chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pruritus
Clinical narrative: Itching sensation hands legs and feet.; Maternal Exposure During Pregnancy, first trimester; This is a spontaneous report from a contactable consumer (patient). A 31-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27Feb2021 13:00 (Batch/Lot Number: En6203) (at the age of 31 years) as dose 1, single for covid-19 immunisation. Last menstrual date was 03Jan2021. Medical history included asthma from an unknown date and unknown if ongoing. The patient had no COVID prior vaccination. Patient was not tested post vaccination. There were no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) and azelastine hydrochloride, fluticasone propionate (DYMISTA), both taken for an unspecified indication, start and stop date were not reported. The patient experienced itching sensation hands legs and feet on 28Feb2021 02:00 with outcome of not recovered, and Maternal Exposure During Pregnancy, first trimester on 27Feb2021 with outcome of unknown. The mother was 8 Weeks pregnant at the onset of the event. The mother was due to deliver on 10Oct2021.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I noticed 2 days after the 2nd shot, my fingers were not hurting me; This is a spontaneous report received from a contactable reporter(patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 02Feb2021 as dose 2, single for COVID-19 immunisation. The medical history of the patient included osteoarthritis in my hands. The concomitant medications of the patient were not reported. The patient previously took lidocaine cream for osteoarthritis from 2018 and also took first dose of BNT162B2(solution for injection) on an unspecified date as single dose for COVID-19 immunisation. The patient reported "I am writing to you because I received my 2nd vaccine on 02Feb2021. I have suffered greatly for the last 3 years with osteoarthritis in my hands. Prior to getting the vaccine I was wrapping two of my really bad fingers with self adherent wrap & lidocaine cream. I noticed 2 days after the 2nd shot, my fingers were not hurting me as much and I have not had to wrap them or put cream on since then, now a month later. There is no way this is a coincidence and thought your company should know! This is amazing!"  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Face was swollen; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 23Feb2021 (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported of having the vaccine on 23Feb2021 and was concerned since the patient's face was swollen on an unspecified date. The patient wanted to know what can be done to get it to go down. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint injury
Clinical narrative: bad knee; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 05Mar2021 [Friday], as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On an unspecified date, patient experienced bad knee and would need a steroid shot. Patient was scheduled to receive the second dose of the vaccine on 29Mar2021. Patient asked if it would be fine. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthropathy
Clinical narrative: bad knee; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 05Mar2021 [Friday], as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On an unspecified date, patient experienced bad knee and would need a steroid shot. Patient was scheduled to receive the second dose of the vaccine on 29Mar2021. Patient asked if it would be fine. 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: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a non-contactable consumer (patient) received via the Medical Information Team. A female patient of an unspecified age (reported as patient age: 88; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 21Jan2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced sore arm for a couple of days. The patient recovered from the event on an unspecified date in 2021. The patient received the second dose of BNT162B2 on 11Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dizziness, Dyspnoea, Heart rate decreased
Clinical narrative: chest pressure; shortness of breath; low heart rate; low energy; dizziness; spikes of higher heart rates; This is a spontaneous report from a contactable consumer (patient herself). A 37-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: En6203), via an unspecified route of administration, administered in right arm on 28Feb2021 17:00 (age at vaccination: 37 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included endometriosis. The patient was taking birch control pills. The patient did not have any other vaccine in four weeks. The patient on 02Sep2020, underwent sars-cov-2 antibody test (nasal swab) which was negative. On 28Feb2021 22:00, the patient experienced chest pressure, shortness of breath, low heart rate, low energy, dizziness, spikes of higher heart rates. Everyday since it's gotten a bit worse, low heart rate, low energy, dizziness was worse at night and in the morning, sleeping heart rate has been in the low to mid forties. With also spikes of higher heart rates. While laying in bed it would be in the forties then jump to 90 and back down then up again, all in the middle of the night while not moving. The adverse events resulted in physician's office visit and emergency room visit. The patient did not receive any treatment for the adverse events. The patient did not have covid prior vaccination. The patient underwent lab tests and procedures which included: on 23Feb2021, sars-cov-2 antibody test (nasal swab) which was negative. The outcome of the events was not recovered.   No follow up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, SARS-CoV-2 antibody test
Clinical narrative: chest pressure; shortness of breath; low heart rate; low energy; dizziness; spikes of higher heart rates; This is a spontaneous report from a contactable consumer (patient herself). A 37-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: En6203), via an unspecified route of administration, administered in right arm on 28Feb2021 17:00 (age at vaccination: 37 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included endometriosis. The patient was taking birch control pills. The patient did not have any other vaccine in four weeks. The patient on 02Sep2020, underwent sars-cov-2 antibody test (nasal swab) which was negative. On 28Feb2021 22:00, the patient experienced chest pressure, shortness of breath, low heart rate, low energy, dizziness, spikes of higher heart rates. Everyday since it's gotten a bit worse, low heart rate, low energy, dizziness was worse at night and in the morning, sleeping heart rate has been in the low to mid forties. With also spikes of higher heart rates. While laying in bed it would be in the forties then jump to 90 and back down then up again, all in the middle of the night while not moving. The adverse events resulted in physician's office visit and emergency room visit. The patient did not receive any treatment for the adverse events. The patient did not have covid prior vaccination. The patient underwent lab tests and procedures which included: on 23Feb2021, sars-cov-2 antibody test (nasal swab) which was negative. The outcome of the events was not recovered.   No follow up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Eye injury, Headache, Pain
Clinical narrative: felt like my whole body was on fire inside; My eyes hurt; headache; The burning pain lasted for almost 24 hours.; This is a spontaneous report from contactable consumer reported for herself. A 41-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EN6206), via an unspecified route in the left arm on 09Mar2021 at 09:15 (age at vaccination: 41-year-old), as a single dose for covid-19 immunization. Medical history included pituitary tumor and known allergies with Tylenol, many foods and environmental allergies. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL), ibuprofen, vitamin B complex and vitamin D. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 09Mar2021 at 18:30, 9 hours after getting first vaccine shot, patient had just come back from taking a walk and suddenly felt like her whole body was on fire inside. Her eyes hurt, had a headache, but no fever. The burning pain lasted for almost 24 hours. Patient did not receive any treatment for the events. The clinical outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache, Malaise, Pain in extremity, Vaccination site erythema
Clinical narrative: I have a red spot there; my arm is sore and I got a red spot where the needle was inserted; this redness it's about 4 inches wide; I have a red spot there; my arm is sore and I got a red spot where the needle was inserted; this redness it's about 4 inches wide; I have a red spot there; my arm is sore and I got a red spot where the needle was inserted; this redness it's about 4 inches wide; I really didn't feel well for half a day or 2 days really; I felt kind of sick; I really didn't feel well for half a day or 2 days really; I felt kind of sick; Headache; This is a spontaneous report from a contactable consumer or other non hcp. An 87-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration in Arm on 09Mar2021 (age at vaccination 87years old) as single dose for covid-19 immunisation. The patient medical history was not reported.The patient had historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 16Feb2021 (age at vaccination 87years old) as single dose for covid-19 immunisation. Concomitant medication(s) included hydrochlorothiazide (HYDROCHLOROTHIAZIDE); lisinopril (LISINOPRIL); acetylsalicylic acid (ASPIRIN (E.C.)), all taken for an unspecified indication, start and stop date were not reported. On unspecified date in Mar2021 the patient experienced I have a red spot there; my arm is sore, and I got a red spot where the needle was inserted; this redness it's about 4 inches wide, I really didn't feel well for half a day or 2 days really; I felt kind of sick, headache. Additional Context reported as she had Pfizer second shot the vaccine for COVID and she has my arm, this morning, she had it on the 9th, which was 2 days ago, but she has a red spot there and she just wondering if there is anything wrong with it. she really didn't feel well for half a day or 2 days really, and I am feeling okay. When confirmed the vaccine as Pfizer's COVID 19 vaccine, she received it in (Withheld)." When informed the role of Pfizer Drug Safety and that for the concern we do have a separate department named Pfizer Medical Information, well she is feeling better today but you know she had a reaction, the first afternoon she has got a headache and the next day and then this morning she got up and her arm is sore, and she had a red spot where the needle was inserted but she thinks it's going away and she is feeling better. The patient underwent lab tests and procedures which included blood test: unknown results on unspecified date. The clinical outcome of the event was recovering.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pruritus, Swelling, Vaccination site mass
Clinical narrative: swollen lymph nodes under arm; extremely large swelling under arm that spread to front of chest.; large swelling also at site of shot and itchy.; large swelling also at site of shot and itchy.; This is a spontaneous report from a contactable consumer(patient) reported that. A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 09Mar2021 14:15 (Batch/Lot number was not reported) as DOSE 2 SINGLE for covid-19 immunization. The patient past Medical history included chronic lymphocytic leukemia from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) included insulin (INSULIN) taken for an unspecified indication, metformin (METFORMIN) taken for an unspecified indication, dapagliflozin propanediol monohydrate (FARXIGA) taken for an unspecified indication, simvastatin (SIMVASTATIN) taken for an unspecified indication, and acetylsalicylic acid (ASP) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On an unspecified date the patient experienced swollen lymph nodes under arm, extremely large swelling under arm that spread to front of chest and large swelling also at site of shot and itchy. No treatment was reported. The event outcome was recovering.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Productive cough, Vaccination site bruising, Vaccination site mass
Clinical narrative: Right arm (injection arm) was very sore /soreness in right arm.; bump and bruise all on his right arm at the vaccination site; bump and bruise all on his right arm at the vaccination site; getting some phlegm and felt like someone hit me with a hammer; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6207, NDC number and Expiry Date: Not Provided), via an unspecified route administration administered in right arm on 18Mar2021 09:20 (at the age of 71-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced right arm (injection arm) was very sore /soreness in right arm, bump and bruise all on his right arm at the vaccination site and getting some phlegm and felt like someone hit me with a hammer. It was reported that patient stated he got a flu shot in Nov2021 and didn't feel the needle but with the Covid vaccine he said it hurt and they used a long needle. Patient stated his right arm (injection arm) was very sore and has a bump and bruise on it. The pain was less today after taking a warm bath. Patient also reported getting some phlegm and felt like someone hit me with a hammer. Patient was concerned because everyone in the clinic seemed suspicious of him. Patient wanted to voice his concerned about the necessity of receiving the vaccine  was it a necessity now. Will it give him something else like cancer or a disease that he can't treat. Patient knew the vaccine cannot go into the nucleus of the cell but he stated it can get other cells to turn against each other. This can kill people, you people who have made this shot you haven't figured out all the side effects. Therapeutic measures were taken as a result of his right arm (injection arm) is very sore /soreness in right arm. The outcome of event right arm (injection arm) was very sore /soreness in right arm was recovering at the time of last observation, while outcome of other events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Mammogram, Swelling face, Ultrasound scan
Clinical narrative: Right side of her face was swollen; Having an allergic reaction to the Pfizer-BioNTech COVID-19 Vaccine; This is a spontaneous report from a contactable consumer (patient). This is report 1 of 2. A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP7534; Expiration Date: Jul2021), via an unspecified route of administration, in Right Arm on 16Mar2021 15:30 (at the age of 39-years-old) as dose 1, single for covid-19 immunization at pharmacy. Vaccine was not administered at military facility. The patient medical history was not reported. No Family Medical History Relevant to adverse event. There were no concomitant medications. No other products. There was no 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). There were no additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks) If applicable and no list of any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. No Adverse events following prior vaccinations. This consumer was the patient who was administered her first dose of Pfizer-BioNTech COVID-19 Vaccine on 16Mar2021 around 15:30. Approximately 2-3 hours later, around 17:30-18:30 she noticed the right side of her face was swollen. She was not sure if it was swollen a little or a lot. Patient sister was a nurse, so patient called her sister last night and sister said she was probably having an allergic reaction to the Pfizer-BioNTech COVID-19 Vaccine, so the patient took some Benadryl last night and the Benadryl seemed to help, the event has improved, was less today. She reported initially she thought maybe she was just having an allergic reaction to the Pfizer-BioNTech COVID-19 Vaccine, but then patient girlfriend came to her house yesterday after she was also administered the Pfizer-BioNTech COVID-19 Vaccine at the same administering facility as reporter and her girlfriend also had right side of her face was swollen. Girlfriend information documented in clone report 2 of 2. Reporter requested contact information. The adverse event did not require a visit to emergency room and physician office. The patient was not hospitalized. The patient underwent lab tests and procedures which included mammogram and ultrasound scan: nothing found, no notable results on 08Mar2021. No more information available. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury, Pruritus, Skin abrasion
Clinical narrative: itchy area on her hip and scratched it; had a small abrasion on her hip; had a small abrasion on her hip; This is a spontaneous report from a Pfizer-sponsored program  Support via contactable other hcp (retired nurse) (patient). An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 80-year-old), dose 1 via an unspecified route of administration on 25Feb2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. About a week ago, on an unspecified date, she had an itchy area on her hip and scratched it. It was a small abrasion and applied cream, but it never bled and had no discharge and it had a thin scab on it now. She used Voltaren ointment and used it in the area and her skin reacts to everything. She was not concerned that it was an allergic reaction to the vaccine, she was just concerned that she had this abrasion. She was wondering if for some reason she would be unable to get the second vaccine. She had read all the information that came with the vaccine and saw nothing about this. She had a call in to her doctor, too. Caller was asking if she would be to take the second dose. Creating an AE Form since the caller second dose was more than 21 days on and second dose on 25Mar2021. Therapeutic measures were taken as a result of had a small abrasion on her hip. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Vein disorder
Clinical narrative: ivy flush; it feels like rushing of cold water inside her veins and it's been for 4 days; This is a spontaneous report from contactable female consumer (patient herself) via a Pfizer Sponsored Program Support. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 17Mar2021 as dose 1, single for Covid-19 immunisation. Patients medical history and concomitant medications were not reported. Patient experienced ivy flush in her body in an unspecified date. She explained that it feels like rushing of cold water inside her veins and it's been for 4 days. It comes and goes away after she took the 1st dose of vaccine. The outcome of event for unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mass, Pain in extremity, Peripheral swelling
Clinical narrative: arm was sore; arm swelled; their is a lump; This is a spontaneous report from a from a Pfizer Sponsored Program COVAX US Support. A contactable female of an unspecified age reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration on 18Mar2021 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration on unspecified date of 2021 single for covid-19 immunization. On unspecified date of Mar2021 the patient experienced her arm swelled and was sore. She was told to put ice on it and did that but it is not working and now there was a lump. She wanted to know if the lump will go away and her arm was still sore. The outcome of the event arm was sore was unknown. While outcome of the rest of the events was not recovered.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Vaccination site mass, Vaccination site swelling
Clinical narrative: arm was sore; arm swelled; their is a lump; This is a spontaneous report from a from a Pfizer Sponsored Program COVAX US Support. A contactable female of an unspecified age reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration on 18Mar2021 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration on unspecified date of 2021 single for covid-19 immunization. On unspecified date of Mar2021 the patient experienced her arm swelled and was sore. She was told to put ice on it and did that but it is not working and now there was a lump. She wanted to know if the lump will go away and her arm was still sore. The outcome of the event arm was sore was unknown. While outcome of the rest of the events was not recovered.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Flu-like symptoms; Fever; Dizziness; Chills; Sweating; Full body aches; Exhaustion; headache; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6201) via an unspecified route of administration on 12Feb2021 18:45(age at vaccination 31-years-old) as dose 1, single for covid-19 immunisation. Medical history included live birth patient it was reported gave birth to her first child on 12Mar2020. Concomitant medication(s) included ascorbic acid, beta-carotene, calcium sulphate, cholecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopherol acetate, zinc oxide (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient did not diagnose with covid-19 prior to the vaccination. The patient did not test for covid-19 post vaccination. On 13Feb2021 10:00(15 hrs 15 min from vaccination), she was breastfeeding mom and had an adverse reaction to both the first and second dose of the Pfizer vaccine. With the first dose, she started to have flu-like symptoms about 16 hours after her shot. This included a fever (101.5), dizziness, chills with sweating, full body aches, exhaustion and a headache. This lasted approximately 24 hours for the first shot. For her second shot, she had the same symptoms and experienced extreme fatigue, a fever of at least 102.3, chills with sweating, full body aches, dizziness and a headache. she started having symptoms approximately 13 hours after she shot and stayed in bed for approximately 48 hours once my symptoms started. She breastfed before, during and after both reactions. When she was unable to breastfeed, she pumped and have frozen milk from before, during and after her second dose. The milk from 3/6 and 3/7, which was when her reaction was strongest, has a green tint to it compared to her milk on a typical day. The patient received second dose BNT162b2, Lot Number: EN6205) via an unspecified route of administration on 04Mar2021 16:45. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature: 101.5 on Feb2021. The outcome of the events was recovered on 14Feb2021.   No follow up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) :-PFIZER INC-2021355753 same reporter/drug, different patient and event.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu-like symptoms; Fever; Dizziness; Chills; Sweating; Full body aches; Exhaustion; headache; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6201) via an unspecified route of administration on 12Feb2021 18:45(age at vaccination 31-years-old) as dose 1, single for covid-19 immunisation. Medical history included live birth patient it was reported gave birth to her first child on 12Mar2020. Concomitant medication(s) included ascorbic acid, beta-carotene, calcium sulphate, cholecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopherol acetate, zinc oxide (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient did not diagnose with covid-19 prior to the vaccination. The patient did not test for covid-19 post vaccination. On 13Feb2021 10:00(15 hrs 15 min from vaccination), she was breastfeeding mom and had an adverse reaction to both the first and second dose of the Pfizer vaccine. With the first dose, she started to have flu-like symptoms about 16 hours after her shot. This included a fever (101.5), dizziness, chills with sweating, full body aches, exhaustion and a headache. This lasted approximately 24 hours for the first shot. For her second shot, she had the same symptoms and experienced extreme fatigue, a fever of at least 102.3, chills with sweating, full body aches, dizziness and a headache. she started having symptoms approximately 13 hours after she shot and stayed in bed for approximately 48 hours once my symptoms started. She breastfed before, during and after both reactions. When she was unable to breastfeed, she pumped and have frozen milk from before, during and after her second dose. The milk from 3/6 and 3/7, which was when her reaction was strongest, has a green tint to it compared to her milk on a typical day. The patient received second dose BNT162b2, Lot Number: EN6205) via an unspecified route of administration on 04Mar2021 16:45. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature: 101.5 on Feb2021. The outcome of the events was recovered on 14Feb2021.   No follow up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) :-PFIZER INC-2021355753 same reporter/drug, different patient and event.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Chest discomfort, Fatigue
Clinical narrative: Cold sensation in the chest; my blood pressure spiked up then after like 3 or 5 min somewhere in between when I lost the heart beat my blood pressure went down; heart beat was very faint; I felt like a weird sensation like tired, a little relax; I felt tired like sleepy; I felt like a weird sensation like tired, a little relax; I felt tired like sleepy; Pulse were very faint; Low grade fever; Sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar event for two patients. This is 2nd of 2 reports. This consumer reported for a male patient (Husband) that: A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Right (Right Shoulder)on 23Mar2021 (Batch/Lot Number: EN6204) as DOSE 1, SINGLE for Covid-19 Immunisation. Medical history included Asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced cold sensation in the chest within 6-7 minutes, My blood pressure spiked up then after like 3 or 5 min somewhere in between when i lost the heart beat my blood pressure went down; heart beat was very faint, I felt like a weird sensation like tired, a little relax; i felt tired like sleepy, Pulse were very faint, Low grade fever,Sore arm on 23Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: spiked up on an unspecified date, blood test: unknown on an unspecified date, heart rate: decreased on an unspecified date. The outcome for all the events was recovered on an unspecified date in 2021 except for the event sore arm it was not recovered.  QR comment: This case might be split case however, it was not made by call handler.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021346339 Same reporter/drug/, different patient/ similar events
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Cold sensation in the chest; my blood pressure spiked up then after like 3 or 5 min somewhere in between when I lost the heart beat my blood pressure went down; heart beat was very faint; I felt like a weird sensation like tired, a little relax; I felt tired like sleepy; I felt like a weird sensation like tired, a little relax; I felt tired like sleepy; Pulse were very faint; Low grade fever; Sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar event for two patients. This is 2nd of 2 reports. This consumer reported for a male patient (Husband) that: A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Right (Right Shoulder)on 23Mar2021 (Batch/Lot Number: EN6204) as DOSE 1, SINGLE for Covid-19 Immunisation. Medical history included Asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced cold sensation in the chest within 6-7 minutes, My blood pressure spiked up then after like 3 or 5 min somewhere in between when i lost the heart beat my blood pressure went down; heart beat was very faint, I felt like a weird sensation like tired, a little relax; i felt tired like sleepy, Pulse were very faint, Low grade fever,Sore arm on 23Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: spiked up on an unspecified date, blood test: unknown on an unspecified date, heart rate: decreased on an unspecified date. The outcome for all the events was recovered on an unspecified date in 2021 except for the event sore arm it was not recovered.  QR comment: This case might be split case however, it was not made by call handler.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021346339 Same reporter/drug/, different patient/ similar events
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Dysgeusia, Feeling abnormal, Pain in extremity
Clinical narrative: felt like a metallic taste in her mouth.; sinus headache; felt faint; I felt really bad; a bit anxious; little bump area was still there 2 weeks later and she was quite surprised; didn't have very much pain in her arm; This is a spontaneous report from a contactable consumer (patient). A 64-years and 5 months old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6204, expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 14Mar2021 11:48 as dose 1, 0.3 ml single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included Cefalexin from 08Mar2021 to around 15Mar2021 or 16Mar2021, Differin face gel (stated this was over the counter), Centrum Silver for women over 50 (takes with a glass of water) and multivitamin. The patient previously took excedrin aspirin free possibly around 2008-2009 and experienced feeling abnormal and she feels like she is going to pass out and in Oct2020, when she was going back for her 2nd part of the Shingles vaccine and she thinks she also received a flu shot and the next day she had a reaction where she felt bad like she almost had the flu, but it was gone in 4-6 hours. It was reported that patient was taking Covid 19 vaccine so that she would not have a severe reaction to the Covid 19. On 15Mar2021, the patient experienced sinus headache, felt really bad it was like when she did not do well when she takes Excedrin which patient stated it did not last long, like 45 minutes, faint, a bit anxiousPatient stated that after she felt bad, she was going to pass out stopped after about 45 minutes and has been gone. She felt really bad and went to go take a shower and get ready to go to the ER and after the shower she had water and felt a lot better and did not feel like she needed to go to the ER and longer and it had not happened again and she did not go to the ER. On 16Mar2021, she felt like a metallic taste in her mouth. In Mar2021, she had little bump area was still there 2 weeks later and she was quite surprised as it was much smaller 26Mar2021 and yesterday she did not feel a bump at all at the shot site and did not have very much pain in her arm. On 15Mar2021, patient recovered from the events sinus headache started the same day in that 45 minute time frame and lasted that 45 minutes and was the same for the anxious feeling, felt faint and really bad. On 18Mar2021, patient recovered from the event metallic taste which was lasted for 2 days. On 29Mar2021, patient recovered from little bump area was still there 2 weeks later and she was quite surprised and in Mar2021, she had recovered from the event did not have very much pain in her arm  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache, Vaccination site mass
Clinical narrative: felt like a metallic taste in her mouth.; sinus headache; felt faint; I felt really bad; a bit anxious; little bump area was still there 2 weeks later and she was quite surprised; didn't have very much pain in her arm; This is a spontaneous report from a contactable consumer (patient). A 64-years and 5 months old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6204, expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 14Mar2021 11:48 as dose 1, 0.3 ml single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included Cefalexin from 08Mar2021 to around 15Mar2021 or 16Mar2021, Differin face gel (stated this was over the counter), Centrum Silver for women over 50 (takes with a glass of water) and multivitamin. The patient previously took excedrin aspirin free possibly around 2008-2009 and experienced feeling abnormal and she feels like she is going to pass out and in Oct2020, when she was going back for her 2nd part of the Shingles vaccine and she thinks she also received a flu shot and the next day she had a reaction where she felt bad like she almost had the flu, but it was gone in 4-6 hours. It was reported that patient was taking Covid 19 vaccine so that she would not have a severe reaction to the Covid 19. On 15Mar2021, the patient experienced sinus headache, felt really bad it was like when she did not do well when she takes Excedrin which patient stated it did not last long, like 45 minutes, faint, a bit anxiousPatient stated that after she felt bad, she was going to pass out stopped after about 45 minutes and has been gone. She felt really bad and went to go take a shower and get ready to go to the ER and after the shower she had water and felt a lot better and did not feel like she needed to go to the ER and longer and it had not happened again and she did not go to the ER. On 16Mar2021, she felt like a metallic taste in her mouth. In Mar2021, she had little bump area was still there 2 weeks later and she was quite surprised as it was much smaller 26Mar2021 and yesterday she did not feel a bump at all at the shot site and did not have very much pain in her arm. On 15Mar2021, patient recovered from the events sinus headache started the same day in that 45 minute time frame and lasted that 45 minutes and was the same for the anxious feeling, felt faint and really bad. On 18Mar2021, patient recovered from the event metallic taste which was lasted for 2 days. On 29Mar2021, patient recovered from little bump area was still there 2 weeks later and she was quite surprised and in Mar2021, she had recovered from the event did not have very much pain in her arm  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Heart rate, Heart rate decreased
Clinical narrative: she was still kind of chilly/ Chilliness; Resting heart rate dropped to 63; This is a spontaneous report from a contactable consumer. This 51-year-old female consumer (patient) reported for herself that: A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown, Expiry date: Unknown) via intramuscular route of administration on arm right on 30Mar2021 at 08:15 (at the age of 51-year-old) as dose 1, single for COVID-19 immunization. Patient relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Obese and date is unknown. She said she is obese in the sense of being overweight but is not severely obese. ongoing cardiac disorder (She is on a lot of pills for her heart). Family medical history was unknown. Patient didn't had other vaccines before and no other vaccines within four weeks. Patient didn't had AE prior vaccination. 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): No previous. The patient's concomitant medications were not reported.  On 30Mar2021 after couple of hours (09:30-10:00) patient experienced still kind of little chilly/ Chilliness and notice while resting her heart beats per second has gotten down to like /heart rate dropped to 63. Patients want to know what number would be too low for resting heart rate. She is not going to say sometimes she doesn't feel chilly but did notice it after getting the vaccine. She did low impact cycling for 30minutes to warm up and her heart rate up and now heart rate at rest is 78. While resting she is monitoring (around 70). She does not usually see it in the 60's unless she is asleep. Patient took lot of pills for heart this morning and didn't know if they were relevant or not. Patient didn't require ER or physician's office. The patient underwent lab tests and procedures which included heart rate: 63 on 30Mar2021 (heart rate at rest is 78. But it had dropped to 63). The clinical outcome of the event heart rate decreased recovering while chilly was unknown.   PSCC Communication: Attempted to warm transfer caller to Pfizer Medical Information, however, due to extended hold time, caller opted to be transferred to hold place in the queue. Provided caller with websites, along with phone, with hours of 8a-8p, Monday-Friday, 9a-3p, Saturday and Sunday, prior to transfer, in the event of disconnection.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Breast milk discolouration, Chills, Dizziness, Fatigue
Clinical narrative: flu-like symptoms; a fever of at least 102.3; dizziness; chills; sweating; full body aches; extreme fatigue; headache; The milk from 3/6 and 3/7, which was when my reaction was strongest, has a green tint to it compared to my milk on  a typical day; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 31-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Batch/Lot Number: EN6205) via an unspecified route of administration on 04Mar2021 at 16:45 as DOSE 2 SINGLE (Age at vaccination: 31-year-old) for covid-19 immunization at Hospital. Medical history included I gave birth to my first child on 12Mar2020. 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) taken for an unspecified indication. The patient had no covid prior vaccination and no covid tested post vaccination. The patient did not take any other vaccines within 4 weeks. The patient had no known allergies. Historical Vaccine received as bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration on 12Feb2021 at 06:45 as DOSE 1, SINGLE for covid-19 immunisation at Hospital and experienced flu-like symptoms about 16 hours after her shot. This included a fever (101.5), dizziness, chills with sweating, full body aches, exhaustion and a headache. This lasted approximately 24 hours for the first shot. On 05Mar2021 at 06:00 The patient experienced flu-like symptoms, fever, dizziness, chills, sweating, full body aches, exhaustion, headache, and the milk from 3/6 and 3/7, which was when my reaction was strongest, has a green tint to it compared to my milk on a typical day. It was reported that for second shot, the patient had the same symptoms and experienced extreme fatigue, a fever of at least 102.3, chills with sweating, full body aches, dizziness and a headache. Patient started having symptoms approximately 13 hours after her shot and stayed in bed for approximately 48 hours once my symptoms started. She breastfed before, during and after both reactions. When the patient was unable to breastfeed, the patient pumped and have frozen milk from before, during and after my second dose. The patient did not take any treatment for the events. The patient underwent lab tests and procedures which included body temperature: 102.3 on 05Mar2021. The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.