chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Cyanosis, Pain in extremity, Peripheral coldness
Clinical narrative: Hashimoto's disease; Painful, cold, purple feet; Painful, cold, purple feet; Painful, cold, purple feet; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported), as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced Hashimoto's disease (medically significant) on an unspecified date with outcome of unknown and painful, cold, purple feet (non-serious) on an unspecified date with outcome of unknown.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: COVID toes; This is a spontaneous report from a contactable consumer or other non hcp. A male patient (caller's friend's husband) of an unspecified age received BNT162B2, Solution for injection, Batch/Lot number was not reported, Expiry date was not provided) via an unspecified route of administration on an unspecified date (at an unspecified age) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date he patient experienced covid toes. Additional information: Within the original report the caller was following up on two previous reports that she had made for side effects from the COVID vaccine. Within the original report the caller mentioned that her friend's husband had the same kind of side effects with the COVID toes and he said that the good news is that the vaccine was rolled out early but the bad news is also that the vaccine was rolled out early. Reporter seriousness for COVID toes was reported as unspecified. Investigation Assessment was not provided. The outcome of the event was unknown.   Additional Context: The report is cross referenced to report ID: 6L9I1WGJ  Information about lot/Batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain
Clinical narrative: Left underarm and left breast pain; Left underarm and left breast pain; This is a spontaneous report from a contactable other hcp (patient). A 59-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: Fa6780), via an unspecified route of administration, administered in Arm Left on 12Jul2021 16:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension and Penicillin allergy. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient received within 2 weeks of vaccination: Blood pressure meds. The patient experienced left underarm and left breast pain on 13Jul2021. The outcome of the events was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Bone pain, Tooth demineralisation
Clinical narrative: My front left tooth and two bottom teeth have been demineralizing and you can see through them now.; I have bone pain in my pelvic bone.; This is a spontaneous report received from contactable consumer (pharmacist reported for herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0180; Expiration Date: Aug2021), via an unspecified route of administration on 22Jun2021 at 12:00 (at the age of 41-year-old), as dose 1, single; and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EY0584, Expiration Date: Oct2021), via an unspecified route of administration on 14Jul2021 at 12:00, (at the age of 41-year-old), as dose 2, single in left arm for COVID-19 immunization at Pharmacy/drug store. The patient's medical history included multiple sclerosis, and ulcerative colitis. Concomitant medications included natalizumab (TYSABRI) taken for multiple sclerosis, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to Covid19 vaccine. The pharmacist reported that she had an adverse drug reaction, that has been occurring since her first COVID vaccine and she got her second COVID vaccine on 14Jul2021 and it was more pounced since that point of time. On an unspecified date, the patient's front left tooth and two bottom teeth had been demineralized and could see through them now and had bone pain in her pelvic bone. The events were persistent. It was progressively getting worst. Patient had appointment with her doctor and took blood test. Patient tried her pain medication that she had for Ulcerative colitis and had Tylenol. The patient bought toothpaste and mouth wash that contain high concentration of fluoride. The patient underwent lab tests and procedures which included blood test: unknown, on an unspecified date. The clinical outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Dysstasia, Insomnia, Pain in extremity
Clinical narrative: have now leg//knee problems; have now leg//knee problems.knee pain; drag right leg in home, and they fell like rubber as hard standing; in bed is worse as hard to get into position to get asleep; This is a spontaneous report from a contactable consumer (Patient). A 82-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as dose 2, single and dose 1 via an unspecified route of administration on an unspecified date in Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient have leg, knee problems. Some times patient drag right leg in home, and they felt like rubber as hard standing. In bed it was worse as hard to get into position to get asleep for knee pain. Patient can not see a doctor as they only will talk on phone so this is hard. The outcome of events was unknown.  Information about lot/batch number is requested.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Sjogren's syndrome, Systemic lupus erythematosus
Clinical narrative: lupus and Sjogren syndrome; lupus and Sjogren syndrome; This is a spontaneous report from a contactable consumer (patient), reported to the Pfizer Clinical Trials Contact Center.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via unspecified route of administration, on an unspecified date in 2021, as dose 1 and dose 2, single (both the doses) for COVID-19 immunisation. Medical history included immunosuppressed system. Concomitant medications included unspecified immuno-suppressant medication. The patient received both Pfizer Covid vaccine shots in 2021. On an unspecified date in 2021, the patient experienced lupus and Sjogren's syndrome. The events were serious (medically significant). The patient underwent lab test which included Antibodies test: unknown results (still do not have any antibodies). The outcome of the events was unknown.   Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash starting on her face down to her chest and its getting worse; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable female consumer reported for herself that a patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine; formulation: solution for injection), dose 2 via an unspecified route of administration on 24Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included BNT162B2 1st dose for covid-19 immunization and no events were reported for 1st dose. The patient reported in Jun2021 that 2 weeks after her 2nd dose (24Jun) she experienced rash and it got worse. Rash starting on her face down to her chest. Patient was unable to remember her 1st dose schedule. She was asking what to do. The outcome of the event was unknown.  Information about batch/ lot number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Flushing, Insomnia, Oropharyngeal pain
Clinical narrative: Itching all over and hurting, I have sore throat.; Itching all over and hurting, I have sore throat.; have not slept, it kept me over night long; Itching and my face is red and hot hot but I am cold, covered with three blankets and I have chills, sore throat, but I do not have fever; my face is red and hot hot; It just started hurting little bit; Itching and my face is red and hot hot but I am cold, covered with three blankets and I have chills, sore throat, but I do not have fever.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8733), via an unspecified route of administration on 13Jul2021 (at the age of 66-year-old), as dose 1, single for COVID-19 Immunization. Medical history included 14 back surgeries, had 2 shoulder surgery, had 1 hand surgery and 1 hip surgery. Concomitant medications included 13 unspecified medications (also reported as: take lot of medication, yes. Kidney). Consumer stated that she took the shot yesterday and last time she was okay. On an unknown date in Jul2021, just started hurting little bit, have not slept, it kept her over night long. On 13Jul2021 either between 8 and 10 clock, started itching all over and hurting. She had sore throat, itching all over and her face was red and hot but she was cold, covered with three blankets and she have chills, hurting and they told her that she will hurt but she do not have fever. Consumer stated that she had an appointment on 03Aug2021 for 2nd dose. Consumer stated lab test was not done, and she have to go for lab test. Regarding treatment consumer stated that she does not know what to do. The outcome of the event pruritus was not recovered. The outcome of the remaining events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: Itching all over and hurting, I have sore throat.; Itching all over and hurting, I have sore throat.; have not slept, it kept me over night long; Itching and my face is red and hot hot but I am cold, covered with three blankets and I have chills, sore throat, but I do not have fever; my face is red and hot hot; It just started hurting little bit; Itching and my face is red and hot hot but I am cold, covered with three blankets and I have chills, sore throat, but I do not have fever.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8733), via an unspecified route of administration on 13Jul2021 (at the age of 66-year-old), as dose 1, single for COVID-19 Immunization. Medical history included 14 back surgeries, had 2 shoulder surgery, had 1 hand surgery and 1 hip surgery. Concomitant medications included 13 unspecified medications (also reported as: take lot of medication, yes. Kidney). Consumer stated that she took the shot yesterday and last time she was okay. On an unknown date in Jul2021, just started hurting little bit, have not slept, it kept her over night long. On 13Jul2021 either between 8 and 10 clock, started itching all over and hurting. She had sore throat, itching all over and her face was red and hot but she was cold, covered with three blankets and she have chills, hurting and they told her that she will hurt but she do not have fever. Consumer stated that she had an appointment on 03Aug2021 for 2nd dose. Consumer stated lab test was not done, and she have to go for lab test. Regarding treatment consumer stated that she does not know what to do. The outcome of the event pruritus was not recovered. The outcome of the remaining events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: Developing a skin rash; it spread all over my body; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 11Jul2021 12:15 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 20Jun2021 as dose 1, single for covid-19 immunisation. The patient received the second dose of the vaccine on Sunday afternoon and developed a skin rash (on Jul2021). The patient was not sure if it was from the vaccine or not, but it spread all over the body and patient was little bit concerned. The patient does not know if that vaccine was good, it does give an allergic reaction or something in the vaccine (Further clarification was unknown) that was not sure of. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine back in December. Then a week after, she was diagnosed with Covid-19.; This is a spontaneous report from a contactable consumer via Pfizer sponsored program COVAX US Support. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on Dec2020 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received the 1st dose of the Pfizer-BioNTech COVID-19 Vaccine back in December. Then a week after, she was diagnosed with COVID-19. Due to this, instead of receiving the 2nd dose 3 weeks after, she received it 6 months after the 1st dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Influenza like illness, Nasopharyngitis, Rhinorrhoea, Throat irritation
Clinical narrative: Runny nose; Coughing; her throat is irritated/scratchy; feels like she flu like symptoms; feels like she is getting a cold; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unknown route of administration on 13Jul2021 as dose 1, single for covid-19 immunization. Medical history included diabetes and hypertension. The patient's concomitant medication included unspecified medication for her high blood pressure. The patient reported that, she took the shot on Tuesday 13Jul2021 and yesterday (as reported) on an unknown date in Jul2021 she started having a runny nose and has been coughing. She was not really sick. Her nose has been running a lot and she was coughing a lot. She feels like her throat is irritated/ scratchy and flu-like symptoms. On an unknown date in Jul2021, she felt like she is getting a cold. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 9.0
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: fainting episodes; This spontaneous report was received from a registered nurse via a sales representative and refers to a 9-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in 2021 (reported as in the past 4 to 6 months), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 milliliter, intramuscularly (injection site, lot # and expiration date were not provided) for prophylaxis.   On the same date right after the injection, the patient experienced fainting episode. The patient was kept in the clinic for a while, recovered, and was sent home. It was reported the patient sought medical attention but it was unknown if any treatment was given.   The relatedness between the event and the suspect vaccine was not provided.  Upon internal review, the event of fainting episode was considered to be medically significant.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA007327: US-009507513-2107USA007555:
Age: 9.0
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: fainting episodes; This spontaneous report was received from a registered nurse via a company representative and refers to a 9-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in 2021 (reported as in the past 4 to 6 months), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 milliliter, intramuscularly (injection site, lot # and expiration date were not provided) for prophylaxis.   On the same date right after the injection, the patient experienced fainting episode. The patient was kept in the clinic for a while, recovered, and was sent home. It was reported the patient sought medical attention but it was unknown if any treatment was given.   The relatedness between the event and the suspect vaccine was not provided.  Upon internal review, the event of fainting episode was considered to be medically significant.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA007327: US-009507513-2107USA007519:
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: received one shingles vaccine/ 10/22/2020 / 2nd dose/ put off because /covid vaccine; This case was reported by a consumer via call center representative and described the occurrence of social problem in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 22nd October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided are as follows: The case was reported by consumer for herself. The age at vaccination was not applicable for this report. The patient had put off 2nd dose of Shingrix vaccine because she had took Pfizer covid vaccine which led to social problem. The reporter asked if she get 2nd dose today would be okay to be around her on. The reporter also asked question about her 32 year old nine month pregnant daughter who was just diagnosed with Shingles yesterday. The reporter wanted to know could 32 year old take shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had a shot in 2020 February 2021 I got the shingles/ suspected vaccination failure; I got the shingles; This case was reported by a consumer via media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In February 2021, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the consumer. The age at vaccination was not reported. The reporter stated that, in 2020 received shot and in February 2021, had shingles. The reporter stated that, in July 2021, was still dealing with shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; I got it on my back but it was mild and no pain afterwards/I got it again on my face but it was a small case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (face was the first and the worst case). Concomitant products included valaciclovir hydrochloride (Valtrex) and gabapentin.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient reported that, his/her face shingles was the first and the worst case. The patient started Valtrex twice and till the time of reporting, he/she was still on Gabapentin since 2017.  The patient was told that since he/she got shingles he/she had to wait one year to receive the Shingles shot. Th patient received Shingles shot but then was told that, shingles laid dormant in the body and even though he/she got the shot it could be reoccurrences. After receiving Shingles vaccine, the patient got it on his/her back but it was mild and no pain afterwards. The patient got it again on his/her face but it was a small case.  This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR158719:Same reporter
Sex: F
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Pediatric patients be given Havrix Adult Dose; Pediatric patients be given Havrix Adult Dose; This case was reported by a other health professional via sales rep and described the occurrence of overdose in a 12-year-old female patient who received HAV (Havrix adult) (batch number EK59B, expiry date 20th November 2020) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, 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 outcome of the overdose and adult product administered to child were unknown.   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: The age at vaccination was not reported. The reporter stated that, the Pediatric patient received Havrix adult dose, which led to  overdose and adult product administered to child. The reporter consented to follow up. This was 1 of 4 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR159012:Same reporter US-GLAXOSMITHKLINE-US2021AMR159011:Same reporter US-GLAXOSMITHKLINE-US2021AMR159013:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; have shingles on the average of twice a year; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient had shingles on the average of twice a year. The patient reported that, he/she was learning to live without taking medications. He/she reported that, it was not easy, but steroids were not good all the time either. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered the adjuvant without using the powder portion.; administered the adjuvant without using the powder portion.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number EG3A3, expiry date 10th December 2021) for prophylaxis.   On 13th July 2021, the patient received the 1st dose of Shingrix. On 13th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details provided were as follows: This case was reported by the medical assistant. The patient received 1st dose of Shingrix but they only administered the adjuvant without using the powder portion which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter consented to follow-up.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Influenza, SARS-CoV-2 test
Clinical narrative: TESTED POSITIVE FOR COVID-19; DIZZINESS; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 43 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced fatigue. On 22-JUL-2021, the subject experienced tested positive for covid-19. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive, Influenza A virus infection (NR: not provided) not reported, and Influenza B virus infection (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, headache, and fatigue on 15-APR-2021, and had not recovered from tested positive for covid-19. This report was non-serious. This report was associated with product quality complaint: 90000186982; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID-19; DIZZINESS; HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 43 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced fatigue. On 22-JUL-2021, the subject experienced tested positive for covid-19. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive, Influenza A virus infection (NR: not provided) not reported, and Influenza B virus infection (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, headache, and fatigue on 15-APR-2021, and had not recovered from tested positive for covid-19. This report was non-serious. This report was associated with product quality complaint: 90000186982; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer (Moderna) concerned 3 male patients unspecified race and ethnicity. 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) one total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient's experienced suspected clinical vaccination failure and confirmed covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187091.; Sender's Comments: V0:20210747855-Covid-19 Vaccine Ad26.Cov2.S -Suspected Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Agitation, Lymphadenopathy, Paraesthesia, Pyrexia
Clinical narrative: MASSIVE LYMPH NODE SWELLING ON NECK FOR 6 STRAIGHT WEEKS; TINGLING IN LEGS AS IF THEY WOULD FALL ASLEEP, COULDN'T EVEN WORK OUT FOR 2 STRAIGHT WEEKS; FREAKING OUT; HIGH FEVER 12 HOURS AFTER VACCINATION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient worked out routinely.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced massive lymph node swelling on neck for 6 straight weeks. On APR-2021, the subject experienced tingling in legs as if they would fall asleep, couldn't even work out for 2 straight weeks. On APR-2021, the subject experienced freaking out. On APR-2021, the subject experienced high fever 12 hours after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever 12 hours after vaccination, massive lymph node swelling on neck for 6 straight weeks, tingling in legs as if they would fall asleep, couldn't even work out for 2 straight weeks and freaking out was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Paralysis, Sensory disturbance
Clinical narrative: FEEL BLOOD FLOW THROUGH VEIN IN ANKLE; NO STRENGTH IN LEFT LEG/PARALYSIS; This spontaneous report received from a patient concerned a 60 year white old male of unknown ethnicity. 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: 1808978 and expiry: 28-JUL-2021) dose was not reported, 1 total, administered on 19-MAY-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-JUL-2021, the patient experienced muscle problems in leg, glutes, thigh quad, hard time standing and supporting self. On 07-JUL-2021, the patient experienced paralysis, pain in the hip when standing, no strength in left leg, pain in the thigh and leg when standing. On 16-JUL-2021, the patient experienced feel blood flow through vein in ankle. On 17-JUL-2021, the patient experienced numb around skin, tingly around left ankle. On an unspecified date, the patient experienced no reflex in left leg. On 19-JUL-2021, the patient visited urgent care and physical therapist. Perform first chiropractor on 21-JUL-2021 at after noon and second chiropractor on 22-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel blood flow through vein in ankle, and no strength in left leg/paralysis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210753159;covid-19 vaccine ad26.cov2. s- No strength in left leg/paralysis. This event is considered unassessable. The 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.
Sex: U
Vaccine: COVID19
Symptoms: Eye discharge, Sinus operation
Clinical narrative: LEFT EYE DRAINING, FELT LIKE THERE WAS A LOT OF DIRT IN IT; SINUS RUNNING AS EXCESSIVE DRAINING; This spontaneous report received from a patient concerned a 56 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of sinus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-JUL-2021, the subject experienced left eye draining, felt like there was a lot of dirt in it. On 24-JUL-2021, the subject experienced sinus running as excessive draining. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left eye draining, felt like there was a lot of dirt in it, and sinus running as excessive draining. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Gait inability, Thrombosis
Clinical narrative: MAJOR BLOOD CLOT IN LEG; UNABLE TO WALK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. 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 and expiry: Unknown) dose was not reported, 1 total administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date (after vaccination), patient woke up out of bed and had a major blood clot in leg and was unable to walk. Patient had just got home from the hospital and was in a hospital for five days and had no idea why got that blood clot, because patient was in pretty good shape and just wanted to report. Patient reported shot became the only thing which was done in the last ten years different. So patient did not know. It just seemed really weird to patient that woke up and had a mass of blood clot in life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unable to walk and major blood clot in leg was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0; 20210755344-COVID-19 VACCINE AD26.COV2.S-major blood clot in leg, unable to walk. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Contusion, Dehydration, Fall
Clinical narrative: sore shoulder; chills; fever; passed out; sore; Bruise near the eye; falling down; dehydration; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), PAIN (sore), CONTUSION (Bruise near the eye), FALL (falling down), DEHYDRATION (dehydration), ARTHRALGIA (sore shoulder), PYREXIA (fever) and CHILLS (chills). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), PAIN (sore), CONTUSION (Bruise near the eye), FALL (falling down), DEHYDRATION (dehydration), ARTHRALGIA (sore shoulder), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            He was given IV fluids as a treatment . No Concomitant medications were reported by the reporter.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain, Pyrexia
Clinical narrative: sore shoulder; chills; fever; passed out; sore; Bruise near the eye; falling down; dehydration; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), PAIN (sore), CONTUSION (Bruise near the eye), FALL (falling down), DEHYDRATION (dehydration), ARTHRALGIA (sore shoulder), PYREXIA (fever) and CHILLS (chills). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), PAIN (sore), CONTUSION (Bruise near the eye), FALL (falling down), DEHYDRATION (dehydration), ARTHRALGIA (sore shoulder), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            He was given IV fluids as a treatment . No Concomitant medications were reported by the reporter.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac ventricular thrombosis, Renal infarct
Clinical narrative: bilateral renal infarcts; blood clot lower left ventrical; This spontaneous case was reported by a consumer and describes the occurrence of RENAL INFARCT (bilateral renal infarcts) and CARDIAC VENTRICULAR THROMBOSIS (blood clot lower left ventrical) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL INFARCT (bilateral renal infarcts) (seriousness criteria hospitalization and medically significant) and CARDIAC VENTRICULAR THROMBOSIS (blood clot lower left ventrical) (seriousness criteria hospitalization and medically significant). At the time of the report, RENAL INFARCT (bilateral renal infarcts) and CARDIAC VENTRICULAR THROMBOSIS (blood clot lower left ventrical) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: Very limited information regarding these events have been provided at this time. Further information regarding temporal association is necessary.; Sender's Comments: MR-QC: Please don't review this case. Very limited information regarding these events have been provided at this time. Further information regarding temporal association is necessary.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose Covid 19 vaccine administered 2 months after first dose; This is a spontaneous report from a contactable other healthcare professional (registered nurse). A 56-year-old male patient received second dose of BNT162B2 (Pfizer, Solution for injection) intramuscularly in left deltoid on 09Jul2021 (Batch/Lot Number: EW0182; Expiration Date: 31Aug2021) (at the age of 56-year-old) at 0.3 mL as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 on 08Apr2021 (NDC number: Unknown, Lot number: EP7533, Expiration date: Unknown) (at the age of 56-year-old) for Covid-19 immunization. On an unspecified date, 2 months after first dose, the patient received the first dose of the Pfizer Covid-19 vaccine. Stated that the dose was not delivered. It was not their vaccine, so they did not have any further information. It was a diluted vaccine that had been stored in the syringe longer than 6 hours. Had discussed that with a medical doctor and was thinking of re vaccination because they were not sure if the vaccine was viable at that time. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Somnolence
Clinical narrative: Feeling very tired; I just sleep more than I normally do; I don't feel right since I have took the vaccine; Feeling very tired/Fatigue; This is a spontaneous report from a non-contactable consumer (patient) or other non-healthcare professional.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was trying to find out what are side effects of them because since patient had took the vaccine, on an unknown date in 2021, just being feeling very tired and very fatigue and just sleep more than normally does and wanted to find out if that is the part of the side effects and would like to know if people has been calling you to repot this and how long does it last and would like to find out how long does the vaccine is going to effect for because they said 'we don't' took our second vaccine but they are saying something about giving me the booster and patient don't want to get the booster (Further clarification was unknown). Patient don't feel right since have took the vaccine and wanted to know why they wanting to give the third shot. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Illness, Rhinorrhoea
Clinical narrative: Runny nose; Headache; Feeling weak; Ill/Sick; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient's husband) via medical information team. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported) via an unspecified route of administration in an unspecified anatomical location on an unspecified date in Feb2021 (at the age of 67-year-old) as single dose for COVID-19 immunisation. Medical history included influenza from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunization. The patient has not been tested for Covid at the time of reporting. The patient experienced runny nose, headache and feeling weak on 07Jul2021, ill/sick in 2021. The patient reported that his wife started having symptoms last Wednesday, 07Jul2021 and she was getting better. States she was still somewhat weak from being sick but is improving. Though it was not confirmed yet, they believe that it was because of the delta variant of Covid.  Information about lot/batch number has been requested.