chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Throwing up for almost a week, she's violently throwing up, can't hold anything down liquid or food; Severe pain; If you just touch her, her whole body is like on fire; Headache; Senses are magnified, her sense of smell is overwhelming. Her hearing, she is in tears because just somebody talking to her in a normal voice is like they are screaming at her; Can't taste anything; This is a spontaneous report from a contactable consumer, reporting on behalf of a friend (Patient) via India Call Centre. A female patient (Friend) of an unspecified age received second dose bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The Patient's Medical history included Blood cancer, Heart problems and concomitant medications included unspecified heart medications. The Patient received first dose of historical vaccine, bnt162b2 on an unspecified date for covid-19 immunisation. It was reported that the patient has been throwing up for almost a week, she was violently throwing up. She cannot hold anything down liquid or food. She has had severe pain like if you just touch her, her whole body was like on fire, have a horrible headache, her senses are magnified, her sense of smell was overwhelming. Her hearing, she was in tears because just somebody talking to her in a normal voice was like they were screaming at her. Taste, well she cannot taste anything because has not been eating anything on an unspecified date around 23Feb2021 (Reporter was not sure about the date). Reporter stated, "That they don't have. She has been throwing up for a week and she has had vaccine probably 3 days prior to that 2 or 3 days prior to that." Reporter stated, When probed if still experiencing events (event not specified), "Yes it continues to get worse." It was also reported that that patient was in the hospital right now. They believe that she has had a reaction to her Pfizer vaccine, the hospital there doesn't seem to know what to do, they were kind of just given up on her and we don't know who to contact for help. The Clinical outcome of the events was unknown.  Information about batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable consumer (patient) via pfizer sponsored program.  A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number and expiry date: unknown), on an unspecified route of administration on 12Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient received the first dose of vaccine on 12Feb2021. On an unknown date in 2021, the patient tested positive for COVID. The patient had scheduled her second dose of vaccine on 06Mar2021 and was worried if she can continue for second dose. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: received 1st dose of Covid vaccine and then found out the next day that he had Covid; the next day that he had Covid; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient (son) reported that.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was that reporters son received 1st dose of Covid vaccine and then found out the next day that he had Covid. Wondering what to do about 2nd dose. Caller also wants to know if there was any more information available about pregnant women and the Covid vaccine. The patient underwent lab tests and procedures which included sars-cov-2 antibody test was positive on unspecified date. Outcome of the events were unknown.  Information about Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Drug ineffective; had her first dose and tested positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that (reporting for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was vaccinated with the first dose and tested positive. She was scheduled to have 2nd dose on 09Mar2021 and based on the information given to her, there should be a 30days interval before getting the 2nd shot if someone tested positive for Covid (drug ineffective and covid-19). She would like to confirm if that information is correct. The patient underwent lab tests and procedures which included sars-cov-2 antibody test and was positive on unspecified date. Case considered as serious (medically significant). Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Incontinence, Investigation, Loss of consciousness, Malaise
Clinical narrative: unconscious about 2 minutes; moderate headache; I had a general unwell feeling; nauseated; incontinent; I became faint; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient had received first dose of COVID-19 vaccine previously. The patient stated that they had their second Covid-19 vaccine on 16Feb2021. Approximately 10 hours (on 16Feb2021) afterward the patient developed a moderate headache, which 400 mg of ibuprofen eased. The patient had a general unwell feeling much of the following day (16Feb2021), so the patient rested and napped. About 36 hours after the injection the patient became faint, nauseated, and incontinent. The patient was unconscious about 2 minutes. The patient was taken by ambulance to the hospital and remained through the night for observation for the event loss of consciousness. To date, all the tests were negative. The patient received treatment for the event headache. The outcome of the event headache was recovering. The outcome of the events loss of consciousness, syncope, malaise and nausea was unknown.  Information about Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Syncope
Clinical narrative: unconscious about 2 minutes; moderate headache; I had a general unwell feeling; nauseated; incontinent; I became faint; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient had received first dose of COVID-19 vaccine previously. The patient stated that they had their second Covid-19 vaccine on 16Feb2021. Approximately 10 hours (on 16Feb2021) afterward the patient developed a moderate headache, which 400 mg of ibuprofen eased. The patient had a general unwell feeling much of the following day (16Feb2021), so the patient rested and napped. About 36 hours after the injection the patient became faint, nauseated, and incontinent. The patient was unconscious about 2 minutes. The patient was taken by ambulance to the hospital and remained through the night for observation for the event loss of consciousness. To date, all the tests were negative. The patient received treatment for the event headache. The outcome of the event headache was recovering. The outcome of the events loss of consciousness, syncope, malaise and nausea was unknown.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood immunoglobulin G, Dizziness, Dysgeusia, Fatigue, Feeling abnormal
Clinical narrative: when they gave me the vaccination I was in the bed the whole time almost 2 weeks; had Meniere's disease and made worse; hard to breath; did not feel good; could taste sodium in her mouth; felt tired for two days; She felt very dizzy immediately after receiving the vaccine; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 19Apr2021, this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient medical history included Meniere's' disease, ongoing Allergies, ongoing Asthma and sulfa deadly to me. The patient concomitant medication was not reported. The patient reported I was in the bed the whole time almost 2 weeks. The felt tired for two days, she felt very dizzy immediately after receiving the vaccine and could taste sodium in her mouth and it was hard to breath. The patient did not feel good and felt tired for two days. The patient had Meniere's disease and made worse. The patient took Prednisone and rescue inhalers as a treatment medication to all the events. The patient also questioned about the ingredients of vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immobile, Meniere's disease
Clinical narrative: when they gave me the vaccination I was in the bed the whole time almost 2 weeks; had Meniere's disease and made worse; hard to breath; did not feel good; could taste sodium in her mouth; felt tired for two days; She felt very dizzy immediately after receiving the vaccine; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 19Apr2021, this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient medical history included Meniere's' disease, ongoing Allergies, ongoing Asthma and sulfa deadly to me. The patient concomitant medication was not reported. The patient reported I was in the bed the whole time almost 2 weeks. The felt tired for two days, she felt very dizzy immediately after receiving the vaccine and could taste sodium in her mouth and it was hard to breath. The patient did not feel good and felt tired for two days. The patient had Meniere's disease and made worse. The patient took Prednisone and rescue inhalers as a treatment medication to all the events. The patient also questioned about the ingredients of vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood sodium, Blood test, Dyspnoea, Taste disorder, Vaccination site pain
Clinical narrative: when they gave me the vaccination I was in the bed the whole time almost 2 weeks; had Meniere's disease and made worse; hard to breath; did not feel good; could taste sodium in her mouth; felt tired for two days; She felt very dizzy immediately after receiving the vaccine; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 19Apr2021, this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient medical history included Meniere's' disease, ongoing Allergies, ongoing Asthma and sulfa deadly to me. The patient concomitant medication was not reported. The patient reported I was in the bed the whole time almost 2 weeks. The felt tired for two days, she felt very dizzy immediately after receiving the vaccine and could taste sodium in her mouth and it was hard to breath. The patient did not feel good and felt tired for two days. The patient had Meniere's disease and made worse. The patient took Prednisone and rescue inhalers as a treatment medication to all the events. The patient also questioned about the ingredients of vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight
Clinical narrative: when they gave me the vaccination I was in the bed the whole time almost 2 weeks; had Meniere's disease and made worse; hard to breath; did not feel good; could taste sodium in her mouth; felt tired for two days; She felt very dizzy immediately after receiving the vaccine; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 19Apr2021, this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient medical history included Meniere's' disease, ongoing Allergies, ongoing Asthma and sulfa deadly to me. The patient concomitant medication was not reported. The patient reported I was in the bed the whole time almost 2 weeks. The felt tired for two days, she felt very dizzy immediately after receiving the vaccine and could taste sodium in her mouth and it was hard to breath. The patient did not feel good and felt tired for two days. The patient had Meniere's disease and made worse. The patient took Prednisone and rescue inhalers as a treatment medication to all the events. The patient also questioned about the ingredients of vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Condition aggravated
Clinical narrative: Auto-immune flare up; Lichen Sclerosus and had a flare up 2 days following shot; This is a spontaneous report received from a non-contactable other HCP (patient herself). A 38-year-old female patient received second dose of BNT162B2 (Solution for injection, lot number: unknown, Expiration date: Unknown) on 17Feb2021 18:30 via unspecified route of administration as SINGLE DOSE for covid-19 immunisation. The patient medical history included Lichen Sclerosus ongoing from an unknown date. The patient has not allergies. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Solution for injection, lot number: unknown, Expiration date: Unknown) on 27Jan2021 18:30 via unspecified route of administration as SINGLE DOSE for covid-19 immunisation. The patient had no other vaccine within four weeks. The patient was not tested for COVID-19 prior to vaccination and not post vaccination. Two days after her second dose of vaccination, on 19Feb2021, the patient had flare up of Lichen Sclerosus over the weekend and had a flare up 2 days following shot. Treatment medication was given Clobetesol. The outcome of the events was recovered.   Follow up Information on batch/lot number was requested.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular, Rash papular
Clinical narrative: I am fine except these little red bumps come up; rash; red spots /blotches; This is a spontaneous report received from a contactable consumer (patient himself). An 89-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included cancer sores and History of cancer. The patient's concomitant medications were not reported. Patient previously took first dose of COVID-19 vaccine for COVID-19 immunization and he states that he has red spots/blotches on his ankles, hips, back and chest. The patient experienced fine except little red bumps come up on an unspecified date and was hospitalized. He also experienced rash on an unspecified date. Therapeutic measures for the rash included he had an unspecified cream two times a day. The outcome for the both the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive  after the 1st dose; tested positive  after the 1st dose; This is a spontaneous from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was tested positive after his 1st dose of vaccine. The consumer already received 2 doses of the vaccine; she received her 2nd dose last Saturday (unspecified date). She inquired if she needed to be quarantined from the patient or if she could go to work. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Head injury, SARS-CoV-2 test, Wound haemorrhage
Clinical narrative: noticed cut on my head, stopped bleeding with gentle pressure; noticed cut on my head, stopped bleeding with gentle pressure; Fell in my bedroom; felt dizzy for a few seconds; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: EL3302) via Intramuscular in deltoid muscle on 18Jan2021 at 10 AM as single dose for COVID-19 immunisation in nursing home/senior living facility. Patient's medical history included high cholesterol, acid reflux, both ongoing. Concomitant medications included ongoing simvastatin oral for high cholesterol (for years), oral generic acid reducer for acid reflux (for years). On Wednesday 20Jan2021 at 11 AM he fell in bedroom in narrow area between bed, bookcase, and file cabinet. Did not lose consciousness but felt dizzy for a few seconds. Got up quickly; noticed cut on his head; stopped bleeding with gentle pressure. The patient underwent lab test which included Covid 19 test on 07Jul2020: Negative. Initiation of new medication / other treatment / procedure was not required for event. The outcome of event cut on his head was unknown, for other events was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Fatigue, Lymphadenopathy, Mastication disorder
Clinical narrative: tiredness/chill; tiredness/chill; left lymph node in jaw swollen; couldnt bite or chew on left side; This is a spontaneous report from a contactable consumer. This 62-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6207) intramuscularly on left arm on 12Mar2021 15:00 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8734) intramuscularly on left arm on 02Apr2021 15:50 as single dose for COVID-19 immunisation. The patient medical history included history included anticoagulant therapy, gastro oesophageal reflux disease, blood cholesterol abnormal and blood pressure abnormal. The patient concomitant medications included Eliquis for blood thinner from 15Apr2020 (ongoing), Omeprazole-DR 20mg for acid reflux from 12Dec2020 (ongoing), Atorvastatin for cholesterol from 15Apr2020 (ongoing), Lisinopril for blood pressure from 2018 (ongoing). On 16Mar2021 at about 07:00 hours, she had her left lymph node in jaw swollen and could not bite or chew on left side. On 03Apr2021 about at about 14:00 hours, she had tiredness/chill. She states that she was on blood thinners and takes Eliquis and no one asked her at the vaccination site. She did not know if that was a complicated adverse event and did not tell them and would like to know why it was mentioned in the factsheet and if there was something she should be looking out for. Treated with Tylenol and clod compress had eased. No relevant tests were done. No Adverse reaction to vaccine from Eliquis. No prior vaccinations. Outcome was recovering for left lymph node in jaw swollen and could not bite or chew on left side and recovered for tiredness/chill.  Follow-up (12Mar2021): This is a follow-up spontaneous report from a Pfizer sponsored program.  Information on lot number/batch number has been requested.  Follow up (13Apr2021): This is a follow-up spontaneous report from a contactable consumer which included information on dose, start dates, route of administration, concomitant medications and adverse events.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Investigation, Neuromyelitis optica spectrum disorder, Visual acuity reduced
Clinical narrative: Other vaccine same date details/other vaccine same date product; mild visual acuity decrease/slight decrease Visual Acuity and depth perception; Neuromyelitis optica exacerbation; This is a spontaneous report from a contactable Physician. A 68-years-old (non-pregnant) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9265, expiration date was not provided), via intramuscular route of administration at right arm on 09Feb2021 14:00 (at the age of 68-years-old) as single dose for COVID-19 immunization. Medical history included Addisons Ds, hypertension, Post Hysterectomy, Optic Neuritis type symptoms and Minor visual symptom. Concomitant medications included amlodipine for hypertension, estradiol for hysterectomy, fludrocortisone for addisons disease, hydrocortisone for addison's disease, metoprolol hypertension olmesartan hypertension. On 28Feb2021, the patient awoke with slight decrease visual acuity and depth perception and neuromyelitis Optica exacerbation and required visit to physician office. Other vaccine same date details/other vaccine same date product. The patient was treated with solumedrol high dose iv starting Rituxan Infusions for event neuromyelitis Optica exacerbation. The seriousness of the event neuromyelitis Optica exacerbation was considered as medically significant. The patient was not pregnant at the time of vaccination. The patient did not have any known allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient provided information to you regarding the reported adverse event(s) with the use of the product as consider the Pfizer product had a casual effect to the adverse event. The outcome of the event was event neuromyelitis Optica exacerbation was recovering on 03Mar2021, and outcome of other events was unknown.  No follow-up attempts are needed. No further Information is expected.; Sender's Comments: Based on medical history and concurrent disease the event neuromylitis optica progression and visual acuity decreased mostly represented intercurrent condition in this patient unrelated to Bnt162b2.   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 RAs, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male consumer reported for himself that he received the first dose of the Pfizer COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number/expiry date: unknown) via an unspecified route of administration as a single dose for COVID-19 immunization on 23Feb2021. The patients past medical history and concomitant medications were not reported. The patient reported that he received the first dose of the Pfizer COVID-19 and was tested positive for COVID on 01Mar2021." He received monoclonal antibodies via IV. Patient was scheduled to receive the second dose tomorrow. He wants to know if he can still receive the second dose as scheduled.  E-transmitting AE due to long hold time, requested a call back.  Information regarding lot/batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he received the first dose of Pfizer COVID vaccine on 09Mar2021.On 17Mar2021, he tested positive for COVID and is wondering if he is still able to get his second dose on 30Mar2021 as scheduled.; This is a spontaneous report from a contactable consumer or other non-HCP via Medical Information Team. A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 09Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 17Mar2021, patient underwent lab tests and procedures which included sars-cov-2 test which patient got positive for covid and was wondering if he could still be able to get his second dose on 30mar2021 as scheduled. The outcome of the event was unknown. No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sacroiliitis, X-ray
Clinical narrative: sacroiliitis; pain in her thigh; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date it was reported that patient was due for her 2nd dose and wanted to know if she can take the vaccine. She was diagnosed with sacroiliitis by her doctor upon her X-Ray. She did not experience any side effects after the first dose but had pain in her thigh. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received both doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on and unspecified dates in Dec2020 and Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 13Mar2021, the patient tested positive for the virus. Fortunately, the patient had a mild case. The seriousness of the event was considered as medically significant. Outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Peripheral swelling, Vaccination site haemorrhage, Vaccination site induration
Clinical narrative: blood under the bandaid where injection was; arm was swollen; injection site felt like a ball; colorless liquid under the bandaid where injection was/wondering if she received the full dose; This is a spontaneous report from a contactable pharmacist from a sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 27Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. On 27Mar2021, the patient experienced blood under the bandaid where injection was, arm was swollen, injection site felt like a ball, and colorless liquid under the bandaid where injection was/wondering if she received the full dose. The clinical details were reported as: When the patient got home, she noticed blood and a colorless liquid under the band aid where her injection was. The patient stated that she had no fever, fatigue, or chills but her arm was swollen. She was questioning whether she got a valid dose/full dose. The pharmacist stated they use collapsible needles to administer the vaccine and was inquiring about back flow. The clinical outcome of blood under the bandaid where injection was, arm was swollen, injection site felt like a ball, and colorless liquid under the bandaid where injection was/wondering if she received the full dose was unknown.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: 103F fever; Chills; Body aches; Headache; This is a spontaneous report from a contactable consumer (patient). This 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 27Mar2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, foods or other products, was not diagnosed with COVID-19 prior to vaccination and had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number unknown) on 06Mar2021 (at the age of 41-years-old) in the right arm for COVID-19 immunisation. On 27Mar2021 the patient experienced 103 Fahrenheit (F) fever, chills, and body aches starting 9 hours following injection. The patient reported the duration of side effects as 48 hours, continued by headache thereafter that had yet to subside. No treatment was provided for the events. The clinical outcomes of 103F fever, chills, and body aches were recovered on 29Mar2021. The clinical outcome of headache was not recovered. The patient also however reported the outcome of unspecified reaction as recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: brain fog; Mild Headache; swelling in hands; fever; joint pain; Extreme Fatigue/ severe fatigue; Dizziness; This is a spontaneous report received from a contactable consumer (patient). This 54-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 14:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, no known allergies to medications, food, or other products, had not been diagnosed with COVID-19 prior to vaccination and had not received any other vaccines within 4-weeks prior to the COVID vaccine. The patient had no concomitant medications. On 30Mar2021 at 19:00 the patient experienced extreme fatigue and dizziness four hours after vaccination; six hours post-vaccination the patient experienced mild headache, swelling in hands, fever, and joint pain. The patient further reported the next day she had mild hand swelling, severe fatigue, brain fog and mild joint pain. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of extreme fatigue, dizziness, mild headache, swelling in hands, fever, joint pain, and brain fog were recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: brain fog; Mild Headache; swelling in hands; fever; joint pain; Extreme Fatigue/ severe fatigue; Dizziness; This is a spontaneous report received from a contactable consumer (patient). This 54-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 14:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, no known allergies to medications, food, or other products, had not been diagnosed with COVID-19 prior to vaccination and had not received any other vaccines within 4-weeks prior to the COVID vaccine. The patient had no concomitant medications. On 30Mar2021 at 19:00 the patient experienced extreme fatigue and dizziness four hours after vaccination; six hours post-vaccination the patient experienced mild headache, swelling in hands, fever, and joint pain. The patient further reported the next day she had mild hand swelling, severe fatigue, brain fog and mild joint pain. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of extreme fatigue, dizziness, mild headache, swelling in hands, fever, joint pain, and brain fog were recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Body pains; Muscles and bone aches; Muscles and bone aches; Headache; Fatigue; This is a spontaneous report received from a contactable consumer (patient). This non-pregnant 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP7534) via an unspecified route of administration in the left arm on 29Mar2021 at 9:30 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies from an unknown date and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Concomitant medications included citalopram hydrobromide (CELEXA), carvedilol, allergy pill, and fish oil, all from unknown dates for unknown indications. The patient previously received prochlorperazine edisylate (COMPAZINE), azithromycin, and fluoxetine hydrochloride (PROZAC), all from unknown dates for unknown indications and experienced allergies; the patient previously received the first dose of BNT162B2 (lot number not reported) on 08Mar2021 at 09:45 (at the age of 75-years-old) for COVID-19 immunisation. On 30Mar2021 at 02:30 the patient experienced body pains consisting of muscle and bone aches, headache and fatigue. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of body pains consisting of muscle and bone aches, headache and fatigue were recovering. It was also reported that since vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Entire body itching, no hives or rash; This is a spontaneous report from a contactable consumer (patient). As 32-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 29Mar2021 at 11:00 (at the age of 32-years-old) as a single dose in the left arm for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. On 30Mar2021 at 12:00 the patient experienced entire body itching, no hives or rash. The patient did not receive any treatment for the event. The outcome of entire body itching was not recovered. It was also reported that since the vaccine, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypoaesthesia, Nausea, Vertigo
Clinical narrative: Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; This is a spontaneous report received from a contactable consumer (patient). A 32-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 15Mar2021 at 13:30 (at the age of 32-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included lupus. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. On 17Mar2021 at 12:00 the patient experienced dizziness, vertigo, numbness on the left side of the body, and nausea. The patient visited a doctor or other healthcare professional office/clinic and an emergency room/department or urgent care as a result of the events. The patient did not receive any treatment for the events. The outcomes of dizziness, vertigo, numbness on the left side of the body, and nausea were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Autoantibody test, Bacterial test, Blood creatine phosphokinase normal, Blood thyroid stimulating hormone
Clinical narrative: Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; This is a spontaneous report received from a contactable consumer (patient). A 32-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 15Mar2021 at 13:30 (at the age of 32-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included lupus. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. On 17Mar2021 at 12:00 the patient experienced dizziness, vertigo, numbness on the left side of the body, and nausea. The patient visited a doctor or other healthcare professional office/clinic and an emergency room/department or urgent care as a result of the events. The patient did not receive any treatment for the events. The outcomes of dizziness, vertigo, numbness on the left side of the body, and nausea were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein normal, Central nervous system lesion, Complement factor C3, Complement factor C3 decreased, Complement factor C4
Clinical narrative: Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; This is a spontaneous report received from a contactable consumer (patient). A 32-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 15Mar2021 at 13:30 (at the age of 32-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included lupus. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. On 17Mar2021 at 12:00 the patient experienced dizziness, vertigo, numbness on the left side of the body, and nausea. The patient visited a doctor or other healthcare professional office/clinic and an emergency room/department or urgent care as a result of the events. The patient did not receive any treatment for the events. The outcomes of dizziness, vertigo, numbness on the left side of the body, and nausea were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Complement factor C4 decreased, Differential white blood cell count normal, Dizziness, Electrocardiogram normal, Electrophoresis protein
Clinical narrative: Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; This is a spontaneous report received from a contactable consumer (patient). A 32-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 15Mar2021 at 13:30 (at the age of 32-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included lupus. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. On 17Mar2021 at 12:00 the patient experienced dizziness, vertigo, numbness on the left side of the body, and nausea. The patient visited a doctor or other healthcare professional office/clinic and an emergency room/department or urgent care as a result of the events. The patient did not receive any treatment for the events. The outcomes of dizziness, vertigo, numbness on the left side of the body, and nausea were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Hypoaesthesia, Impaired driving ability, Impaired work ability, Intervertebral disc protrusion
Clinical narrative: Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; This is a spontaneous report received from a contactable consumer (patient). A 32-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 15Mar2021 at 13:30 (at the age of 32-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included lupus. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. On 17Mar2021 at 12:00 the patient experienced dizziness, vertigo, numbness on the left side of the body, and nausea. The patient visited a doctor or other healthcare professional office/clinic and an emergency room/department or urgent care as a result of the events. The patient did not receive any treatment for the events. The outcomes of dizziness, vertigo, numbness on the left side of the body, and nausea were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.