chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Just a small amount of facial burning; This is a spontaneous report received from a contactable other health care professional. This 55-years-old female patient received  second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number& Expiry date not reported) via intramuscular route of administration in left deltoid on 11Jan2021 (at age of 55-years-old) as single dose for COVID-19 Immunization. Patient medical history include allergies sinuses, JRA (Juvenile rheumatoid arthritis at age of 16), GERD (Gastroesophageal reflux disease 2years ago),PSVT (Paroxysmal supraventricular tachycardia,15 years ago).Patients concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number:E49899 & Expiry date not reported) via intramuscular route of administration in left deltoid on 21Dec2020 at 13:40 as single dose for COVID-19 Immunization. On unspecified date , patient experienced  just a small amount of facial burning, intermittent for 24 hours with second dose. No treatment received for event. The outcome of event was unknown.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus
Clinical narrative: Itchiness of the ear.; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program . A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that on an unspecified date, the patient experienced itchiness of the ear. She asked if she could take Nasacort. She also mentioned that she took Omeprazole the day after the first dose. The outcome of event was unknown.  Information on the Lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information was expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: Mild Facial Burning; Tingling to bilat hands; This is a spontaneous report from a contactable Nurse (Patient). A 52-years-old male patient received second doe second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EJ1686) via intramuscular route of administration in right arm on 08Jan2021 09:15 as single dose for COVID-19 immunization Hospital. The patient medical history and concomitant medications were not reported. Patient previously took first dose BNT162B2, Batch/Lot Number: EJ1685) via intramuscular route of administration in right arm on 18Dec2020 for COVID-19 immunization patient had extreme itching, burning over entire body, awoke 08:00 with body ache, headache. On 08Jan2021 11:30 the patient experienced mild facial burning, tingling to bilat hands on 08Jan2021 11:30. Patient had a visit to Emergency room and physician office for the events. Therapeutic measures were taken as a result of mild facial burning, tingling to bilat hands Benadryl, hydroxyzine, Loratadine, Pepsin. The outcome of the events mild facial burning, tingling to bilat hands was recovered on unspecified date.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Decreased appetite, Diarrhoea
Clinical narrative: Fever; Chills; Nausea; Abdominal pain; Diarrhea; Decreased Po food intake; Myalgia's; Arthralgia's; B/L Extremity (Lower) swelling; Fatigue; Headache; Muscle tightness; This is a spontaneous report from a contactable Nurse (Patient) reported in response to HCP letter sent in cross referenced case.   A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247 and Expiry date: Unknown), via an unspecified route of administration, administered in left deltoid on 13Jan2021 (at the age of 37-years-old) as dose 2, single for COVID-19 immunization in Hospital. The patient medical history included workplace exposure previous Covid infection on 11Mar2020. The patient had undetectable antibodies in Apr2020. The patient had post viral syndrome (covid) or Long Covid from 05Apr2020 with fatigue, SOB, dizziness, myalgias, arthralgia, Headache and post Covid, with diarrhea, vaginal bleeding, anisamide, hair loss, and small fiber neuropathy (from COVID); all stopped on an unspecified date. Officially dx Sep2020. The patient concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, Solution for injection, Lot number: EK9231 and Expiry date: Unknown), via intramuscular route of administration, administered in left deltoid on 22Dec2020 at 12:30 as dose 1, single for COVID-19 immunization and experienced myalgias, arthralgias, B/L Extremity (Lower) swelling, fatigue, headache, muscle tightness and other events. On an unspecified date after dose 2, the patient experienced fever, chills, nausea, abdominal pain, diarrhea, decreased po food intake, along with events which were inherited from dose 1 which included myalgia's, arthralgia's, b/l extremity swelling, fatigue, headache, muscle tightness. The events did not result in emergency room or physician office visit. The patient underwent lab tests which included Semi quantitative Covid 19 IgG (SARS-CoV-2 antibody test): High with >125 Au/mL (greater than > 40 Au/mL considered Strong Positive) on 23Jan2021. The outcome of the events myalgia and arthralgia was recovered on 18Jan2021, while outcome of other events was unknown. The patient who was a healthcare professional had considered the Pfizer product had a casual effect to the adverse event.  Additional comment section: I'm a covid long hauler infection Mar2020, Apr2020 My body had undetectable IgG. When I took Covid 19 Vaccine, 9.5 months passed and I was just starting to feel better, m RNA vaccine is the 1 st time I have active immunity IgG, Concern for other long haulers (Natural infection) who may have undetectable IgG and unable to mount vaccine IgG  Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle tightness, Myalgia, Nausea
Clinical narrative: Fever; Chills; Nausea; Abdominal pain; Diarrhea; Decreased Po food intake; Myalgia's; Arthralgia's; B/L Extremity (Lower) swelling; Fatigue; Headache; Muscle tightness; This is a spontaneous report from a contactable Nurse (Patient) reported in response to HCP letter sent in cross referenced case.   A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247 and Expiry date: Unknown), via an unspecified route of administration, administered in left deltoid on 13Jan2021 (at the age of 37-years-old) as dose 2, single for COVID-19 immunization in Hospital. The patient medical history included workplace exposure previous Covid infection on 11Mar2020. The patient had undetectable antibodies in Apr2020. The patient had post viral syndrome (covid) or Long Covid from 05Apr2020 with fatigue, SOB, dizziness, myalgias, arthralgia, Headache and post Covid, with diarrhea, vaginal bleeding, anisamide, hair loss, and small fiber neuropathy (from COVID); all stopped on an unspecified date. Officially dx Sep2020. The patient concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, Solution for injection, Lot number: EK9231 and Expiry date: Unknown), via intramuscular route of administration, administered in left deltoid on 22Dec2020 at 12:30 as dose 1, single for COVID-19 immunization and experienced myalgias, arthralgias, B/L Extremity (Lower) swelling, fatigue, headache, muscle tightness and other events. On an unspecified date after dose 2, the patient experienced fever, chills, nausea, abdominal pain, diarrhea, decreased po food intake, along with events which were inherited from dose 1 which included myalgia's, arthralgia's, b/l extremity swelling, fatigue, headache, muscle tightness. The events did not result in emergency room or physician office visit. The patient underwent lab tests which included Semi quantitative Covid 19 IgG (SARS-CoV-2 antibody test): High with >125 Au/mL (greater than > 40 Au/mL considered Strong Positive) on 23Jan2021. The outcome of the events myalgia and arthralgia was recovered on 18Jan2021, while outcome of other events was unknown. The patient who was a healthcare professional had considered the Pfizer product had a casual effect to the adverse event.  Additional comment section: I'm a covid long hauler infection Mar2020, Apr2020 My body had undetectable IgG. When I took Covid 19 Vaccine, 9.5 months passed and I was just starting to feel better, m RNA vaccine is the 1 st time I have active immunity IgG, Concern for other long haulers (Natural infection) who may have undetectable IgG and unable to mount vaccine IgG  Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Fever; Chills; Nausea; Abdominal pain; Diarrhea; Decreased Po food intake; Myalgia's; Arthralgia's; B/L Extremity (Lower) swelling; Fatigue; Headache; Muscle tightness; This is a spontaneous report from a contactable Nurse (Patient) reported in response to HCP letter sent in cross referenced case.   A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247 and Expiry date: Unknown), via an unspecified route of administration, administered in left deltoid on 13Jan2021 (at the age of 37-years-old) as dose 2, single for COVID-19 immunization in Hospital. The patient medical history included workplace exposure previous Covid infection on 11Mar2020. The patient had undetectable antibodies in Apr2020. The patient had post viral syndrome (covid) or Long Covid from 05Apr2020 with fatigue, SOB, dizziness, myalgias, arthralgia, Headache and post Covid, with diarrhea, vaginal bleeding, anisamide, hair loss, and small fiber neuropathy (from COVID); all stopped on an unspecified date. Officially dx Sep2020. The patient concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, Solution for injection, Lot number: EK9231 and Expiry date: Unknown), via intramuscular route of administration, administered in left deltoid on 22Dec2020 at 12:30 as dose 1, single for COVID-19 immunization and experienced myalgias, arthralgias, B/L Extremity (Lower) swelling, fatigue, headache, muscle tightness and other events. On an unspecified date after dose 2, the patient experienced fever, chills, nausea, abdominal pain, diarrhea, decreased po food intake, along with events which were inherited from dose 1 which included myalgia's, arthralgia's, b/l extremity swelling, fatigue, headache, muscle tightness. The events did not result in emergency room or physician office visit. The patient underwent lab tests which included Semi quantitative Covid 19 IgG (SARS-CoV-2 antibody test): High with >125 Au/mL (greater than > 40 Au/mL considered Strong Positive) on 23Jan2021. The outcome of the events myalgia and arthralgia was recovered on 18Jan2021, while outcome of other events was unknown. The patient who was a healthcare professional had considered the Pfizer product had a casual effect to the adverse event.  Additional comment section: I'm a covid long hauler infection Mar2020, Apr2020 My body had undetectable IgG. When I took Covid 19 Vaccine, 9.5 months passed and I was just starting to feel better, m RNA vaccine is the 1 st time I have active immunity IgG, Concern for other long haulers (Natural infection) who may have undetectable IgG and unable to mount vaccine IgG  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Headache, Pyrexia
Clinical narrative: Fever with associated chills and shivering; Fever with associated chills and shivering; Fever with associated chills and shivering; Soreness at injection site; Headache; Fatigue; This is a spontaneous report from a contactable consumer (Age: 50; Units: Unknown) reported for self. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/Lot Number was not reported) via an unspecified route of administration on 04Feb2021 13:45 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (first dose) for covid-19 immunisation. On 05Feb2021, the patient experienced soreness at injection site, headache, fatigue 24 hours after administration, fever with associated chills and shivering 36 hours after administration. The clinical outcome of the all the events on 06Feb2021 was resolved.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: Fever with associated chills and shivering; Fever with associated chills and shivering; Fever with associated chills and shivering; Soreness at injection site; Headache; Fatigue; This is a spontaneous report from a contactable consumer (Age: 50; Units: Unknown) reported for self. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/Lot Number was not reported) via an unspecified route of administration on 04Feb2021 13:45 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (first dose) for covid-19 immunisation. On 05Feb2021, the patient experienced soreness at injection site, headache, fatigue 24 hours after administration, fever with associated chills and shivering 36 hours after administration. The clinical outcome of the all the events on 06Feb2021 was resolved.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Oral discomfort
Clinical narrative: Funny feeling in her lips; felt funny; Funny feeling in her lips; felt funny; This is a spontaneous report from a contactable consumer or other non health care professional (patient) reported in response to Non-health care professional letter sent in cross referenced case. An 85-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on 27Jan2021 (at the age of 85-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced same reaction as first shot: funny feeling in her lips; felt funny. Patient took benadryl as treatment for the events. Symptoms disappeared in about 5 min, fine afterwards. The outcome of evens was resolved on an unspecified date in 2021.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Throat tightness
Clinical narrative: felt flushed; her throat was mildly tight; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EN5318) (at the age of  37-year-old) via an unspecified route of administration in left arm on 11Feb2021 at 1:15-1:20pm as single dose for COVID-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. There was no prior vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to AE(s) and relevant tests were none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional vaccines administered on same date of the Pfizer suspect was none. The patient had no allergies. Caller, reporting on the COVID vaccine and who had the first dose and explains she had a question. The first dose was yesterday and after getting it she felt flushed/ flushed- this was in her chest that she felt the flushed sensation and her throat was mildly tight (on 11Feb2021). After 5 minutes it went away. The caller was wondering could that be a reaction, she called the doctor who would not say it was a reaction and was therefore told to call us. Her fear was that with the second dose, could she have a worse reaction after that one. The patient did not visit emergency room or physician office. The patient did not receive any treatment for the events. The outcome of the events was recovered/resolved on 11Feb2021.  Follow-up attempts completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Vaccination site pain
Clinical narrative: Arm pain, a throbbing arm pain at the injection site/Arm started throbbing and hurting/pretty extreme arm pain; Arm pain, a throbbing arm pain at the injection site/Arm started throbbing and hurting/pretty extreme arm pain; Arm pain, a throbbing arm pain at the injection site, it was preventing her from sleeping; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in arm on an unspecified date (reported as 3-4 days ago at 15:30 in the afternoon) as a Dose number Unknown Single for COVID-19 immunization. The patient's medical history included The patient previously took shingles shot and flu shot and stated she has reacted like that with the shingles shot and sometimes with the flu shot just slightly. The patient's concomitant medications were not reported.  On an unspecified date, the patient experienced arm pain, a throbbing arm pain at the injection site/arm started throbbing and hurting/pretty extreme arm pain and arm pain, a throbbing arm pain at the injection site, it was preventing her from sleeping. The consumer reported that "she received the first dose of the vaccine about 3-4 days ago. She stated she was fine, she just had some pretty extreme arm pain for a day or two. She stated it didn't come right away. She had the shot at 3:30 in the afternoon and during the night (also reported as 13 hours after vaccination) the arm got pretty sore. She took ibuprofen and wondered if that was okay. She took a small dose, the over the counter simple dose and two of the 200 mg only once. The patient took this to relieve the arm pain, a throbbing arm pain at the injection site. It was preventing her from sleeping. The next night she put cool packs on it. She stated it was gone now. She stated she heard it can be more severe with the second shot. She heard something about maybe she shouldn't have taken the ibuprofen and asked, is it okay that i took the Ibuprofen?" The patient received treatment for the event Arm pain, a throbbing arm pain at the injection site/Arm started throbbing and hurting/pretty extreme arm pain with ibuprofen. The outcome of event Arm pain, a throbbing arm pain at the injection site/Arm started throbbing and hurting/pretty extreme arm pain was resolved whereas the outcome of other event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: vomiting; diarrhea; fever of over 101 degrees/fever of 102 degrees; weight loss (approximately to 10lbs to date); This is a spontaneous report from a contactable consumer. A 66-year-old female patient received Bnt162b2 (BNT162B2; Formulation: Solution for injection) via unknown route of administration from 31Jan2021 at SINGLE DOSE for unknown indication. Patient's medical history included Mrs. (Name) stated that she has known co-morbidities, including Lupus. She has visited medical facilities several times since receiving the vaccine. Patient's concomitant medications were not reported. It was reported that Ms. (Name) states she has been vomiting, had diarrhea and had a fever of over 101 degrees for the past 6 days. Patient received her 1st dose of the vaccine on 31Jan2021 and within 24 hours began experience multiple symptoms including a fever of 102 degrees or higher temperature every day since receiving the vaccine. She has also experienced vomiting, diarrhea and weight loss (approximately to 10lbs to date), She believes that the vaccine may have contaminated or a counterfeit. She stated that she had some concerns regarding the qualifications of the persons administering the vaccine and that is why she believes may have been compromised in some way. She has been received multiple tests for COVID-19, but the results have come back negative; the HCP's treating her all believe to be the cause of her symptoms. The outcome of the events was unknown.  Follow-up (09Feb2021): New information received from a contactable consumer which includes: New clinical information reported.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: vomiting; diarrhea; fever of over 101 degrees/fever of 102 degrees; weight loss (approximately to 10lbs to date); This is a spontaneous report from a contactable consumer. A 66-year-old female patient received Bnt162b2 (BNT162B2; Formulation: Solution for injection) via unknown route of administration from 31Jan2021 at SINGLE DOSE for unknown indication. Patient's medical history included Mrs. (Name) stated that she has known co-morbidities, including Lupus. She has visited medical facilities several times since receiving the vaccine. Patient's concomitant medications were not reported. It was reported that Ms. (Name) states she has been vomiting, had diarrhea and had a fever of over 101 degrees for the past 6 days. Patient received her 1st dose of the vaccine on 31Jan2021 and within 24 hours began experience multiple symptoms including a fever of 102 degrees or higher temperature every day since receiving the vaccine. She has also experienced vomiting, diarrhea and weight loss (approximately to 10lbs to date), She believes that the vaccine may have contaminated or a counterfeit. She stated that she had some concerns regarding the qualifications of the persons administering the vaccine and that is why she believes may have been compromised in some way. She has been received multiple tests for COVID-19, but the results have come back negative; the HCP's treating her all believe to be the cause of her symptoms. The outcome of the events was unknown.  Follow-up (09Feb2021): New information received from a contactable consumer which includes: New clinical information reported.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: soar throat; headache; This is a spontaneous report from a contactable physician. A 38-year-old male physician received Bnt162b2 (BNT162B2; Formulation: Solution for injection) via unknown route of administration from unknown date at unknown single dose for unknown indication. Patient's medical history and concomitant medications were not reported. It was reported that experiencing sore throat and headache four weeks after receiving second dose of covid vaccine. Event took place after use of product. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: After taste in mouth; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 2nd of two reports. This consumer (Wife) reported for a male patient (Husband) that, A male patient of an unspecified age received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 05Feb2021 15:00 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included meniere's disease. No known allergies. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. Concomitant medication(s) included Multi Vitamins, rosuvastatin calcium (CRESTOR); furosemide (FUROSEMIDE) and sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported. On 05Feb2021 15:30 patient experienced after taste in mouth, Strong immediately after vaccine. Husband had same response. NO treatment was received for event. The outcome of event after taste was recovered on an unspecified date in Feb2021.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021127141 Same reporter/drug/event, different patient
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: fever of 101 F; muscle aches; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for 6 patients. This is 1st of 6 reports. This 31-year-old female consumer reported.   A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 31-years-old) on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced fever of 101 F and muscle aches 26 hours after receiving her second Pfizer - BioNTech COVID vaccine. Symptoms lasted approximately 7 hours and symptoms were relieved with treatment medication. Patient stated that 5 other individuals within her department also experienced similar symptoms after receiving the second dose. Treatment medication included one dose of Tylenol. The patient underwent lab test and procedures on an unspecified date which included body temperature of 101 F. Outcome of the events was reported was recovered on an unspecified date.   Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021157492 Same reporter/ drug/ event for different patients;US-PFIZER INC-2021157494 Same reporter/ drug/ event for different patients;US-PFIZER INC-2021157495 Same reporter/ drug/ event for different patients;US-PFIZER INC-2021157496 Same reporter/ drug/ event for different patients;US-PFIZER INC-2021157493 Same reporter/ drug/ event for different patients
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: fever of 101 F; muscle aches; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for 5 patients. This is 1st of five reports. This consumer reported for a patient (1st coworker) that:   A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced fever of 101 F and muscle aches 26 hours after receiving her second Pfizer- BioNTech COVID vaccine. Symptoms lasted approximately 7 hours and symptoms were relieved with treatment medication. Patient stated that 5 other individuals within her department also experienced similar symptoms after receiving the second dose. Treatment medication included one dose of Tylenol. The patient underwent lab test and procedures on an unspecified date which included body temperature of 101 F. Outcome for the events was reported as resolved on an unspecified date.    Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021157330 Same reporter/ drug/ event for different patients
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: fever of 101 F; muscle aches; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for herself and 5 patients. This is 4th of 6 reports. This consumer reported for a patient that:  A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine,, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever of 101 f, muscle aches.  The patient underwent lab tests and procedures which included body temperature: 101 fahrenheit on an unknown date. The outcome of the events were unknown.   Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021157330 Same reporter/ drug/ event for different patients
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: fever of 101 F; muscle aches; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for 5 patients. This is 5 of 5 reports. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was not reported), administered on an unspecified date as single dose for COVID-19 immunisation. The patient received of second Pfizer - BioNTech COVID vaccine, after 26 hours experienced fever of 101 F and muscle aches. The symptoms lasted approximately 7 hours and symptoms were relieved with one dose of Tylenol. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit. Therapeutic measures were taken as a result of events and treatment with Tylenol. Outcome of the events was resolved on an unknown date.  Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021157330 Same reporter/ drug/ event for different patients
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had soreness in her arm; This is a spontaneous report from a non-contactable consumer or other non HCP (patient, self-reporting). An adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter reported that a friend shared that her adult daughter had soreness in her arm after the first does of the vaccine.  No follow up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Felt fatigued; Aches; This is a spontaneous report from a contactable other health care professional (patient). This report was received via a sales representative. A 5-decade-old (age: mid-40s, unit: unknown) male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for COVID-19 immunization. The patient reported having a rough time after his second vaccination which was received on a Wednesday. He left work early Thursday. The patient experienced felt fatigued and aches. Therapeutic measures were taken as a result of the events which included Tylenol. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extreme soreness in arm after COVID vaccine; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (patient) via Pfizer sales representative.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced extreme soreness in arm after COVID vaccine. The event was occurred after use of product. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash
Clinical narrative: Full body rash with burning sensation; Full body rash with burning sensation; This is a spontaneous report from a Contactable consumer (patient) or other non HCP.   A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration DOSE 2 SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration at DOSE 1 SINGLE for covid-19 immunization. After 3 days post second dose, patient experienced full body rash with burning sensation. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Repeated nose bleed (3) after second Pfizer COVID vaccine shot; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. On an unspecified date, the patient experienced repeated nose bleed (3) after second pfizer covid vaccine shot. The outcome of the event was unknown.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Bloody noses 3 days after 2nd dose of Pfizer COVID vaccine; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a patient of an unknown gender and age received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified) on an unspecified as historical vaccination as single dose for covid-19 immunisation. On an unspecified date, the patient had bloody noses 3 days after 2nd dose of Pfizer COVID vaccine. The outcome of the event was unknown.  Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible. Information about lot/batch number cannot been obtain. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Neuralgia, Pyrexia
Clinical narrative: Muscle, joint and nerve pain; Muscle, joint and nerve pain; Muscle, joint and nerve pain; fatigue; Fever; This is a spontaneous report from a contactable other hcp. This HCP (Patient) reported that a 36-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EM9810), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 09:00 as DOSE 2, SINGLE for covid-19 immunisation. The patient had no medical history. Concomitant medication(s) included escitalopram oxalate (LEXAPRO) 20mg/day. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unknown route of administration on 15Jan2021 at 05:00 PM in Arm Left (Batch/Lot number : EL3248) as 1ST DOSE, SINGLE for covid-19 immunisation. Patient had no known allergies. On 05Feb2021 07:00, the patient experienced muscle, joint and nerve pain; fatigue and fever. The patient underwent lab tests and procedures which included pyrexia: 101-103 f on 05Feb2021 Fever starting -15 hrs after shot lasting -6 hours, ranging 101-103 F. Patient was received self treatment and OTC medications for events. It was reported that With 2nd shot, Fatigue starting 8 hours after shot lasting for 2 days, not improved with rest, Fever starting 15 hrs. After shot lasting 6 hours, ranging 101-103 F, resolved without medications. Muscle, joint and nerve pain starting 12 hours after shot, muscle and joint pain resolved within 30-60 min of taking 1 tablet naproxen 220 mg, nerve pain (characterized by pressure perceived as burning/tingling pain) resolved 12-15 hours after start but did not improve with rest or OTC painkillers. The clinical outcome of event fatigue was not recovered; while others were recovered.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Influenza like illness, Pain
Clinical narrative: His sinuses are acting up; feels like he has the flu; aches; Chills; blood pressure has spiked/His blood pressure has been in the 120s on the high side over the 60s. His blood pressure has gone up to 160+ over 80+; This is a spontaneous report from a contactable consumer or other non hcp. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number was not reported), via an unspecified route of administration at the age of 76-year-old on 01Feb2021 as single dose for covid-19 immunization. Medical history included blood pressure abnormal. The patient's concomitant medications were not reported. The patient reported that his sinuses were acting up and he called about the Pfizer covid vaccine. He read the pamphlet on the side effects. He did not have all of the side effects and he felt like he has the flu, aches, chills and did not have a fever and his blood pressure had spiked. The patient reported that he has never had a blood pressure problem except way back. His blood pressure had been in the 120s on the high side over the 60s, but his blood pressure had gone up to 160+ over 80+. He did not know if that has anything to do with the vaccine. The patient that he was on blood pressure medication and he has never had a problem. The patient underwent lab tests and procedures which included blood pressure measurement: spiked. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: His sinuses are acting up; feels like he has the flu; aches; Chills; blood pressure has spiked/His blood pressure has been in the 120s on the high side over the 60s. His blood pressure has gone up to 160+ over 80+; This is a spontaneous report from a contactable consumer or other non hcp. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number was not reported), via an unspecified route of administration at the age of 76-year-old on 01Feb2021 as single dose for covid-19 immunization. Medical history included blood pressure abnormal. The patient's concomitant medications were not reported. The patient reported that his sinuses were acting up and he called about the Pfizer covid vaccine. He read the pamphlet on the side effects. He did not have all of the side effects and he felt like he has the flu, aches, chills and did not have a fever and his blood pressure had spiked. The patient reported that he has never had a blood pressure problem except way back. His blood pressure had been in the 120s on the high side over the 60s, but his blood pressure had gone up to 160+ over 80+. He did not know if that has anything to do with the vaccine. The patient that he was on blood pressure medication and he has never had a problem. The patient underwent lab tests and procedures which included blood pressure measurement: spiked. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: not provided), via an unspecified route of administration on 14Feb2021 as a dose 2, single for COVID-19 immunization. The patient had received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: not provided), via an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On 14Feb2021, the patient experienced symptoms of a urinary tract infection the night. The outcome of the event was unknown.  Information about lot/batch number is requested.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood test, Chills, Insomnia, Pain in extremity
Clinical narrative: couldn't sleep, up all night; chills; With the second vaccine, her arm hurts; This is a spontaneous report from a Contactable Consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: E20792 (but she doesn't know for sure) and Expire Date: unknown) intramuscularly administered in left arm on 04Feb2021 10:15 (at the age 76-year-old) as dose 2, single for COVID-19 immunisation. Patient took her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) intramuscularly administered in left arm on 14Jan2021 (at the age of 76 years), and stated that arm was really, really painful on 15Jan2021. Vaccination facility type was physician's office.  The patient's medical history was not reported. She mentions she takes thyroid pills as concomitant medication. No further details provided or obtained regarding this statement. None of the additional vaccines administered on same date of the suspect. The patient did not receive any Prior vaccines within 4 weeks. With the second vaccine in feb2021, her arm hurts but it is not anything she cannot stand. However, she didn't sleep again all night last night. She was so tired but she could not sleep. She has taken other medications and she does have insomnia. She has tried melatonin for sleep and it worked just the opposite. It kept her up all night. Caller verifies she has no NDC, Lot number or expiry date for the melatonin, this was a while back. She mentions someone also told her to take Benadryl which typically makes one sleepy but she stayed up all night when she took it. She confirms she has no NDC/UPC, Lot, or expiry date to provide. She took that a while back. She was just wondering if the vaccine could cause patient not to sleep it was weird. The first vaccine she had, her arm was really, really painful. She was up all night but she was up because her arm was in so much pain. She just inquired if this could be a side effect of the vaccine and there been any reports of this. In  Feb2021,She also had the chills which she read was normal. She mentions she does have sleep medication but she didn't know if it was safe to take after having a shot. Every once in a while she takes it. Caller mentions she did have a blood test done, not too long ago. Like cholesterol and everything and it was good. Caller verifies this was prior to receiving the vaccine. Caller was curious if this common or anybody else have trouble sleeping after receiving the vaccine. No emergency room visit and physician office visit was reported. Treatment was received for couldn't sleep, up all night. The outcome of events was unknown.  No further details were provided or obtained. Follow-up attempts are completed. No further information is expected.