrix adult and Havrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: This case initially considered as invalid but upon follow up, it was confirmed to be valid. The patient was the patient's mother. The reporter stated, the patient had received hepatitis A vaccine from her health care professional in an unknown arm. The patient had received 2 vaccines on that day (other vaccine was not specified). It was later confirmed that, the patient received adult Havrix which led to adult product administered to child and overdose. The reporter stated that, the patient said for the past several days, her forehead hurt.  She was not sure that the patient might had bumped her head while playing.  The reporter did not consent to follow-up. Note- the onset date for headache was provided as 7th April 2021 however the patient's mother reported on 5th April 20201 and mentioned that, the patient said her head was hurting for several days, TTO kept as less than a week instead of 7 days.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Fatigue; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient received 1st dose of shingrix and experienced fatigue. The patient had taken Advil for treatment of fatigue. The reporter did not  provided the information about date of birth, full mailing address and additional question in regards to filling a symptomatic AE (such as lot number, expiration date, dose, route of administration. date of administration, formulation, outcome, etc.). The reporter refused when asked for consent to follow-up with his healthcare provider. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Malaise, Product administered at inappropriate site
Clinical narrative: received the first Shingrix dose in Mar-2020  / she has yet to receive the second Shingrix; was given the Shingrix dose in the butt and not her arm; made her sick for a week; This case was reported by a consumer via call center representative and described the occurrence of sickness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In March 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced sickness and incomplete course of vaccination. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the vaccine administered at inappropriate site and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 73 or 74 years for the 1st dose. The age at vaccination was not applicable for the 2nd dose. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix because of what hapenned with the 1st dose, which led to incomplete course of vaccination. The patient received the 1st dose in the butt and not her arm, which led to  vaccine administered at inappropriate site. The patient stated that, the 1st dose made her sick for a week. The patient was unable to provide the dosage as well as lot number and expiration date for the Shingrix dose. The patient declined to provide her date of birth, address, phone number or any other contact information. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix in September 2018 / forgot to receive 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in september 2018).   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 for this report. The patient forgot to receive 2nd dose of Shingrix. Till the time of reporting,the patient did not received the 2nd dose of shingrix which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: FEVER; MUSCLE ACHES; NAUSEA; CHILLS; This spontaneous report received from a parent concerned a 23 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 09-MAR-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced muscle aches. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.4 F, 102 F. On 10-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F, 100 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and chills on 10-MAR-2021, and had not recovered from fever, and muscle aches. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Pain
Clinical narrative: THREW UP TWICE; BODY ACHES; JOINT PAIN; FELT WEAK; 103 DEGREE FEVER; CHILLS DESCRIBED AS SHE WAS JUMPING THE CHILLS WERE SO STRONG, AND THEY WERE BETTER DURING THE DAYTIME,; This spontaneous report received from a parent concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included social alcohol user, non smoker, and birth control pills, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills which were described as she was jumping the chills were so strong, and they were better during the daytime. On 09-MAR-2021 11:00, the subject experienced 103 degree fever. On 10-MAR-2021, the subject experienced threw up twice. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced joint pain. On 10-MAR-2021, the subject experienced felt weak. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 103 degree fever, and threw up twice on 10-MAR-2021, and had not recovered from chills described as she was jumping the chills were so strong, and they were better during the daytime, body aches, joint pain, and felt weak. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: THREW UP TWICE; BODY ACHES; JOINT PAIN; FELT WEAK; 103 DEGREE FEVER; CHILLS DESCRIBED AS SHE WAS JUMPING THE CHILLS WERE SO STRONG, AND THEY WERE BETTER DURING THE DAYTIME,; This spontaneous report received from a parent concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included social alcohol user, non smoker, and birth control pills, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 09-MAR-2021, the subject experienced chills which were described as she was jumping the chills were so strong, and they were better during the daytime. On 09-MAR-2021 11:00, the subject experienced 103 degree fever. On 10-MAR-2021, the subject experienced threw up twice. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced joint pain. On 10-MAR-2021, the subject experienced felt weak. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 103 degree fever, and threw up twice on 10-MAR-2021, and had not recovered from chills described as she was jumping the chills were so strong, and they were better during the daytime, body aches, joint pain, and felt weak. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; SORENESS; This spontaneous report received from a patient concerned a  male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: not reported) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced soreness. On 09-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever on 11-MAR-2021, and was recovering from soreness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Dry mouth, Fatigue, Headache
Clinical narrative: NO APPETITE; HEADACHE; FEVER; NAUSEA; BODY ACHE; FATIGUE; DRY MOUTH; 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 past medical history included anemia, pcos, drain cysts, and drug allergy, and concurrent conditions included non-smoker. The patient was previously treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: 26-MAY-2021) .5 ml, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced body ache. On 11-MAR-2021, the subject experienced fatigue. On 11-MAR-2021, the subject experienced dry mouth. Laboratory data included: Body temperature (NR: not provided) 101.8 F, 101.3 F. On an unspecified date, the subject experienced no appetite, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nausea, body ache, fatigue, and dry mouth, and the outcome of no appetite and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: NO APPETITE; HEADACHE; FEVER; NAUSEA; BODY ACHE; FATIGUE; DRY MOUTH; 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 past medical history included anemia, pcos, drain cysts, and drug allergy, and concurrent conditions included non-smoker. The patient was previously treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: 26-MAY-2021) .5 ml, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced body ache. On 11-MAR-2021, the subject experienced fatigue. On 11-MAR-2021, the subject experienced dry mouth. Laboratory data included: Body temperature (NR: not provided) 101.8 F, 101.3 F. On an unspecified date, the subject experienced no appetite, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nausea, body ache, fatigue, and dry mouth, and the outcome of no appetite and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: BLOOD CLOTS IN BRAIN; This spontaneous report was received concerning a female patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration not reported), administered on an unspecified date in MAR-2021. The batch number was not reported. No medical history or concomitant medications were reported.  On an unspecified date in MAR-2021, the patient was ill for a few weeks with a headache and was subsequently hospitalized with blood clots in her brain. The outcome of blood clots in brain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210425372 V0:  This is a spontaneous report of a female of unspecified age who experienced a headache and reportedly blood clots in her brain (cerebral thrombosis), a few weeks after receipt of the Janssen COVID-19 vaccine. No medical history, concomitant medications or additional details were reported. No laboratory results were provided. Additional information has been requested. The blood clot could represent cerebral venous sinus thrombosis (to be clarified).  The case will be assessed further when additional information is received.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOT IN LEG; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient was reported to be over 6 feet tall and not overweight. The patient's past medical history included cataract surgery (in his 60s); and concurrent conditions included former smoker (ex-smoker who quit 1 year ago). The patient had no chronic medical conditions and had no history of recent travel or trauma. 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-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. The patient was not taking any concomitant medications. On 04-APR-2021, the patient's leg felt abnormal and on 05-APR-2021, the patient went to urgent care center, where an ultrasound found a blood clot. The patient was prescribed Eliquis (apixaban) and was since feeling better, however, still had leg discomfort.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in leg. This report was serious (Other Medically Important Condition).  Additional information was received from consumer (daughter of patient) via telephone follow up on 16-APR-2021. The following information was updated and incorporated into the case narrative: patient details, medical history, concurrent conditions, medical story including treatment, and event details.; Sender's Comments: V1: Follow up from the patient's daughter provided additional clinical details. This case concerns a 72 year-old male without significant medical history who was diagnosed with a blood clot in his leg 4 days after receiving the Janssen Covid-19 vaccine. He is not overweight, is not taking chronic medication, and had no recent trauma or travel. He quit smoking one year ago. Three days after vaccination, his leg felt abnormal. The following day, he went to an urgent care center where an ultrasound revealed a lower extremity blood clot. He was sent home with apixaban. No information regarding blood testing was provided. As of the time of the report (i.e. 11 days after his diagnosis), he is feeling better but still has leg discomfort. Based on the limited information, the relationship with Janssen Covid-19 vaccine is considered inconsistent. Additional information is being sought.
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Dyspnoea, Headache, Pyrexia, Tremor
Clinical narrative: DVT; HEADACHE; UNCONTROLLED SHAKING; TROUBLE BREATHING; FEVER; This spontaneous report received from a company representative concerned a 29-year-old female. The company representative heard the information on the local news.  The patient's height, and weight were not reported. The patient was taking estrogen-based birth control pills. 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 19-MAR-2021 for prophylactic vaccination. Concomitant medications included estradiol for birth control. On an unspecified date in MAR-2021, one-week post-vaccination, patient developed uncontrolled shaking, had trouble breathing and fever. She went to the emergency room for her symptoms and was sent home (no time frame was reported). One week later, she developed swollen legs and couldn't walk, and she was diagnosed with a deep vein thrombosis (DVT). On an unspecified date she was hospitalized and admitted in the intensive care unit (ICU). Patient was out of the ICU on 11-APR-2021 (Sunday). Patient was still under treatment. It was also reported that patient had headache that persisted for 2 weeks. The report was from the local news and follow-up was not possible.  The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the uncontrolled shaking, trouble breathing, fever, headache and DVT was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This is a spontaneous report of a 29-year-old female who developed a deep vein thrombosis two weeks after receipt of the Janssen COVID-19 vaccine.  She also reported uncontrolled shaking, trouble breathing, and fever one week after vaccine administration, and a headache which had persisted for two weeks.  No medical history was reported; she was taking estrogen-based birth control pills.  Estrogen-based birth control pills place the patient at risk for thrombosis, but there are insufficient other details to make a meaningful medical assessment regarding the events in the case.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Skeletal injury, Thrombosis
Clinical narrative: BLOOD CLOT; BROKE TAIL BONE; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report was received from a pharmacist via a company representative, and concerned an approximately 40 year old female. The patient's height, weight, and medical history were not reported.  The patient received Covid-19 vaccine Ad26.COV2.S (suspension for injection, route of administration not reported, batch number: unknown) dose and vaccination site were not reported, administered in 2021 for prophylactic vaccination. No concomitant medications were reported.  In 2021, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not provided. In 2021, the patient experienced broke tail bone during labor and gave birth (live birth).  On an unspecified date in 2021, the patient experienced a blood clot and died. It was noted that she was at high risk for clots because she was 4 weeks post partum (gravida 1, para 1).  Action taken with Covid-19 vaccine Ad26.COV2.S was not applicable. The patient died of a blood clot and broke tail bone in 2021; the outcome of vaccine exposure during pregnancy was not reported. It was unspecified if an autopsy was performed. This report was serious (Death). This case, from the same reporter is linked to 20210430297.; Sender's Comments: V0: The case concerns a pregnant female subject around age of 40, who developed thrombosis, skeletal injury and exposure during pregnancy an unspecified time after Janssen COVID-19 vaccine was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. The subject's past medial history, last menstrual period, estimated date of delivery and concomitant medications were not provided. Per the reporter (pharmacist) the patient was at a high risk for blood clots because she was 4 weeks post-partum. The patient broke her tail bone during the labor, gave a birth, and later died of a blood clot. No additional information was provided. It is not known whether the autopsy was performed. Given alternative explanation and risk factors of pregnancy, labor and skeletal injury (trauma) the event of thrombosis is considered inconsistent with the causal association to immunization, per the WHO causality classification for adverse events following immunization. Events of skeletal injury was result of an accident and therefore not considered related. Company causality for event of thrombosis is considered not related to Janssen COVID-19 vaccine (Level 4 -Insufficient information available to confirm a possible, probable or a definitive case of venous thrombosis, per the Brighton Collaboration case definition); Reported Cause(s) of Death: BLOOD CLOTS; BROKE TAIL BONE
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombophlebitis superficial
Clinical narrative: SUPERFICIAL THROMBOPHLEBITIS; This spontaneous report received from a patient and concerned a 40 year old white, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included varicose veins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total administered on 17-MAR-2021 to Left deltoid in arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-MAR-2021 and on 31-MAR-2021, the patient experienced severe leg pain on right side. Patient tried hot and cold compress. The patient wore compression stockings but nothing helped. Patient went to doctor on 13-APR-2021 and doctor diagnosed Superficial thrombophlebitis. The patient planned to get ultrasound on 14-APR-2021, next day, at 6 pm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from superficial thrombophlebitis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: A 40-year-old woman with a history of varicose veins experienced superficial thrombophlebitis 13 days after vaccine. An ultrasound was planned to confirm the diagnosis. Varicose veins provide a plausible alternate risk factor for the event. However, there is insufficient information to make a meaningful medical assessment. Additional information has been requested, including the ultrasound report.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer via a company representative and concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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, a week or so after the Covid-19 vaccination the patient passed away in his sleep. The patient had no underlying condition. An autopsy was performed on an unspecified date and the patient was found to have blood clot.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: A male patient of unspecified age passed away in his sleep an unspecified time after receiving the Janssen COVID-19 vaccine for prevention of COVID-19 infection. It stated that the patient had no underlying condition. A blood clot was found by autopsy; no further details are provided. There is insufficient information to make a meaningful medical assessment. Additional information is being sought.; Reported Cause(s) of Death: BLOOD CLOT; Autopsy-determined Cause(s) of Death: BLOOD CLOT
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: PASSED AWAY; This spontaneous report was received from a partner, and concerned a 64 year old patient of an unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included strokes; concurrent conditions included heavy smoker, caffeine consumption, unspecified heart issues, and felling unwell. The patient received Covid-19 vaccine Ad26.COV2.S (suspension for injection, route of admin, and batch number were not reported) dose, vaccination site, and 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 patient passed away. It was reported that the patient received Covid-19 vaccine in the morning and passed away later that day. The patient had felt unwell upon waking up that morning prior to vaccination. The coroner ruled out the vaccine as a potential cause of death due to the individual's past and concurrent medical conditions. It was unspecified if an autopsy was performed. Action taken with Covid-19 vaccine Ad26.COV2.S was not applicable. This report was serious (Death).; Sender's Comments: V0: A 64-year-old patient of unspecified sex received the Janssen COVID vaccine in the morning and died later that day. The coroner ruled out the vaccine as a potential cause of death due to the individual's past and concurrent medical conditions, although these conditions weren't specifically reported. Given the coroner's assessment and symptoms preceding vaccination, there is a plausible alternate explanation for the death.; Reported Cause(s) of Death: PASSED AWAY
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Oedema peripheral, Thrombosis
Clinical narrative: POTENTIAL DEEP VEIN THROMBOSIS; SMALL BLOOD CLOT; ANKLE CALF BOTH SWOLLEN; This spontaneous self-report was received from a patient and concerned a 64 year old female. The patient's height and weight were not reported. The patient's concurrent conditions included no known allergies and smoker. Other relevant history included no alcohol intake, nor any drug abuse/illicit drug use. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration and dose not reported, batch number: 1805029, and expiry: unknown) administered on 14-MAR-2021 on the left arm for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the patient had "ankle calf both swollen" indicating potential deep vein thrombosis. She went to hospital emergency room, and "HCP confirmed small  clot". The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient was recovering from "ankle calf both swollen" and had not recovered from potential deep vein thrombosis and small blood clot. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a spontaneous report of a 64 year old female who developed a swollen calf and ankle swelling indicating a potential deep vein thrombosis 3 days after receipt of Janssen COVID 19 vaccine. Patient was seen in the emergency room by HCP, who confirmed a small clot. No other medical history was reported but patient was noted to be a smoker, reported as 2x a year. Age increases the risk of deep vein thrombosis, but the there is insufficient other details to make a meaningful medical assessment.