chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Onset of fever (100.5); aches; headache; tiredness; muscle pain; chills; joint pain; feeling unwell; This is a spontaneous report from a contactable healthcare professional (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 14Jan2021 at 10:00, at single dose (left arm) for COVID-19 immunization. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had no allergies to medications, food and/or other products. Concomitant medications included simvastatin and omeprazole (OMEPRAZOL). The patient received simvastatin and omeprazole within 2 weeks of vaccination. On 14Jan2021, at 22:00, the patient experienced onset of fever (100.5) aches, headache, tiredness, muscle pain, chills, joint pain, and was feeling unwell. The patient did not received treatment for the event. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was not recovered.  Information about Lot/Batch has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: Onset of fever (100.5); aches; headache; tiredness; muscle pain; chills; joint pain; feeling unwell; This is a spontaneous report from a contactable healthcare professional (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 14Jan2021 at 10:00, at single dose (left arm) for COVID-19 immunization. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had no allergies to medications, food and/or other products. Concomitant medications included simvastatin and omeprazole (OMEPRAZOL). The patient received simvastatin and omeprazole within 2 weeks of vaccination. On 14Jan2021, at 22:00, the patient experienced onset of fever (100.5) aches, headache, tiredness, muscle pain, chills, joint pain, and was feeling unwell. The patient did not received treatment for the event. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was not recovered.  Information about Lot/Batch has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, COVID-19, Chills, Inappropriate schedule of product administration, Pain
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist (patient). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 28Dec2020 at 18:00 at a single dose for COVID-19 immunization.  Medical history included diabetic and blood pressure high, both from 10-15 years.  There were no concomitant medications. The patient does nursing homes and assisted living facilities and also the employees of the nursing home. The patient received the first dose of COVID-19 vaccine on 28Dec2020 at 1800 PM in the left arm. He tested negative on 27Dec2020, 04Jan2021, and 08Jan2021 and tested positive for COVID-19 on 11Jan2021, which was 2 weeks after the administration of the vaccine. He reported no severe symptoms, all he got from the COVID-19 infection was a little bit of chills, temperatures rising to a maximum of 100 degrees Fahrenheit (temperature back and forth), body aches, oxygen levels at 95%, and no cough. His oxygen saturation has always been good between 95% and 96%. The patient asked what caused the positive test and asked if he was going to have protection after receiving the first dose of COVID vaccine. The patient is due for the second dose of the COVID vaccine on Monday, the 18th (18Jan2021), in which he will still be under isolation. The patient asked if he should wait until he gets out of isolation to receive the second vaccine. The patient asked if that is part of the vaccine to test positive for COVID or if he actually does have COVID. The patient also asked if he can have the second dose. He will be unable to receive second dose of the COVID vaccine at the 21-day mark due to being in isolation from the COVID virus. The patient was recovering from the events.   Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist (patient). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 28Dec2020 at 18:00 at a single dose for COVID-19 immunization.  Medical history included diabetic and blood pressure high, both from 10-15 years.  There were no concomitant medications. The patient does nursing homes and assisted living facilities and also the employees of the nursing home. The patient received the first dose of COVID-19 vaccine on 28Dec2020 at 1800 PM in the left arm. He tested negative on 27Dec2020, 04Jan2021, and 08Jan2021 and tested positive for COVID-19 on 11Jan2021, which was 2 weeks after the administration of the vaccine. He reported no severe symptoms, all he got from the COVID-19 infection was a little bit of chills, temperatures rising to a maximum of 100 degrees Fahrenheit (temperature back and forth), body aches, oxygen levels at 95%, and no cough. His oxygen saturation has always been good between 95% and 96%. The patient asked what caused the positive test and asked if he was going to have protection after receiving the first dose of COVID vaccine. The patient is due for the second dose of the COVID vaccine on Monday, the 18th (18Jan2021), in which he will still be under isolation. The patient asked if he should wait until he gets out of isolation to receive the second vaccine. The patient asked if that is part of the vaccine to test positive for COVID or if he actually does have COVID. The patient also asked if he can have the second dose. He will be unable to receive second dose of the COVID vaccine at the 21-day mark due to being in isolation from the COVID virus. The patient was recovering from the events.   Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is extremely sore; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient).  A female patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 13Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On 13Jan2021, she said that her arm is extremely sore. Caller would like to know if she can take Ibuprofen or something that may help with the pain. Outcome was unknown.  Information on the lot/ batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Vaccination site pain
Clinical narrative: My arm was really sore at the site of injection; Developed body aches similar to the flu; Nauseous; Fatigued; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 12Jan2021 at a SINGLE DOSE (30mcg) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose on 23Dec2020. The patient stated, "I received my second vaccine shot on Tuesday, 12Jan2021. On Wednesday (13Jan2021), my arm was really sore at the site of injection and I developed body aches similar to the flu. I was also nauseous and fatigued (Jan2021). Thursday I started to feel better. I am 95% better today on Friday." The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number could not be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Unbelievably severe back pain; This is a spontaneous report from a contactable Physician.  A patient of unknown gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknow date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient complained of unbelievably severe back pain that lasted a few days. The patient recovered on unknown date. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: contracted covid after receiving the 1st vaccine dose; contracted covid after receiving the 1st vaccine dose; This is Spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 3rd of 6 reports.   A patient of unspecified age and gender received the first dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient contracted COVID after receiving the 1st vaccine dose on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.,Linked Report(s) : US-PFIZER INC-2021035078 same reporter/product/event, different patient;US-PFIZER INC-2021035069 Same reporter/drug, different patient/ event
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID; COVID; This is spontaneous report from a contactable Nurse. This Nurse reported similar events for 6 patients. This is 5th of six reports.   An unknown age and gender patient received 1st of BTN162B2 (Pfizer BioNTech Covid 19 vaccine) on 22Dec2020 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. it was reported that patient contracted COVID after receiving the 1st vaccine dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient, who contracted COVID after receiving the 1st vaccine dose, cannot be completely excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchospasm, Dyspnoea, Wheezing
Clinical narrative: shortened of breath; Wheezing; bronchospasm; This is a spontaneous report from a non-contactable nurse. (patient).  This 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot El3246 at the left arm on 15Jan2021 12:45 at SINGLE DOSE for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination.No COVID prior vaccination.  Concomitant medications were not reported. On 15Jan2021 17:00, the patient experienced wheezing and shortened of breath. The patient visited physician office for the event and treatment for the events  was received, Albuterol for bronchospasm. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Condition aggravated, Fatigue, Headache
Clinical narrative: Severe neuralgia pain over 75% of her skin surface; Severe neuralgia pain over 75% of her skin surface; Severe joint pain; Muscle aches; Swollen lymph nodes; Headache; Fatigue; Upper body sporadic shivering; Interval between the first and second doses of BNT162B2 is 27 days; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246), via an unspecified route of administration in right arm, on 14Jan2021 at 17:15, at a single dose, for COVID-19 immunization. The patient's medical history included sporadic neuralgia, numbness to patches on legs, shift-work sleep disorder, and generalized anxiety. The patient's concomitant medications included armodafinil (NUVIGIL), paracetamol (TYLENOL), and alprazolam (XANAX). The patient previously took ferric subsulfate (MONSELS Solution) and experienced allergy; and the first dose of BNT162B2 (Lot Number: EH9899) on 18Dec2020 (6 PM) for COVID-19 immunization (in left arm). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 14Jan2021 (05:15 PM), the interval between the first and second doses of BNT162B2 is 27 days. On 15Jan2021 at 9:15 AM, the patient experienced severe neuralgia pain over 75% of her skin surface beginning at 14 hours post-second dose (as reported) and still continuing now at 30 hours post-dose. Also, the patient experienced severe joint pain, muscle aches, swollen lymph nodes, headache, fatigue, and upper body sporadic shivering (not cold). It was unknown if the patient received treatment for the events. The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Myalgia, Neuralgia
Clinical narrative: Severe neuralgia pain over 75% of her skin surface; Severe neuralgia pain over 75% of her skin surface; Severe joint pain; Muscle aches; Swollen lymph nodes; Headache; Fatigue; Upper body sporadic shivering; Interval between the first and second doses of BNT162B2 is 27 days; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246), via an unspecified route of administration in right arm, on 14Jan2021 at 17:15, at a single dose, for COVID-19 immunization. The patient's medical history included sporadic neuralgia, numbness to patches on legs, shift-work sleep disorder, and generalized anxiety. The patient's concomitant medications included armodafinil (NUVIGIL), paracetamol (TYLENOL), and alprazolam (XANAX). The patient previously took ferric subsulfate (MONSELS Solution) and experienced allergy; and the first dose of BNT162B2 (Lot Number: EH9899) on 18Dec2020 (6 PM) for COVID-19 immunization (in left arm). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 14Jan2021 (05:15 PM), the interval between the first and second doses of BNT162B2 is 27 days. On 15Jan2021 at 9:15 AM, the patient experienced severe neuralgia pain over 75% of her skin surface beginning at 14 hours post-second dose (as reported) and still continuing now at 30 hours post-dose. Also, the patient experienced severe joint pain, muscle aches, swollen lymph nodes, headache, fatigue, and upper body sporadic shivering (not cold). It was unknown if the patient received treatment for the events. The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: Sore injection site, lump and warm; Sore injection site, lump and warm; Sore injection site, lump and warm; This is a spontaneous report from a contactable Other-HCP. A 65-year-old female patient reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL12F3), at single dose into the right arm on 14Jan2021 at 01:15 PM for COVID-19 immunization. Medical history was none. The patient had no history of allergies to medications, food, or other products. The patient had a negative Covid test Nasal Swab on 20Nov2020. Concomitant medications included Omeprazole, Atorvastatin, Buspirone, Lisinopril. On 15Jan2021 at 9:00 AM the patient experienced sore injection site, lump and warm. No treatment was received. The events were considered non-serious. The outcome of the events was not recovered.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; nausea; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3247), via an unspecified route of administration on the left arm on 14Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included depression and anxiety from an unknown date and unknown if ongoing.  Concomitant medication included alprazolam (ALPRAZOLAM), melatonin (MELATONIN), escitalopram (ESCITALOPRAM). The patient experienced headache and nausea on 16Jan2021 19:00. The outcome of the event was recovering.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Tunnel vision
Clinical narrative: tunnel vision; 2 minutes after injection Heart rate went to 138/Hr 110/elevated heart rate.; dizziness; This is a spontaneous report from a contactable nurse reporting for herself. A 46-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number Ek9231, via an unspecified route of administration in left arm on 28Dec2020 at 11:45, at 46 years of age, at single dose for COVID-19 immunization. The patient was not pregnant when she was vaccinated and received the vaccine in Hospital. She didn't receive any other vaccine in the previous 4 weeks. Medical history included Meniere's disease with sudden hearing loss in left ear from an unknown date, gastrooesophageal reflux disease from an unknown date and allergy to penicillin and sulfa drugs. Concomitant medication included famotidine (PEPCID), paracetamol (TYLENOL), ergocalciferol (VITAMIN D) supplements and cetirizine hydrochloride (ZYRTEC). On 28Dec2020, 2 minutes after vaccine injection, the patient experienced tunnel vision, assessed as medically significant, her heart rate went to 138 and she experienced dizziness. The same happened again "at the 8 min mark": heart rate at 110 and dizziness. The events resolved on their own. Dizziness and elevated heart rate happened again later that evening. At the time of the report the reported events had resolved without any treatment.; Sender's Comments: Based on the compatible time association, the events tunnel vision, heart rate increased and dizziness are reasonably related to suspect BNT162B2 administration. 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.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: bell's palsy from covid vaccine; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose on Jan2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On Jan2021 the patient experienced bell's palsy from COVID-19 vaccine. The event resulted in doctor office/clinic visit, disability or permanent damage. Since the vaccination, the patient has not been tested for COVID-19. At the time of reporting the outcome of the event was not recovered.    Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age (reported as 72, unknown unit) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced sore arm on 15Jan2021. Outcome of the event was unknown. Patient was asking if e was allowed to drink cocktail at night and if the second dose can be administered before or after 21 days.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Discomfort, Insomnia, Musculoskeletal discomfort
Clinical narrative: My hips are killing me/I am having difficulty sleeping due to this; My hips are killing me/I am having difficulty sleeping due to this; I was not feeling comfortable; My back, knees and ankles were also hurting me; knees and ankles were also hurting me; This is a spontaneous report from a contactable nurse and a contactable physician. A male patient of an unspecified age receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was administered the second dose of Pfizer vaccine on Thursday. Unlike the first dose, the second one had adverse events. The patient stated, 'My hips are killing me, I am having difficulty sleeping due to this. I was not feeling comfortable. My back, knees and ankles were also hurting me' on an unspecified date. It was also stated that many of his colleagues had similar experiences. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable pharmacist reporting for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a sore arm for about 2 hours after receiving the first dose of COVID-19 vaccine on 02Jan2021. The outcome of the event was unknown.  Information of lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Gait inability, Nausea, Neurological symptom
Clinical narrative: It affected him neurologically and he can't walk, nor stand without wanting to vomit.; It affected him neurologically and he can't walk, nor stand without wanting to vomit.; It affected him neurologically and he can't walk, nor stand without wanting to vomit.; It affected him neurologically and he can't walk, nor stand without wanting to vomit.; This is a spontaneous report from a non-contactable consumer (patient's wife) A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was hospitalized on 12Jan2021 and reported  that on unspecified date "affected him neurologically and he can not walk, nor stand without wanting to vomit. Everything, and I mean everything else has been ruled out". Events outcome were unknown. The action taken was not applicable. No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: chills; body aches; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative.   A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Historical vaccination included first dose of BNT162B2 on an unknown date at single dose for COVID-19 immunisation. Patient had chills and body aches after receiving second dose. Outcome was unknown. No follow-up attempts are possible; Information about Lot/Batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; arm pain; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative. A female patient of unspecified age received first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache and arm pain on an unspecified date. The outcome of the events was unknown.  Information on Lot/ Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: white spots forming on arm post vaccine injection; This is a spontaneous report from a contactable Pharmacist (patient) via a manufacturer sales representative.   A patient of unknown age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient complains of white spots forming on arm post vaccine injection of first dose. Outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Muscle spasms
Clinical narrative: severe cramping; really bad period after receiving vaccine; This is a spontaneous report received from a non-contactable consumer via a Pfizer sales representative. A female patient of an unspecified age received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown), via an unspecified route of administration, on 29Dec2020, at single dose, for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included an unspecified birth control that takes away her period, she has been on it for 2+ years. The patient experienced severe cramping and really bad period on an unspecified date after receiving vaccine 15 days ago. The outcome of the events was unknown. The patient thinks the events are correlated to the vaccine.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Localised oedema, Oedema, Pain, Paraesthesia
Clinical narrative: Headache and body aches for 24 hours; Headache and body aches for 24 hours; edema left arm pit and left collarbone and neck; edema left arm pit and left collarbone and neck; tingling down the back of neck to shoulder blade for 1 week; All left side, pain at injection site with warm to touch for three days; All left side, pain at injection site with warm to touch for three days; This is a spontaneous report from a contactable nurse (patient). A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via intramuscular in left arm on 08Jan2021 13:15 at second single dose for covid-19 immunization. Medical history included diabetes type 2, allergies. Concomitant medication included metformin, simvastatin, semaglutide (RYBELSUS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose BNT162B2 (LOT# EL1685) on 20Dec2020 01:15 PM, via intramuscular in left arm for Covid-19 immunization. The patient experienced headache and body aches for 24 hours, edema under left arm pit and left collarbone and neck with tingling down the back of neck to shoulder blade for 1 week. All left side, pain at injection site with warm to touch for three days. Adverse event start date/time: 09Jan2021 06:00 AM. Events were considered as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. Outcome of the events was recovering.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Headache and body aches for 24 hours; Headache and body aches for 24 hours; edema left arm pit and left collarbone and neck; edema left arm pit and left collarbone and neck; tingling down the back of neck to shoulder blade for 1 week; All left side, pain at injection site with warm to touch for three days; All left side, pain at injection site with warm to touch for three days; This is a spontaneous report from a contactable nurse (patient). A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL1283), via intramuscular in left arm on 08Jan2021 13:15 at second single dose for covid-19 immunization. Medical history included diabetes type 2, allergies. Concomitant medication included metformin, simvastatin, semaglutide (RYBELSUS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose BNT162B2 (LOT# EL1685) on 20Dec2020 01:15 PM, via intramuscular in left arm for Covid-19 immunization. The patient experienced headache and body aches for 24 hours, edema under left arm pit and left collarbone and neck with tingling down the back of neck to shoulder blade for 1 week. All left side, pain at injection site with warm to touch for three days. Adverse event start date/time: 09Jan2021 06:00 AM. Events were considered as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. Outcome of the events was recovering.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm soreness and tenderness; This is a spontaneous report from a non-contactable consumer reported for herself. A 24-year-old female patient (no pregnant at the time of vaccination) received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3302) at single dose via an unknown route at left arm on an unknown date for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced left arm soreness and tenderness on 15Jan2021. The event was reported as not serious. No treatment received for the adverse event. Outcome of the event was resolved.        No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Cough, Decreased appetite
Clinical narrative: Severe headache; tiredness; muscle pain; chills; fever 99.7; joint pain; feeling unwell; cough; no appetite; This is a spontaneous report from a contactable consumer reported for self. This 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246) via unspecified route of administration at 08Jan2021 10:30 AM at single dose in right arm for COVID-19 immunization. The patient is not pregnant. The age at vaccination is reported as 74 years old. The patient medical history and concomitant medications were not reported. The patient previously received benzoin and experienced allergy. The patient experienced severe headache, tiredness, muscle pain, chills, fever 99.7, joint pain, feeling unwell, cough, no appetite at 15Jan2021 18:00 PM. The events are reported as non-serious by reporter. The patient received no treatment. The patient was not diagnosed with COVID-19 prior to and since the vaccination. The patient was recovering from the events.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: Severe headache; tiredness; muscle pain; chills; fever 99.7; joint pain; feeling unwell; cough; no appetite; This is a spontaneous report from a contactable consumer reported for self. This 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246) via unspecified route of administration at 08Jan2021 10:30 AM at single dose in right arm for COVID-19 immunization. The patient is not pregnant. The age at vaccination is reported as 74 years old. The patient medical history and concomitant medications were not reported. The patient previously received benzoin and experienced allergy. The patient experienced severe headache, tiredness, muscle pain, chills, fever 99.7, joint pain, feeling unwell, cough, no appetite at 15Jan2021 18:00 PM. The events are reported as non-serious by reporter. The patient received no treatment. The patient was not diagnosed with COVID-19 prior to and since the vaccination. The patient was recovering from the events.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Influenza, Pyrexia
Clinical narrative: fever of 103 degrees; major flu symptoms; This is a spontaneous report from a contactable physician received via a manufacturer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had a major flu symptoms including a fever of 103 degrees after receiving the shot on an unknown date. Outcome of the event was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: mild flu symptoms for 24 hours.; This is a spontaneous report from a contactable physician via Pfizer sales representative. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 (reported as 3 weeks ago) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced mild flu symptoms for 24 hours in Dec2020.  Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Vertigo positional
Clinical narrative: acute vertigo/most likely benign paroxysmal positional vertigo; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly, on 22Dec2020 at a single dose (reported as 0.3) for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient experienced acute vertigo/most likely benign paroxysmal positional vertigo on 02Jan2021, which was reported as medically significant. The patient could barely get out of bed on 02Jan2021. The clinical course was reported as follows: The patient did not have any systemic symptoms after receiving the first vaccine but 12 days (as reported) after, she did have some acute vertigo; reported as very serious for her. She could barely get out of bed the first couple of days after getting it. The patient went to ear-nose-and throat (ENT) because she wanted to determine the likelihood of the vertigo having anything to do with her getting the vaccine before she got her second vaccine. She was told it was most likely benign paroxysmal positional vertigo, most likely positional, had nothing to do with the vaccine, and that she was okay to go ahead and get her second vaccine. The vertigo went away within a couple of days. The patient clarified that by 06Jan2021, she was feeling much better and recovered completely. The clinical outcome of acute vertigo/most likely benign paroxysmal positional vertigo and barely get out of bed was recovered on 06Jan2021.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: The reported acute vertigo/most likely benign paroxysmal positional vertigo occurred 12 days after the first dose of COVID 19 vaccine, BNT162B2, is considered an intercurrent disease, unlikely related to BNT162B2 administration.   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 RA, IEC, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Cold sweat, Dyspnoea, Myalgia
Clinical narrative: dyspnea; myalgias; chest pain/Chest pain is moderately severe and worse with deep inspiration; back aches; feeling clammy; This is a spontaneous report from a contactable pharmacist. A 37-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3248, expiration date unspecified), via an unspecified route of administration on 11Jan2021 12:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 21Dec2020 and experienced fever, chills, myalgias, and some sensory changes to the left arm; and vancomycin and experienced allergies. On 11Jan2021, the patient experienced dyspnea and myalgias following her second vaccination today. It was reported that she received the second dose of the vaccine around noon and then began having dyspnea and chest pain around an hour later. Chest pain was moderately severe and worse with deep inspiration. Patient was also having back aches and was feeling clammy. Patient represented to the vaccine site and was brought to the emergency room department/urgent care for evaluation. Patient denied any history of vaccine associated reactions. The patient received therapy for the events which included acetaminophen, ketorolac and intravenous (IV) fluids. The patient had no other vaccine in four weeks. Outcome of events was unknown.; Sender's Comments: Based on the time association, the events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Painful respiration
Clinical narrative: dyspnea; myalgias; chest pain/Chest pain is moderately severe and worse with deep inspiration; back aches; feeling clammy; This is a spontaneous report from a contactable pharmacist. A 37-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3248, expiration date unspecified), via an unspecified route of administration on 11Jan2021 12:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 21Dec2020 and experienced fever, chills, myalgias, and some sensory changes to the left arm; and vancomycin and experienced allergies. On 11Jan2021, the patient experienced dyspnea and myalgias following her second vaccination today. It was reported that she received the second dose of the vaccine around noon and then began having dyspnea and chest pain around an hour later. Chest pain was moderately severe and worse with deep inspiration. Patient was also having back aches and was feeling clammy. Patient represented to the vaccine site and was brought to the emergency room department/urgent care for evaluation. Patient denied any history of vaccine associated reactions. The patient received therapy for the events which included acetaminophen, ketorolac and intravenous (IV) fluids. The patient had no other vaccine in four weeks. Outcome of events was unknown.; Sender's Comments: Based on the time association, the events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dysgeusia, Pain in extremity, SARS-CoV-2 test, Wrong technique in product usage process
Clinical narrative: mild metallic taste; poor administration tech; extreme burning for 10 min following vax-I; arm soreness; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), via an unspecified route of administration on 21Dec2020 11:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. Patient is not pregnant. The facility type vaccine was Workplace clinic. Medical history included obesity from an unknown date. Known allergies included sulfa and penicillin. Concomitant medication included metoprolol, vitamin d3, calcium, probiotics. Patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced mild metallic taste on 22Dec2020 11:30 with outcome of recovered, arm soreness on 21Dec2020 with outcome of recovered, poor administration tech on 21Dec2020 11:40 with outcome of recovered, extreme burning for 10 min following vax-i on 21Dec2020 11:40 with outcome of recovered. The verbatim as follow: 1st Vax: mild metallic taste and arm soreness (including extreme burning for 10 min following vax-I believe this was poor administration tech), slight metallic taste 24 hrs post vax, lasted a few hours. Patient didn't receive treatment for the adverse events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Jan2021. The covid test type post vaccination was Nasal Swab. The covid test name post vaccination was PCR.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Chills; low grade fever; extreme fatigue; headache; newmuscle pain; joint pain; weakness; This is a spontaneous report from a non-contactable other HCP(patient). A 26-years-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EJ1686), via an unspecified route of administration at Arm Left on an unknown date at single dose for COVID-19 immunization.  The medical history included Asthma, eczema, Sulfonamides allergy , cephalosporins allergy, penicillin allergy. The concomitant medications were montelukast, sertraline. The patient previously took azithromycin and experienced allergy. The Historical Vaccine was first dose BNT162B2 for COVID-19 immunization. The patient experienced Chills, low grade fever, extreme fatigue, headache, new muscle pain, joint pain and weakness on an unknown date. The symptoms occurred 8 hours after receiving injection. There was no treatment received for all the events. There was no other vaccine in four weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Chills; low grade fever; extreme fatigue; headache; newmuscle pain; joint pain; weakness; This is a spontaneous report from a non-contactable other HCP(patient). A 26-years-old male patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EJ1686), via an unspecified route of administration at Arm Left on an unknown date at single dose for COVID-19 immunization.  The medical history included Asthma, eczema, Sulfonamides allergy , cephalosporins allergy, penicillin allergy. The concomitant medications were montelukast, sertraline. The patient previously took azithromycin and experienced allergy. The Historical Vaccine was first dose BNT162B2 for COVID-19 immunization. The patient experienced Chills, low grade fever, extreme fatigue, headache, new muscle pain, joint pain and weakness on an unknown date. The symptoms occurred 8 hours after receiving injection. There was no treatment received for all the events. There was no other vaccine in four weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.