chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry throat, Dyspnoea, Fatigue, Nasal congestion
Clinical narrative: out of breath at times; Tiredness, fatigue; Sinus allergy; cold; sore throat; dryness feeling throat and nose; dryness feeling throat and nose; congestion; runny nose; cough; This is a spontaneous report from a contactable consumer (Patient). A 52-year-old non-pregnant female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration, administered in arm left on 10Feb2021 at 12:30 PM (at the age of 52-year-old) as dose 1, single for covid-19 immunisation . The patients medical history included allergies, known allergies to Aspirin, Penicillin, and Sulfas. The patients past drugs included Tetracycline, Advil, Ibuprofen, and experienced allergies. Concomitant medication in two weeks included cetirizine hydrochloride (ZYRTEC), taken for unspecified indication, start and stop dates were not reported. Patient did not receive other vaccine in four weeks. On 16Feb2021 at 01:30 AM, five days later, she experienced tiredness, fatigue, out of breath at time, cold or sinus allergies. It started with a sore throat, dryness feeling throat and nose, congestion, runny nose and cough. Adverse events resulted in physician office visit. The patient did not receive treatment for adverse events. The patient had no COVID prior vaccination and was tested for COVID post vaccination. The patient underwent lab test and procedure which included SARS-CoV-2 test (Nasal Swab, polymerase chain reaction, and Antigen): result unknown, on 17Feb2021. The clinical outcome of all the events was resolving. Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal dryness, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: out of breath at times; Tiredness, fatigue; Sinus allergy; cold; sore throat; dryness feeling throat and nose; dryness feeling throat and nose; congestion; runny nose; cough; This is a spontaneous report from a contactable consumer (Patient). A 52-year-old non-pregnant female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration, administered in arm left on 10Feb2021 at 12:30 PM (at the age of 52-year-old) as dose 1, single for covid-19 immunisation . The patients medical history included allergies, known allergies to Aspirin, Penicillin, and Sulfas. The patients past drugs included Tetracycline, Advil, Ibuprofen, and experienced allergies. Concomitant medication in two weeks included cetirizine hydrochloride (ZYRTEC), taken for unspecified indication, start and stop dates were not reported. Patient did not receive other vaccine in four weeks. On 16Feb2021 at 01:30 AM, five days later, she experienced tiredness, fatigue, out of breath at time, cold or sinus allergies. It started with a sore throat, dryness feeling throat and nose, congestion, runny nose and cough. Adverse events resulted in physician office visit. The patient did not receive treatment for adverse events. The patient had no COVID prior vaccination and was tested for COVID post vaccination. The patient underwent lab test and procedure which included SARS-CoV-2 test (Nasal Swab, polymerase chain reaction, and Antigen): result unknown, on 17Feb2021. The clinical outcome of all the events was resolving. Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: out of breath at times; Tiredness, fatigue; Sinus allergy; cold; sore throat; dryness feeling throat and nose; dryness feeling throat and nose; congestion; runny nose; cough; This is a spontaneous report from a contactable consumer (Patient). A 52-year-old non-pregnant female consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration, administered in arm left on 10Feb2021 at 12:30 PM (at the age of 52-year-old) as dose 1, single for covid-19 immunisation . The patients medical history included allergies, known allergies to Aspirin, Penicillin, and Sulfas. The patients past drugs included Tetracycline, Advil, Ibuprofen, and experienced allergies. Concomitant medication in two weeks included cetirizine hydrochloride (ZYRTEC), taken for unspecified indication, start and stop dates were not reported. Patient did not receive other vaccine in four weeks. On 16Feb2021 at 01:30 AM, five days later, she experienced tiredness, fatigue, out of breath at time, cold or sinus allergies. It started with a sore throat, dryness feeling throat and nose, congestion, runny nose and cough. Adverse events resulted in physician office visit. The patient did not receive treatment for adverse events. The patient had no COVID prior vaccination and was tested for COVID post vaccination. The patient underwent lab test and procedure which included SARS-CoV-2 test (Nasal Swab, polymerase chain reaction, and Antigen): result unknown, on 17Feb2021. The clinical outcome of all the events was resolving. Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hyperaesthesia, Myalgia
Clinical narrative: This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265, Expiry Date: 31May2021) via an unspecified route of administration in left arm on 18Feb2021 (at the age of 70-year-old) as dose 2, single for COVID- 19 immunisation. Relevant medical history included ongoing secondary hypoadrenalism (diagnosed 8 years ago, she takes steroids for it). It was further clarified that secondary hypoadrenalism came from her having a pituitary brain tumor benign that was diagnosed 8 years ago, and radiation to that in Feb2018; ongoing Hypothyroidism (she has had this for 20 years, she takes a thyroid medication). Concomitant medications were none (the patient had not received any other recent vaccinations or medications). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) on 26Jan2021 (at the age of 70-year-old) as dose 1, single for Covid-19 immunization. The patient received her second dose of the Pfizer covid vaccine on the 18Feb2021 and clarified that she had muscle achiness, she had joint pain in her knees and shoulder. The patient had facial skin sensitivity. She said for the sensitive skin on face treatment she was going to see her doctor today to see if it could be shingles, thought there was no rash, it was just sensitive around her right eye. At the time of reporting, the patient aching got better. Seriousness was not provided. The outcome of the event of hyperaesthesia was unknown and other events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose fluctuation, Headache, Lip blister, Mouth haemorrhage, Oral mucosal blistering
Clinical narrative: they are like water blisters inside the lymph of my mouth and inside of my lips; headache; water blisters on roof of mouth that pop and have a slight blood discharge; water blisters on roof of mouth that pop and have a slight blood discharge; have a little bit of sore arm; This is a spontaneous report from a contactable consumer or other non hcp.    An 82-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 20Feb2021 14:00 as 2nd dose, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, COPD, he takes Symbicort for that, dose says 160/4.5. caller said that this was diagnosed 20 years ago, type 2 diabetes mellitus and takes Onglyza and Glipizide for this. Caller said he had that probably 30 years. Concomitant medication(s) included budesonide; formoterol fumarate (SYMBICORT) taken for chronic obstructive pulmonary disease; saxagliptin hydrochloride (ONGLYZA) taken for type 2 diabetes mellitus; glipizide (GLIPIZIDE) taken for type 2 diabetes mellitus. It was Reported that, the patient experienced headache on 21Feb2021 with outcome of recovered, water blisters on roof of mouth that pop and have a slight blood discharge on 20Feb2021 with outcome of unknown, have a little bit of sore arm on 20Feb2021 with outcome of unknown, they are like water blisters inside the lymph of my mouth and inside of my lips on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood glucose fluctuation: 108 on 24Feb2021. Therapeutic measures were taken as a result of headache (headache).  Information on the lot/batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: they are like water blisters inside the lymph of my mouth and inside of my lips; headache; water blisters on roof of mouth that pop and have a slight blood discharge; water blisters on roof of mouth that pop and have a slight blood discharge; have a little bit of sore arm; This is a spontaneous report from a contactable consumer or other non hcp.    An 82-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 20Feb2021 14:00 as 2nd dose, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, COPD, he takes Symbicort for that, dose says 160/4.5. caller said that this was diagnosed 20 years ago, type 2 diabetes mellitus and takes Onglyza and Glipizide for this. Caller said he had that probably 30 years. Concomitant medication(s) included budesonide; formoterol fumarate (SYMBICORT) taken for chronic obstructive pulmonary disease; saxagliptin hydrochloride (ONGLYZA) taken for type 2 diabetes mellitus; glipizide (GLIPIZIDE) taken for type 2 diabetes mellitus. It was Reported that, the patient experienced headache on 21Feb2021 with outcome of recovered, water blisters on roof of mouth that pop and have a slight blood discharge on 20Feb2021 with outcome of unknown, have a little bit of sore arm on 20Feb2021 with outcome of unknown, they are like water blisters inside the lymph of my mouth and inside of my lips on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood glucose fluctuation: 108 on 24Feb2021. Therapeutic measures were taken as a result of headache (headache).  Information on the lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling, Lip pruritus, Lip swelling, Pruritus
Clinical narrative: My eyes itched; My lips itched; My eyes swollen; My tongue itched; My tongue swollen; My lips swollen; I itched all over and still itch; This is a spontaneous report from a contactable consumer or other non hcp. A 49-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number: em9810) via an unspecified route of administration, administered in arm left on 08Feb2021 14:00 (at the age of 49-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included asthma, hypertension and drug hypersensitivity. Concomitant medications included telmisartan taken for blood pressure. The patient previously took Benadryl and sulfa and experienced allergies. Patient did not have COVID prior vaccination. Patient was tested for COVID post vaccination.  On 08Feb2021 at 02:00PM the patient lips tongue and eyes itched and became swollen. The patient itched all over and still itching and had to rush to the urgent care for treatment and the went to an allergist a few days later. The patient was advised not to take the second shot and was given epi pen. The patient received treatment with steroids and allergy medication. Patient underwent lab test on an unspecified date: COVID test result: negative. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swollen tongue, Tongue pruritus
Clinical narrative: My eyes itched; My lips itched; My eyes swollen; My tongue itched; My tongue swollen; My lips swollen; I itched all over and still itch; This is a spontaneous report from a contactable consumer or other non hcp. A 49-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number: em9810) via an unspecified route of administration, administered in arm left on 08Feb2021 14:00 (at the age of 49-year-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included asthma, hypertension and drug hypersensitivity. Concomitant medications included telmisartan taken for blood pressure. The patient previously took Benadryl and sulfa and experienced allergies. Patient did not have COVID prior vaccination. Patient was tested for COVID post vaccination.  On 08Feb2021 at 02:00PM the patient lips tongue and eyes itched and became swollen. The patient itched all over and still itching and had to rush to the urgent care for treatment and the went to an allergist a few days later. The patient was advised not to take the second shot and was given epi pen. The patient received treatment with steroids and allergy medication. Patient underwent lab test on an unspecified date: COVID test result: negative. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Hypersensitivity, Migraine
Clinical narrative: This is a spontaneous report from a contactable consumer. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) unspecified route of administration on 30Jan2021 (at the age of 66-years) as dose 1, single for covid-19 immunization. The patient concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021, the patient had migraine headache that got worse after the shot and she said she had sensitivity and tasted soap for about a day. The migraine was reported better the next day. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On an unspecified date in 2021, the outcome of the events were recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Influenza like illness, Pyrexia
Clinical narrative: she really just felt terrible, felt like she had the flue; she really just felt terrible, felt like she had the flue; hives; chills; high temperature/sometimes having a fever; This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EM9810) via an unspecified route of administration, administered in Arm Left on 12Feb2021 (at the age of 80-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included covid-19 from 07Oct2020 to an unknown date (Tested positive for coronavirus on 07Oct2020). The patient's concomitant medications were not reported. On 12Feb2021, 12 hours later in the middle of the night the patient experienced chills, high temperature, it was up to102.5 and naturally that day it was about 101 and slowly started going down, states that she is still sometimes having a fever of about 99 or so, no tall the time. On 13Feb2021 hives on next night, on an unspecified date, she really just felt terrible, felt like she had the flue. On 12Feb2021, the patient underwent lab tests and procedures which included body temperature: 99, body temperature: 102.5, body temperature: 101. The outcome of events chills, high temperature was recovering, while the outcome of other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: she really just felt terrible, felt like she had the flue; she really just felt terrible, felt like she had the flue; hives; chills; high temperature/sometimes having a fever; This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EM9810) via an unspecified route of administration, administered in Arm Left on 12Feb2021 (at the age of 80-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included covid-19 from 07Oct2020 to an unknown date (Tested positive for coronavirus on 07Oct2020). The patient's concomitant medications were not reported. On 12Feb2021, 12 hours later in the middle of the night the patient experienced chills, high temperature, it was up to102.5 and naturally that day it was about 101 and slowly started going down, states that she is still sometimes having a fever of about 99 or so, no tall the time. On 13Feb2021 hives on next night, on an unspecified date, she really just felt terrible, felt like she had the flue. On 12Feb2021, the patient underwent lab tests and procedures which included body temperature: 99, body temperature: 102.5, body temperature: 101. The outcome of events chills, high temperature was recovering, while the outcome of other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swelling at the injection site; Redness at the injection site; Itching at the injection site; Has a small place on her foot in which it looks like she is getting a hive or rash/ rash on her foot; This is a spontaneous report from a Pfizer-sponsored program. A contactable (age: 79; Unit: unknown) female consumer who 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 an unspecified date in 23Feb2021 as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Medical history she used to having allergic reactions and she has a history of swelling, done this for years. She has been prescribed an Epipen that she keeps on hand and she never had to use it. The patient's concomitant medications were not reported. In Feb2021, she was experiencing redness, swelling, itching at the injection site, and has a small place on her foot in which it looks like rash. She has been prescribed with an Epipen that she kept on hand and she never had to use it. Reporter asked if she can take an antihistamine that she has on hand and wanted to know if it will interfere with the vaccine. The reporter considered the events as non-serious. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Sinus pain
Clinical narrative: sinus issues/sinus pain; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 14Jan2021 (Lot number and expiry date was not provided) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sinus issues/sinus pain on an unspecified date. She had sinus issues and she was wondering if she could take a Tylenol due to the sinus pain not the vaccine. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pain
Clinical narrative: aches all over after taking the first dose; she has arthritis and her pain is worse than she had before; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 1 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. The concomitant medications were not reported. The patient experienced aches all over after taking the first dose on an unknown date. It was reported that patient had arthritis and her pain worsen than she had before. The patient asking if she can take Tylenol. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: arm soreness; headache; This is a spontaneous report from a contactable consumer. A 59 year old female patient had received bnt162b2 (Pfizer-biontech COVID-19 vaccine, Solution for injection, Batch/lot number: EL1283 was reported) via an unspecified route of administration on 26Jan2021 as DOSE 1, SINGLE for COVID-19 immunization(at age of 59 years). The patient medical history had included type 2 diabetes and concomitant medications was Metformin hydrochloride, Sitagliptin(JANUMET,500-100mg , take two tablets once a day).The patient did not take any vaccination within 4 weeks prior to vaccination. On 27 Jan 2021 the patient had experienced arm soreness and a slight headache. On Jan 2021 the clinical outcome of the event was recovered.  Follow-up (28May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: body temperature was 102.2 F; I started feeling body aches mainly of my legs; This is a spontaneous report from a contactable other hcp (Patient). A 46-year-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: 5318) dose 2 via an unspecified route of administration on 17Feb2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date as single for COVID-19 immunization. On 18Feb2021 13:30 the patient started feeling body aches mainly of my legs and body temperature was 102.2 f. On 18Feb2021 the patient underwent lab tests and procedures which included body temperature result with 102.2 Fahrenheit. No other potential adverse events to report at this time. Patient was in good physical health. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Vaccination site reaction
Clinical narrative: I am really upset; I got the first shot and I got a reaction through that; sick; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9263) via an unspecified route of administration on an unspecified date as dose 1 single for COVID-19 immunization. Medical history included AFib, breathing problem. Concomitant medications were not reported. On an unspecified date, patient got the first shot and patient stated I got a reaction through that, I got all the symptoms. Patient stated I am really upset from that shot so patient was calling about should I go tomorrow to get the second shot.The patient also experienced sick. Patient stated thatI am alright now, I come out if it, right now. It lasted for a few days and it left. The outcome of the events was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: Soreness at injection site; fatigue; headache; body aches; This is a spontaneous report from a contactable consumer (patient herself).  A 22-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 09:00 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE (age at vaccination was 22 years old) for covid-19 immunisation at a Workplace clinic. The patient medical history was not reported. Concomitant medication(s) included birth control, loratadine, ibuprofen and paracetamol (TYLENOL), all taken for an unspecified indication, start and stop dates were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021 at 09:00 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE. No other vaccine was administered to the patient in four weeks. She was not tested for covid prior to vaccination and post vaccination. On 17Feb2021, at 07:00 hrs, the patient experienced soreness at injection site, fatigue, headache and body aches. No treatment was received by the patient. At the time of this report, the outcome of all the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Dyspepsia, Expired product administered, Eye pain
Clinical narrative: General malaise; Eyes were achy; Decreased appetite; Stomach was hurting; Indigestion; Took expired Aleve; Arm was sore after getting the injection; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Formulation: Solution for injection; Lot number: EL9267, Expiration date: 31May2021 via unspecified route of administration in Arm Left on 12Feb2021, at 11:30 (Age at vaccination: 67-years-old) as dose 1, single for COVID-19 immunization and patient received ALEVE (NAPROXEN SODIUM; Lot number: NAA5E5D, Expiration date: Mar2020) via oral route of administration on 12Feb2021 for her sore arm. The patient's medical history included osteoporosis. She takes medication for osteoporosis. Concomitant medications were not reported. On 12Feb2021, patient stated arm was sore after getting the injection, took expired Aleve, on 15Feb2021 after 3 days, patient had Indigestion. on 16Feb2021, after 4 days patient experienced stomach was hurting, Decreased appetite. on 17Feb2021, 5 days after second dose patient experienced General malaise, eyes were achy. Patient stated she took the first dose of the Covid-19 vaccine on Friday 12Feb2021. She received it around 11:30am. Her arm was sore that day. She moved it around and also used the rowing machine. She took 2 Aleve at bedtime. She woke up feeling great. On Monday she had indigestion which she has from time to time. She is healthy. She has annual check ups. She takes medication for osteoporosis. She adds that her stomach hurt. She did not have any aches or nausea. She was careful about what she ate. She felt worse yesterday and her stomach hurt more. It was like with having the flu. She had general malaise and her eyes were achy. She didn't see that these were reactions to the first dose. Her stomach felt better with food. She was still eating but she wasn't as hungry as normal. Two to three weeks ago she had food poisoning and was throwing up. She has a sensitive digestive system. She took Aleve the night that she received the vaccine. Prior vaccinations (within 4 weeks) were none. Relevant test was none. The outcome of events Decreased appetite, General malaise, Stomach was hurting, was recovered on 18Feb2021, outcome of event Indigestion recovered with Sequel on 18Feb2021, outcome of evet arm was sore after getting the injection recovered on 14Feb2021, outcome of event eyes were achy was recovering, while outcome of other event was unknown.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: General malaise; Eyes were achy; Decreased appetite; Stomach was hurting; Indigestion; Took expired Aleve; Arm was sore after getting the injection; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Formulation: Solution for injection; Lot number: EL9267, Expiration date: 31May2021 via unspecified route of administration in Arm Left on 12Feb2021, at 11:30 (Age at vaccination: 67-years-old) as dose 1, single for COVID-19 immunization and patient received ALEVE (NAPROXEN SODIUM; Lot number: NAA5E5D, Expiration date: Mar2020) via oral route of administration on 12Feb2021 for her sore arm. The patient's medical history included osteoporosis. She takes medication for osteoporosis. Concomitant medications were not reported. On 12Feb2021, patient stated arm was sore after getting the injection, took expired Aleve, on 15Feb2021 after 3 days, patient had Indigestion. on 16Feb2021, after 4 days patient experienced stomach was hurting, Decreased appetite. on 17Feb2021, 5 days after second dose patient experienced General malaise, eyes were achy. Patient stated she took the first dose of the Covid-19 vaccine on Friday 12Feb2021. She received it around 11:30am. Her arm was sore that day. She moved it around and also used the rowing machine. She took 2 Aleve at bedtime. She woke up feeling great. On Monday she had indigestion which she has from time to time. She is healthy. She has annual check ups. She takes medication for osteoporosis. She adds that her stomach hurt. She did not have any aches or nausea. She was careful about what she ate. She felt worse yesterday and her stomach hurt more. It was like with having the flu. She had general malaise and her eyes were achy. She didn't see that these were reactions to the first dose. Her stomach felt better with food. She was still eating but she wasn't as hungry as normal. Two to three weeks ago she had food poisoning and was throwing up. She has a sensitive digestive system. She took Aleve the night that she received the vaccine. Prior vaccinations (within 4 weeks) were none. Relevant test was none. The outcome of events Decreased appetite, General malaise, Stomach was hurting, was recovered on 18Feb2021, outcome of event Indigestion recovered with Sequel on 18Feb2021, outcome of evet arm was sore after getting the injection recovered on 14Feb2021, outcome of event eyes were achy was recovering, while outcome of other event was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Pain in extremity
Clinical narrative: she had arthritis, extreme pain in her shoulder after her first dose; she had arthritis, extreme pain in her shoulder after her first dose; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: Unknown) via an unspecified route of administration on 14Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced arthritis, extreme pain in her shoulder after her first dose on an unspecified date. The outcome of both events was unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Headache, fatigue, injection site pain after second dose; Headache, fatigue, injection site pain after second dose; Headache, fatigue, injection site pain after second dose; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient (Non pregnant)  received bnt162b2 (BNT162B2, Formulation:Solution for injection, Batch/Lot Number: EL3247) , dose 2 via an unspecified route of administration, administered in left arm on 17Feb2021 at 10:30 am as  a single dose for (at the age of 50 year) Covid-19 immunisation at Workplace clinic. The patient medical history and concomitant medications were not reported. No known allergies.  The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and received other medications in two weeks include birth control pills.  Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19.  Historical vaccine include  bnt162b2 (BNT162B2,Formulation: Solution for injection Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in left arm on 27Jan2021, at 12:15 pm as  a single dose for (at the age of 50 year)  Covid-19 immunisation at Workplace clinic and experienced Enlarged lymph nodes on left side (vaccination side) in recent mammogram on 16Feb2021 after first dose. The patient experienced, headache, fatigue, injection site pain after second dose on 17Feb2021. Treatment not received for the events. Outcome of the event was unknown.  .  No follow up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headaches; This is a spontaneous report from a contactable Nurse. A 38-year-old non pregnant 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 38 years), dose 2 intramuscular, administered in Arm Left on 12Feb2021 16:00 PM as dose 2, single for COVID-19 immunisation administered in hospital. Medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 38 years), dose 1 intramuscular, administered in Arm Left on 22Jan2021 16:00 PM as dose 1, single for COVID-19 immunisation. The patient did not receive any other medications within 2 weeks of vaccination. The nurse reported, the patient experienced severe headaches on 16Feb2021. The reporter assessed the event as non-serious. Covid was not tested prior to or post vaccination. The outcome of event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site pain
Clinical narrative: Very sore pain from muscle of injection site as early as an hour post vaccination; Limited arm movement going into the next day; This is a spontaneous report from a non-contactable consumer. This consumer reported that, A 20-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6198) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization (age at vaccination 20-years-old). The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced very sore pain from muscle of injection site as early as an hour post vaccination, limited arm movement going into the next day on an unspecified date. Outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Nausea; Headache; This is a spontaneous report from contactable consumer. 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 an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced nausea and headache. The outcome of events was unknown.  Information on the lot/batch number has been requested  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slightly sore arm after second dose; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9264 ) dose 2 via an unspecified route of administration, administered in left arm on 17Feb2021 at 02:00 PM (at the age of 71-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included High blood pressure, High Cholesterol, Hypothyroid, Known allergies to sulfa and bees. Concomitant medication(s) included LEVOTHYROXINE, SANCTURA, PRAVASTATIN, BUSPAR, and ATENOLOL. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. The patient previously took Tramadol, Celebrex, Theophylline, and experienced known allergies to Tramadol, Celebrex, Theophylline. The patient previously took bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 1 via an unspecified route of administration, administered in left arm on 28Jan2021 at 01:00 pm in hospital for (at the age of 71-years-old) Covid-19 immunisation and experienced very slight chills lasting 2 hours evening after first dose. The patient experienced slightly sore arm after second dose (on an unspecified date in Feb2021) but took Tylenol immediately after shot. Therapeutic measures were taken as a result of event occurred taken Tylenol immediately after shot. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Migraine, Mycobacterium tuberculosis complex test
Clinical narrative: Drowsiness; aches and pains; normal headache; She gets migraines; She didn't go to work because it made her nervous; tongue has been numb; side of face numb; This is a spontaneous report from a contactable consumer (patient herself).   A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EN6200, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Age at vaccination 41-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included high cholesterol from an unknown date and unknown if ongoing she is not medicated because it is not at that point. The patient concomitant medications were not reported. The patient did not receive any other products. Caller confirmed product as COVID19 Vaccine. She was an educator. On an unspecified date, the patient had her Pfizer first vaccination yesterday afternoon. She had typical side effects such as, drowsiness and aches and pains. Her tongue had been numb since yesterday. She gets migraines and had numbness of the tongue and face, but the tongue and side of her face had remained numb since getting the vaccine. It is not as bad as yesterday, but it was still there this morning when she woke up. She didn't go to work because it made her nervous. With the side effects her coworkers had she wasn't sure if she needed to report it. No further details provided. The caller declined to provide HCP information. It was crazy at the site yesterday and she had been holding for a long time. She was sure it is crazy everywhere. After the vaccine she waited for 15 minutes. When she got in the car she noticed her tongue and side of her face were numb. She would say that was about 20 minutes after the vaccine. It was at 15:30 on 17Feb2021. Yesterday it was more of the right side of her face and today it is more so the left lower side of face that it numbs. Yesterday and today, it is the entire tongue that is numb. Numbness of tongue and face is normal for her with migraines, but usually it goes away. She had a normal headache, but not a migraine since getting the vaccine. There is a number on the card, but she was not sure what that is for. It was just weird that the numbness didn't go away. No. The only thing was in her 20's she had a positive TB test result. No further details provided. Prior Vaccinations, the patient had not received any other vaccine within 4 weeks. The patient underwent lab tests and procedures which included mycobacterium tuberculosis complex test: positive on an unspecified date the only thing was in her 20's she had a positive TB test result. The outcome of events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pain, Somnolence
Clinical narrative: Drowsiness; aches and pains; normal headache; She gets migraines; She didn't go to work because it made her nervous; tongue has been numb; side of face numb; This is a spontaneous report from a contactable consumer (patient herself).   A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EN6200, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Age at vaccination 41-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included high cholesterol from an unknown date and unknown if ongoing she is not medicated because it is not at that point. The patient concomitant medications were not reported. The patient did not receive any other products. Caller confirmed product as COVID19 Vaccine. She was an educator. On an unspecified date, the patient had her Pfizer first vaccination yesterday afternoon. She had typical side effects such as, drowsiness and aches and pains. Her tongue had been numb since yesterday. She gets migraines and had numbness of the tongue and face, but the tongue and side of her face had remained numb since getting the vaccine. It is not as bad as yesterday, but it was still there this morning when she woke up. She didn't go to work because it made her nervous. With the side effects her coworkers had she wasn't sure if she needed to report it. No further details provided. The caller declined to provide HCP information. It was crazy at the site yesterday and she had been holding for a long time. She was sure it is crazy everywhere. After the vaccine she waited for 15 minutes. When she got in the car she noticed her tongue and side of her face were numb. She would say that was about 20 minutes after the vaccine. It was at 15:30 on 17Feb2021. Yesterday it was more of the right side of her face and today it is more so the left lower side of face that it numbs. Yesterday and today, it is the entire tongue that is numb. Numbness of tongue and face is normal for her with migraines, but usually it goes away. She had a normal headache, but not a migraine since getting the vaccine. There is a number on the card, but she was not sure what that is for. It was just weird that the numbness didn't go away. No. The only thing was in her 20's she had a positive TB test result. No further details provided. Prior Vaccinations, the patient had not received any other vaccine within 4 weeks. The patient underwent lab tests and procedures which included mycobacterium tuberculosis complex test: positive on an unspecified date the only thing was in her 20's she had a positive TB test result. The outcome of events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Malaise, Rhinorrhoea
Clinical narrative: Chills; Weakness; Nose running; Feeling Unwell; This is a spontaneous report from a contactable consumer (parent) or other non-health care professional. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry Date: unknown) via an unspecified route of administration on 17Feb2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced chills, weakness, nose running and was feeling unwell. Reporter stated, he was at work so reporter was assuming he got off of work and was calling to share that he was not feeling well, feeling very weak. Reporter called to inform that he was having some type of symptoms. Limited information was available over the call. Outcome of the events were unknown.  Information of lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site pain
Clinical narrative: Extreme soreness/pain at injection site intermittently for at least 11 hrs post dose; Hard to lift arm up.; This is a spontaneous report from a non-contactable consumer (patient).   A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number were not provided, Expiration date were not provided), via an unspecified route of administration on administered in arm left on 17Feb2021 at 13:30 (at the age of 42-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included Obesity. Concomitant medications included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. On an17Feb2021 at 17:00, the patient experienced extreme soreness/pain at injection site intermittently for at least 11 hrs post dose and hard to lift arm up. The patient not received treatment. The outcome of the events was not recovered.   No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained. No further information is expected.