chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: feeling sore; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 22-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Aug2022, outcome "unknown", described as "feeling sore".  Additional information: The patient received two shots of the pfizer vaccine and remembered feeling sore the first days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I currently have Covid; I currently have Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (179885). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "I currently have Covid". It was reported that patient currently has Covid. The patient reported that vaccines are not really a vaccine or he wouldn't had Covid for the second time this year.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testing positive for Covid-19; testing positive for Covid-19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "testing positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She ended up testing positive for Covid-19. The patient received both primary series and booster of Pfizer BioNTech Covid-19 vaccine. She ended up testing positive for Covid-19. She recovered but didn't know anything else. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information , there is reasonable possibility of causal association between the events Drug Ineffective and COVID-19  and the suspect drug BNT162b2 .
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller received the first & second dose and booster dose of the Pfizer Covid 19 vaccine and got Covid; Caller received the first & second dose and booster dose of the Pfizer Covid 19 vaccine and got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller received the first & second dose and booster dose of the Pfizer Covid 19 vaccine and got Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received the first and second dose and booster dose of the Pfizer Covid 19 vaccine and got Covid. Then he was prescribed with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: my son has covid bad; my son has covid bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "my son has covid bad".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: A caller wants to know if she got the second booster if they will check it to see if the Covid was present or not; A caller wants to know if she got the second booster if they will check it to see if the Covid was present or not; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "A caller wants to know if she got the second booster if they will check it to see if the Covid was present or not".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Body temperature increased, Chills, Musculoskeletal stiffness
Clinical narrative: That evening around midnight/sweats; Chills; armpit pain; 103.4 F temporal; body aches; couldn't move neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2021 at 18:00 as dose 2, single (Lot number: EW0170) at the age of 30 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: ER8733; Anatomical Site: Right arm; Vaccine administration time: 18:00), administration date: 26Mar2021, when the patient was 30-year-old, for COVID-19 Immunization, reaction(s): "COVID-19", "Vaccination failure". The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021), described as "103.4 F temporal"; CHILLS (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021); NIGHT SWEATS (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021), described as "That evening around midnight/sweats"; AXILLARY PAIN (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021), described as "armpit pain"; PAIN (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021), described as "body aches"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021), described as "couldn't move neck". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: It was reported that events lasted until morning of 18Apr2021. There were no prior vaccinations (within 4 weeks). No relevant or specific relevant test for thromboembolic events with thrombocytopenia were done. Vaccination date and time for dose 2 was also reported as 16Apr2021 at 17:00.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain
Clinical narrative: That evening around midnight/sweats; Chills; armpit pain; 103.4 F temporal; body aches; couldn't move neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2021 at 18:00 as dose 2, single (Lot number: EW0170) at the age of 30 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: ER8733; Anatomical Site: Right arm; Vaccine administration time: 18:00), administration date: 26Mar2021, when the patient was 30-year-old, for COVID-19 Immunization, reaction(s): "COVID-19", "Vaccination failure". The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021), described as "103.4 F temporal"; CHILLS (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021); NIGHT SWEATS (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021), described as "That evening around midnight/sweats"; AXILLARY PAIN (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021), described as "armpit pain"; PAIN (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021), described as "body aches"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021), described as "couldn't move neck". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: It was reported that events lasted until morning of 18Apr2021. There were no prior vaccinations (within 4 weeks). No relevant or specific relevant test for thromboembolic events with thrombocytopenia were done. Vaccination date and time for dose 2 was also reported as 16Apr2021 at 17:00.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed with COVID after 3rd dose; diagnosed with COVID after 3rd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 11Feb2021 at 10:00 as dose 1, single (Lot number: EN6201), in arm, on 04Mar2021 at 10:00 as dose 2, single (Lot number: EN6206), in arm and on 05Nov2021 at 11:00 as dose 3 (booster), single (Lot number: FA8020), in arm for covid-19 immunisation. The patient's relevant medical history included: "moderate to severe eczema", start date: 2019 (ongoing), notes: DOSE 4 seemed to help eczema. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Feb2022, outcome "unknown", COVID-19 (medically significant) with onset Feb2022, outcome "recovered" (Feb2022) and all described as "diagnosed with COVID after 3rd dose". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) Positive.  Clinical course: The patient was diagnosed with Covid after dose 3 but friend, who I was on vaccination with and who was not vaccinated, has never tested positive. The only medication that Withheld has provided is topical. Prior Vaccinations were unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220752153( 0.0 ) (Janssen).  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160291) at citrate free, subcutaneous for rheumatoid arthritis, uveitis. The patient's relevant medical history included: "Non-infectious intermediate posterior and panuveitis" (ongoing); "Moderate to severe rheumatoid arthritis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" (Jul2022) and all described as "COVID-19 virus test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive. The action taken for adalimumab was unknown.  Clinical course: The patient previously received COVID-19 vaccine ad26.cov2.s (those number in series 1) (suspension for injection intramuscular, batch number was not reported) dose, start therapy date were not reported, one total for COVID-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of COVID-19 vaccine (dose number in series 1). It was unknown if patient was enrolled in a COVID-19 vaccine trial. Causality for COVID-19 virus test positive was possible as per reporter with Janssen COVID-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Mobility decreased
Clinical narrative: loss of mobility and could not walk for approximately two days; loss of mobility and could not walk for approximately two days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US295201_NS.  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: KESIMPTA. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: MOBILITY DECREASED (non-serious), GAIT INABILITY (non-serious), outcome "unknown" and all described as "loss of mobility and could not walk for approximately two days".  Additional information: Patient stated that he received two Covid-19 booster shots while on Kesimpta therapy.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain in extremity
Clinical narrative: felt sick; very sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL3247) at the age of 38 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: Nov2012 (ongoing); "Major Depressive Disorder", start date: Jun2013 (ongoing); "Appendectomy", start date: 1987 (ongoing), notes: Summer; "Gallbladder Removal", start date: 1993 (unspecified if ongoing), notes: Fall; "Depression" (ongoing); "Graves Disease", start date: Mar2022 (ongoing). The patient's family history included: "Asthma" (unspecified if ongoing), notes: Mother has asthma, diabetes, bipolar disease (Age: 76 years old); "Diabetes" (unspecified if ongoing), notes: Mother has asthma, diabetes, bipolar disease (Age: 76 years old); "Bipolar Disorder" (unspecified if ongoing), notes: Mother has asthma, diabetes, bipolar disease (Age: 76 years old). Concomitant medication(s) included: METFORMIN oral taken for diabetes mellitus (ongoing); GLIMEPIRIDE oral taken for diabetes mellitus (ongoing); LANTUS taken for diabetes mellitus (ongoing); PROZAC oral taken for depression (ongoing); METHIMAZOLE oral taken for basedow's disease (ongoing); PROPRANOLOL oral taken for basedow's disease (ongoing). The following information was reported: ILLNESS (non-serious) with onset 29Jan2021, outcome "unknown", described as "felt sick"; PAIN IN EXTREMITY (non-serious) with onset 29Jan2021, outcome "unknown", described as "very sore arm".
Sex: U
Vaccine: COVID19
Symptoms: Bronchitis, Fatigue, Pain, Sinusitis
Clinical narrative: extreme fatigue; sinus infections; bronchitis; achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, With the first dose I was fine. Zero side effects.), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: PAIN (non-serious), outcome "recovered", described as "achy"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; SINUSITIS (non-serious), outcome "not recovered", described as "sinus infections"; BRONCHITIS (non-serious), outcome "not recovered".  Additional Information: just wanted to take a moment to provide you with feedback regarding your COVID vaccine. I had both of my shots last Mar2021 and Apr2021. With the first dose I was fine. Zero side effects. With the 2nd dose I was run down, extreme fatigue and achy. That lasted 3 days. Before the vaccine I never got sick. I work in a school and had a great immune system. Since the vaccine I have had extreme fatigue, sinus infections and bronchitis. I have not had COVID. so bravo on that note.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I recently tested positive for COVID-19, even though I am fully vaccinated; I recently tested positive for COVID-19, even though I am fully vaccinated; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I recently tested positive for COVID-19, even though I am fully vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I recently tested positive for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive PCR test for Covid; Positive PCR test for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive PCR test for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive PCR test for COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200036625 same reporter/ drug/ event, different patient;
Age: 72.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis, SARS-CoV-2 test, Sunburn
Clinical narrative: Rheumatoid Arthritis; sun blister due to out in sun a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: RO-NMA-2022-SPCOV17451.   A 67-year-old female patient received BNT162b2 (COMIRNATY), on 28Mar2021 as dose 2, single (Lot number: ET7205) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacture Unknown), for Covid-19 Immunization.   The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 29Mar2021, outcome "recovering", described as "Increased blood pressure"; HEADACHE (non-serious) with onset 29Mar2021, outcome "recovering", described as "Severe headache". Relevant laboratory tests and procedures are available in the appropriate section.   Clinical course: The patient received COVID-19 vaccine ad26 Cov2.s (Dose number in series 1) (suspension for injection intramuscular, batch number was not reported, expiry: unknown' dose was not repotted, 1 total (dose 1) (1 in 1 once) administered on 09Apr2021 for COVID-19 prophylaxis. The batch number was not repotted. The Company is unable to perform fallow-up to request batch and lot number. Age at time of vaccination 71-years-old. Concomitant medications included hydroxy chloroquine and prednisone for drug used for unknown indications. On Oct2021, the patient experienced COVID-19 virus test positive (drug Start period: 06 months) (Dose number in series1) Laboratory data included: COVID-19 test positive. On an unspecified date, the patient experienced rheumatoid arthritis and sun blister due to being Out in Sur. a lot (Dose number in series I). The patient received additional. two doses of non-company suspect vaccine of Tozinameran (Pfizer) (Dose number in series 2) (form of admin not reported, intramuscular, batch number: unknown, expiry: dose was not reported administered on 01Apr2021 (second dose) and 02May2022 (booster dose) one in 1 Once' for COVID-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with two doses of tozinameran (Pfizer vaccine) (dose number in series 2). The patient had Non-company suspect drugs included: adalimumab (Humira) (solution injection in pre-pen, citrate free, subcutaneous, batch number was not. reported, expiry: unknown) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Caller mentioned that her brother and sister took the Pfizer Vaccine shot and are both dead now and his best friend". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: No, medical inquiry was not forwarded. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202201034250 Same drug, same event, different patient; US-PFIZER INC-202201034251 Same drug, same event, different patient; Reported Cause(s) of Death: Caller mentioned that her brother and sister took the Pfizer Vaccine shot.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she has had covid; she has had covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she has had covid".  Clinical course: Patient wanted to know if she got the second booster if they will check it to see if the Covid was present or not. She mentioned she has had covid. While checking for the information the call got disconnected. She refused to provide any of her information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative
Clinical narrative: I have Ulcerative Colitis. It has been in remission for a long time. But it is in a severe flair; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (002591).  A 69-year-old female patient received tofacitinib citrate (XELJANZ), at 10 mg; BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative Colitis" (unspecified if ongoing), notes: remission for a long time. The patient's concomitant medications were not reported. Past drug history included: Covid-19 vaccine for Covid-19 Immunization, notes: Primary Immunization Series completed; Manufacturer Unknown. The following information was reported: COLITIS ULCERATIVE (medically significant), outcome "unknown", described as "I have Ulcerative Colitis. It has been in remission for a long time. But it is in a severe flair". The action taken for tofacitinib citrate was unknown. Clinical course: Patient has ulcerative colitis. It has been in remission for a long time. But it is in a severe flair. The reporter thought that the Pfizer Covid-19 booster was what triggered this flair. The patient was also prescribed Xeljanz 10 mg.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Your so-called vaccine which is not a vaccine has killed my brother and my sister; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "Your so-called vaccine which is not a vaccine has killed my brother and my sister". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200037221 same reporter/suspect drug/event, different patient;US-PFIZER INC-PV202200037223 same reporter/suspect drug/event, different patient;; Reported Cause(s) of Death: Your so-called vaccine which is not a vaccine has killed my brother and my sister
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: give this shot to people knowing that it kills them; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "give this shot to people knowing that it kills them". The date and cause of death for the patient were unknown. It was not reported that is unknown if an autopsy was performed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200037222 same reporter/suspect drug/event, different patient;US-PFIZER INC-PV202200037221 same reporter/suspect drug/event, different patient;; Reported Cause(s) of Death: give this shot to people knowing that it kills them
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: on 8/23/2021 I got the second dose of the vaccinated and a few days later i noticed a blister on my right breast.  I did not report it then because i did not think nothing about it.  So, on 7/25/22 I got the 3rd dose and i got another blister in the same spot on my right breast.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Arthralgia, Burning sensation, Eye inflammation, Eye swelling
Clinical narrative: Severe inflammatory response developed 2 days after vaccine. Right wrist became swollen and painful at joint. Right hip/lower quadrant painful, tender-to-touch with problems bearing weight on hip. Burning feeling of gut. Severe headache. Eyes swollen with red/inflammation to left eye (slight blurriness to vision in that eye). Tachycardia. Red splotches to chest/back. Symptoms remained for approximately 48 hours. Except right wrist pain, still continues after 1 week. The right quadrant/gut burning still active but lessened. If continues; will see GI specialist.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inflammation, Joint swelling, Ocular hyperaemia, Rash macular
Clinical narrative: Severe inflammatory response developed 2 days after vaccine. Right wrist became swollen and painful at joint. Right hip/lower quadrant painful, tender-to-touch with problems bearing weight on hip. Burning feeling of gut. Severe headache. Eyes swollen with red/inflammation to left eye (slight blurriness to vision in that eye). Tachycardia. Red splotches to chest/back. Symptoms remained for approximately 48 hours. Except right wrist pain, still continues after 1 week. The right quadrant/gut burning still active but lessened. If continues; will see GI specialist.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Tenderness, Vision blurred, Weight bearing difficulty
Clinical narrative: Severe inflammatory response developed 2 days after vaccine. Right wrist became swollen and painful at joint. Right hip/lower quadrant painful, tender-to-touch with problems bearing weight on hip. Burning feeling of gut. Severe headache. Eyes swollen with red/inflammation to left eye (slight blurriness to vision in that eye). Tachycardia. Red splotches to chest/back. Symptoms remained for approximately 48 hours. Except right wrist pain, still continues after 1 week. The right quadrant/gut burning still active but lessened. If continues; will see GI specialist.
Age: 87.0
Sex: M
Vaccine: PNC20
Symptoms: Hypersensitivity, Injection site pruritus, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: rash on lwer arms bot. red. pt self administered beandryl. applied vaseline and moisturizer
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, COVID-19, Chest X-ray, Dyspnoea
Clinical narrative: Every two weeks for 4 months and the once a month for 8 months I would have severe joint pain in different joints for two to three days.  I went to the emergency room three times before I determined it was from the shot. My primary physician wouldn't believe me until I went to a bone and joint specialist and  he confirmed several other patients were reporting the same result.  I tested positive for COVID-19 on October 28, 2021 and have had extreme fatigue and shortness of breath for 10 months now.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Pulmonary function test, SARS-CoV-2 test positive
Clinical narrative: Every two weeks for 4 months and the once a month for 8 months I would have severe joint pain in different joints for two to three days.  I went to the emergency room three times before I determined it was from the shot. My primary physician wouldn't believe me until I went to a bone and joint specialist and  he confirmed several other patients were reporting the same result.  I tested positive for COVID-19 on October 28, 2021 and have had extreme fatigue and shortness of breath for 10 months now.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram abnormal, Myocarditis, Troponin increased
Clinical narrative: Patient developed severe chest pain about week after the injection. Found to have elevated troponin consistent with myocarditis. Patient was admitted to the hospital and cardiology consulted.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy site unspecified abnormal, Lip blister, Noninfective gingivitis, Oral discomfort, Skin lesion
Clinical narrative: Inflammation of gums and burning mouth and Blistered lips
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Stomatitis
Clinical narrative: Inflammation of gums and burning mouth and Blistered lips
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Oligomenorrhoea, Pain
Clinical narrative: Change in menses, more frequent instead of every 28 days about every 21 days, instead of 3-5 days of bleeding, 5-7 days of bleeding, increased pain. Still continuing 11 months later with no improvement.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Sleep disorder, Tremor
Clinical narrative: Patient woke up in the middle of the night with a high fever (patient reported 105 F) and very bad chills and shaking.  Patient stated this lasted approximately 5 hours before she was able to get back to sleep.  She reported that the fever and chills had resolved by the following morning at 10:00 AM but she was still feeling tired and fatigued.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Loss of consciousness
Clinical narrative: Woke up with significant nose bleed causing a blackout
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Decreased appetite, Intussusception, Lethargy, Surgery, Ultrasound abdomen abnormal
Clinical narrative: Intussusception 8/5/22 with bilious vomiting, lethardy, anorexia
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Intussusception 8/5/22 with bilious vomiting, lethardy, anorexia
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Cerebrovascular accident
Clinical narrative: On 7/26 @ about 1200(noon) she lost most of vision in left eye.  Saw local eye doctor at 1:00pm. He stated he believed she had a CVA in her left eye and sent us to ER. Arrived there about 4:30.  Code STROKE activated.  Saw by cardiology, nurology and optic teams. Dx with CVA left eye.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Mildly positive home test 7/28/22 after symptoms the evening before.  Took 5 days Paxlovid ending 8/1.   Home tested mildly positive 8/2.    Symptoms returning during last night and home tested strongly positive this morning.  I had a v-safe check in call back and was told if I had a breakthrough to report it this way
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Chest pain, Death, Dyspnoea, Peripheral swelling
Clinical narrative: First shot there was swelling, complained of chest pains and followed up with ER visit and visit to heart specialist Second shot there was swelling in hands and arms, breathing difficulty, death within 12 hours.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Tongue cyst
Clinical narrative: Bad headache and fatigue. White cyst-like pimple in the middle of the top of my tongue. Doctor visit on 7/25/2022.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Malaise, Nausea, Pyrexia
Clinical narrative: Patient's husband reports patient had chills, fever, and nausea in the evening the day of vaccination.  Patient went to bed and woke up the next day and told her husband she was still not feeling well.  At that time she also told him that she had been having trouble breathing the previous night.  The husband stated he was not sure if she was just having trouble catching her breath from shivering or if her airway was actually being affected.  The pharmacist advised the husband that if the patient is having trouble breathing at any time that she should seek immediate medical attention.  The husband said she was at home resting now but they would go see a doctor if she was having more trouble breathing or if symptoms got worse.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Epistaxis, Facial paralysis, Hypertension
Clinical narrative: I am very healthy, exercise, eat properly. I developed Bell's Palsy, which is now Facial Paralysis, high blood pressure, nose bleeds.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Catheterisation cardiac, Computerised tomogram, Echocardiogram, Magnetic resonance imaging, Palpitations
Clinical narrative: Palpitations, Tachycardias
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: Palpitations, Tachycardias
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Heavy menstrual bleeding, Impaired work ability, Malaise
Clinical narrative: I have had the two course vaccine in January and February 2021. I had the booster shot in December 2021 (all three moderna). I had normal reactions to each shot, including fever, headache, and body aches for several days.   What I still have are the worst and heaviest periods of my lif that started since I completed the first two vaccine doses. There is a significant difference in my cycle pre and post vaccination. I pass multiple, gigantic blood clots each cycle for days that can range from the size of a silver dollar to the entire size of my palm. In addition to clots, I go through more pads than ever and bleed significantly more. It feels like a flood. This all started post vaccination and it hasn?t subsided.  Im frustrated at how debilitating it is, how much work I miss, and how sick I get as a result of this each month.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Pain, Pyrexia, Thrombosis
Clinical narrative: I have had the two course vaccine in January and February 2021. I had the booster shot in December 2021 (all three moderna). I had normal reactions to each shot, including fever, headache, and body aches for several days.   What I still have are the worst and heaviest periods of my lif that started since I completed the first two vaccine doses. There is a significant difference in my cycle pre and post vaccination. I pass multiple, gigantic blood clots each cycle for days that can range from the size of a silver dollar to the entire size of my palm. In addition to clots, I go through more pads than ever and bleed significantly more. It feels like a flood. This all started post vaccination and it hasn?t subsided.  Im frustrated at how debilitating it is, how much work I miss, and how sick I get as a result of this each month.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose of Moderna given at a 21 day interval vs 28 day interval. 2nd dose administered too early, invalid dose that will have to be repeated
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: pharmacist on duty, administered without "dilute prior to use" for pfizer covid vaccine (age 5-11).
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: pharmacist on duty administered without "dilute prior to use" for pfizer covid vaccine (age 5-11).
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: While attempting to administer the vaccine into the left arm the patient moved. Vaccinator determined that no vaccine was given to the patient. It was determined per protocol that the vaccine be redone. The mother approved the re-administering of the vaccine. Patient was observed for a 15 minute period with no adverse events.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Crying, Vomiting
Clinical narrative: Patient vomited in waiting room. He was brought back into the exam room and assessed. VS stable and exam unremarkable. His father thought the patient threw up due to crying while getting the vaccine. Patient reported that he no longer felt like he needed to through up and that he felt "good".
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Patient complains of extreme muscle pain at site of reaction. Stated he had site pain on the day of the injection. The following day he was unable to move his arm. Today he stated that he can move his arm up and down but can not move side to side. When asked, patient stated he does not feel shoulder pain or discomfort and specified it felt like muscle pain specifically at site of injection. Patient was advised to treat pain with acetaminophen and make an appointment to be checked out.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Eye swelling, Headache, Mouth swelling, Swelling face
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Headache-Medium
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Headache-Medium
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injected limb mobility decreased, Pain in extremity
Clinical narrative: The nurse providing the injection was standing next to the sitting patient.  The injection was placed into the joint space at the superior end of the humerus, far too superior to the appropriate location (mid-deltoid).  The patient suffered severe pain and limited ROM of the left arm for a week after the vaccination.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: apx 5 cm area of erythema wheal, no treatment
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt received the wrong age appropriate dose of the Moderna COVID-19 vaccine. Pt did not have any adverse reaction.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Chills, Pyrexia
Clinical narrative: C hills. Fever weakness
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Patient states that about 24 hours after receiving vaccine, she started getting swelling in lymph nodes near her collarbone and shoulder area.  She said they are extremely sore to the touch.  She also had fever (102.1) , body aches and fatigue.  Advised patient to monitor and seek treatment if needed.  She was going to use some blue emu to help with pain.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Extremity contracture, Fatigue, Febrile convulsion, Gaze palsy, Influenza B virus test positive
Clinical narrative: Exactly 3 weeks after my son's first Covid Vaccine he had his first ever Febrile Seizure at 3:25 am on Thursday, July 28th 2022. I thought he felt warm around midnight when I was rocking him in the glider but when I took his temperature the head thermometer gave me different readings ranging from normal 98.6 degrees to 99 - 100 degrees Fahrenheit. I did not give him any fever reducing medications. At 3:25 am when he was sleeping with me in my bed I woke up to him having a full body convulsion, fists clenched and eyes rolling around. I called his name and he did not respond therefore I immediately called 911. The seizure lasted about 20 seconds (from the time I woke up and saw him). After the convulsions stopped he immediately regained conscience and started calling out to me "mama, mama" he seemed tired and would open and close his eyes. When the paramedics arrived about 10 minutes later (I stayed on the phone with the 911 operator until they arrived) they undressed him and got a reading of 100.7 degrees Fahrenheit. The ambulance took him to hospital.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea, Seizure, Skin warm
Clinical narrative: Exactly 3 weeks after my son's first Covid Vaccine he had his first ever Febrile Seizure at 3:25 am on Thursday, July 28th 2022. I thought he felt warm around midnight when I was rocking him in the glider but when I took his temperature the head thermometer gave me different readings ranging from normal 98.6 degrees to 99 - 100 degrees Fahrenheit. I did not give him any fever reducing medications. At 3:25 am when he was sleeping with me in my bed I woke up to him having a full body convulsion, fists clenched and eyes rolling around. I called his name and he did not respond therefore I immediately called 911. The seizure lasted about 20 seconds (from the time I woke up and saw him). After the convulsions stopped he immediately regained conscience and started calling out to me "mama, mama" he seemed tired and would open and close his eyes. When the paramedics arrived about 10 minutes later (I stayed on the phone with the 911 operator until they arrived) they undressed him and got a reading of 100.7 degrees Fahrenheit. The ambulance took him to hospital.