chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation
Clinical narrative: he lost sense of taste and smell; he lost sense of taste and smell; legs feeling heavy and hard to move; restless sleep; This is a spontaneous report from a contactable consumer (patient). An 84-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021 at single dose for COVID-19 immunisation.  Medical history included Patient has recently had a pacemaker implanted. Concomitant medication included potassium Once a day, hydrochlorothiazide (DIURETIC), 20 mg Twice a day, dutasteride (AVODART), Once a day, acetylsalicylic acid (ASPIRIN (E.C.) 81 mg Once a day and a multivitamin QD (Once a day). The patient had the COVID-19 vaccine administered on 14Jan2021. That evening he began waking up several times after a restless sleep approximately six times on 14Jan2021. This lasted approximately two more evenings. On 19Jan2021 he lost sense of taste and smell for approximately three days. As of 20Jan2021 he has regained some sense of taste. The patient's temperature has been normal with no fever and pulse oximetry has been approximately 96%. Lastly on 17Jan2021 patient reported his legs feeling heavy and hard to move which lasted approximately three days. The outcome was recovering.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very sick after the injections; This is a spontaneous report from non-contactable Other-HCP. This Other-HCP reported similar events for six patients. This is second of six reports (6 coworkers). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 20Jan2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was very sick after the injections on an unspecified date. The outcome was unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076655 same reporter, same drug/event, different patient;US-PFIZER INC-2021076654 same reporter, same drug/event, different patient;US-PFIZER INC-2021076551 same reporter, same drug/event, different patient;US-PFIZER INC-2021076656 same reporter, same drug/event, different patient;US-PFIZER INC-2021076654 same reporter, same drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: 6 coworkers were very sick after the injections; This is spontaneous report from a non-contactable other HCP. This Other HCP reported similar events for 6 patients. This is 3rd of 6 reports. A patient of unspecified age and gender received the second dose of BNT162B2 via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter explained that 6 coworkers were very sick after the injections on Jan2021. The reporter did not share any symptoms. Rather, reporter noted that they were miserable the day after, and were all now back at work today. Event outcome was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076551 Same drug and event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report from a non-contactable healthcare professional reporting similar events for six  patients. This report is for the fourth of the six patients. A patient of an unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE lot number/expiration date: not provided), via an unspecified route of administration, on an unspecified date (reported as "as recently as 20Jan2021"), as a single dose for COVID-19 vaccination. Relevant medical history was not reported. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE lot number/expiration date unknown) on an unspecified date. Concomitant medication were not reported. On an unknown date, the patient was sick. The outcome of the event sick was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.  .; Sender's Comments: Linked Report(s) : US-PFIZER INC- 2021076551 Same drug and event, different patient;US-PFIZER INC- 2021076656 Same drug and event, different patient;US-PFIZER INC- 2021076655 Same drug and event, different patient;US-PFIZER INC- 2021076652 Same drug and event, different patient;US-PFIZER INC-2021076653 Same drug and event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report from a non-contactable other HCP. The other HCP reported same event for six patients. This is the sixth of six reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, first dose on an unspecified date, then second dose on 20Jan2021, both at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced very sick after the injection in Jan2021. Outcome of the event was not recovered/not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076551 Same drug and event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: asthma and COPD and having more episodes; asthma and COPD and having more episodes; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable male consumer (patient) with unspecified age reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. Medical history included asthma and COPD both ongoing (he clarified he was having episode before doing the vaccination, he had had the breathing issues for a very long time).  The patient's concomitant medications were not reported. Patient had asthma and COPD and having more episodes in Jan2021 with outcome of unknown, and was given methylprednisolone (MEDROL) dose pack, he was asking if he took this would it affect the efficacy of vaccine. It was reported patient would be due for second dose of BNT162B2 on 01Feb2021.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A patient of unknown gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient had an allergic reaction to the COVID vaccine and she/ he was sent to the ER for treatment. The outcome of the event was unknown. Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: positive side effects; This is a spontaneous report. received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she wanted to talk to a medical professional in regard to the positive side effects that the Covid vaccine has had on her. The event details, onset date and outcome were unknown at the time of the report.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Fatigue, Pain
Clinical narrative: 99.4 F temperature 20 hours post dose; General fatigue; local soreness; This is a spontaneous report from a contactable consumer.  A 27-years-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number EL3247, via an unspecified route of administration, in the left arm, on 19Jan2021 at  13:45 (at the age of 27 years old) as a  single dose for COVID-19 immunization. The vaccination was administered in a workplace clinic. There was no medical history and no concomitant medications were reported.  The patient was not tested for COVID-19 prior to vaccination. There was no other vaccination given in 4 weeks. On 20Jan2021 at 10:00, the patient experienced a temperature of 99.4 F 20 hours post dose, general fatigue and local soreness. There was no treatment for the events. The clinical outcome of the temperature, general fatigue and local soreness was recovering. The patient was not tested for COVID-19 post-vaccination.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: He felt a little lightheaded afterwards; This is a spontaneous report from a contactable registered nurse (RN) who reported for her husband. A 74-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot#: EK9231) via an unspecified route of administration on 13Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history included high blood pressure and cholesterol, both controlled with medication, both from unspecified dates and unspecified if ongoing. Concomitant medications included lisinopril taken for blood pressure at 30mg, daily, lovastatin taken for cholesterol at 40mg, daily and acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication at 1 DF (dosage form) daily, all from unspecified dates and unspecified if ongoing.  The patient experienced "he felt a little lightheaded afterwards" on 12Jan2021. It was reported that "the reporter and her husband got the vaccine at the same time. They did not put their names on the cards, but they got the same lot number. It was written small on the card. The reporter's husband felt a little lightheaded afterwards but otherwise he had been fine. He received his first dose on 13Jan2021. He sat and waited for 15 minutes and when he stood up to leave, he was lightheaded. He sat back down and was okay." The clinical outcome of the event "he felt a little lightheaded afterwards" was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body height decreased, Dizziness postural, Nausea, Pain in extremity
Clinical narrative: she used to be 6'2 but she thinks she has shrunk a little; nauseous/she is still just a little queasy; tried to get out of bed, and the whole world tilted on her/everything turned upside down; sore arm; This is a spontaneous report from a contactable consumer, the patient.  A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1283), via an unspecified route of administration in the right arm on 17Jan2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation.  Medical history included Breast cancer in 2003 or 2004, for which the patient was in three clinical trials following that time. The patient reported that she requested to have the vaccine administered into her right arm because she is a breast cancer survivor. The patient has no concomitant medications.  The patient confirmed that she did not have any other vaccines on the same day as the COVID vaccine. The patient previously received Letrozole for breast cancer and provided that she has not taken letrozole or any or medications, not even vitamins, for the last three years.   On 18Jan2021 the patient experienced sore arm, which was not severe per the patient. On 21Jan2021 at around 03:00, the patient was nauseous and when the patient tried to get out of bed, the patient felt like the  "whole world tilted on her". The patient reported the same thing continued a few times when she tried to get up, she just couldn't because everything turned upside down. So the patient went back to sleep, and she got up at 11:00AM, and she feels much better now, and now she is just having a little bit of remaining queasiness, like she can't go on a run right now, she is not 100%.  The patient inquired if these are known side effects of the product. The patient also reported that she that she used to be 6'2 but she thinks she has shrunk a little from an unknown date. The patient stated that her PCP was not aware that she received the vaccine. The clinical outcome of the sore arm was recovered on 19Jan2021.  The clinical outcome of the nauseous/she is still just a little queasy, tried to get out of bed, and the whole world tilted on her, and thinks she has shrunk a little was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypersensitivity, Myalgia, Pain
Clinical narrative: Joints hurt and achy; wondering if his joints hurting and achy was an allergy; body ache (muscle pain); body ache (muscle pain); This is a spontaneous report from two contactable consumers (one was the patient). A 65-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, Expiry Date: 31May2021), via an unspecified route of administration on 20Jan2021 09:45 to at a single dose on left arm for COVID-19 immunization. Medical history included cholesterol, glaucoma, COVID-19, blood thinner, pressure, allergies, Acid Reflux/Stomach. Concomitant medication included atorvastatin calcium for cholesterol, clopidogrel for Blood thinner, amlodipine besilate for Pressure, lisinopril, flunisolide for Allergies, latanoprost for Glaucoma, famotidine for Acid Reflux/Stomach, alprazolam (XANAX). The patient previously received flu vaccine for immunization three months ago in Oct2020. Patient received the first dose of the vaccine yesterday 20Jan2021 9:45AM and between 6:00-7:00PM he started experiencing body ache (muscle pain), he's still achy and he would like to know what should he take, if he can take Tylenol. He mentioned him and his wife got the COVID Vaccine yesterday 20Jan2021. However, he is calling today because his joints hurt and achy. He initially stated he noticed his joints hurt and achy last night on 20Jan2021 around 7PM or 8PM, later stated like 6PM or 7PM. He also mentioned he told the lady yesterday a few months ago he tested positive for COVID. He was told he probably came in contact with it for a brief moment. He stated they could tell he had it in his blood and the antibodies not the first set, but second set was working. He later added, he took a blood test for COVID and was positive. He confirmed this was all prior to getting the COVID Vaccine, it was a few months ago like 3-4 months ago. He mentioned he was really calling because he is wondering if his joints hurting and achy was an allergy. He mentioned he has gone through this before with this allergy. Stated he has gone through these symptoms before.  He wants to know what he can take for it. He did not do anything. He did not have a fever or anything. Stated he did not even take his nasal spray because he was unsure if he could. No treatment received for the events. The outcome of the events was not recovered. The events were assessed as non-serious. Vaccination Facility was Hospital. The adverse events did not require a visit to Emergency Room or Physician Office. No Prior vaccinations within 4 weeks.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: pain in her hand unable to use it for a few days; This is a spontaneous report from a non-contactable nurse reporting for herself  An adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on 04Jan2021 for covid-19 immunisation. Medical history was none. Concomitant medication included ibuprofen. The patient experienced pain in her hand unable to use it for a few days on Jan2021. Therapeutic measures included tylenol. SARS-Cov-2 test nasal swab in Jan2021 was negative. The outcome was recovered  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of event Pain in hand cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Heart rate, Palpitations
Clinical narrative: His heart is racing and feels like it will jump out of his chest; His blood pressure is not consistent. It goes way up and comes way down.; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK4176, expiration date unspecified), via an unspecified route of administration on 16Jan2021 at single dose (left arm) for COVID-19 immunization. Medical history included back surgery and patient used to weigh 218 but lost weight due to a back surgery. This was prior to getting the vaccine. There were no concomitant medications.  On 16Jan2021, the patient experienced his heart was racing and felt like it will jump out of his chest and his blood pressure was not consistent and it goes way up and comes way down. He was told by the individual who gave him the vaccine to call and report this. There was no treatment received. Patient was scheduled for the second dose on 06Feb2021. Outcome of events was not recovered.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid Positive; Covid Positive; This is a spontaneous report from a contactable consumer (wife). A 72-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1283  and Expiration Date unknown) via Intramuscular on 12Jan2021 16:30 (vaccine location: right arm ) at single dose for COVID-19 immunisation. The patient's medical history included Kidney stones and heart issues (sees a cardiologist). The concomitant medications was reported as unspecified drugs. No previous vaccine in four weeks. Patient went to urgent care this morning and had a rapid test that came back positive and had covid.  Lab test included positive rapid covid test on 21Jan2021. The outcome of event was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dry mouth, Ear infection, Fatigue
Clinical narrative: Start of an ear infection; Stuffy nose; Sore throat; Headache; Muscle and joint pain; Muscle and joint pain; Chills; Dry mouth; White coating all over tongue; Nausea; Unbelievable thirst; Slight swelling at injection site; Injection site pain; Tiredness; swollen tonsils; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1283), via an unspecified route of administration in the right arm on 13Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation.  Medical history included Transverse Myelitis ongoing from 2016, neurologic lime disease ongoing from 1992 due to which the patient gets migraines (from 1992), H. Pylori in May2019 and the patient is hard of hearing, ongoing from an unknown date. The patient's concomitant medications included unspecified migraine medication.  On 13Jan2021 the patient experienced injection site pain, slight swelling at injection site, tiredness, and unbelievable thirst. On 14Jan2021 the patient experienced headache, muscle and joint pain, chills (which come and go), nausea (which is off and on), dry mouth, and white coating all over tongue. On 15Jan2021 the patient experienced stuffy nose and sore throat. The patient stated she still has tonsils on her right side where she has the earache and they are swollen (from an unknown date in Jan2021). On 17Jan2021 the patient experienced start of an ear infection (earache on the right side). The patient has had no fever and no redness. The patient stated she knows injection site pain is standard for a lot of people. The patient stated on Monday, 18Jan2021 she saw her provider and went over some of this. She stated she would not think that 4 days later she would still be feeling the side effects. The patient was inquiring if this only occurs with the first dose or will it also occur with the second? She is scheduled for the second one on 05Feb2021. The patient asked what was the time frame between injections? The patient was treated for the ear infection Neomycin/Polymyxin Sulfate ear drops and for the tiredness she has been walking around and trying light exercises. The patient turned down other medication as she did not want it to have any effect with the vaccine. The patient asked if there were any recommendations for the nausea and headaches. She stated she does have her migraine medication which she is trying to use to deal with the headaches.  The clinical outcome of the injection site pain and slight swelling at injection site was recovered on 14Jan2021 and the white coating all over tongue recovered on 18Jan2021. The clinical outcome of the tiredness and start of an ear infection was recovering.  The clinical outcome of the headache, muscle and joint pain, chills, nausea, stuffy nose, sore throat, thirst, and dry mouth was not recovered. The clinical outcome of the swollen tonsils was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasal congestion, Nausea, Oropharyngeal pain
Clinical narrative: Start of an ear infection; Stuffy nose; Sore throat; Headache; Muscle and joint pain; Muscle and joint pain; Chills; Dry mouth; White coating all over tongue; Nausea; Unbelievable thirst; Slight swelling at injection site; Injection site pain; Tiredness; swollen tonsils; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1283), via an unspecified route of administration in the right arm on 13Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation.  Medical history included Transverse Myelitis ongoing from 2016, neurologic lime disease ongoing from 1992 due to which the patient gets migraines (from 1992), H. Pylori in May2019 and the patient is hard of hearing, ongoing from an unknown date. The patient's concomitant medications included unspecified migraine medication.  On 13Jan2021 the patient experienced injection site pain, slight swelling at injection site, tiredness, and unbelievable thirst. On 14Jan2021 the patient experienced headache, muscle and joint pain, chills (which come and go), nausea (which is off and on), dry mouth, and white coating all over tongue. On 15Jan2021 the patient experienced stuffy nose and sore throat. The patient stated she still has tonsils on her right side where she has the earache and they are swollen (from an unknown date in Jan2021). On 17Jan2021 the patient experienced start of an ear infection (earache on the right side). The patient has had no fever and no redness. The patient stated she knows injection site pain is standard for a lot of people. The patient stated on Monday, 18Jan2021 she saw her provider and went over some of this. She stated she would not think that 4 days later she would still be feeling the side effects. The patient was inquiring if this only occurs with the first dose or will it also occur with the second? She is scheduled for the second one on 05Feb2021. The patient asked what was the time frame between injections? The patient was treated for the ear infection Neomycin/Polymyxin Sulfate ear drops and for the tiredness she has been walking around and trying light exercises. The patient turned down other medication as she did not want it to have any effect with the vaccine. The patient asked if there were any recommendations for the nausea and headaches. She stated she does have her migraine medication which she is trying to use to deal with the headaches.  The clinical outcome of the injection site pain and slight swelling at injection site was recovered on 14Jan2021 and the white coating all over tongue recovered on 18Jan2021. The clinical outcome of the tiredness and start of an ear infection was recovering.  The clinical outcome of the headache, muscle and joint pain, chills, nausea, stuffy nose, sore throat, thirst, and dry mouth was not recovered. The clinical outcome of the swollen tonsils was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst, Tongue discolouration, Tonsillar hypertrophy, Vaccination site pain, Vaccination site swelling
Clinical narrative: Start of an ear infection; Stuffy nose; Sore throat; Headache; Muscle and joint pain; Muscle and joint pain; Chills; Dry mouth; White coating all over tongue; Nausea; Unbelievable thirst; Slight swelling at injection site; Injection site pain; Tiredness; swollen tonsils; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1283), via an unspecified route of administration in the right arm on 13Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation.  Medical history included Transverse Myelitis ongoing from 2016, neurologic lime disease ongoing from 1992 due to which the patient gets migraines (from 1992), H. Pylori in May2019 and the patient is hard of hearing, ongoing from an unknown date. The patient's concomitant medications included unspecified migraine medication.  On 13Jan2021 the patient experienced injection site pain, slight swelling at injection site, tiredness, and unbelievable thirst. On 14Jan2021 the patient experienced headache, muscle and joint pain, chills (which come and go), nausea (which is off and on), dry mouth, and white coating all over tongue. On 15Jan2021 the patient experienced stuffy nose and sore throat. The patient stated she still has tonsils on her right side where she has the earache and they are swollen (from an unknown date in Jan2021). On 17Jan2021 the patient experienced start of an ear infection (earache on the right side). The patient has had no fever and no redness. The patient stated she knows injection site pain is standard for a lot of people. The patient stated on Monday, 18Jan2021 she saw her provider and went over some of this. She stated she would not think that 4 days later she would still be feeling the side effects. The patient was inquiring if this only occurs with the first dose or will it also occur with the second? She is scheduled for the second one on 05Feb2021. The patient asked what was the time frame between injections? The patient was treated for the ear infection Neomycin/Polymyxin Sulfate ear drops and for the tiredness she has been walking around and trying light exercises. The patient turned down other medication as she did not want it to have any effect with the vaccine. The patient asked if there were any recommendations for the nausea and headaches. She stated she does have her migraine medication which she is trying to use to deal with the headaches.  The clinical outcome of the injection site pain and slight swelling at injection site was recovered on 14Jan2021 and the white coating all over tongue recovered on 18Jan2021. The clinical outcome of the tiredness and start of an ear infection was recovering.  The clinical outcome of the headache, muscle and joint pain, chills, nausea, stuffy nose, sore throat, thirst, and dry mouth was not recovered. The clinical outcome of the swollen tonsils was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure to SARS-CoV-2, Pain, SARS-CoV-2 test
Clinical narrative: He tested positive for COVID on 13Jan2021. Since then, my 3 children have also tested positive for COVID. We did not isolate anyone once they were sick.; chills; body aches; This is a spontaneous report from a contactable consumer reporting for herself  A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 11Jan2021 at single dose via an unspecified route of administration  for COVID-19 immunization. The patient received first dose of BNT162B2 on 23Dec2020. Additional medical history or concomitant medications were not reported. On 11Jan2021 the patient experienced chills and body aches. Patient also informed that her husband started with symptoms of COVID on Sunday 10Jan2021. He tested positive for COVID on 13Jan2021. Since then, my 3 children have also tested positive for COVID. We did not isolate anyone once they were sick. (We realized this was a gamble). Patient informed that she was only person in the house who has not developed symptoms. She underwent SARS-CoV-2 test on 16Jan2021 which was negative. The patient recovered from chills and body aches on 13Jan2021.  Information about lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest X-ray, Muscle strain, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: feels like a muscle pull; Breathing was a little compromised; Oxygen saturation was down; Pain on left side to left breast; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730, expiry date: Mar2021), via an unspecified route of administration on 15Jan2021 10:47 at SINGLE DOSE reported in left shoulder for covid-19 immunisation. Medical history included asthma from 1971 and ongoing Diagnosed 50 years ago, Allergies from 1971 Diagnosed 50 years ago, Sarcoids from 2008 Sarcoids, Biopsy in 2008 and that is when she was diagnosed, ongoing sinus problems, pneumonia, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. There were no concomitant medications. On 18Jan2021 07:00, on Monday, she had pain from her left side to left breast, it was a sharp pain.  Monday and Tuesday, she had to sleep sitting up.  Her breathing was a little compromised so she went on the breathing machine at 09:30. Her oxygen saturation went down a little. Oxygen saturation was down 09:30. Her oxygen saturation was probably at 91-92%. She thought it was Pneumonia, so they did a chest x -ray and her lungs were clear.  She got it through hospital because she has higher risk. She feels like now it is better. Sometimes with deep breaths, it feels like a muscle pull on an unspecified date. She does have asthma and allergies and went on the breathing machine and she knew her oxygen levels were down. She has an oximeter that she uses to check it at home.  She did not know the name of the medication she uses on the breathing machine. Today, she did not take a breathing treatment but her oximeter registered between 94-93.  Usually she is at 95. She is at 94 right now. She did not have any pain at the injection site. She is unable to confirm if the injection was given intramuscularly. The breathing machine was the only medication she took. Relevant test: Chest X ray to rule out pneumonia on 20Jan2021 and it was negative. The outcome of the events Pain on left side to left breast and Breathing was a little compromised was recovering, not recovered for the event Oxygen saturation was down, while unknown for the event "feels like a muscle pull".
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory disorder
Clinical narrative: feels like a muscle pull; Breathing was a little compromised; Oxygen saturation was down; Pain on left side to left breast; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730, expiry date: Mar2021), via an unspecified route of administration on 15Jan2021 10:47 at SINGLE DOSE reported in left shoulder for covid-19 immunisation. Medical history included asthma from 1971 and ongoing Diagnosed 50 years ago, Allergies from 1971 Diagnosed 50 years ago, Sarcoids from 2008 Sarcoids, Biopsy in 2008 and that is when she was diagnosed, ongoing sinus problems, pneumonia, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. There were no concomitant medications. On 18Jan2021 07:00, on Monday, she had pain from her left side to left breast, it was a sharp pain.  Monday and Tuesday, she had to sleep sitting up.  Her breathing was a little compromised so she went on the breathing machine at 09:30. Her oxygen saturation went down a little. Oxygen saturation was down 09:30. Her oxygen saturation was probably at 91-92%. She thought it was Pneumonia, so they did a chest x -ray and her lungs were clear.  She got it through hospital because she has higher risk. She feels like now it is better. Sometimes with deep breaths, it feels like a muscle pull on an unspecified date. She does have asthma and allergies and went on the breathing machine and she knew her oxygen levels were down. She has an oximeter that she uses to check it at home.  She did not know the name of the medication she uses on the breathing machine. Today, she did not take a breathing treatment but her oximeter registered between 94-93.  Usually she is at 95. She is at 94 right now. She did not have any pain at the injection site. She is unable to confirm if the injection was given intramuscularly. The breathing machine was the only medication she took. Relevant test: Chest X ray to rule out pneumonia on 20Jan2021 and it was negative. The outcome of the events Pain on left side to left breast and Breathing was a little compromised was recovering, not recovered for the event Oxygen saturation was down, while unknown for the event "feels like a muscle pull".
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Pain
Clinical narrative: left side of her head is hurting/the whole left side of her head hurts from her temple to her chin; in pain; migraine; This is a spontaneous report from Pfizer Sponsored program,received by a contactable consumer (patient's daughter).  A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 21Jan2021 at a single dose for COVID-19 immunisation. Relevant medical history included some dementia. (ongoing). No relevant concomitant medications were provided. She said her mother had no side effects at the time she received the COVID-19 Vaccine. She said her mother's arm didn't even hurt. She said her mother (who lives with her) woke up this morning (25Jan2021) around 4:30AM to go to bathroom, and then went back to bed. Caller stated she, herself, had left her house around 7:00AM this morning to go shopping, and when she got back from shopping 25 minutes later, her husband said her mother was in pain, left side of her head is hurting and he gave her mother a couple of paracetamol (TYLENOL). She said her mother told her the whole left side of her head hurts from her temple to her chin. Her mother was talking fine, and her mother was able to lift both her arms up, so she didn't think her mother had a stroke. She said for the past 20 minutes her mother has been laying back down and seemed to be doing better. The reporter stated that her mother could be having a migraine. She asked if anyone has previously reported to Pfizer developing a headache 4 days after receiving the COVID-19 Vaccine. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's mother reported that her daughter received the vaccine and experienced a sore arm. The clinical outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Back pain, Headache, Heart rate
Clinical narrative: Nausea; Elevated Heart Rate (24+Hours After); Tingling; Numbness of the arm (24+ Hours); Pain in the armpit (started approx 36 hours after the injection; Fever; Pain in hips and entire back; Pain in hips and entire back; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient received second dose of bnt162b2 (Brand: Pfizer, Lot number: EJ1686), via an unspecified route of administration in left arm on 19Jan2021 15:45 at single dose for covid-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previous received first dose of bnt162b2 (Brand: Pfizer, Lot number: EK9231), via an unspecified route of administration in left arm on 29Dec2020 07:00 AM for covid-19 immunization. The patient experienced nausea, elevated heart rate (24+hours after), tingling, numbness of the arm (24+ hours), pain in the armpit (started approx 36 hours after the injection), fever, pain in hips and entire back, headache (24+ hours) all on 19Jan2021 19:30. The patient underwent lab tests and procedures which included heart rate: elevated on 19Jan2021. The outcome of events was not resolved. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment received. No other vaccine in four weeks. Other medications in two weeks: Birth control. No COVID prior vaccination. No COVID tested post vaccination. Not known allergies.  No follow up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Nausea, Paraesthesia, Pyrexia
Clinical narrative: Nausea; Elevated Heart Rate (24+Hours After); Tingling; Numbness of the arm (24+ Hours); Pain in the armpit (started approx 36 hours after the injection; Fever; Pain in hips and entire back; Pain in hips and entire back; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient received second dose of bnt162b2 (Brand: Pfizer, Lot number: EJ1686), via an unspecified route of administration in left arm on 19Jan2021 15:45 at single dose for covid-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previous received first dose of bnt162b2 (Brand: Pfizer, Lot number: EK9231), via an unspecified route of administration in left arm on 29Dec2020 07:00 AM for covid-19 immunization. The patient experienced nausea, elevated heart rate (24+hours after), tingling, numbness of the arm (24+ hours), pain in the armpit (started approx 36 hours after the injection), fever, pain in hips and entire back, headache (24+ hours) all on 19Jan2021 19:30. The patient underwent lab tests and procedures which included heart rate: elevated on 19Jan2021. The outcome of events was not resolved. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment received. No other vaccine in four weeks. Other medications in two weeks: Birth control. No COVID prior vaccination. No COVID tested post vaccination. Not known allergies.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: arm soreness - i know surprise, surprise. felt it after 4-6h mark, felt it overnight, minimal discomfort this morning; headache - mild and dull but it made me spend the evening on the couch watching tv; fatigue - definitely felt this, spent the evening watching tv and went to bed early; This is a spontaneous report from a non-contactable consumer. An adult male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in Jan2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (Pfizer) in Dec2020 for COVID-19 vaccination, in left arm, dose number=1 with no reported adverse event(s). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient stated, "arm soreness - I know surprise, surprise. Felt it after 4-6h mark, felt it overnight, minimal discomfort this morning (TYLENOL did the trick), headache - mild and dull but it made me spend the evening on the couch watching TV, fatigue - definitely felt this, spent the evening watching TV and went to bed early" in Jan2021. Treatment provided for the event arm soreness included acetaminophen (TYLENOL). The outcome of the events arm soreness, headache and fatigue was recovered in Jan2021. Since the vaccination, it was unknown if the patient has been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain where I had the vaccine; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old (also reported as 72-year-old, pending clarification) male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in the left arm, on 20Jan2021 09:00, at single dose, for COVID-19 immunization, at a public health department. Medical history included diabetes, blood cholesterol abnormal (reported as cholesterol) and blood pressure high (reported as high pressure, pending clarification). The patient had no known allergies. Concomitant medication included amlodipine, atorvastatin, cyclobenzaprine, and losartan potassium (COZAAR). The patient did not have other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient reported he had "pain where I had the vaccine" on 20Jan2021 at 14:00. No treatment was given for the events. The outcome of the event was not recovered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Inappropriate schedule of product administration, Tachycardia
Clinical narrative: First dose administered on 17Jan2021/Secodn dose administered on 23Dec2020; Headache, hypertension, tachycardia; hypertension; tachycardia; This is a spontaneous report from a contactable Pharmacist. A 35-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3249), via intramuscular route on the left arm on 17Jan2021 as a single dose for COVID-19 immunization. The patient had no medical history. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical vaccine data included the firs dose of BNT162B2 (Lot Number EL0140; at the age of 35-years) via intramuscular route on the left arm on 23Dec2020 as a single dose. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Past drug history included known allergies to codeine and sulfamethoxazoletrimethoprim. On 17Jan2021, the patient experienced headache, hypertension, tachycardia. The patient was seen at the Emergency Department/ Department of urgent care. The patient was treated for the events headache, hypertension, tachycardia with acetaminophen and lorazepam. The patient was not tested for Covid-19 post vaccination. The clinical outcome of the events headache, hypertension, tachycardia was not recovered. The outcome of event, Inappropriate schedule of vaccine administered, was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: injection site soreness; low grade fever; whole body muscle soreness; fatigue; headache; malaise; This is a spontaneous report from a non-contactable healthcare professional.  A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EK9231, via an unspecified route of administration on 19Jan2021 10:00 at a single dose in left arm  (Dose 1) for COVID-19 immunization.  The patient was not pregnant. The patient did not receive any other vaccine in the 4 weeks prior to COVID vaccination. Medical history included irritable bowel syndrome, herniated disc issues, and migraine. There were no known allergies. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included tramadol, colecalciferol (VITAMIN D), vitamin C, magnesium,  and probiotics. On 20Jan2021 at 14:00 , the patient experienced injection site soreness, low grade fever, whole body muscle soreness, fatigue, headache, and malaise. There was no treatment received for the events. The outcome of the events injection site soreness, low grade fever, whole body muscle soreness, fatigue, headache, and malaise was recovering. The patient was not COVID tested post-vaccination.  No follow up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site soreness; low grade fever; whole body muscle soreness; fatigue; headache; malaise; This is a spontaneous report from a non-contactable healthcare professional.  A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EK9231, via an unspecified route of administration on 19Jan2021 10:00 at a single dose in left arm  (Dose 1) for COVID-19 immunization.  The patient was not pregnant. The patient did not receive any other vaccine in the 4 weeks prior to COVID vaccination. Medical history included irritable bowel syndrome, herniated disc issues, and migraine. There were no known allergies. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included tramadol, colecalciferol (VITAMIN D), vitamin C, magnesium,  and probiotics. On 20Jan2021 at 14:00 , the patient experienced injection site soreness, low grade fever, whole body muscle soreness, fatigue, headache, and malaise. There was no treatment received for the events. The outcome of the events injection site soreness, low grade fever, whole body muscle soreness, fatigue, headache, and malaise was recovering. The patient was not COVID tested post-vaccination.  No follow up attempts are possible. No further information is expected.