chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle disorder, Muscle tightness, Myalgia
Clinical narrative: Headache; Muscle soreness/ muscle soreness and knots; Muscle soreness/ muscle soreness and knots; Severe joint pain; Muscle tightness; Chest pain; Moderate chills; Exhaustion; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3248) via an unspecified route of administration on right arm on 11Jan2021 06:30 at single dose for COVID-19 immunisation. Medical history included nail patella syndrome. Concomitant medication included ethinylestradiol, levonorgestrel (LESSINA), escitalopram. There was no other vaccine in four weeks. The patient had not COVID prior vaccination. The patient had not COVID tested post vaccination. The patient previously took amoxicillin and experienced allergies. The patient received the first dose of BNT162B2 (Brand: Pfizer, Lot number: EH9899) on right arm on 21Dec2020 16:00 PM for COVID-19 immunisation. First dose came with moderate muscle fatigue and joint pain, chills, headache and fatigue.  Events occurred 7 days post vaccination. Second dose had almost immediate side effects beginning post vaccination beginning with headache, then muscle soreness. Followed by severe joint pain and muscle tightness, including chest pain. Moderate chills. Exhaustion. Both instances were elevated with ibuprofen, water, and a night's rest. Upon waking after second dose side effects, muscle soreness and knots probably from muscle tightness night before. A muscle relaxant might have helped. All events started from 11Jan2021 17:00. No treatment received for muscle tightness and muscle disorder, treatment was received for the other remain events. The outcome of the event was recovering.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Fatigue, Gastrointestinal viral infection, Pain in extremity
Clinical narrative: very low grade fever; it was 99.5 degrees Fahrenheit; getting a GI cold; Arm pain; General fatigue; This is a spontaneous report from a contactable nurse, reporting for herself. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration at the left arm on 17Dec2020 at single dose for COVID-19 vaccination. Vaccination was done in a hospital. Medical history included celiac disease from 2011 and ongoing (very well controlled, she eats gluten-free. This is an autoimmune disease, but she is not immunocompromised like they ask with the Pfizer COVID-19 Vaccine. She is typically very healthy) and irritable bowel syndrome from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that following the first dose, she just experienced arm pain and general fatigue, just the basics. Arm pain and general fatigue with first dose she described as she did not really have a negative effect from; just the basics what everyone was saying. She did not feel anything when the first dose was injected; she did not have any issues until about 3 hours later that day on 17Dec2020 when she had onset of arm pain and general fatigue where she just felt tired for a few days; nothing big; she was able to work after the first dose; she just took ibuprofen for the first 2 days and the arm pain went away. She also mentioned that before getting the second dose of the vaccine she had a very low grade fever; it was 99.5 degrees Fahrenheit but she felt fine. Her stomach she was kind of having a little issue with loose stools for a few days before the second dose of the vaccine. She had celiac disease and a history of irritable bowel syndrome; and her uncle died on 02Jan2021 so she blamed the symptoms going on stress due to that. She does not know if maybe she was getting a GI cold at that time, the symptoms were a little mild before getting the second dose of the vaccine, she never felt sick or anything like that. She told the doctor about these symptoms during her appointment on 06Jan2021. Seriousness criteria of very low grade fever and a little issue with loose stools unknown. The patient underwent lab tests and procedures which included body temperature: 99.5 degrees fahrenheit on an unspecified date and COVID-19 test: negative on 06Jan2021. The outcome of the events was unknown. The reporter assessed the events arm pain and general fatigue as related to BNT162B2.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: very low grade fever; it was 99.5 degrees Fahrenheit; getting a GI cold; Arm pain; General fatigue; This is a spontaneous report from a contactable nurse, reporting for herself. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration at the left arm on 17Dec2020 at single dose for COVID-19 vaccination. Vaccination was done in a hospital. Medical history included celiac disease from 2011 and ongoing (very well controlled, she eats gluten-free. This is an autoimmune disease, but she is not immunocompromised like they ask with the Pfizer COVID-19 Vaccine. She is typically very healthy) and irritable bowel syndrome from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that following the first dose, she just experienced arm pain and general fatigue, just the basics. Arm pain and general fatigue with first dose she described as she did not really have a negative effect from; just the basics what everyone was saying. She did not feel anything when the first dose was injected; she did not have any issues until about 3 hours later that day on 17Dec2020 when she had onset of arm pain and general fatigue where she just felt tired for a few days; nothing big; she was able to work after the first dose; she just took ibuprofen for the first 2 days and the arm pain went away. She also mentioned that before getting the second dose of the vaccine she had a very low grade fever; it was 99.5 degrees Fahrenheit but she felt fine. Her stomach she was kind of having a little issue with loose stools for a few days before the second dose of the vaccine. She had celiac disease and a history of irritable bowel syndrome; and her uncle died on 02Jan2021 so she blamed the symptoms going on stress due to that. She does not know if maybe she was getting a GI cold at that time, the symptoms were a little mild before getting the second dose of the vaccine, she never felt sick or anything like that. She told the doctor about these symptoms during her appointment on 06Jan2021. Seriousness criteria of very low grade fever and a little issue with loose stools unknown. The patient underwent lab tests and procedures which included body temperature: 99.5 degrees fahrenheit on an unspecified date and COVID-19 test: negative on 06Jan2021. The outcome of the events was unknown. The reporter assessed the events arm pain and general fatigue as related to BNT162B2.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: Swollen lip; Hives near the groin area; This is a spontaneous report from a contactable consumer (patient's daughter).  An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via an unknown route of administration, at single dose on 12Jan2021 for COVID-19 immunisation. Relevant medical history included gout and sinuses. The patient did not have relevant concomitant medications.On 12Jan2021, after vaccination, the patient had swollen lips and he thinks like hives on his thought near his groin, on the upper inside of his thighs on both sides, like hives, with swelling but not a rash. She said her father put hydrocortisone cream on his thighs and they were getting better. She said the lip swelling had not gone down, he took an allergy pill for that, he did not apply cream to his lips. She clarified that the hydrocortisone cream was brand Equate 1% Hyrdocortisone Maximum Strength Cream (UPC 319162ET4, Batch: 8JT0419, and EXP Aug2021). She reported that the allergy pill was generic Equate Allergy Relief (UPC: Unknown, LOT P121359, EXP Aug2022). The patient was recovering from the events.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Headache, Neck pain
Clinical narrative: 2030 arm became quite sore/remaining symptom slight soreness at injection site; 1700 achiness in upper back and neck; 1700 achiness in upper back and neck; 1200 extreme fatigue/tiredness became more pronounced; On day of 2nd shot:1100 dizziness and slight headache; On day of 2nd shot:1100 dizziness and slight headache; This is a spontaneous report from a contactable Healthcare Professional reporting for herself. A 47-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot # EL3246, via an unspecified route of administration on 12Jan2021 at 08:30, at 47-years of age, at single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Lot # EL0140) in left arm on 22Dec2020 at 08:30 am; medical history included food allergy including fish, shellfish, seafood of all types and corn, gastrooesophageal reflux disease, an unspecified neoplasm malignant, Vertical Sleeve gastrectomy (VSG) and neuropathy peripheral, all from an unknown date. Concomitant medication included amlodipine, pantoprazole, cetirizine hydrochloride (ZYRTEC), zinc and magnesium. The patient was vaccinated in Hospital and she was not pregnant when she received the vaccine. On 12Jan2021, day of 2nd vaccine shot, at 11:00 the patient experienced dizziness and slight headache, at 12:00 she experienced extreme fatigue, at 17:00 she suffered from achiness in upper back and neck, at 20:30 her arm became quite sore; on 13Jan2021 all symptoms continued and tiredness became more pronounced and, on 14Jan2021, the only remaining symptoms were slight soreness at injection site and some achiness in upper back. All other symptoms had resolved. No treatment was received for the reported events. The patient has not been tested for COVID-19 after vaccination. At the time of the report the events dizziness, slight headache, extreme fatigue/tiredness became more pronounced had resolved and the events soreness at injection site and achiness in upper back were recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 2030 arm became quite sore/remaining symptom slight soreness at injection site; 1700 achiness in upper back and neck; 1700 achiness in upper back and neck; 1200 extreme fatigue/tiredness became more pronounced; On day of 2nd shot:1100 dizziness and slight headache; On day of 2nd shot:1100 dizziness and slight headache; This is a spontaneous report from a contactable Healthcare Professional reporting for herself. A 47-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot # EL3246, via an unspecified route of administration on 12Jan2021 at 08:30, at 47-years of age, at single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Lot # EL0140) in left arm on 22Dec2020 at 08:30 am; medical history included food allergy including fish, shellfish, seafood of all types and corn, gastrooesophageal reflux disease, an unspecified neoplasm malignant, Vertical Sleeve gastrectomy (VSG) and neuropathy peripheral, all from an unknown date. Concomitant medication included amlodipine, pantoprazole, cetirizine hydrochloride (ZYRTEC), zinc and magnesium. The patient was vaccinated in Hospital and she was not pregnant when she received the vaccine. On 12Jan2021, day of 2nd vaccine shot, at 11:00 the patient experienced dizziness and slight headache, at 12:00 she experienced extreme fatigue, at 17:00 she suffered from achiness in upper back and neck, at 20:30 her arm became quite sore; on 13Jan2021 all symptoms continued and tiredness became more pronounced and, on 14Jan2021, the only remaining symptoms were slight soreness at injection site and some achiness in upper back. All other symptoms had resolved. No treatment was received for the reported events. The patient has not been tested for COVID-19 after vaccination. At the time of the report the events dizziness, slight headache, extreme fatigue/tiredness became more pronounced had resolved and the events soreness at injection site and achiness in upper back were recovering.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness to both legs; This is a spontaneous report from a contactable Other Health Professional (patient). This 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot # EL1283), intramuscular, on 13Jan2021 at single dose for COVID-19 immunisation. Vaccine location was right arm.  Age at vaccination was 29-years-old. No other vaccine was received in four weeks. Medical history and concomitant medications were none. On 13Jan2021 at 09:00 PM, the patient experienced numbness to both legs, went to sleep and when he woke up both legs were completely numb. This had never happened to him before, so he assumes it's attributable to the vaccine. The event was reported as non-serious. No treatment was received for the event. Outcome was not recovered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Headache, Nausea, Vomiting
Clinical narrative: Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.)  This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number: EH9899, expiration date: 31Mar2021) on the left deltoid intramuscularly on 22Dec2020 08:24 at a single dose (30mcg/0.3mL) for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient reported she took the first Pfizer Covid-19 shot and is scheduled to take the second one today 12Jan2021. She had nausea and diarrhea and wanted to know if it's okay to go take the second vaccine, Pfizer Covid-19. The nausea and vomiting started on 11Jan2021 and she also had a headache, but the headache has resolved on 12Jan2021. She felt like crap. Nausea and diarrhea were reported as worsened. No other vaccines given at that time with the first dose. No vaccines 4 weeks prior. Received this vaccine at her workplace and they were very efficient and very quick. Did have a flu shot 30Oct2020. Provides flu shot Lot number of 33BN3 and expiry of 30Jun2021, left deltoid. Never had any problems with previous vaccines. No relevant tests done. No known allergies. Outcome of the event headache was resolved on 12Jan2021; nausea aggravated, and diarrhea aggravated were not recovered and unknown for the other events.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: patient received his first dose of covid-19 vaccine and tested positive.; patient received his first dose of covid-19 vaccine and tested positive.; This is a spontaneous report from a contactable nurse (patient himself).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date were not reported) , via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, patient received his first dose of covid-19 vaccine and tested positive.  He will be getting the 2nd dose due today and wanted to know if it's still recommended. The outcome of the events was unknown.   Information of lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Severe headache with sharp pains in neck and head; sharp pains in neck; severe muscle and joint pains entire body from feet to hands; severe muscle and joint pains entire body from feet to hands; mild chills; fatigue; mild nausea; temperature 101.7; This is a spontaneous report from a contactable Nurse reporting for herself. A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), on 12Jan2021 at 12:30 at single dose intramuscular in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Age at vaccination was 50 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140) on 22Dec2020 at 12:45PM, at single dose intramuscular in left arm. Medical history included Long QT syndrome, chronic pain, and depression. The patient has no known allergies. Concomitant medications included metoprolol, bupropion, fluoxetine, omeprazole, pregabalin (LYRICA), cyanocobalamin (VITAMIN B-12), vitamin D3. On 12Jan2021 at 08:30PM the patient experienced severe headache, with sharp pains in neck and head; severe muscle and joint pains entire body from feet to hands; mild chills, temperature 101.7; fatigue, mild nausea. The patient received the following treatments for the events: treatment medications (Metaxalone, Vicodin, Lyrica) and OTC meds (Tylenol, Advil, Aleve, vitamin B-12 & D3). The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Neck pain, Pyrexia
Clinical narrative: Severe headache with sharp pains in neck and head; sharp pains in neck; severe muscle and joint pains entire body from feet to hands; severe muscle and joint pains entire body from feet to hands; mild chills; fatigue; mild nausea; temperature 101.7; This is a spontaneous report from a contactable Nurse reporting for herself. A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), on 12Jan2021 at 12:30 at single dose intramuscular in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Age at vaccination was 50 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140) on 22Dec2020 at 12:45PM, at single dose intramuscular in left arm. Medical history included Long QT syndrome, chronic pain, and depression. The patient has no known allergies. Concomitant medications included metoprolol, bupropion, fluoxetine, omeprazole, pregabalin (LYRICA), cyanocobalamin (VITAMIN B-12), vitamin D3. On 12Jan2021 at 08:30PM the patient experienced severe headache, with sharp pains in neck and head; severe muscle and joint pains entire body from feet to hands; mild chills, temperature 101.7; fatigue, mild nausea. The patient received the following treatments for the events: treatment medications (Metaxalone, Vicodin, Lyrica) and OTC meds (Tylenol, Advil, Aleve, vitamin B-12 & D3). The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: So far just arm soreness; This is a spontaneous report received from a non-contactable consumer (patient). This patient of unspecified age and gender received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021, for COVID-19 immunization. Medical history and concomitant medications were not reported. Since an unspecified date in Jan2021 the patient experienced so far just arm soreness. Event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Ocular hyperaemia
Clinical narrative: numbing a little on her face; redness on her eyes; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Her face was numbing a little on her face and there was redness on her eyes. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swelling in left arm on injection site has now become hard and itchy.; Swelling in left arm on injection site has now become hard and itchy.; Swelling in left arm on injection site has now become hard and itchy.; This is a spontaneous report from a contactable Other HCP (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3249, on 08Jan2021 15:30 at single dose on left arm for COVID-19 immunization. Medical history was not reported. Concomitant medications were none. The patient has no other vaccine in four weeks. The patient had no Other medications in two weeks. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient had no Known allergies. The patient had Swelling in left arm on injection site had now become hard and itchy on 09Jan2021. No treatment was received for all events. The outcome of the events was not resolved.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Vaccination site pain
Clinical narrative: Myalgias; Arthralgias; Pain at injection site; Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 33-year-old female patient received BNT162B2 (lot number: EL0140), via an unspecified route of administration in left arm on 29Dec2020 08:00 at single dose for COVID-19 immunization. Medical history included celiacs disease, dermatitis herpetiformis, melanoma in situ, known allergies: Gluten, and COVID prior vaccination. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). Patient experienced myalgias, arthralgias, headache, and pain at injection site on 30Dec2020 00:00. No treatment was received for these events. Outcome of the events was not resolved.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program Pfizer First Connect.  A 48-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration in the left arm on 26Dec2020 08:00 at single dose for covid-19 immunisation at hospital. Medical history and concomitant medications were none. The patient came down with covid symptoms on 31Dec2020. On 04Jan021 she saw doctor and tested positive for covid. The outcome of the events was recovering. On 24Dec2020 the patient underwent Covid rapid testing and was negative, on 04Jan2021 it was positive. Was given an antibiotic, Doxycycline Hyclate 100mg to take twice daily on 04Jan2021. The patient wanted to know the time frame to take the second dose or/and if it was okay to proceed with the second dose.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Headache, Hyperhidrosis
Clinical narrative: Muscle aches; chills; nausea; vomiting; diarrhea; sweating; fever to 101.2; headache; This is a spontaneous report from a contactable nurse (patient). This 37-year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EK4176), via an unspecified route of administration on 09Jan2021 15:15 at single dose on the left arm for COVID-19 immunization. The patient's medical history was none. No known allergies. No other medications received in two weeks. The patient previously took the first dose of BNT162B2 (Lot number: EK5730) on 20Dec2020 15:15 at single dose on the left arm for COVID-19 immunization. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient experienced muscle aches, chills, nausea, vomiting, diarrhea, sweating, fever to 101.2, headache on 10Jan2021 02:00. No treatment received. Outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Muscle aches; chills; nausea; vomiting; diarrhea; sweating; fever to 101.2; headache; This is a spontaneous report from a contactable nurse (patient). This 37-year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EK4176), via an unspecified route of administration on 09Jan2021 15:15 at single dose on the left arm for COVID-19 immunization. The patient's medical history was none. No known allergies. No other medications received in two weeks. The patient previously took the first dose of BNT162B2 (Lot number: EK5730) on 20Dec2020 15:15 at single dose on the left arm for COVID-19 immunization. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient experienced muscle aches, chills, nausea, vomiting, diarrhea, sweating, fever to 101.2, headache on 10Jan2021 02:00. No treatment received. Outcome of the events was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: Body aches, headache and fever up to 104.1 degrees taken orally.; Body aches, headache and fever up to 104.1 degrees taken orally.; Body aches, headache and fever up to 104.1 degrees taken orally.; This is a spontaneous report from a non contactable nurse.  A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK5730), intramuscular on 11Jan2021 07:00 at single dose for covid-19 immunisation.  Medical history included Allergies, anxiety, depression.  Concomitant medication included sertraline, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took minocycline and experienced drug hypersensitivity. The patient received 1st dose of bnt162b2 on 21Dec2020 10:00 AM Intramuscular at Left arm.  The patient experienced Body aches, headache and fever up to 104.1 degrees taken orally. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: Joint pain (left leg); Fever up to 38.9 Centigrade; Chills; Myalgia; This is a spontaneous report from a contactable physician (patient). A 38-year old male patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. el3302) intramuscularly, in the right arm, at single dose, on 10Jan2021, at 09:45 AM, for COVID-19 immunisation. Relevant medical history included asthma and known allergies to penicillin, and diphtheria vaccine. Concomitant medications were unknown. The patient had not received any other vaccines within 2 and 4 weeks prior to the BNT162B2 vaccine. The patient previously, on 20Dec2020 at 10:00, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. el3302) intramuscularly, in the right arm, at single dose, for COVID-19 immunisation. On 10Jan2021, 09:00 PM, the patient experienced fever up to 38.9 Centigrade, chills, myalgia and joint pain (left leg). The patient was treated with Tylenol. COVID was not tested prior and post vaccination. The patient recovered from the events on an unspecified date, in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Confusional state, Headache, Myalgia, Pyrexia
Clinical narrative: headaches; Confusion; Fever; muscle aches all over; This is a spontaneous report from a contactable consumer (patient). A 19-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: EL0140), intramuscular in upper left arm on 11Jan2021 around noon at second single dose for preventative. Medical history included ongoing attention deficit hyperactivity disorder (ADHD, diagnosed when she was 14 or 15 years old), ongoing anxiety (Diagnosed when she was 16 years old), depression. Concomitant medication included ongoing methylphenidate (has been taking for about 4 or 5 years) for ADHD, to help focus and keeps her sane, ongoing primidone (has been taking less than a year) for hand tremors, ongoing fluvoxamine maleate (taking for about 4 years) for anxiety depression. The patient previously took first dose BNT162B2 on 21Dec2020 around noon, intramuscular injection in upper left arm for preventative (Lot: EJ1685). No other prior vaccinations within 4 weeks. No AE following prior vaccinations. The patient got the second dose yesterday (reported on 12Jan2021) around noon and she was experiencing not so great side effects. The biggest thing was headaches that were pretty debilitating. She was experiencing confusion and muscle aches all over. Stated that all the side effects started around the same time around 9 pm last night. The patient reported that her fever was down a bit so she was a little bit more coherent. Fever was slightly improved at 101.5. The patient took a few medicines for ADHD or anxiety and was wondering if they could have interacted with the vaccine. The events did not require a visit to emergency room and physician office. The patient reported her headache with medication was slightly better, but consistently the same. Treatment for headache inclued Ibuprofen. Outcome of event headache and fever was recovering, of event muscle aches all over was not recovered, of event confusion was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: The arm that was injected was sore for 1-2 days then went away; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown), via an unspecified route of administration on arm on Dec2020 at single dose for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported. It was reported that he received the Pfizer Covid19 vaccine about 2 weeks ago, and the arm that was injected was sore for 1-2 days then went away. He feel fine now, reported no other adverse events, intended to get his second shot, and does not wish to be further contacted. The outcome of the event was recovered.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Pruritus
Clinical narrative: itching down the side of her face; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at first single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer said she had a question, she got the COVID vaccine 09Jan2021, this past Saturday, and yesterday (11Jan2021) she started itching on her face around her eye and below her left eye and down the side of her face, itching bad. She said it is like an allergic reaction. Caller said she took Benadryl but it was not helping, she was trying not to rub it. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Tiredness; Joint pain in right arm; This is a spontaneous report from a contactable consumer. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 12Jan2021 10:30 at single dose for covid-19 immunisation.  Medical history included chronic obstructive pulmonary disease.  Concomitant medication included guaifenesin (MUCINEX), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), fish oil (OMEGA 3 FISH OIL [FISH OIL]).  The patient experienced Tiredness and joint pain in right arm on 12Jan2021 17:30 with outcome of recovering.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: felt feverish and a little achy; felt feverish and a little achy; This is a spontaneous report from a contactable consumer (patient's brother). A 57-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at left arm at SINGLE DOSE for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. historical vaccine included first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 at left arm for COVID-19 vaccination. The patient felt feverish and a little achy. No treatment received for the events. No COVID prior vaccination, no COVID tested post vaccination. The outcome of the events was recovering. Information on the lot/ batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Rash macular, Restlessness, Urticaria, Vaccination site urticaria
Clinical narrative: her spot on chest is now hives on chest, back, arms, and at injection site.; her spot on chest is now hives on chest, back, arms, and at injection site.; her chest had a red spot; vivid dreams; restlessness; This is a spontaneous report from a contactable Nurse.    A 36-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot# EK9231) vaccine , intramuscular in the left arm  on 11Jan2021 08:00 at single dose for Covid-19 immunisation .  Medical history included drug hypersensitivity to azithromycin, morphine and sulfa.  Concomitant medication included levothyroxine (LEVOTHYROXINE), liothyronine (LIOTHYRONINE), abaloparatide (TYMLOS).  The patient received the first dose of bnt162b2 vaccine on 21Dec2020 .  The patient experienced her chest had a red spot  on 11Jan2021 10:00 with outcome of unknown , vivid dreams on 11Jan2021 with outcome of unknown , restlessness on 11Jan2021 with outcome of unknown , her spot on chest is now hives on chest, back, arms, and at injection site on 12Jan2021 14:00 with outcome of unknown.  The patient received cetirizine (ZYRTEC) and acetaminophen (TYLENOL) as treatment of rash. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Vaccination site pain
Clinical narrative: Site tenderness; Feeling light headed; Flu-like symptoms; This is a spontaneous report from a contactable Nurse (patient). A 36-year-old male patient received the second dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization and experienced site tenderness, arm felt sore and heavy. The patient stated apart from site tenderness which was pretty much the same from the first dose, he was feeling light headed, flu-like symptoms. He had not checked his temperature though, maybe he should do that when he got back from break. He heard a lot of terrible stories from their second dose so yeah, be cautious about it. The outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever; chills; body aches; headache; This is a spontaneous report from a contactable Physician via a sales srepresentative. This Physician reported similar events for 3 patients. This is report 2 of 3.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever, chills, body aches and headache for about 24 hours. Events took place after receiving BNT162B2. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034918 Same drug and event, Different patient;US-PFIZER INC-2021034920 Same drug, Different patient and event
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dyspnoea, Fatigue, Headache, Pain
Clinical narrative: fever/102.3 temperature; headache; achy all over; Within 3 minutes had tingling pins in mouth tongue and throat; Within 3 minutes had tingling pins in mouth tongue and throat; had hard time breathing; O2 sat were at 91; i had High BP 148/92; severe fatigue; This is a spontaneous report from a contactable Other HCP (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EJ1686), via an unspecified route of administration on 05Jan2021 07:00 at single dose on the left arm for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), asthma, depression, irritable bowel syndrome (IBS), known allergies included bacitracin, penicillin, levofloxacin (LEVAQUIN), metronidazole (FLAGYL), oseltamivir phosphate (TAMIFLU), Bees, Hornets. Patient took other medications in two weeks. No other vaccine received in four weeks. Patient was not pregnant. Facility type vaccine was hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Jan2021 07:03, within 3 minutes patient had tingling pins in mouth tongue and throat, had hard time breathing. The nurses gave her 50 mg of diphenhydramine hydrochloride (BENADRYL). The doctors checked her O2 sat were at 91, and she had High BP 148/92. After 40 minutes (05Jan2021 07:43) after the medication her symptoms seem to go away and she could breath better. She went home and went to bed because she work night shift. She got the vaccine when she got off work, then about six hours later (05Jan2021 13:00) she had bad headache and achy all over, 12 hours later (05Jan2021 19:00) she had 102.3 temperature and took paracetamol (TYLENOL) every 4 hours and fever finally broke 26 hours later (06Jan2021 21:00). She continued to have a headache for about 5 days and severe fatigue. Adverse event resulted in life threatening illness (immediate risk of death from the event). Patient was recovered with lasting effects.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported  life threatening events including tingling pins in mouth tongue and throat, had hard time breathing, PO2 decreased, blood pressure increased, bad headache, achy all over, fever, and severe fatigue, and the administration of the COVID 19 vaccine, BNT162B2, considering the plausible temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia, Pyrexia
Clinical narrative: fever/102.3 temperature; headache; achy all over; Within 3 minutes had tingling pins in mouth tongue and throat; Within 3 minutes had tingling pins in mouth tongue and throat; had hard time breathing; O2 sat were at 91; i had High BP 148/92; severe fatigue; This is a spontaneous report from a contactable Other HCP (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EJ1686), via an unspecified route of administration on 05Jan2021 07:00 at single dose on the left arm for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), asthma, depression, irritable bowel syndrome (IBS), known allergies included bacitracin, penicillin, levofloxacin (LEVAQUIN), metronidazole (FLAGYL), oseltamivir phosphate (TAMIFLU), Bees, Hornets. Patient took other medications in two weeks. No other vaccine received in four weeks. Patient was not pregnant. Facility type vaccine was hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Jan2021 07:03, within 3 minutes patient had tingling pins in mouth tongue and throat, had hard time breathing. The nurses gave her 50 mg of diphenhydramine hydrochloride (BENADRYL). The doctors checked her O2 sat were at 91, and she had High BP 148/92. After 40 minutes (05Jan2021 07:43) after the medication her symptoms seem to go away and she could breath better. She went home and went to bed because she work night shift. She got the vaccine when she got off work, then about six hours later (05Jan2021 13:00) she had bad headache and achy all over, 12 hours later (05Jan2021 19:00) she had 102.3 temperature and took paracetamol (TYLENOL) every 4 hours and fever finally broke 26 hours later (06Jan2021 21:00). She continued to have a headache for about 5 days and severe fatigue. Adverse event resulted in life threatening illness (immediate risk of death from the event). Patient was recovered with lasting effects.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported  life threatening events including tingling pins in mouth tongue and throat, had hard time breathing, PO2 decreased, blood pressure increased, bad headache, achy all over, fever, and severe fatigue, and the administration of the COVID 19 vaccine, BNT162B2, considering the plausible temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: runny nose; sneezing; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself that a female patient of an unspecified age received first dose BNT162B2, via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The patient got the first dose of the covid-19 vaccine yesterday on 12Jan2021 and she was currently experiencing runny nose and she continuously sneezing in Jan2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cyanosis, Erythema, Paraesthesia, Peripheral swelling, Platelet count
Clinical narrative: middle finger turned purple, it felt pins and needles, felt like there was like a tourniquet around the base of my finger/it turned red/swelled; middle finger turned purple, it felt pins and needles, felt like there was like a tourniquet around the base of my finger/it turned red/swelled; middle finger turned purple, it felt pins and needles, felt like there was like a tourniquet around the base of my finger/it turned red/swelled; middle finger turned purple, it felt pins and needles, felt like there was like a tourniquet around the base of my finger/it turned red/swelled; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date were unknown), via an unspecified route of administration from an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced, "My middle finger turned purple, it felt pins and needles, felt like there was like a tourniquet around the base of my finger and then it turned red, then it swelled and then it turned purple and it stayed purple for two days. Then it went away for the most part and then yesterday it came back as a blue circle in the middle of my finger. " The patient went to the doctor, "I asked them to check my platelets or whatever and I haven't gotten the results yet and then which I am assuming they are okay I hope so that. And then I also I have called back this morning to just say it turned blue in the middle last night it was like in a circle of my finger in the middle segments between the two joints on the middle finger on the right hand it just turned blue like in a circle I don't know how to describe it just a small circle, way smaller than a dime like almost like I would say a quarter of a dime. So, I was just wondering has anyone had any vascular issues after getting the vaccine." Outcome of all the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Condition aggravated, Off label use, Pain assessment
Clinical narrative: Severe joint pain; Wrist pain; Knee and elbow pain; Knee and elbow pain; Raised rash on hands and shin; Raised rash on hands and shin; Raised rash on hands and shin; condition has not improved and seems to be getting worse; Patient is currently breastfeeding; Patient is currently breastfeeding; This is a spontaneous report from a contactable Health Care Professional. A 30-year-old female patient who is currently breastfeeding received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, 3 weeks after the vaccination, the patient experienced severe joint pain, wrist pain, knee and elbow pain (10 out of 10 knee and elbow pain), raised rash on hands and shin. Bloodwork were done in order to clarify that there were no underlying conditions, but patient stated pain was still severe a couple days later. Patient initially went to the emergency room thinking it was bladder infection and mastitis and that was not the case since her condition did not improve and seem to be getting worse. The patient did not recover from the events at time of this report.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021037719 Parent/fetus cases