chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pain
Clinical narrative: Get achy/flush 24 hrs out from the 2nd dose; Get achy/flush 24 hrs out from the 2nd dose; This is a spontaneous report from a non-contactable physician (Patient)   A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient reported she was starting to get achy/flush 24 hour out her second dose. She also confirmed that she didn't have any significant effects after the 1st dose though. At the time of the reporting events outcome was unknown.   No follow-up attempts are possible: information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 this week; COVID-19; This is a spontaneous report from a Pfizer-sponsored program Pfizer. A contactable consumer (patient) reported that a 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3249), via an unspecified route of administration in left arm on 07Jan2021 13:30 at single dose for covid-19 immunization (vaccination). Medical history included pleurisy. Family medical history was none. There were no concomitant medications. Historically she felt like she had the flu when she had gotten the flu vaccine (years not specified); but she did not feel like she had the flu after getting flu vaccine this year in 2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no additional vaccines administered on same date of the Pfizer suspect. The patient received the Pfizer COVID-19 vaccine 07Jan2021; and she tested positive for COVID-19 this week. Then clarified that she was administered first dose of Pfizer COVID-19 Vaccine 07Jan2021. She had onset of COVID-19 around 15Jan2021 when she became unable to smell. She had 2 COVID-19 tests performed on 16Jan2021, one was a rapid COVID-19 nasal swab test with positive result; the other was a COVID-19 nasal swab test that they had to send off to test which was also positive. No medications were taken prior to vaccination/event. She asked if she should still get the second dose as scheduled relative to this event. Second dose was scheduled for 27Jan2021. No emergency room visit required, physician office visit (urgent care) required for event COVID-19. She mentioned she was not the only patient to test positive for COVID-19 that received Pfizer COVID-19 Vaccine same date she received Pfizer COVID-19 Vaccine on 07Jan2021. She declined to provide any further information regarding those patients/events/products/report. The sample of product was not available to return. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive after the first dose; tested positive after the first dose; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of bnt162b2 (COVID vaccine), lot number: EL0140, via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller, a registered nurse, calling about the COVID vaccine. She explained there was no problem but more of a concern. It was explained that on 29Dec2020 she got her first dose and on 08Jan2021 she found out she tested positive for COVID. She would be on day 12 tomorrow when the facility would be giving the second dose. She was told she can't get the second dose by her administrator as she was going by the 14 day requirement. Caller wanted to know if this was true, was it 14 days or 10 days after testing positive before she can get the next shot. If this was true, where can she get the second dose as she would miss the dose at her facility. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of [COVID vaccine] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [COVID vaccine] has submitted the same report to the regulatory authorities.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive after first dose was given; tested positive after first dose was given; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse reported similar events for 3 patients. This is the first of 3 reports.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry 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 patient had tested positive on an unspecified date in Jan2021, after the first dose of the vaccine was given. The second dose was set up and the patient would be off of the 14-day quarantine by then, but the reporter was not sure if the people was eligible to get the second dose. The outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 test positive and suspected LOE  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  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.,Linked Report(s) : US-PFIZER INC-2021058678 Same reporter/ vaccine, different patient/ similar AE;US-PFIZER INC-2021058679 Same reporter/ vaccine, different patient/ similar AE;US-PFIZER INC-2021058679 Same reporter/ vaccine, different patient/ similar AE
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Diarrhoea, Pain
Clinical narrative: Fever/gone up to 106.0 Fahrenheit and as high as 107.0 Fahrenheit; Body aches; chills; Diarrhea; upset stomach; This is a spontaneous report from a contactable consumer reported for son. A 26-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) intramuscular in the left deltoid on 15Jan2021 at 0.3 ml single for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient had the Pfizer Vaccine last Friday 15Jan2021. Later that evening on 15Jan2021 he got a fever. It has gone up to 106.0 Fahrenheit and as high as 107.0 Fahrenheit. Reporter has given patient Ibuprofen and Tylenol. The fever has gradually come down. He has also been having upset stomach and diarrhea, and body aches and chills, all on 15Jan2021. The fever went down to 104 degrees Fahrenheit and is now 100.3 degrees Fahrenheit. Their provider told reporter to call the Hospital Hotline or go to the Emergency Room. Reporter has also been giving patient Imodium and a probiotic for the upset stomach and diarrhea. The reporter did not believe the temperatures when he took them, so reporter went out and bought a new under the tongue thermometer, and they are all consistent. Event outcome of fever/gone up to 106.0 Fahrenheit and as high as 107.0 Fahrenheit, chills, body aches was recovering, for diarrhea and upset stomach was not recovered.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever/gone up to 106.0 Fahrenheit and as high as 107.0 Fahrenheit; Body aches; chills; Diarrhea; upset stomach; This is a spontaneous report from a contactable consumer reported for son. A 26-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) intramuscular in the left deltoid on 15Jan2021 at 0.3 ml single for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient had the Pfizer Vaccine last Friday 15Jan2021. Later that evening on 15Jan2021 he got a fever. It has gone up to 106.0 Fahrenheit and as high as 107.0 Fahrenheit. Reporter has given patient Ibuprofen and Tylenol. The fever has gradually come down. He has also been having upset stomach and diarrhea, and body aches and chills, all on 15Jan2021. The fever went down to 104 degrees Fahrenheit and is now 100.3 degrees Fahrenheit. Their provider told reporter to call the Hospital Hotline or go to the Emergency Room. Reporter has also been giving patient Imodium and a probiotic for the upset stomach and diarrhea. The reporter did not believe the temperatures when he took them, so reporter went out and bought a new under the tongue thermometer, and they are all consistent. Event outcome of fever/gone up to 106.0 Fahrenheit and as high as 107.0 Fahrenheit, chills, body aches was recovering, for diarrhea and upset stomach was not recovered.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Nausea, Off label use
Clinical narrative: Date of start of drug 18Dec2020/ Date of start of drug 12Jan2021; Date of start of drug 18Dec2020/ Date of start of drug 12Jan2021; Dizziness; nausea; fever; joint pain; body aches; throbbing headache x 24 hours; This is a spontaneous report from a contactable Nurse (patient). A 26-year-old female patient received BNT162b2 BNT162b2 (lot number: EL3246) second dose on 12Jan2021 on Right Arm at single dose for covid-19 immunization. Medical history included Headaches of an unknown origin. Concomitant medications were not reported. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Facility type vaccine was Workplace clinic. No other vaccine in four weeks. Patient is not pregnant. The patient previously took BNT162b2 (lot number: EL0140) first dose on 18Dec2020 12:00 PM (age 26-year-old) Intramuscular on left arm at single dose for covid-19 immunization and experienced Sore arm, joint pain that started in the left elbow and moved down to the wrist/hand and eventually joint pain and body aches all over for the next 2 days. For 2nd shot: Dizziness, nausea, fever, body aches, joint pain, throbbing headache x 24 hours. Started at 9pm on the evening of the shot (12Jan2021) and symptoms ceased exactly 24 hours later. The outcome of the events was recovered on 13Jan2021 21:00. No treatment for the events.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Product use issue, Pyrexia
Clinical narrative: Date of start of drug 18Dec2020/ Date of start of drug 12Jan2021; Date of start of drug 18Dec2020/ Date of start of drug 12Jan2021; Dizziness; nausea; fever; joint pain; body aches; throbbing headache x 24 hours; This is a spontaneous report from a contactable Nurse (patient). A 26-year-old female patient received BNT162b2 BNT162b2 (lot number: EL3246) second dose on 12Jan2021 on Right Arm at single dose for covid-19 immunization. Medical history included Headaches of an unknown origin. Concomitant medications were not reported. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Facility type vaccine was Workplace clinic. No other vaccine in four weeks. Patient is not pregnant. The patient previously took BNT162b2 (lot number: EL0140) first dose on 18Dec2020 12:00 PM (age 26-year-old) Intramuscular on left arm at single dose for covid-19 immunization and experienced Sore arm, joint pain that started in the left elbow and moved down to the wrist/hand and eventually joint pain and body aches all over for the next 2 days. For 2nd shot: Dizziness, nausea, fever, body aches, joint pain, throbbing headache x 24 hours. Started at 9pm on the evening of the shot (12Jan2021) and symptoms ceased exactly 24 hours later. The outcome of the events was recovered on 13Jan2021 21:00. No treatment for the events.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sore (herpes labialis); This is a spontaneous report from a non-contactable physician (Patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration on 08Jan2021 20:30 (08:30 PM) at single dose  on the right arm for COVID-19 immunization. Patient is not pregnant. Medical history included allergies with mango. No other medical history. There were no concomitant medications (reported as "Other medications in two weeks: No"). No other vaccines in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient received the first dose on 17Dec2020 03:00 PM  (lot number: EH9899) on the right arm. The patient experienced cold sore (herpes labialis) on 11Jan2021 20:00 (reported as "08:00 PM"). No treatment was received for the event. Outcome of the event was recovered in Jan2021. Patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Discomfort, Headache
Clinical narrative: 12hr after second dose: increased pain at injection site, but no swelling or redness; headache; Discomfort is a 6/10; gradual onset of soreness raidiating from lymphnodes in neck; gradual onset of soreness in chest/ soreness in bronchi; gradual onset of soreness in back; gradual onset of soreness in hips; gradual onset of soreness in legs; gradual onset of soreness in glutes; soreness in upper lungs; soreness in upper respiratory system; This is a spontaneous report from a non-contactable consumer. A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247), via an unspecified route of administration on the left arm from 18Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included major depression, anxiety; increased airway sensitivity due to being former smoker from an unknown date and unknown if ongoing. Concomitant medication included vilazodone hydrochloride (VIIBRYD), loratadine (LORATADINE), theanine (THEANINE).  The patient previously received the first dose on 28Dec2020 (Lot number=EK3730). There were no noticable effects after the first dose but 12hrs after second dose (19Jan2021), the patient experienced increased pain at injection site, but no swelling or redness. There was gradual onset of soreness raidiating from lymphnodes in neck, chest, back, hips/glutes, and legs; headache; soreness in upper lungs/bronchii (they are hypersensitive and usually sometimes get sore in reaction to irritants in the air), as well as upper respiratory system, but no difficulty breathing. Discomfort was at 6/10 on 19Jan2021. The outcome of the events was not recovered.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Musculoskeletal pain, Pain in extremity, Pulmonary pain, Respiratory symptom
Clinical narrative: 12hr after second dose: increased pain at injection site, but no swelling or redness; headache; Discomfort is a 6/10; gradual onset of soreness raidiating from lymphnodes in neck; gradual onset of soreness in chest/ soreness in bronchi; gradual onset of soreness in back; gradual onset of soreness in hips; gradual onset of soreness in legs; gradual onset of soreness in glutes; soreness in upper lungs; soreness in upper respiratory system; This is a spontaneous report from a non-contactable consumer. A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247), via an unspecified route of administration on the left arm from 18Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included major depression, anxiety; increased airway sensitivity due to being former smoker from an unknown date and unknown if ongoing. Concomitant medication included vilazodone hydrochloride (VIIBRYD), loratadine (LORATADINE), theanine (THEANINE).  The patient previously received the first dose on 28Dec2020 (Lot number=EK3730). There were no noticable effects after the first dose but 12hrs after second dose (19Jan2021), the patient experienced increased pain at injection site, but no swelling or redness. There was gradual onset of soreness raidiating from lymphnodes in neck, chest, back, hips/glutes, and legs; headache; soreness in upper lungs/bronchii (they are hypersensitive and usually sometimes get sore in reaction to irritants in the air), as well as upper respiratory system, but no difficulty breathing. Discomfort was at 6/10 on 19Jan2021. The outcome of the events was not recovered.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 12hr after second dose: increased pain at injection site, but no swelling or redness; headache; Discomfort is a 6/10; gradual onset of soreness raidiating from lymphnodes in neck; gradual onset of soreness in chest/ soreness in bronchi; gradual onset of soreness in back; gradual onset of soreness in hips; gradual onset of soreness in legs; gradual onset of soreness in glutes; soreness in upper lungs; soreness in upper respiratory system; This is a spontaneous report from a non-contactable consumer. A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247), via an unspecified route of administration on the left arm from 18Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included major depression, anxiety; increased airway sensitivity due to being former smoker from an unknown date and unknown if ongoing. Concomitant medication included vilazodone hydrochloride (VIIBRYD), loratadine (LORATADINE), theanine (THEANINE).  The patient previously received the first dose on 28Dec2020 (Lot number=EK3730). There were no noticable effects after the first dose but 12hrs after second dose (19Jan2021), the patient experienced increased pain at injection site, but no swelling or redness. There was gradual onset of soreness raidiating from lymphnodes in neck, chest, back, hips/glutes, and legs; headache; soreness in upper lungs/bronchii (they are hypersensitive and usually sometimes get sore in reaction to irritants in the air), as well as upper respiratory system, but no difficulty breathing. Discomfort was at 6/10 on 19Jan2021. The outcome of the events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive; tested positive; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse reported similar events for 3 patients. This is the second of 3 reports.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry 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 patient had tested positive on an unspecified date in Jan2021, after the first dose of the vaccine was given. The second dose was set up and the patient would be off of the 14-day quarantine by then, but the reporter was not sure if the people was eligible to get the second dose. The outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported events.,Linked Report(s) : US-PFIZER INC-2021058398 same reporter/vaccine/AE and different patients.;US-PFIZER INC-2021058679 same reporter/vaccine/AE and different patients.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive after receiving first vaccination; tested positive after receiving first vaccination; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable nurse reported similar events for 3 patients. This is the third of 3 reports.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry 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 patient had tested positive after receiving first vaccination in Jan2021. The second dose was set up and the patient would be off of the 14-day quarantine by then, but the reporter was not sure if those who tested positive were still advised to get the second vaccine. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 test positive and suspected LOE  due to temporal relationship.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  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.,Linked Report(s) : US-PFIZER INC-2021058398 Same reporter/ vaccine, different patient/ similar AE
Sex: M
Vaccine: COVID19
Symptoms: Gingival swelling, Nasal discomfort, Noninfective gingivitis, Oral disorder, Pharyngeal inflammation
Clinical narrative: had tickling in his nose/one of his nostrils felt like it was spasming; inflamed throat which blossomed into him having to clear it often; stated that the area at the top of his teeth on each side where they end at gum got inflamed and swollen and spread to the inside of his cheeks; stated that the area at the top of his teeth on each side where they end at gum got inflamed and swollen and spread to the inside of his cheeks; stated that the area at the top of his teeth on each side where they end at gum got inflamed and swollen and spread to the inside of his cheeks; stated that the area at the top of his teeth on each side where they end at gum got inflamed and swollen and spread to the inside of his cheeks; This is a spontaneous report from a non-contactable consumer.  A male patient of an unspecified age received bnt162b2 (BNT162B2; Covid vaccine), via an unspecified route of administration on 08Jan2021 to 08Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated that he had the first shot a week ago Saturday of the Covid vaccine. Stated that had ticking in his nose and one of his nostrils felt like it was spasming. Stated that over the next couple of days that started getting an inflamed throat which blossomed into him having to clear it often. Stated that the area at the top of his teeth on each side where they end at gum got inflamed and swollen and spread to the inside of his cheeks. Wanted to know if this was from the vaccine or if it has been heard of. Did not want to mess up his chances of having a second shot. The outcome of events was unknown.    No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: had tickling in his nose/one of his nostrils felt like it was spasming; inflamed throat which blossomed into him having to clear it often; stated that the area at the top of his teeth on each side where they end at gum got inflamed and swollen and spread to the inside of his cheeks; stated that the area at the top of his teeth on each side where they end at gum got inflamed and swollen and spread to the inside of his cheeks; stated that the area at the top of his teeth on each side where they end at gum got inflamed and swollen and spread to the inside of his cheeks; stated that the area at the top of his teeth on each side where they end at gum got inflamed and swollen and spread to the inside of his cheeks; This is a spontaneous report from a non-contactable consumer.  A male patient of an unspecified age received bnt162b2 (BNT162B2; Covid vaccine), via an unspecified route of administration on 08Jan2021 to 08Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated that he had the first shot a week ago Saturday of the Covid vaccine. Stated that had ticking in his nose and one of his nostrils felt like it was spasming. Stated that over the next couple of days that started getting an inflamed throat which blossomed into him having to clear it often. Stated that the area at the top of his teeth on each side where they end at gum got inflamed and swollen and spread to the inside of his cheeks. Wanted to know if this was from the vaccine or if it has been heard of. Did not want to mess up his chances of having a second shot. The outcome of events was unknown.    No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: severe body aches; Fatigue; chills; This is a spontaneous report from a non-contactable Other HCP. This 54-year-old female Other HCP (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Ek4176/expiration date: unknown), via an unspecified route of administration, on 16Jan2021 09:30 AM (at the age of 54 years old) as a single dose on left arm for COVID-19 immunisation at a hospital facility. Relevant medical history was none. Historical vaccine history included first dose of BNT162B2 vaccine (Pfizer product) on 31Dec2020 (lot number: EL0140) on left arm. The patient did not have any known allergies to medications, food, or other products. Patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Jan2021 08:30 PM, the patient stated that approximately 12 hours after 2nd dose, she experienced severe body aches, fatigue, chills lasting approximately 20 hours.  The outcome of the events severe body aches, fatigue, chills was recovered.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Left v1 distribution shingles; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: Eh9899) intramuscular on the left arm on 18Dec2020 11:00 at a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medication included diphenhydramine hydrochloride (BENADRYL), diphenhydramine hydrochloride (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]) and zolpidem tartrate (AMBIEN). On 21Dec2020 10: 00 AM, the patient experienced left v1 distribution shingles. Therapeutic measures were taken as a result of the event which included valaciclovir (VALTREX) and dexamethasone (DECADRON). Patient was not pregnant. The facility where the vaccine was administered was in a hospital. 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. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was recovered on an unspecified date.   No follow up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood cholesterol, Blood cholesterol increased, Dizziness, Vitamin D
Clinical narrative: Cholesterol little elevated; Vitamin D two points low; just about face planted; dizziness worsened; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL8982 or E68982), intramuscular on 13Jan2021 16:00 at single dose in left deltoid for COVID-19 immunisation. Patient age at time of vaccination was 42 years. Medical history included retinal blood clot in his retina which was why he was tested for rheumatoid arthritis (RA), and Meniere's disease for which he was asked to try meclizine which was for inner ear but he did not start taking meclizine, and six years ago, they did blood work and he was told he may have RA or he may have markers for RA but he has had no further issues and does not take any medication for this. The patient's concomitant medications were not reported.  Historical vaccine included  influenza immunisation (flu shot) in Sep2020 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) administered on 22Dec2020 around 15:15 at single dose intramuscular injection in left deltoid, and on 06Jan2021 he started to experience dizziness/feeling dizzy and going to throw up on 11Jan2021. He received the second dose of the Pfizer's COVID-19 vaccine on 13Jan2021 and for the last days it seems that the dizziness is being incrementing, reported as worsened. His physician recommended him to perform laboratory tests and the results came back without abnormal findings except for cholesterol and vitamin D. He was told his cholesterol was a little elevated and his vitamin D was two points low, regarding his lab work. He got a vitamin D supplement which he started to take. He will start on his cholesterol medication today that was prescribed. Reportedly he has a Roomba and when he went to go press the button for it, he just about face planted. He looked online and could not find anything about the dizziness aside from dizziness could be a sign of a severe allergic reaction. He does not have hypotension or anything like that. Dizziness was not resolved, while outcome of other events was unknown. It was stated dizziness is not reported as a side effect of the vaccine.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vitamin D decreased
Clinical narrative: Cholesterol little elevated; Vitamin D two points low; just about face planted; dizziness worsened; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A 42-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL8982 or E68982), intramuscular on 13Jan2021 16:00 at single dose in left deltoid for COVID-19 immunisation. Patient age at time of vaccination was 42 years. Medical history included retinal blood clot in his retina which was why he was tested for rheumatoid arthritis (RA), and Meniere's disease for which he was asked to try meclizine which was for inner ear but he did not start taking meclizine, and six years ago, they did blood work and he was told he may have RA or he may have markers for RA but he has had no further issues and does not take any medication for this. The patient's concomitant medications were not reported.  Historical vaccine included  influenza immunisation (flu shot) in Sep2020 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) administered on 22Dec2020 around 15:15 at single dose intramuscular injection in left deltoid, and on 06Jan2021 he started to experience dizziness/feeling dizzy and going to throw up on 11Jan2021. He received the second dose of the Pfizer's COVID-19 vaccine on 13Jan2021 and for the last days it seems that the dizziness is being incrementing, reported as worsened. His physician recommended him to perform laboratory tests and the results came back without abnormal findings except for cholesterol and vitamin D. He was told his cholesterol was a little elevated and his vitamin D was two points low, regarding his lab work. He got a vitamin D supplement which he started to take. He will start on his cholesterol medication today that was prescribed. Reportedly he has a Roomba and when he went to go press the button for it, he just about face planted. He looked online and could not find anything about the dizziness aside from dizziness could be a sign of a severe allergic reaction. He does not have hypotension or anything like that. Dizziness was not resolved, while outcome of other events was unknown. It was stated dizziness is not reported as a side effect of the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: a patient in a nursing home facility that tested positive after receiving the first COVID vaccine; a patient in a nursing home facility that tested positive after receiving the first COVID vaccine; This is a spontaneous report from a contactable Nurse via a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at first single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive after receiving the first covid vaccine. The patient is asymptomatic. The reporter just need to know if she can give this man the second vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported events.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Back pain, COVID-19
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; joint pain hips and back; arm pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) on 08Jan2021 at 12:30 PM (that is 09Jan2021 00:30 AM) in the left arm at single dose for COVID-19 immunization. None Medical History. Concomitant product includes ongoing ethinylestradiol, ferrous fumarate, norethisterone (KAITLIB FE) for oral contraceptive taking for a long time. No Prior Vaccinations within 4 weeks. Patient received the first dose of the vaccine on 08Jan2021 at 12:30 PM and then COVID-19 PCR test positive the following 12Jan2021. Clinical course as: On 09Jan2021, some arm pain at the injection site. On 10Jan2021, she had some joint pain hips and back; chills. On 10Jan2021 night into 11Jan2021 she had some nasal congestion. On 12Jan2021, she lost her sense of taste and smell. All of these effects have resolved except for the loss of taste and smell. She is planning to get the next dose on 29Jan2021. Patient was asking about getting the second dose of the vaccine since she tested positive. She tested negative prior on 04Jan2021; 06Jan2021 and 08Jan2021, until 12Jan2021 when she was tested positive. No events require a visit to physician or ER. The outcome of arm pain and joint pain was recovered on 10Jan2021, of other event was not recovered.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; joint pain hips and back; arm pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) on 08Jan2021 at 12:30 PM (that is 09Jan2021 00:30 AM) in the left arm at single dose for COVID-19 immunization. None Medical History. Concomitant product includes ongoing ethinylestradiol, ferrous fumarate, norethisterone (KAITLIB FE) for oral contraceptive taking for a long time. No Prior Vaccinations within 4 weeks. Patient received the first dose of the vaccine on 08Jan2021 at 12:30 PM and then COVID-19 PCR test positive the following 12Jan2021. Clinical course as: On 09Jan2021, some arm pain at the injection site. On 10Jan2021, she had some joint pain hips and back; chills. On 10Jan2021 night into 11Jan2021 she had some nasal congestion. On 12Jan2021, she lost her sense of taste and smell. All of these effects have resolved except for the loss of taste and smell. She is planning to get the next dose on 29Jan2021. Patient was asking about getting the second dose of the vaccine since she tested positive. She tested negative prior on 04Jan2021; 06Jan2021 and 08Jan2021, until 12Jan2021 when she was tested positive. No events require a visit to physician or ER. The outcome of arm pain and joint pain was recovered on 10Jan2021, of other event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chest discomfort, Chills, Illness
Clinical narrative: sick; arm pain; redness at injection site; chest tightness; low grade fever of 99°F; severe and horrible chills; joint and muscle pain; joint and muscle pain; flu like symptoms; severely achy; This is a spontaneous report from a contactable other HCP. This other HCP (patient) reported that the 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unknown route of administration on 14Jan2021 at single dose for covid-19 immunisation. Medical history included she had a heart attack 20 years ago and she felt similar chest tightness and she also has coronary artery disease and autoimmune deficiency (ATS) which is not a contraindication for the vaccine she checked with her physician before receiving. Concomitant medications included clopidogrel bisulfate (PLAVIX) and warfarin sodium (COUMADIN). The patient previously received first dose of COVID vaccine on 25Dec2020 and  experienced arm pain and redness that went away. The patient received second dose of COVID vaccine on 14Jan2021 and stated she did not think she was going to make it through the night because she was very sick. The patient states she had arm pain, redness at injection site, chest tightness, low grade fever of 99°F, severe and horrible chills, joint and muscle pain, flu like symptoms, severely achy. The patient states he did not have a reaction or feel any pain after either dose and he felt as though he received a placebo both times. The patient and her husband are on the line and the patient husband would like to know of the 5% that the vaccine was not effective did it lessen their symptoms that did get the virus and was their any fatalities. The patient would also like to know what the age group was between for the 5% that the vaccine was not effective. The patient would like to know when can you take an antibody test after receiving second dose of vaccine. The patient would like to know if you had a reaction or symptoms after second dose of COVID vaccine does it mean that you have antibodies. The patient states she is fine now will never take another MRNA vaccine again. The events started from Jan2021 and outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: sick; arm pain; redness at injection site; chest tightness; low grade fever of 99°F; severe and horrible chills; joint and muscle pain; joint and muscle pain; flu like symptoms; severely achy; This is a spontaneous report from a contactable other HCP. This other HCP (patient) reported that the 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unknown route of administration on 14Jan2021 at single dose for covid-19 immunisation. Medical history included she had a heart attack 20 years ago and she felt similar chest tightness and she also has coronary artery disease and autoimmune deficiency (ATS) which is not a contraindication for the vaccine she checked with her physician before receiving. Concomitant medications included clopidogrel bisulfate (PLAVIX) and warfarin sodium (COUMADIN). The patient previously received first dose of COVID vaccine on 25Dec2020 and  experienced arm pain and redness that went away. The patient received second dose of COVID vaccine on 14Jan2021 and stated she did not think she was going to make it through the night because she was very sick. The patient states she had arm pain, redness at injection site, chest tightness, low grade fever of 99°F, severe and horrible chills, joint and muscle pain, flu like symptoms, severely achy. The patient states he did not have a reaction or feel any pain after either dose and he felt as though he received a placebo both times. The patient and her husband are on the line and the patient husband would like to know of the 5% that the vaccine was not effective did it lessen their symptoms that did get the virus and was their any fatalities. The patient would also like to know what the age group was between for the 5% that the vaccine was not effective. The patient would like to know when can you take an antibody test after receiving second dose of vaccine. The patient would like to know if you had a reaction or symptoms after second dose of COVID vaccine does it mean that you have antibodies. The patient states she is fine now will never take another MRNA vaccine again. The events started from Jan2021 and outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: sick; arm pain; redness at injection site; chest tightness; low grade fever of 99°F; severe and horrible chills; joint and muscle pain; joint and muscle pain; flu like symptoms; severely achy; This is a spontaneous report from a contactable other HCP. This other HCP (patient) reported that the 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unknown route of administration on 14Jan2021 at single dose for covid-19 immunisation. Medical history included she had a heart attack 20 years ago and she felt similar chest tightness and she also has coronary artery disease and autoimmune deficiency (ATS) which is not a contraindication for the vaccine she checked with her physician before receiving. Concomitant medications included clopidogrel bisulfate (PLAVIX) and warfarin sodium (COUMADIN). The patient previously received first dose of COVID vaccine on 25Dec2020 and  experienced arm pain and redness that went away. The patient received second dose of COVID vaccine on 14Jan2021 and stated she did not think she was going to make it through the night because she was very sick. The patient states she had arm pain, redness at injection site, chest tightness, low grade fever of 99°F, severe and horrible chills, joint and muscle pain, flu like symptoms, severely achy. The patient states he did not have a reaction or feel any pain after either dose and he felt as though he received a placebo both times. The patient and her husband are on the line and the patient husband would like to know of the 5% that the vaccine was not effective did it lessen their symptoms that did get the virus and was their any fatalities. The patient would also like to know what the age group was between for the 5% that the vaccine was not effective. The patient would like to know when can you take an antibody test after receiving second dose of vaccine. The patient would like to know if you had a reaction or symptoms after second dose of COVID vaccine does it mean that you have antibodies. The patient states she is fine now will never take another MRNA vaccine again. The events started from Jan2021 and outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Pyrexia
Clinical narrative: fever 102.7; myalgia; fatigue; This is a spontaneous report from a non-contactable physician.   A patient of unspecified age and gender started received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on an unspecified date single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever 102.7 after 24 hours, and myalgia, fatigue both on an unspecified date. The events outcome was recovered.   No follow-up attempts are possible; information on lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Hypersensitivity, Pain in extremity, Rhinorrhoea
Clinical narrative: Runny nose; allergies; sore arm; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982), via an unspecified route of administration at the left arm on 14Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing high blood pressure (has had for 10+ years), ongoing high cholesterol (has had for 10+ years) and pulled a muscle in her arm on an unspecified date prior to vaccination. She received the vaccine because she is considered a front-line worker. She works and must go into homes. She also adds that her mother in law was buried because she died from COVID. There were no concomitant medications. The patient received her first dose of the Covid-19 vaccine on 14Jan2021. She was fine other than a sore arm which started on 15Jan2021. On 19Jan2021, she has a runny nose. It is more like allergies. The outcome for the event sore arm was recovered on 16Jan2021; outcome for runny nose and allergies was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable other health professional reporting for himself. A 57-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK4176), via an unspecified route of administration in arm left, on 19Jan2021 at 06:30 AM, at single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and hypothyroidism. Allergies to medications, food or other products: no. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included metformin (unknown manufacturer), insulin glargine (LANTUS), levothyroxine sodium (SYNTHROID). Previously the patient received the 1st dose of BNT162B2 for COVID-19 immunisation, on 29Dec2020, lot# EK9231, in left arm, at 04:00 PM. The patient experienced hives on 21Jan2021 with outcome of recovering. No therapeutic measures were taken as a result of the event. The patient was not tested for COVID-19 since vaccination.