chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Swollen lymph nodes; Nausea; Injection site pain; Headache; Muscle and joint pain; Muscle and joint pain; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 44-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Dec2021 at 09:00 (Lot number: 33025BD) at the age of 44 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None". There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: 33026BD; Anatomical location: Right arm), administration date: 09Dec2021 at 09:00, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 31Dec2021 at 00:00, outcome "not recovered", described as "Swollen lymph nodes"; NAUSEA (non-serious) with onset 31Dec2021 at 00:00, outcome "not recovered", described as "Nausea"; VACCINATION SITE PAIN (non-serious) with onset 31Dec2021 at 00:00, outcome "not recovered", described as "Injection site pain"; HEADACHE (non-serious) with onset 31Dec2021 at 00:00, outcome "not recovered", described as "Headache"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 31Dec2021 at 00:00, outcome "not recovered", and all described as "Muscle and joint pain". The events "Swollen lymph nodes", "Nausea", "Injection site pain", "Headache" and "Muscle and joint pain" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy, nausea, vaccination site pain, headache, myalgia and arthralgia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; Dose 3 (booster); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Dec2021 (Lot number: FF8839) at the age of 47 years as dose 3, single, intramuscular, administered in arm left, administration date 03Mar2021 (Lot number: EN6203) as dose 1, single and intramuscular, administered in arm left, administration date 24Mar2021 (Lot number: EL3248) as dose 2, single for covid-19 immunisation. Relevant medical history included Hypothyroidism (unspecified if ongoing). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has no known allergies. Concomitant medication(s) included SYNTHROID. The following information was reported VACCINATION FAILURE (medically significant) with onset 30Dec2021, outcome unknown, COVID-19 (medically significant) with onset 30Dec2021, outcome recovering; IMMUNISATION (non-serious) with onset 07Dec2021, outcome unknown. The event tested positive for covid-19 and tested positive for covid-19 was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures sars-cov-2 test (30Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Investigation, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19 with symptoms; tested positive for Covid-19 with symptoms; booster; This is a spontaneous report received from a contactable reporter (Consumer) from product quality group. A 62-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 (Lot number: EW0186) at the age of 62 years as dose 3 (booster), single; administered in arm right, administration date 19Mar2021 (Lot number: EN6204) at the age of 61 years as dose 2, single; and administered in arm right, administration date 26Feb2021 (Lot number: EN6205) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Stroke patient" (unspecified if ongoing), notes: Stroke patient; "Heart condition" (unspecified if ongoing), notes: Heart condition. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 05Nov2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "recovering" and all described as "tested positive for Covid-19 with symptoms"; INFECTION (medically significant), outcome "recovering", described as "breakthrough infection". The events "tested positive for Covid-19 with symptoms" and "breakthrough infection" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: lung (01Jan2022) they were clear; PCR [Nasal Swab] (02Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19, infection. Additional information: The reporter reported a breakthrough infection. The reporter's husband tested positive for Covid-19. (02Jan2022) and he had some fever and cough. Since the patient was high risk, his doctor asked him to go by the ER to check his lungs and they were clear on 01Jan2022. The patient has no known allergies. The patient was not diagnosed with Covid-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The reporter considered the events was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Feeling of despair, Immunisation, Tinnitus
Clinical narrative: booster; Tinnitus; anxious; desperate; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 11Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 11Oct2021, outcome "unknown", described as "booster"; TINNITUS (non-serious) with onset 11Oct2021, outcome "not recovered", described as "Tinnitus"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "anxious"; FEELING OF DESPAIR (non-serious) with onset 2021, outcome "unknown", described as "desperate". The event "tinnitus" was evaluated at the physician office visit. Therapeutic measures were taken as a result of anxiety.  Additional information: Caller is a Dentist. Caller stated he received his booster shot of the Pfizer Biontech COVID 19 vaccine adult formulation on 11Oct2021 and that 25 min after receiving the shot to now, present day, he was been experiencing tinnitus or ring in his ears persistently. He described it as been mainly on the right side and as really loud, with a high frequency and continuous sound. Caller also stated he was has gone to different Doctors and no one has treated him. He said he was anxious and he was considering acupuncture as alternative because he is desperate. Caller asked if there was any report this side effect and any possible treatment. Caller states he know Pfizer does lots of research and was wondering if we invented any medication to treat tinnitus.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Glomerular filtration rate, Glomerular filtration rate decreased, Immunisation, Off label use, Product use issue
Clinical narrative: GFR score dropped from 58 to 48 on a scale of >60; BNT162b2 and senior flu shot administered on the same day; BNT162b2 and senior flu shot administered on the same day; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 74-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 (Lot number: FF8839) at the age of 74 years as dose 3 (booster), single for COVID-19 immunisation and also received influenza vaccine (FLU SHOTS), administration date 04Oct2021, for immunization. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing) and "Overweight" (unspecified if ongoing). Concomitant medications included: GABAPENTIN and PANTOPRAZOLE. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0150; Anatomical site: Left Arm; Route of administration: Unspecified), administration date: 03Apr2021, when the patient was 74 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot Number: EN6202; Anatomical site: Left Arm; Route of administration: Unspecified), administration date: 13Mar2021, when the patient was 74 years old, for COVID-19 immunisation.  The following information was reported: OFF LABEL USE (non-serious) and PRODUCT USE ISSUE (non-serious), both with onset 04Oct2021, outcome "unknown", and described as "BNT162b2 and senior flu shot administered on the same day"; IMMUNISATION (non-serious) with onset 04Oct2021, outcome "unknown", described as "Dose number: 3"; GLOMERULAR FILTRATION RATE DECREASED (non-serious) with onset 24Nov2021, outcome "unknown", described as "GFR score dropped from 58 to 48 on a scale of >60". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of glomerular filtration rate decreased.  Additional information: The patient had no known allergies. The patient was not diabetic and had no high blood pressure. The patient received other vaccines within four weeks prior to the COVID vaccine which included influenza vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient queried if decrease in GFR was a known possible side effect of the COVID vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04Nov2021 (Lot number: EW0217) at the age of 31 years as dose 3 (booster), single, administration date 13Mar2021 (Lot number: EN6207) as dose 2, single and administration date 19Feb2021 (Lot number: EL9266) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. No COVID prior vaccination. No known allergies. Concomitant medication(s) included: METHIMAZOLE. No other vaccine in four weeks. The following information was reported: IMMUNISATION (medically significant) with onset 04Nov2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "Tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Cyanosis, Drug ineffective, Fall
Clinical narrative: died of Covid; died of Covid; was found collapsed and blue in their house; was found collapsed and blue in their house; This is a spontaneous report received from a contactable reporter (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, hospitalization, medically significant), COVID-19 (death, hospitalization, medically significant), outcome "fatal" and all described as "died of Covid"; CYANOSIS (death, hospitalization), FALL (death, hospitalization), outcome "fatal" and all described as "was found collapsed and blue in their house". The patient was found collapsed and blue, and was taken to ICU, and then died, date of death was unknown around 25Nov2021. The reported cause of death was covid-19, cyanosis, fall. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the limited information in the case the association between the fatal events of Drug Ineffective, COVID-19, Cyanosis and Fall and the suspect product of BNT162B2 cannot be completely ruled out. The case will be reassessed on receiving follow up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: died of Covid; was found collapsed and blue in their house; was found collapsed and blue in their house
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: their neighbor down the street had died of Covid; This is a spontaneous report received from non-contactable Consumer.  An elderly patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: The reporter had mentioned that most people in her parent's living community were vaccinated, but that their neighbor down the street had died of Covid. The reporter did not know if that individual was vaccinated but this was an important detail. The patient date of death was unknown. The reported cause of death was COVID-19. It was unknown if an autopsy was performed.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: their neighbor down the street had died of Covid
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: breakthrough covid case. Filling out this form as directed by pfizer occupational health.; breakthrough covid case. Filling out this form as directed by pfizer occupational health.; Dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 20Oct2021 11:00 (Lot number: FF8841) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN 5318, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 18Feb2021, when the patient was 25 years old, for COVID-19 immunization, reaction(s): "breakthrough covid case"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN 5318, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 27Jan2021, when the patient was 25 years old, for COVID-19 immunization, reaction(s): "breakthrough covid case". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 25Dec2021, outcome "not recovered" and all described as "breakthrough covid case. Filling out this form as directed by pfizer occupational health."; IMMUNISATION (non-serious) with onset 20Oct2021, outcome "unknown", described as "Dose number=3". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Dec2021) negative, notes: Nasal Swab; (29Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, vaccination failure. No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Lymph node pain
Clinical narrative: Headache; Chills; Sore lymph node in breast on the side vaccine was given in arm.; Dose received: 3; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 30Dec2021 at 16:00 (Lot number: unknown) at the age of 58 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Anatomical Location: Left arm, Administration time: 15:00), administration date: 06Apr2021, when the patient was 58 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Anatomical Location: Left arm, Administration time: 16:00), administration date: 27Apr2021, when the patient was 58 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021 at 16:00, outcome "unknown", described as "Dose received: 3"; HEADACHE (non-serious) with onset 31Dec2021 at 07:00, outcome "recovering", described as "Headache"; CHILLS (non-serious) with onset 31Dec2021 at 07:00, outcome "recovering", described as "Chills"; LYMPH NODE PAIN (non-serious) with onset 31Dec2021 at 07:00, outcome "recovering", described as "Sore lymph node in breast on the side vaccine was given in arm". Therapeutic measures were not taken as a result of headache, chills and lymph node pain.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   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, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; got covid the first time in September/The worst thing I got for Christmas...Covid; got covid the first time in September/The worst thing I got for Christmas...Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster dose), single, administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 19Feb2021 (working off a very blurry image for this date) (Batch/Lot number: unknown) as dose 1, single (at age of 34-year-old) for covid-19 immunisation. Seemed like a date of 12Mar2021 may have been given for the target date of the second dose (unless this was a separate vaccine). It was unsure when received booster or when actually got second shot. Booster could have happened between both covid cases. Relevant medical history included: "has had issues with weight, unsure otherwise" (unspecified if ongoing); "potentially some mental health struggles" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2021, outcome "unknown" and all described as "got covid the first time in September/The worst thing I got for Christmas...COVID". The patient had COVID in Sep2021 (approximately 16 weeks ago), and now in Dec2021 the patient had it for a second time. The patient felt 100% better on last day of isolation when got COVID the first time in Sep2021. COVID was ongoing for the current Dec2021-Jan2022 case. The patient may have caught or contracted COVID around Christmas-time or got exposed to someone with COVID over Christmas. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Sep2021) positive; (Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Back pain, COVID-19, Cough
Clinical narrative: I was not feeling well; I am experiencing mild symptoms of cough; nasal congestion; tired; back pain; lost my taste and smell; lost my taste and smell; took a rapid test yesterday which came out positive for COVID; took a rapid test yesterday which came out positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Iron deficiency anemia" (unspecified if 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 30Dec2021, outcome "unknown" and all described as "took a rapid test yesterday which came out positive for COVID"; MALAISE (non-serious), outcome "recovering", described as "I was not feeling well"; COUGH (non-serious), outcome "recovering", described as "I am experiencing mild symptoms of cough"; NASAL CONGESTION (non-serious), outcome "recovering", described as "nasal congestion"; FATIGUE (non-serious), outcome "not recovered", described as "tired"; BACK PAIN (non-serious), outcome "recovering", described as "back pain"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "lost my taste and smell". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective, covid 19 cannot be totally excluded.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Malaise, Nasal congestion, SARS-CoV-2 test
Clinical narrative: I was not feeling well; I am experiencing mild symptoms of cough; nasal congestion; tired; back pain; lost my taste and smell; lost my taste and smell; took a rapid test yesterday which came out positive for COVID; took a rapid test yesterday which came out positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Iron deficiency anemia" (unspecified if 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 30Dec2021, outcome "unknown" and all described as "took a rapid test yesterday which came out positive for COVID"; MALAISE (non-serious), outcome "recovering", described as "I was not feeling well"; COUGH (non-serious), outcome "recovering", described as "I am experiencing mild symptoms of cough"; NASAL CONGESTION (non-serious), outcome "recovering", described as "nasal congestion"; FATIGUE (non-serious), outcome "not recovered", described as "tired"; BACK PAIN (non-serious), outcome "recovering", described as "back pain"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "lost my taste and smell". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective, covid 19 cannot be totally excluded.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Exposure to SARS-CoV-2, Fatigue, Immunisation
Clinical narrative: Covid test result: Positive; Covid test result: Positive; dizziness; fatigue; runny nose; Patient was exposed to covid 29Dec2021; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 31 year-old patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: FF2589) at the age of 31 years as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 08Oct2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "Covid test result: Positive"; EXPOSURE TO SARS-COV-2 (non-serious) with onset 29Dec2021, outcome "unknown", described as "Patient was exposed to covid 29Dec2021"; DIZZINESS (non-serious) with onset 31Dec2021, outcome "recovering", described as "dizziness"; FATIGUE (non-serious) with onset 31Dec2021, outcome "recovering", described as "fatigue"; RHINORRHOEA (non-serious) with onset 31Dec2021, outcome "recovering", described as "runny nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive, notes: Nasal Swab; (02Jan2022) positive, notes: Unknown; (02Jan2022) unknown results/ pending, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, dizziness, fatigue, rhinorrhoea. Patient was exposed to covid 29Dec then symptoms of dizziness fatigue and runny nose on 31Dec.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result: Positive; Covid test result: Positive; dizziness; fatigue; runny nose; Patient was exposed to covid 29Dec2021; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 31 year-old patient received bnt162b2 (BNT162B2), administration date 08Oct2021 (Lot number: FF2589) at the age of 31 years as dose 3 (booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 08Oct2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "Covid test result: Positive"; EXPOSURE TO SARS-COV-2 (non-serious) with onset 29Dec2021, outcome "unknown", described as "Patient was exposed to covid 29Dec2021"; DIZZINESS (non-serious) with onset 31Dec2021, outcome "recovering", described as "dizziness"; FATIGUE (non-serious) with onset 31Dec2021, outcome "recovering", described as "fatigue"; RHINORRHOEA (non-serious) with onset 31Dec2021, outcome "recovering", described as "runny nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive, notes: Nasal Swab; (02Jan2022) positive, notes: Unknown; (02Jan2022) unknown results/ pending, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, dizziness, fatigue, rhinorrhoea. Patient was exposed to covid 29Dec then symptoms of dizziness fatigue and runny nose on 31Dec.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Dyspnoea, Loss of consciousness, Pulmonary thrombosis, SARS-CoV-2 test
Clinical narrative: Developed a large blood clot in my leg; passed out before being hospitalized.; pieces broke off and traveled to my lungs.; One clot in particular was very large and my artery was dilated and one side of my heart was under a lot of stress.; I experienced difficulty breathing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. No known allergies. No Covid prior vaccination. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. No other vaccine in four weeks or other medications in two weeks. The following information was reported: THROMBOSIS (hospitalization, disability, life threatening), outcome "recovered with sequelae", described as "Developed a large blood clot in my leg"; LOSS OF CONSCIOUSNESS (hospitalization, disability, life threatening), outcome "recovered with sequelae", described as "passed out before being hospitalized."; PULMONARY THROMBOSIS (hospitalization, disability, life threatening), outcome "recovered with sequelae", described as "pieces broke off and traveled to my lungs."; CARDIAC DISCOMFORT (hospitalization, disability, life threatening), outcome "recovered with sequelae", described as "One clot in particular was very large and my artery was dilated and one side of my heart was under a lot of stress."; DYSPNOEA (hospitalization, disability, life threatening), outcome "recovered with sequelae", described as "I experienced difficulty breathing". The patient was hospitalized for thrombosis, loss of consciousness, pulmonary thrombosis, cardiac discomfort, dyspnoea (hospitalization duration: 8 day(s)). The events "developed a large blood clot in my leg", "passed out before being hospitalized.", "pieces broke off and traveled to my lungs.", "one clot in particular was very large and my artery was dilated and one side of my heart was under a lot of stress." and "i experienced difficulty breathing" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of thrombosis, loss of consciousness, pulmonary thrombosis, cardiac discomfort, dyspnea with Catheter inserted in groin to deliver medication. Clinical course: Developed a large blood clot in the leg and pieces broke off and traveled to the lungs. One clot in particular was very large and her artery was dilated and one side of her heart was under a lot of stress. She experienced difficulty breathing and passed out before being hospitalized.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Developed a large blood clot in my leg; passed out before being hospitalized.; pieces broke off and traveled to my lungs.; One clot in particular was very large and my artery was dilated and one side of my heart was under a lot of stress.; I experienced difficulty breathing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. No known allergies. No Covid prior vaccination. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. No other vaccine in four weeks or other medications in two weeks. The following information was reported: THROMBOSIS (hospitalization, disability, life threatening), outcome "recovered with sequelae", described as "Developed a large blood clot in my leg"; LOSS OF CONSCIOUSNESS (hospitalization, disability, life threatening), outcome "recovered with sequelae", described as "passed out before being hospitalized."; PULMONARY THROMBOSIS (hospitalization, disability, life threatening), outcome "recovered with sequelae", described as "pieces broke off and traveled to my lungs."; CARDIAC DISCOMFORT (hospitalization, disability, life threatening), outcome "recovered with sequelae", described as "One clot in particular was very large and my artery was dilated and one side of my heart was under a lot of stress."; DYSPNOEA (hospitalization, disability, life threatening), outcome "recovered with sequelae", described as "I experienced difficulty breathing". The patient was hospitalized for thrombosis, loss of consciousness, pulmonary thrombosis, cardiac discomfort, dyspnoea (hospitalization duration: 8 day(s)). The events "developed a large blood clot in my leg", "passed out before being hospitalized.", "pieces broke off and traveled to my lungs.", "one clot in particular was very large and my artery was dilated and one side of my heart was under a lot of stress." and "i experienced difficulty breathing" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of thrombosis, loss of consciousness, pulmonary thrombosis, cardiac discomfort, dyspnea with Catheter inserted in groin to deliver medication. Clinical course: Developed a large blood clot in the leg and pieces broke off and traveled to the lungs. One clot in particular was very large and her artery was dilated and one side of her heart was under a lot of stress. She experienced difficulty breathing and passed out before being hospitalized.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Gait disturbance, Limb mass, Malaise, Peripheral swelling
Clinical narrative: DVT - Deep Vein Thrombosis; Blood Clot; was not feeling well; left leg was very swollen; left leg was very hard; he could not walk comfortably.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 18:00 (Lot number: 30145BA) at the age of 64 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "onion/garlic allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: 30145BA, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 19Oct2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: DEEP VEIN THROMBOSIS (hospitalization, medically significant, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "DVT - Deep Vein Thrombosis"; THROMBOSIS (hospitalization, medically significant, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "Blood Clot"; MALAISE (hospitalization, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "was not feeling well"; PERIPHERAL SWELLING (hospitalization, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "left leg was very swollen"; LIMB MASS (hospitalization, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "left leg was very hard"; GAIT DISTURBANCE (hospitalization, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "he could not walk comfortably.". The patient was hospitalized for deep vein thrombosis, thrombosis, malaise, peripheral swelling, limb mass, gait disturbance (start date: Dec2021, discharge date: Dec2021, hospitalization duration: 4 days). The events "dvt - deep vein thrombosis", "blood clot", "was not feeling well", "left leg was very swollen", "left leg was very hard" and "he could not walk comfortably." were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of deep vein thrombosis, thrombosis, malaise, peripheral swelling, limb mass, gait disturbance and included treatment with blood thinner and angioplasty. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. There were no list of any other medications the patient received within 2 weeks of vaccination. On 03Dec2021 (on Friday), 15 days after taking his second Covid Vaccine by Pfizer, the patient was not feeling well. By late evening, the patient's left leg was very swollen and hard and he could not walk comfortably. The patient was transported by ambulance to the hospital where he was treated for a DVT-deep vein thrombosis.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: DVT - Deep Vein Thrombosis; Blood Clot; was not feeling well; left leg was very swollen; left leg was very hard; he could not walk comfortably.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 18:00 (Lot number: 30145BA) at the age of 64 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "onion/garlic allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: 30145BA, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 19Oct2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: DEEP VEIN THROMBOSIS (hospitalization, medically significant, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "DVT - Deep Vein Thrombosis"; THROMBOSIS (hospitalization, medically significant, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "Blood Clot"; MALAISE (hospitalization, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "was not feeling well"; PERIPHERAL SWELLING (hospitalization, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "left leg was very swollen"; LIMB MASS (hospitalization, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "left leg was very hard"; GAIT DISTURBANCE (hospitalization, life threatening) with onset 03Dec2021 22:00, outcome "recovering", described as "he could not walk comfortably.". The patient was hospitalized for deep vein thrombosis, thrombosis, malaise, peripheral swelling, limb mass, gait disturbance (start date: Dec2021, discharge date: Dec2021, hospitalization duration: 4 days). The events "dvt - deep vein thrombosis", "blood clot", "was not feeling well", "left leg was very swollen", "left leg was very hard" and "he could not walk comfortably." were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of deep vein thrombosis, thrombosis, malaise, peripheral swelling, limb mass, gait disturbance and included treatment with blood thinner and angioplasty. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. There were no list of any other medications the patient received within 2 weeks of vaccination. On 03Dec2021 (on Friday), 15 days after taking his second Covid Vaccine by Pfizer, the patient was not feeling well. By late evening, the patient's left leg was very swollen and hard and he could not walk comfortably. The patient was transported by ambulance to the hospital where he was treated for a DVT-deep vein thrombosis.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Drug ineffective, Fatigue
Clinical narrative: Covid-19 rapid test came back positive; Covid-19 rapid test came back positive; chills; fatigue; cough; congestion; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 37 years as dose number unknown, single 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) all with onset 30Dec2021, outcome "unknown" and all described as "Covid-19 rapid test came back positive"; CHILLS (non-serious) with onset 29Dec2021, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 29Dec2021, outcome "not recovered", described as "fatigue"; COUGH (non-serious) with onset 29Dec2021, outcome "not recovered", described as "cough"; PAIN (non-serious) with onset 29Dec2021, outcome "not recovered", described as "body aches"; NASAL CONGESTION (non-serious) with onset 29Dec2021, outcome "not recovered", described as "congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive. Clinical course: On the evening of 29Dec2021 patient became quickly I'll with chills, fatigue, cough, body aches, and congestion. The morning of 30Dec2021 patient work up not better and went for a Covid test. Patients Covid-19 rapid test came back positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, SARS-CoV-2 test
Clinical narrative: Covid-19 rapid test came back positive; Covid-19 rapid test came back positive; chills; fatigue; cough; congestion; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 37 years as dose number unknown, single 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) all with onset 30Dec2021, outcome "unknown" and all described as "Covid-19 rapid test came back positive"; CHILLS (non-serious) with onset 29Dec2021, outcome "not recovered", described as "chills"; FATIGUE (non-serious) with onset 29Dec2021, outcome "not recovered", described as "fatigue"; COUGH (non-serious) with onset 29Dec2021, outcome "not recovered", described as "cough"; PAIN (non-serious) with onset 29Dec2021, outcome "not recovered", described as "body aches"; NASAL CONGESTION (non-serious) with onset 29Dec2021, outcome "not recovered", described as "congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive. Clinical course: On the evening of 29Dec2021 patient became quickly I'll with chills, fatigue, cough, body aches, and congestion. The morning of 30Dec2021 patient work up not better and went for a Covid test. Patients Covid-19 rapid test came back positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Rash
Clinical narrative: rash over entire body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "rash over entire body". The event "rash over entire body" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional information: Patient took the first two vaccine shots and broke out in a rash over my entire body. Patient have seen Dermatologist and have taken all the medications he has prescribed all to no avail. They are getting expensive for me as I am on a fixed income. The Dr. even did a biopsy the last visit.  The lot number for bnt162b2 was not provided and will be requested during follow up.