chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure systolic, Blood pressure systolic increased, Feeling cold, Heart rate, Heart rate increased
Clinical narrative: muscle joint pint in the fingers on left hand; Feeling shaky and cold; Feeling shaky and cold; HR 100s; SBP 147; left arm started to have tingling sensation. the sensation got worse as the minutes passed/tingling on right side of the face below eye; This is a spontaneous report from a contactable Nurse. A 39-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular (left arm, dose 1) on 05Jan2021 09:00 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No other vaccines in four weeks. No other medications in two weeks.  The patient previously took rocephine and experienced rash. On 09:03, patient received vaccine. On 09:07, left arm started to have tingling sensation. the sensation got worse as the minutes passed. On 0930; vital signs were taken (SBP 147, HR 100s). On 09:40, second set of Vitals (SBP 117, HR in the 80s). On 1028, tingling on right side of the face below eye. On 10:38, tingling on the face got better. Feeling shaky and cold. On 11:15, muscle joint pint in the fingers on left hand. On 13:30, most of the symptoms disappeared. Tingling on left arm still present mostly on in the tip of fingers and inner aspect of the forearm that comes and goes. Symptoms are not as bad as the first 50 minutes into the vaccine. Events occurred on 05Jan2021. No treatment was given. Since the vaccination, the patient has not been tested for COVID-19. Event outcome was recovering. The reporter considered the events as non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Paraesthesia, Tremor
Clinical narrative: muscle joint pint in the fingers on left hand; Feeling shaky and cold; Feeling shaky and cold; HR 100s; SBP 147; left arm started to have tingling sensation. the sensation got worse as the minutes passed/tingling on right side of the face below eye; This is a spontaneous report from a contactable Nurse. A 39-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular (left arm, dose 1) on 05Jan2021 09:00 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No other vaccines in four weeks. No other medications in two weeks.  The patient previously took rocephine and experienced rash. On 09:03, patient received vaccine. On 09:07, left arm started to have tingling sensation. the sensation got worse as the minutes passed. On 0930; vital signs were taken (SBP 147, HR 100s). On 09:40, second set of Vitals (SBP 117, HR in the 80s). On 1028, tingling on right side of the face below eye. On 10:38, tingling on the face got better. Feeling shaky and cold. On 11:15, muscle joint pint in the fingers on left hand. On 13:30, most of the symptoms disappeared. Tingling on left arm still present mostly on in the tip of fingers and inner aspect of the forearm that comes and goes. Symptoms are not as bad as the first 50 minutes into the vaccine. Events occurred on 05Jan2021. No treatment was given. Since the vaccination, the patient has not been tested for COVID-19. Event outcome was recovering. The reporter considered the events as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain in extremity
Clinical narrative: "Foggy" head; Headache; Sore arm; This is a spontaneous report from a non-contactable consumer. A 30-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunisation.  Medical history included COVID-19 (reported as prior to vaccination, the patient was diagnosed with COVID-19) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient experienced ?Foggy? head, headache, and sore arm on an unspecified date in Dec2020. It was reported that no treatment was received for the adverse events. It was reported that prior to vaccination, patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Dec2020.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Myalgia, Nausea
Clinical narrative: Dizziness; weakness; muscle pains; nausea; muscle soreness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient said she got the vaccine yesterday and experiencing some side effects such as dizziness, weakness, muscle pains, nausea and muscle soreness (all occurred in Jan2021). Asking if it was normal to experience these and also asked if she could take paracetamol (TYLENOL). The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vertigo
Clinical narrative: Fatigue; Vertigo; Arm pain; This is a spontaneous report from a contactable other HCP (patient). A 43-year-old male patient received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), intramuscular at left arm on 22Dec2020 13:00 at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient experienced fatigue and vertigo, arm pain on 22Dec2020 20:00. It was unknown if treatment received for the adverse event. The outcome of the events was recovered on unspecified date.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pain
Clinical narrative: Headache; muscle soreness; general all over the body soreness; her arm was very sore/ This was at the injection site; a low grade fever/ a fever of 101.0; chills; This is a spontaneous report from a contactable registered nurse (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, Expiry Date: Mar2021), via an unspecified route of administration in the left biceps of her arm on 05Jan2021 07:15 at single dose for COVID-19 immunization. Medical history included positive on 19Dec2020 for the COVID virus. She had no allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported a side effect she experienced after having the shot. Afterward her arm was very sore. The patient got it at 7:15 am and it didn't feel the sore until about midway through the day (05Jan2021). This was at the injection site. When she got home she had chills and a low grade fever (05Jan2021) so she took Tylenol. The morning (06Jan2021) she woke up with headache and a fever of 101.0. She still had the muscle soreness, it was more at the administration site but there was some general all over the body soreness too. The patient explained she was positive on 19Dec2020 for the COVID virus and felt like these were the same symptoms she had with the virus. When asked about a seriousness criteria, she stated she reported that her fever improved with the Tylenol and she was feeling better now. The outcome of soreness at injection site was not recovered, of fever, headache was recovering, of the other events was unknown. No emergency room or physician office was involved. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Headache; muscle soreness; general all over the body soreness; her arm was very sore/ This was at the injection site; a low grade fever/ a fever of 101.0; chills; This is a spontaneous report from a contactable registered nurse (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, Expiry Date: Mar2021), via an unspecified route of administration in the left biceps of her arm on 05Jan2021 07:15 at single dose for COVID-19 immunization. Medical history included positive on 19Dec2020 for the COVID virus. She had no allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported a side effect she experienced after having the shot. Afterward her arm was very sore. The patient got it at 7:15 am and it didn't feel the sore until about midway through the day (05Jan2021). This was at the injection site. When she got home she had chills and a low grade fever (05Jan2021) so she took Tylenol. The morning (06Jan2021) she woke up with headache and a fever of 101.0. She still had the muscle soreness, it was more at the administration site but there was some general all over the body soreness too. The patient explained she was positive on 19Dec2020 for the COVID virus and felt like these were the same symptoms she had with the virus. When asked about a seriousness criteria, she stated she reported that her fever improved with the Tylenol and she was feeling better now. The outcome of soreness at injection site was not recovered, of fever, headache was recovering, of the other events was unknown. No emergency room or physician office was involved. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: Urticaria; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730) intramuscular on 18Dec2020 at a single dose on the left arm as vaccine. Medical history was not reported. There were no concomitant medications (did not receive other vaccines within four weeks to the COVID vaccine and did not receive other medications within two weeks of vaccination). The patient had no known allergies to medications, food, or other products. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). The patient experienced urticaria on 18Dec2020 assessed as non-serious which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. She was not pregnant at the time of vaccination. She was not diagnosed with COVID-19 prior to vaccination. She had Covid tested post vaccination (had been tested for COVID-19 since vaccination)- nasal swab result negative on 31Dec2020. Treatment for the event included Benadryl. The outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Influenza like illness
Clinical narrative: Bell's Palsy; developed  flu like symptoms; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age (reported as 32-40) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient developed side effects side effects from first vaccine, Bell's palsy 4 days after vaccination (Dec2020) which lasted for 2 weeks and flu like symptoms (Dec2020) which also lasted 2 weeks. The events outcome was unknown. The patient was receiving 2nd dose on 06Jan2021, the reporter asked any information regarding this?  Information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's palsy  and BNT162B2 vaccine cannot be excluded. 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus test, Headache, Pain, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: pain at injection site; body aches; mild headache; This is a spontaneous report from a contactable nurse (patient herself). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142; expiry date: unknown) via an unspecified route of administration, on 04Jan2021, at 0.3 mL, single for COVID-19 immunization. Patient has no relevant medical history. Concomitant medications were not reported. Prior to taking vaccine, she did an antibody test and it was positive for antibodies s in Nov2020, she remembered that she went for a complete physical. All COVID tests were negative but the antibody test was positive. She did a rapid test a week before the vaccine at the end Dec2020. The PCR Test was a couple months before the vaccine in Apr2020 and it was negative. During that time in Apr2020 she had mild symptoms and was not feeling well but then she felt better. The doctor gave her azithromycin and vitamins, a week later she was better. At her job they were doing COVID test every 2 weeks, but she was negative. She had no more symptoms. She has had no issues with vaccines in the past. She would get unspecified flu shots at work  for flu vaccination, but would get mild pain at the injection site. Patient received PFIZER-BIONTECH COVID-19 VACCINE on 04Jan2021 and had been experiencing pain at injection site, mild body aches, and mild headaches. Her 1st dose was on 04Jan2021 at 4 o clock. The pain at injection site began on 05Jan2021. The body aches and headache also started on 05Jan2021, but she noticed relief with Tylenol. She has called her physician since she does not want to go in office. Her symptoms were ordinary and mild but bothersome, she doesn't know with this vaccine and what she would be feeling and decided on staying home. The pain at injection site stopped sometime between yesterday and today. Her 2nd dose is scheduled on 25Jan2021. Outcome of the event pain at injection site was recovered on an unspecified date in Jan2021, while for the remaining events was recovering.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at injection site; body aches; mild headache; This is a spontaneous report from a contactable nurse (patient herself). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142; expiry date: unknown) via an unspecified route of administration, on 04Jan2021, at 0.3 mL, single for COVID-19 immunization. Patient has no relevant medical history. Concomitant medications were not reported. Prior to taking vaccine, she did an antibody test and it was positive for antibodies s in Nov2020, she remembered that she went for a complete physical. All COVID tests were negative but the antibody test was positive. She did a rapid test a week before the vaccine at the end Dec2020. The PCR Test was a couple months before the vaccine in Apr2020 and it was negative. During that time in Apr2020 she had mild symptoms and was not feeling well but then she felt better. The doctor gave her azithromycin and vitamins, a week later she was better. At her job they were doing COVID test every 2 weeks, but she was negative. She had no more symptoms. She has had no issues with vaccines in the past. She would get unspecified flu shots at work  for flu vaccination, but would get mild pain at the injection site. Patient received PFIZER-BIONTECH COVID-19 VACCINE on 04Jan2021 and had been experiencing pain at injection site, mild body aches, and mild headaches. Her 1st dose was on 04Jan2021 at 4 o clock. The pain at injection site began on 05Jan2021. The body aches and headache also started on 05Jan2021, but she noticed relief with Tylenol. She has called her physician since she does not want to go in office. Her symptoms were ordinary and mild but bothersome, she doesn't know with this vaccine and what she would be feeling and decided on staying home. The pain at injection site stopped sometime between yesterday and today. Her 2nd dose is scheduled on 25Jan2021. Outcome of the event pain at injection site was recovered on an unspecified date in Jan2021, while for the remaining events was recovering.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush
Clinical narrative: I've been having Phantom smells of cigarette smoke for the last week. And starting this morning I've had two episodes of having my face completely flush and hot but with no fever
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: a pretty decent sized, red, warm, firm welt that's about 2 inches in diameter at the injection site; a pretty decent sized, red, warm, firm welt that's about 2 inches in diameter at the injection site; a pretty decent sized, red, warm, firm welt that's about 2 inches in diameter at the injection site; This is a spontaneous report from a contactable other hcp (patient). A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unknown route of administration in left arm on 03Jan2021 10:45 at single dose for COVID-19 immunization. Medical history included birth control. No known allergies. Concomitant medications included drospirenone, ethinylestradiol (OCELLA) for birth control, escitalopram oxalate (LEXAPRO). Patient had a pretty decent sized, red, warm, firm welt that's about 2 inches in diameter at the injection site. She noticed it about 4-5 hours after the injection and it hadn't changed since. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The outcome of the events was not recovered.   Information about Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Aching; chills; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced aching and chills on Jan2021.  The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing
Clinical narrative: Dizzy; flushed after injection; This is a spontaneous report from a contactable Other HCP for herself. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: EK9231), via an unspecified route of administration in left arm on 03Jan2021 at single dose for covid-19 immunisation. Medical history included mitral valve prolapse. Patient was allergic to some chilis and animals. There were no concomitant medications. The patient experienced dizzy, flushed after injection on 03Jan2021. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, the patient been not been tested for COVID-19. Outcome of events was recovered in Jan2021.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High Fever 103.2 for 3 days
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Significant chills while trying to sleep. Unable to resolve with blankets.Low grade fever the following morning. Currently taking tylenol.; Significant chills while trying to sleep. Unable to resolve with blankets.Low grade fever the following morning. Currently taking tylenol.; This is a spontaneous report from a contactable Other HCP (patient). A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , intramuscular on 05Jan2021 07:15 at the first single dose at arm left for covid-19 immunisation.  Medical history reported as none.  Concomitant medication included hpv vaccine vlp rl1 9v (yeast) (GARDASIL 9) on 04Jan2021, escitalopram oxalate (LEXAPRO), alprazolam.  The patient experienced significant chills while trying to sleep. unable to resolve with blankets. low grade fever the following morning on 05Jan2021 23:00. currently taking tylenol. The outcome of events was recovering.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Low grade fever of 100.0 degree; This is a spontaneous report from a non-contactable nurse (patient). A 24-year-old female patient received the first dose of BNT162b2 (Lot number: ELO142), via an unspecified route of administration at right arm on 06Jan2021 13:00 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included citalopram, venlafaxine, methylphenidate hydrochloride (CONCERTA), diphenhydramine hydrochloride (BENADRYL). The patient experienced low grade fever of 100.0 degree on 06Jan2021 18:45. It was unknown if the treatment received for the adverse event. The patient was not pregnant. The outcome of the event was recovering.   No follow up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Feeling hot, Headache
Clinical narrative: Achy Joints, Cold and hot at the same time, headache on 1-10-2021 from 2am until 2pm. Took Aleve at 10am
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep paralysis, Tachycardia
Clinical narrative: Sleep paralysis 2 days after vaccine associated with tachycardia; Sleep paralysis 2 days after vaccine associated with tachycardia; This is a spontaneous report from a non-contactable nurse (patient). A currently 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, at the age of 30-years, on an unspecified date at a single dose as COVID-19 vaccine. Medical history/concurrent conditions included positive ANA; ADHD (attention deficit hyperactivity disorder); known allergies to sulfa drugs and mangoes. Concomitant medications included methylprednisolone (MEDROL), ibuprofen, and baclofen (received other medications within 2 weeks of vaccination). She was not pregnant at the time of vaccination. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). She did not receive other vaccines within four weeks prior to the COVID vaccine. The patient experienced sleep paralysis 2 days after vaccine associated with tachycardia on unspecified dates. The events were non-serious which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. She was not diagnosed with COVID-19 prior to vaccination and did not have Covid tested post vaccination (had not been tested for COVID-19 since the vaccination). Treatment was not received for the events. The outcome of the events was recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report from a contactable consumer. A female patient (reporter's mother) of unspecified age (reported as Age: 86; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter's mother, received the vaccine and reported only arm pain in Jan2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Day after vaccine arm was sore, red & slightly swollen then it all went completely away. Exactly 1 week after vaccination the vaccination site became red, itchy & swollen & had a big lump. Today 1/12 is day 7 of this reaction. Although it is starting to improve.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Coronavirus test, Diarrhoea, Haemorrhoids, Headache
Clinical narrative: headache; chills; nauseous; did not feel very well at all; diarrhea; hemorrhoid; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (medical assistant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration on 02Jan2021 15:00 (3:00pm) at a single dose on the left deltoid as vaccination. The patient had no medical history. There were no concomitant medications. The patient reported having side effects from her first dose of Pfizer Coronavirus Vaccine administered on 02Jan2021. She tried reporting this information online but has been unsuccessful. Starting the evening of 04Jan2021, she had a headache, chills, felt nauseous, did not feel very well at all, diarrhea, and got a hemorrhoid. She still has a slight headache today; and when she woke up this morning, she felt a little nauseous but that went away; other side effects have improved at this time. Her doctor made her go get a Coronavirus test today in order to go back to work; because he said that the diarrhea and something else of the side effects, she did not remember were not a symptom of the Pfizer Coronavirus Vaccine. She had the Coronavirus test this morning on 06Jan2021 (unknown result); but would not get the results of that test until 48-72 hours after being tested. They would email her those results. Second dose was scheduled for 23Jan2021 at 3:45pm; she still plans to get the second dose. The outcome of the event nauseous was recovered on 06Jan2021 as it already went away while of the remaining events was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: headache; chills; nauseous; did not feel very well at all; diarrhea; hemorrhoid; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (medical assistant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration on 02Jan2021 15:00 (3:00pm) at a single dose on the left deltoid as vaccination. The patient had no medical history. There were no concomitant medications. The patient reported having side effects from her first dose of Pfizer Coronavirus Vaccine administered on 02Jan2021. She tried reporting this information online but has been unsuccessful. Starting the evening of 04Jan2021, she had a headache, chills, felt nauseous, did not feel very well at all, diarrhea, and got a hemorrhoid. She still has a slight headache today; and when she woke up this morning, she felt a little nauseous but that went away; other side effects have improved at this time. Her doctor made her go get a Coronavirus test today in order to go back to work; because he said that the diarrhea and something else of the side effects, she did not remember were not a symptom of the Pfizer Coronavirus Vaccine. She had the Coronavirus test this morning on 06Jan2021 (unknown result); but would not get the results of that test until 48-72 hours after being tested. They would email her those results. Second dose was scheduled for 23Jan2021 at 3:45pm; she still plans to get the second dose. The outcome of the event nauseous was recovered on 06Jan2021 as it already went away while of the remaining events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Fatigue; tested positive after receiving Covid-19 vaccine; tested positive after receiving Covid-19 vaccine; severely congested; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported that a 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, Expiry Date: Mar2021) via an unspecified route of administration at right deltoid on 20Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing severe asthmatic diagnosed as a child. There were no concomitant medications. Patient (a front line worker) is Grief Counselor. She tested positive after receiving BNT162B2 on 29Dec2020. She was supposed to get the second dose on 10Jan2021. She was having fatigue since 01Jan2021 and was severely congested since 26Dec2020. She was asking if she should get the second dose. The outcome of the events severely congested and fatigue was recovering, of the other events was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Red, erythema, raised, warm, swollen, itchy
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: chills; body aches; fatigue; weakness; H/A; Temp was 99.4 and went up to 102.4 over the next 3 hours; very sore arm which became worse overnight to the point she couldn't move her arm; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246), via an unspecified route of administration at Left arm on 05Jan2021 14:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at workplace clinic. Medical history included covid-19 from 04Sep2020, Penicillin allergy.  Concomitant medication in two weeks included lithium, sertraline, fish oil (OMEGA 3 FISH OILS), ergocalciferol (VIT D). There were no other vaccines administrated on same date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took metronidazole (FLAGYL) and experienced drug hypersensitivity, clindamycin and experienced drug hypersensitivity. On 05Jan2021 at 17:00, the patient experienced very sore arm which became worse overnight to the point she couldn't move her arm. On 06Jan2021 at 12 noon, she started to get the chills, body aches, fatigue, weakness and H/A. Temp was 99.4 and went up to 102.4 over the next 3 hours. The patient took ibuprofen (MOTRIN) 400mg at 3:30 AM with some effect. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: chills; body aches; fatigue; weakness; H/A; Temp was 99.4 and went up to 102.4 over the next 3 hours; very sore arm which became worse overnight to the point she couldn't move her arm; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246), via an unspecified route of administration at Left arm on 05Jan2021 14:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at workplace clinic. Medical history included covid-19 from 04Sep2020, Penicillin allergy.  Concomitant medication in two weeks included lithium, sertraline, fish oil (OMEGA 3 FISH OILS), ergocalciferol (VIT D). There were no other vaccines administrated on same date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took metronidazole (FLAGYL) and experienced drug hypersensitivity, clindamycin and experienced drug hypersensitivity. On 05Jan2021 at 17:00, the patient experienced very sore arm which became worse overnight to the point she couldn't move her arm. On 06Jan2021 at 12 noon, she started to get the chills, body aches, fatigue, weakness and H/A. Temp was 99.4 and went up to 102.4 over the next 3 hours. The patient took ibuprofen (MOTRIN) 400mg at 3:30 AM with some effect. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Body temperature increased, Breast tenderness, Chills, Decreased appetite
Clinical narrative: chills; body aches; fatigue; weakness; H/A; Temp was 99.4 and went up to 102.4 over the next 3 hours; very sore arm which became worse overnight to the point she couldn't move her arm; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246), via an unspecified route of administration at Left arm on 05Jan2021 14:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at workplace clinic. Medical history included covid-19 from 04Sep2020, Penicillin allergy.  Concomitant medication in two weeks included lithium, sertraline, fish oil (OMEGA 3 FISH OILS), ergocalciferol (VIT D). There were no other vaccines administrated on same date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took metronidazole (FLAGYL) and experienced drug hypersensitivity, clindamycin and experienced drug hypersensitivity. On 05Jan2021 at 17:00, the patient experienced very sore arm which became worse overnight to the point she couldn't move her arm. On 06Jan2021 at 12 noon, she started to get the chills, body aches, fatigue, weakness and H/A. Temp was 99.4 and went up to 102.4 over the next 3 hours. The patient took ibuprofen (MOTRIN) 400mg at 3:30 AM with some effect. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Malaise, Mobility decreased, Myalgia
Clinical narrative: chills; body aches; fatigue; weakness; H/A; Temp was 99.4 and went up to 102.4 over the next 3 hours; very sore arm which became worse overnight to the point she couldn't move her arm; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246), via an unspecified route of administration at Left arm on 05Jan2021 14:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at workplace clinic. Medical history included covid-19 from 04Sep2020, Penicillin allergy.  Concomitant medication in two weeks included lithium, sertraline, fish oil (OMEGA 3 FISH OILS), ergocalciferol (VIT D). There were no other vaccines administrated on same date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took metronidazole (FLAGYL) and experienced drug hypersensitivity, clindamycin and experienced drug hypersensitivity. On 05Jan2021 at 17:00, the patient experienced very sore arm which became worse overnight to the point she couldn't move her arm. On 06Jan2021 at 12 noon, she started to get the chills, body aches, fatigue, weakness and H/A. Temp was 99.4 and went up to 102.4 over the next 3 hours. The patient took ibuprofen (MOTRIN) 400mg at 3:30 AM with some effect. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: chills; body aches; fatigue; weakness; H/A; Temp was 99.4 and went up to 102.4 over the next 3 hours; very sore arm which became worse overnight to the point she couldn't move her arm; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246), via an unspecified route of administration at Left arm on 05Jan2021 14:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at workplace clinic. Medical history included covid-19 from 04Sep2020, Penicillin allergy.  Concomitant medication in two weeks included lithium, sertraline, fish oil (OMEGA 3 FISH OILS), ergocalciferol (VIT D). There were no other vaccines administrated on same date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took metronidazole (FLAGYL) and experienced drug hypersensitivity, clindamycin and experienced drug hypersensitivity. On 05Jan2021 at 17:00, the patient experienced very sore arm which became worse overnight to the point she couldn't move her arm. On 06Jan2021 at 12 noon, she started to get the chills, body aches, fatigue, weakness and H/A. Temp was 99.4 and went up to 102.4 over the next 3 hours. The patient took ibuprofen (MOTRIN) 400mg at 3:30 AM with some effect. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Very sore arm hours after vaccine and couldn't move arm during the night- took motrin at 3:30AM with some effect.  Felt OK otherwise until 12 noon on 1/6/21 when I suddenly felt chilled and not well.  Temp went up quickly from 99.4 at 12 noon to 102.4 at 5PM. Temp 101.5 at 9PM.  Had abdominal cramping, general body aches and muscle pains, H/A and left breast tenderness as if I was going to get my period (which I haven't had for 8 years). On 1/7/21 at 7AM temp- 99.7 and 98.8 at 11AM, but still felt tired, H/A, malaise, no appetite. Back to normal good health on 1/8/21 AM. Left arm was sore for 4 days.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Very sore arm hours after vaccine and couldn't move arm during the night- took motrin at 3:30AM with some effect.  Felt OK otherwise until 12 noon on 1/6/21 when I suddenly felt chilled and not well.  Temp went up quickly from 99.4 at 12 noon to 102.4 at 5PM. Temp 101.5 at 9PM.  Had abdominal cramping, general body aches and muscle pains, H/A and left breast tenderness as if I was going to get my period (which I haven't had for 8 years). On 1/7/21 at 7AM temp- 99.7 and 98.8 at 11AM, but still felt tired, H/A, malaise, no appetite. Back to normal good health on 1/8/21 AM. Left arm was sore for 4 days.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Body temperature increased, Breast tenderness, Chills, Decreased appetite
Clinical narrative: Very sore arm hours after vaccine and couldn't move arm during the night- took motrin at 3:30AM with some effect.  Felt OK otherwise until 12 noon on 1/6/21 when I suddenly felt chilled and not well.  Temp went up quickly from 99.4 at 12 noon to 102.4 at 5PM. Temp 101.5 at 9PM.  Had abdominal cramping, general body aches and muscle pains, H/A and left breast tenderness as if I was going to get my period (which I haven't had for 8 years). On 1/7/21 at 7AM temp- 99.7 and 98.8 at 11AM, but still felt tired, H/A, malaise, no appetite. Back to normal good health on 1/8/21 AM. Left arm was sore for 4 days.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Malaise, Mobility decreased, Myalgia
Clinical narrative: Very sore arm hours after vaccine and couldn't move arm during the night- took motrin at 3:30AM with some effect.  Felt OK otherwise until 12 noon on 1/6/21 when I suddenly felt chilled and not well.  Temp went up quickly from 99.4 at 12 noon to 102.4 at 5PM. Temp 101.5 at 9PM.  Had abdominal cramping, general body aches and muscle pains, H/A and left breast tenderness as if I was going to get my period (which I haven't had for 8 years). On 1/7/21 at 7AM temp- 99.7 and 98.8 at 11AM, but still felt tired, H/A, malaise, no appetite. Back to normal good health on 1/8/21 AM. Left arm was sore for 4 days.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Very sore arm hours after vaccine and couldn't move arm during the night- took motrin at 3:30AM with some effect.  Felt OK otherwise until 12 noon on 1/6/21 when I suddenly felt chilled and not well.  Temp went up quickly from 99.4 at 12 noon to 102.4 at 5PM. Temp 101.5 at 9PM.  Had abdominal cramping, general body aches and muscle pains, H/A and left breast tenderness as if I was going to get my period (which I haven't had for 8 years). On 1/7/21 at 7AM temp- 99.7 and 98.8 at 11AM, but still felt tired, H/A, malaise, no appetite. Back to normal good health on 1/8/21 AM. Left arm was sore for 4 days.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: lower back pain; This is a Spontaneous report from a contactable consumer via a Pfizer Sponsored Program Pfizer First Connect. A female patient of an unspecified age received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH) via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient got the first dose of covid vaccine on 29Dec2020. On Friday (01Jan2021) she experienced terrible lower back pain. She was still experiencing the lower back pain but it was getting better. She was asking if this was normal. The outcome of event was recovering.    Information on the Lot/Batch Number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Hyperhidrosis
Clinical narrative: Really bad chills; Body aches; Mild low grade temperature/fever; Sweating; Slight headache; Joints are popping and cracking; Joint pain/joints hurt; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the upper left arm on 05Jan2021 (07:00) at a single dose for COVID-19 immunization at the hospital (not in a military facility). The patient had no relevant medical history and concomitant medications. On 05Jan2021 (14:00), the patient had really bad chills. On 05Jan2021, the patient had body aches; and had mild low grade temperature/fever. In Jan2021, the patient's joints were popping and cracking; had joint pain/joints were hurting; had slight headache; and was sweating. The patient was treated with ibuprofen for the events, 'chills' and 'mild low grade temperature/fever'. The outcome of the events was recovering for 'really bad chills' and 'body aches'; was not recovered for 'joint pain/joints were hurting' and 'slight headache'; was recovered on 06Jan2021 for 'mild low grade temperature/fever'; and was unknown for all the other events.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Joint noise, Pain, Pyrexia
Clinical narrative: Really bad chills; Body aches; Mild low grade temperature/fever; Sweating; Slight headache; Joints are popping and cracking; Joint pain/joints hurt; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the upper left arm on 05Jan2021 (07:00) at a single dose for COVID-19 immunization at the hospital (not in a military facility). The patient had no relevant medical history and concomitant medications. On 05Jan2021 (14:00), the patient had really bad chills. On 05Jan2021, the patient had body aches; and had mild low grade temperature/fever. In Jan2021, the patient's joints were popping and cracking; had joint pain/joints were hurting; had slight headache; and was sweating. The patient was treated with ibuprofen for the events, 'chills' and 'mild low grade temperature/fever'. The outcome of the events was recovering for 'really bad chills' and 'body aches'; was not recovered for 'joint pain/joints were hurting' and 'slight headache'; was recovered on 06Jan2021 for 'mild low grade temperature/fever'; and was unknown for all the other events.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Paraesthesia
Clinical narrative: numbness; tingling; weakness on the side of the body where the injection was given; This is a spontaneous report from a contactable nurse (patient's fiancee) received via Medical Information Team.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Jan2020, the patient experienced numbness, tingling and weakness on the side of the body where the injection was given, from the shoulder to the arms, hands and feet. The reporter stated his fiancee felt the numbness and tingling was paresthesia. The patient outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Headache (4/10 severity), fatigue, and pain at injection site (1/10 severity); Headache (4/10 severity), fatigue, and pain at injection site (1/10 severity); Headache (4/10 severity), fatigue, and pain at injection site (1/10 severity); This is a spontaneous report from a contactable other HCP. A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at 06Jan2021 08:30 at SINGLE DOSE for covid-19 immunization. Vaccine location was left arm. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. The patient medical history was not reported. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), calcium carbonate (TUMS), ibuprofen, tilactase (LACTAID). Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took minocycline and experienced drug hypersensitivity. The patient experienced headache (4/10 severity), fatigue, and pain at injection site (1/10 severity) on 06Jan2021 13:30 with outcome of not recovered. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.  Information on the lot/batch number has been requested.