chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Chest pain, Dizziness
Clinical narrative: Elevated blood pressure; His head took a loop and felt dizzy and hazy; Hard time breathing; Severe headache; Felt like throat was closing; hard to swallow; Chest pain; Weakness; stool was black; Cramps in his feet; urinates every 30 minutes; His head took a loop and felt dizzy and hazy; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 56-years-old male patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection,Lot number was not reported) dose 1 via an unspecified route of administration on 14Apr2021 (at the age of 56-years) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. A minute after the vaccination on 14Apr2021, the patient stated that his head took a loop and felt dizzy and hazy, had elevated blood pressure, hard time breathing. Later that night, patient had been to the emergency department for severe headache, he had felt like throat was closing, hard to swallow, chest pain, weakness and stool was black. Since that time, the patient had experienced headaches, cramps in his feet and urinated every 30 minutes. The patient then queried if he should receive the second dose. Relevant laboratory tests included elevated blood pressure on 14April2021. The outcome of the events was unknown at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Faeces discoloured, Headache, Muscle spasms
Clinical narrative: Elevated blood pressure; His head took a loop and felt dizzy and hazy; Hard time breathing; Severe headache; Felt like throat was closing; hard to swallow; Chest pain; Weakness; stool was black; Cramps in his feet; urinates every 30 minutes; His head took a loop and felt dizzy and hazy; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 56-years-old male patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection,Lot number was not reported) dose 1 via an unspecified route of administration on 14Apr2021 (at the age of 56-years) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. A minute after the vaccination on 14Apr2021, the patient stated that his head took a loop and felt dizzy and hazy, had elevated blood pressure, hard time breathing. Later that night, patient had been to the emergency department for severe headache, he had felt like throat was closing, hard to swallow, chest pain, weakness and stool was black. Since that time, the patient had experienced headaches, cramps in his feet and urinated every 30 minutes. The patient then queried if he should receive the second dose. Relevant laboratory tests included elevated blood pressure on 14April2021. The outcome of the events was unknown at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pollakiuria, Vision blurred
Clinical narrative: Elevated blood pressure; His head took a loop and felt dizzy and hazy; Hard time breathing; Severe headache; Felt like throat was closing; hard to swallow; Chest pain; Weakness; stool was black; Cramps in his feet; urinates every 30 minutes; His head took a loop and felt dizzy and hazy; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 56-years-old male patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection,Lot number was not reported) dose 1 via an unspecified route of administration on 14Apr2021 (at the age of 56-years) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. A minute after the vaccination on 14Apr2021, the patient stated that his head took a loop and felt dizzy and hazy, had elevated blood pressure, hard time breathing. Later that night, patient had been to the emergency department for severe headache, he had felt like throat was closing, hard to swallow, chest pain, weakness and stool was black. Since that time, the patient had experienced headaches, cramps in his feet and urinated every 30 minutes. The patient then queried if he should receive the second dose. Relevant laboratory tests included elevated blood pressure on 14April2021. The outcome of the events was unknown at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus
Clinical narrative: itchy eyes after the first dose; This is a spontaneous report from a contactable consumer (patient herself) a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 13Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Apr2021 the patient experienced itchy eyes after the first dose. The patient is asking how long does the side effects last after getting the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lip swelling, Palpitations
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a reaction to the vaccine. It has been over 10 days since received the vaccination and patient has swollen lips, fatigue, racing heart and more. The outcome of the events: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Dyspnoea, Pain, Pain in extremity, Throat tightness
Clinical narrative: body aches; arm soreness; couldn't breath; throat was closing up; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A male patient of an unspecified age (Age: 58, Unit: not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient just has a question while he was waiting on his doctor to call him. Says he had the first dose of the Covid Vaccine on 03 or 04 Apr2021. He was fine all day. He went to bed around 01:00 and woke up at 06:00 am with body aches and his arm was sore/arm soreness. States that he could not breathe; felt like his throat was closed up. Stated it wasn't like when you have a chest cold, it was like the air didn't want to go in his throat. He states he took a Benadryl and about 10-15 minutes later it had went away. The patient wanted to know about taking the second dose. He said he got tested for antibodies and he was positive for it. He wanted to know about the result/reading of the antibodies level from the test. States that a parent at his daughter's volleyball team said they had the same problem that happened to them overnight. No further information or identifiers for this person provided by caller. States that he was wary about getting the second shot because he heard that it was stronger, and the side effects are worse. Says he does not know what to do and nobody seems to have any information. The patient was declining to complete report. He states he has been on hold for an hour, and he was in the car and has to pick up his kids from school. He states that his next vaccine was scheduled for tomorrow and he just want to transfer to Medical Information. States he can call back or go online to do the report. States he will go online to file the report; he heard he could do that while he was on hold for call handler. The outcome of the event throat was closing up was recovered on Apr2021 and outcome of the other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: loss of sense of taste; This is a spontaneous report from a Pfizer sponsored program  support from a contactable pharmacist reported for a female patient. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer Covid 19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route on 21Apr2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 21Apr2021, after an hour of getting the first dose of vaccine patient experienced loss of sense of taste. Due date to get second shot was 12May2021. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Nausea, Pruritus, Rash, Vomiting
Clinical narrative: Generalized skin rash; pruritus around both eyes and neck area/itchy scalp; Nausea; Vomiting; This is a spontaneous report from a contactable Nurse (patient) reported in response to Pfizer/BioNTech Covid-19 Vaccine Anaphylactic Reaction Data Capture Aid letter sent. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3249), dose 2 via an intramuscular route of administration, administered in Deltoid Left on 08Jan2021 at 11:30 (at the age of 62-year-old), as DOSE 2, SINGLE for covid-19 immunisation. The patient had not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient history of any previous allergies to specific products or any conditions indicative of an allergy was none. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EJ1685), via an intramuscular route of administration, administered in Deltoid Left on 20Dec2020 at 13:30, as single for covid-19 immunisation and experienced skin rashes and pruritus developed around eyes/neck/scalp. The patient was not taking any medications prior to the event being reported. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. On an unspecified date in 2021, after the 2nd dose of vaccination, the patient experienced generalized skin rash, pruritus around both eyes and neck area/itchy scalp, nausea and vomiting. The patient received treatment with Benadryl tablet and cetirizine tablet taken at home at onset of symptoms, Decadron 30 mg, 1 dose at urgent care. The patient underwent lab tests and procedures which included ANA (antinuclear antibody) was negative on 12Feb2021. The response to potential anaphylactic Reaction Data Capture Aid letter as follows: There was no multiorgan involvement of Dermatological/Mucosal, no respiratory involvement, no Bilateral wheeze/bronchospasm, no stridor, no upper airway swelling, no respiratory distress, no tachypnoea, no increased use of accessory respiratory muscles, no recession, no cyanosis, no grunting, no hoarse voice, no Difficulty breathing (without wheeze or stridor), no sensation of throat closure, no sneezing, no rhinorrhea and no other. Cardiovascular was Unknown, Measured hypotension was Unknown, Tachycardia was Unknown, Capillary refill time greater than 3 sec was Unknown, Reduced central pulse volume was unknown, no decreased level of consciousness, no loss of consciousness. Patient outcome following the potential anaphylactic reaction was recovering. The patient had no, no diarrhea, no and abdominal pain. The patient outcome of the events was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site mass, Vaccination site pain
Clinical narrative: As he was administering the shot in my left arm liquid squirted out and the needle broke; my arm has a lump and it hurts; my arm has a lump and it hurts; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: EW0172), via an unspecified route of administration on 24Apr2021 at 13:15(at the age of 49-years-old) administered in Arm Left as a single dose for COVID-19 immunisation at Public health clinic/facility. Medical history included allergies to Sulpha drugs from an unknown date and unknown if ongoing. Concomitant medication(s) included atorvastatin calcium (ATORVASTIN); lansoprazole (PREVACID); Vitamins (all taken for an unspecified indication, start and stop date were not reported).The patient had first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: ER8730), via an unspecified route of administration on 03Apr2021 (at the age of 49-years-old) administered in Arm Left as a single dose for COVID-19 immunisation at Public health clinic/ facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.On 24Apr2021 at 13:15 PM, it was reported that As he was administering the shot in my left arm liquid squirted out and the needle broke, he immediately said uh oh that has never happened, I asked if one the needle was broke in my arm and if I got the vaccine and honestly they weren't sure, my arm has a lump and it hurts and I don't know if I should get an X-ray to see if the needle or part of the needle is in my arm. No treatment was given for the events. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal discomfort
Clinical narrative: something stuck in his throat but he coughed it up; coughing a little but that is really it; This is a spontaneous report from a non-contactable consumer (patient's wife).  A male patient (reporter husband) of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 22Apr2021 (on Thursday) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The wife stated that, on 25Apr2021, her husband experienced that something stuck in his throat but he coughed it up and coughing was a little but that was really it. As per patient, he was alright, and it was fine and that he did not feel no type of way. She stated she was trying to see if that was covid or a side effect. She said he might not even have a cough it might had just been one time. The outcome of the events was unknown, at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Immune system disorder, SARS-CoV-2 test
Clinical narrative: All of the hair on my head fell out .; My auto immune Response Was insanely intense; This is a spontaneous report from a contactable Other HCP (patient). An elderly non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm right on 26Feb2021 14:00 as dose 2, single (age at vaccination: 67 years) for COVID-19 immunisation. Medical history included Hashimoto disease, seborrheic dermatitis, known allergies penicillin, all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration in arm right on an unspecified date as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. It was unknown if covid prior and vaccination covid tested post vaccination. On 08Mar2021 at 01:00 AM, it was reported that the patient experienced all of the hair on my head fell out. My auto immune Response was insanely intense for one month and I am still dealing with the side affects 2 months later. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The patient underwent lab tests and procedures which included nasal swab resulted as negative on 14Apr2021 nasal swab. The clinical outcome of the events was not resolved.  No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Illness
Clinical narrative: Bad headache; Fever; Chills; loss of appetite; fatigue; Nausea; Vomiting; has been in bed all day; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's husband) via a sales representative. A 44-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Apr2021 as dose 2, single for covid-19 immunization. Patient's relevant medical history and concomitant medications were not reported. It was reported that patient got her second dose of the bnt162b2 vaccine on 21Apr2021. On 22Apr2021, patient woke up early morning with fever, chills, loss of appetite, fatigue. She had been in bed all day, had nausea and vomiting along with a bad headache. Outcome of the events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Bad headache; Fever; Chills; loss of appetite; fatigue; Nausea; Vomiting; has been in bed all day; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's husband) via a sales representative. A 44-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Apr2021 as dose 2, single for covid-19 immunization. Patient's relevant medical history and concomitant medications were not reported. It was reported that patient got her second dose of the bnt162b2 vaccine on 21Apr2021. On 22Apr2021, patient woke up early morning with fever, chills, loss of appetite, fatigue. She had been in bed all day, had nausea and vomiting along with a bad headache. Outcome of the events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Illness, Nasal discomfort, Nasopharyngitis, Rhinorrhoea
Clinical narrative: sick; Sneezing; Coughing; Runny nose; clogged nose; has a head cold; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program.  This consumer reported for himself that a 57-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported, caused problems with urination so he stopped it. Stated that it dried up his urination, he was told that it could have been both which dried it up and it resolved when he quit taking it. On an unspecified date, the patient was sick; had sneezing; coughing; runny nose; clogged nose and has a head cold. Stated that he was scheduled for his second shot on Wednesday and just wanted to make sure if he was sick if he was supposed to go to take a second shot or not. Stated that his nose was clogged up again and he has a head cold. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: sick; Sneezing; Coughing; Runny nose; clogged nose; has a head cold; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program.  This consumer reported for himself that a 57-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported, caused problems with urination so he stopped it. Stated that it dried up his urination, he was told that it could have been both which dried it up and it resolved when he quit taking it. On an unspecified date, the patient was sick; had sneezing; coughing; runny nose; clogged nose and has a head cold. Stated that he was scheduled for his second shot on Wednesday and just wanted to make sure if he was sick if he was supposed to go to take a second shot or not. Stated that his nose was clogged up again and he has a head cold. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Decreased appetite, Feeling abnormal
Clinical narrative: Weight loss; fever; Nausea; no appetite; Chills; Headache; started feeling really bad; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 62 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 19:30 (Batch/Lot Number: EW0158) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 (Batch/Lot Number EP7534) as DOSE 1, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient experienced started feeling really bad on 11Apr2021 with outcome of not recovered , fever causing pyrexia on 12Apr2021 with outcome of not recovered, nausea on 11Apr2021 with outcome of recovered, no appetite on 11Apr2021 with outcome of recovered with sequelae, chills on 11Apr2021 with outcome of not recovered, headache on 11Apr2021 with outcome of not recovered and weight loss on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature:with fever that was up to 103 degrees Fahrenheit and covid-19: negative.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Weight decreased
Clinical narrative: Weight loss; fever; Nausea; no appetite; Chills; Headache; started feeling really bad; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 62 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 19:30 (Batch/Lot Number: EW0158) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 (Batch/Lot Number EP7534) as DOSE 1, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient experienced started feeling really bad on 11Apr2021 with outcome of not recovered , fever causing pyrexia on 12Apr2021 with outcome of not recovered, nausea on 11Apr2021 with outcome of recovered, no appetite on 11Apr2021 with outcome of recovered with sequelae, chills on 11Apr2021 with outcome of not recovered, headache on 11Apr2021 with outcome of not recovered and weight loss on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature:with fever that was up to 103 degrees Fahrenheit and covid-19: negative.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Muscle twitching
Clinical narrative: nerve twitching; joint pain; This is a spontaneous report received from a contactable consumer. This consumer reported for herself/himself of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported as dose number unknown single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported have taken Pfizer COVID-19 Vaccine about a week ago and patient got nerve twitching and joint pain that is keeping her up all night. Patient was not certain the best way to report this situation. The clinical outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: injection arm was bruised, itchy, and had red dots; injection arm was bruised, itchy, and had red dots; injection arm was bruised, itchy, and had red dots; This is a spontaneous report from a contactable consumer, the patient.  A 34-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number: EW0169) via an unspecified route of administration on 22Apr2021 as dose number unknown, single (age at vaccination 34 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that he received the Pfizer COVID-19 vaccine on 22Apr2021 and after two hour the injection arm was bruised, itchy, and had red dots. It was reported that the event took place after use of product. The outcome of the events was unknown.   The reporter did not wish to be contacted for follow-up.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling in neck; This is a spontaneous report from a contactable consumer (reporter's friend). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling in neck. On an unspecified date, the patient recovered from the event.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Face oedema, Heart rate increased, Hypoaesthesia, Lip swelling, Skin wrinkling
Clinical narrative: Facial swelling/ Swelling was around the lips and jaw; rapid heart rate; a little bit of facial numbness; Swelling was around the lips and jaw; There was edema around the mouth and cheeks and under her right chin; There was a fold coming down from her mouth that didn't used to be there; This is a spontaneous report from a contactable consumer, the patient.     A 45-years-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) an unspecified route of administration, in arm left on 12Apr2021 at 10:15 as dose 1, single (age at vaccination 45 years) for covid-19 immunisation. Medical history included low thyroid, ongoing. The patient's concomitant medications included natural thyroid for low thyroid that she had been taking for years but does not have name and dose information for this product at the moment. On 16Apr2021 the patient was having facial swelling since 3 days after the vaccine. She got the vaccine on Monday and noticed this by Friday morning, so the fourth day. The swelling was around the lips and jaw on an unknown date in 2021. There was a fold coming down from her mouth that didn't used to be there on an unknown date in 2021. First noticed when she took off her mask. There was edema around the mouth and cheeks and under her right chin on an unknown date in 2021. The patient received treatment for the facial swelling, she had tried antihistamines and Advil, was thinking it might be getting a little better but waking up this morning, it was the same and had been persistent. She even tried acupuncture. Tried things for drainage, lymphatic drainage. The patient did not get any relevant tests done. The patient was told that this will go away, that it was just edema or something but it did not. There was no history of previous immunizations. No additional vaccines were administered on same date. The patient did not visit emergency room or physician's office. There were no prior vaccinations within 4 weeks. She has lots of autoimmunity in the family and sensitive to additives, preservatives and medications. The outcome of the events Facial swelling/ Swelling was around the lips and jaw was not recovered, of rapid heart rate and a little bit of facial numbness was recovered on 12Apr2021, and for the rest was unknown.  Description of Product Complaint: The patient mentioned regarding treatment for the facial swelling that she has tried antihistamines and Advil, was thinking it might be getting a little better but waking up this morning, it is the same and has been persistent.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Facial swelling/ Swelling was around the lips and jaw; rapid heart rate; a little bit of facial numbness; Swelling was around the lips and jaw; There was edema around the mouth and cheeks and under her right chin; There was a fold coming down from her mouth that didn't used to be there; This is a spontaneous report from a contactable consumer, the patient.     A 45-years-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) an unspecified route of administration, in arm left on 12Apr2021 at 10:15 as dose 1, single (age at vaccination 45 years) for covid-19 immunisation. Medical history included low thyroid, ongoing. The patient's concomitant medications included natural thyroid for low thyroid that she had been taking for years but does not have name and dose information for this product at the moment. On 16Apr2021 the patient was having facial swelling since 3 days after the vaccine. She got the vaccine on Monday and noticed this by Friday morning, so the fourth day. The swelling was around the lips and jaw on an unknown date in 2021. There was a fold coming down from her mouth that didn't used to be there on an unknown date in 2021. First noticed when she took off her mask. There was edema around the mouth and cheeks and under her right chin on an unknown date in 2021. The patient received treatment for the facial swelling, she had tried antihistamines and Advil, was thinking it might be getting a little better but waking up this morning, it was the same and had been persistent. She even tried acupuncture. Tried things for drainage, lymphatic drainage. The patient did not get any relevant tests done. The patient was told that this will go away, that it was just edema or something but it did not. There was no history of previous immunizations. No additional vaccines were administered on same date. The patient did not visit emergency room or physician's office. There were no prior vaccinations within 4 weeks. She has lots of autoimmunity in the family and sensitive to additives, preservatives and medications. The outcome of the events Facial swelling/ Swelling was around the lips and jaw was not recovered, of rapid heart rate and a little bit of facial numbness was recovered on 12Apr2021, and for the rest was unknown.  Description of Product Complaint: The patient mentioned regarding treatment for the facial swelling that she has tried antihistamines and Advil, was thinking it might be getting a little better but waking up this morning, it is the same and has been persistent.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: My arm is bad; This is a spontaneous report received from a contactable consumer or other non-health care professional (Patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 20Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. Patient had second shot on Tuesday and experienced the same symptoms but this time my arm Is bad on an unspecified date.  No follow-up information needed. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: A rash on her hand; This is a spontaneous report from a non-contactable consumer reported for a female patient (reporters Another friend). This is second report.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that another friend had a rash on her hand after the vaccine and says she did not see the rash since the friend wore a glove at the time, she visited her. The outcome was unknown for the event.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: He went through 8 days of severe chills, fever and pounding headache; He went through 8 days of severe chills, fever and pounding headache; He went through 8 days of severe chills, fever and pounding headache; This is a spontaneous report from a contactable consumer or other non healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced that he went through 8 days of severe chills, fever and pounding headache on an unspecified date with outcome of unknown   Follow-up (24APR2021) This is a follow-up spontaneous report from a contactable consumer. This contactable male consumer(patient) reported that:Consumer said he had the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine 3 weeks ago and is scheduled to receive the 2nd dose soon. After the 1st dose, he said he had headache, fever, and chills that lasted for 8 days all day. He wants to know if there have been reports of these reactions associated with the vaccine. He also wants to know what type of reactions he would have after the 2nd dose.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe pain on his left shoulder; This is a spontaneous report from a contactable consumer (patient's wife).   A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 as single dose for COVID-19 immunisation. On 14Apr2021, when the patient woke up, the patient experienced severe pain on his left shoulder blade and worked its way on his breast area. There were no unaddressed medical questions referred or forwarded to medical information. The outcome of the event was unknown.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: Severe Nausea; Headache; Fatigue; No appetite; Joint aches; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN9581), dose 2 intramuscular, administered in Deltoid Left on 10Feb2021 13:15 as SINGLE DOSE for covid-19 immunisation (Patient Age at Time of Vaccination: 66 Years). Patient received historical vaccine of dose 1 bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3248), dose 1 intramuscular, administered in Deltoid Left on 20Jan2021 13:30 as SINGLE DOSE for covid-19 immunisation. Medical history included surgery from 12Apr2019 to 15Jun2019 Verbatim: Orthoscopic Surgery, influenza from 2019 to 2019, major depression from an unknown date and unknown if ongoing. Concomitant medications included venlafaxine (VENLAFAXINE) taken for major depression from an unspecified start date and ongoing; bupropion (BUPROPION) taken for major depression from an unspecified start date and ongoing; l-methylfolate (L-METHYLFOLATE) taken for major depression from an unspecified start date and ongoing; armodafinil (ARMODAFINIL) taken for major depression from an unspecified start date and ongoing; estradiol (ESTRADIOL) taken for major depression from an unspecified start date and ongoing; losartan (LOSARTAN) taken for major depression from an unspecified start date and ongoing; rosuvastatin calcium (ROSUVASTIN) taken for major depression from an unspecified start date and ongoing. Vaccination facility type was Public Health Clinic. Patient did not receive other vaccine in four weeks of vaccination. Patient did not have relevant family history or tests. On 11Feb2021 09:00 the patient experienced severe nausea, headache, fatigue, no appetite and joint aches. The outcome for the event joint aches was unknown and rest all events was recovered. No Follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pain, Pyrexia, Sinusitis
Clinical narrative: sinisistus; low grade fever; cough; body aches; chills; This is a spontaneous report received from a non-contactable consumer or other non-health care professional (patient) via a Regulatory Authority.  A female patient with unspecified age received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; batch no/Lot number: not reported) via an unspecified route of administration on 06Apr2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient and her husband had 1st dose of Covid Vaccine on 06Apr2021. On an unspecified date in Apr2021, after 1st dose of Pfizer vaccine patient experienced with Sinusitus and low-grade fever, cough, body aches and chills. Patient was asking the reason for the time lapse in reactions and whether they get the second dose. Outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: chills; headache; fever; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and Expiry date: unknown) (age at the time of vaccination was 50 years), via unspecified route on an unknown date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown)  (age at the time of vaccination was 50 years), via an unspecified route of administration, on an unknown date as dose 1, single for COVID-19 immunization. On an unknown date, after receiving the second dose of the Pfizer COVID-19 vaccine. That night, the patient experienced chills, fever, and headache through the night. The patient got gradually better the next day.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: chills; headache; fever; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and Expiry date: unknown) (age at the time of vaccination was 50 years), via unspecified route on an unknown date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown)  (age at the time of vaccination was 50 years), via an unspecified route of administration, on an unknown date as dose 1, single for COVID-19 immunization. On an unknown date, after receiving the second dose of the Pfizer COVID-19 vaccine. That night, the patient experienced chills, fever, and headache through the night. The patient got gradually better the next day.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Inflammation
Clinical narrative: I felt a pain in my lower back vertebrae that was only noticeable if I pushed a knuckle into the area; It just feels like inflammation; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW1053) via an unspecified route of administration on 10Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient experienced as, i felt a pain in my lower back vertebrae that was only noticeable if i pushed a knuckle into the area, it just feels like inflammation on 21Apr2021. Reported as, patient received his second dose of BioNTech COVID Vaccine on 10Apr2021. It was now 22Apr2021. Yesterday, he felt a pain in his lower back vertebrae that was only noticeable if he pushed a knuckle into the area. Today, that pain is there without any prodding. The pain was not debilitating, it was just noticeable. It just feels like inflammation, nothing serious. He do not know if this pain was related to the vaccine, but he could not imagine what else could have caused it. He know this pain was minor, and possibly unrelated to the vaccine, but he feel obligated to at least report the condition. The enquiry did not involve a report of exposure during pregnancy. Outcome of the events were not recovered.  No follow-up attempts are needed. No further information is expected.