chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever (highest at 101.8); Chills; Moderate nausea; Fatigue; Muscle aches in injection arm; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), intramuscular in left arm, on 09Jan2021 at 17:30, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication included ethinylestradiol/ ferrous fumarate/ norethisterone acetate (JUNEL FE). The patient previously took the first dose of BNT162B2 (Lot Number: EL0140) on 19Dec2020 (04:30 PM) for COVID-19 immunization (intramuscular in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. The most recent vaccine was administered in a hospital facility. On 10Jan2021 at 05:30 AM (day 1 post-dose number 2), the patient experienced fever (highest at 101.8) twice, chills, moderate nausea, fatigue, and muscle aches in injection arm. No treatment was administered for the events. Post-vaccination, the patient has not been tested for COVID-19. The patient recovered from the events in Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: contracted SARS-COV-2; contracted SARS-COV-2; This is a spontaneous report from a contactable physician (patient) via Medical Information. This physician reported similar events for two patients. This is the first of two reports.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received her first COVID-19 vaccination but contracted SARS-COV-2 from her husband, seven days after vaccination. Outcome of the events was unknown.   Information about batch/lot number is requested.; Sender's Comments: Comirnaty's effectiveness is documented after at least seven days from the second vaccination.,Linked Report(s) : US-PFIZER INC-2021036192 same reporter/drug/events, different patients
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Exposure during pregnancy, Inappropriate schedule of product administration, Pregnancy test positive, SARS-CoV-2 test positive
Clinical narrative: I also did the home pregnancy test and I am pregnant; Tested positive for covid; Tested positive for covid; This is a spontaneous report from a contactable nurse (patient). This is a maternal report. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date was not provided), intramuscular via the left deltoid on 29Dec2020 11:15 at a single dose to prevent COVID. Medical history was none. There were no concomitant medications. It was reported that the patient received the Pfizer COVID vaccine on 29Dec2020 at 11:15am. She tested positive for COVID on 11Jan2021. She is supposed to be scheduled for her second dose on 19Jan2021. The patient asked the doctors and they don't know if she should get the second dose of the vaccine or postpone it. The patient called to ask if she should get the second dose. The patient took a home pregnancy test on 11Jan2021 and it came back positive, stated that this all occurred since she got vaccinated. Stated her last period was 13Dec2020. The patient reported that she is experiencing mild covid symptoms. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Limb discomfort, Pain
Clinical narrative: Mild arm soreness; fatigue; mild body aches; chills; received 1st dose of BNT162B2 on 29Dec2020, second dose received 12Jan2021; This is a spontaneous report from a contactable consumer. An adult female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiration date not reported) via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 on 29Dec2020 for COVID-19 immunization. The patient experienced mild arm soreness starting about 4 hours after the shot on 12Jan2021 and able to do subsequent work out. About 12 hours after vaccine, developed fatigue and mild body aches followed by about an hour of chills, which resolved. Took some ibuprofen and melatonin and slept well until 6 am. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes under arm of injection; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular in the right arm on 08Jan2021 10:45 at a single dose for COVID-19 immunization. The patient's medical history included allergies to penicillin and diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. The patient previously took ciprofloxacin (CIPRO) and experienced allergies to ciprofloxacin. The patient had not been tested for COVID-19 since the vaccination. The patient experienced swollen lymph nodes under arm of injection on 11Jan2021 08:00. No treatment was received for the adverse event. Outcome of the event was not recovered.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Large rash around the injection site; This is a spontaneous report from a contactable physician (patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular (left arm) on 28Dec2020 19:00 at single dose for Covid-19 immunization. There was no medical history; no known allergies. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, the patient experienced large rash around the injection site which lasted 7 days. There was no treatment received for the adverse event. The outcome of event was recovered on 04Jan2021. The patient has not been tested for COVID-19 since the vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever 101.4; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient started to receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1284), intramuscular on 12Jan2021 12:00 PM at single dose on the left arm for COVID-19 immunization. The patient is not pregnant. The patient has no known drug allergies (NKDA). There were no medical history and concomitant medications. No other vaccines in four weeks and no other medications in two weeks. No COVID prior vaccination. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685) intramuscular on  22Dec2020 12:00 PM on the left arm. Facility type vaccine was hospital. On 13Jan2021 12:00 PM, the patient experienced fever 101.4. No treatment for the event. Outcome of the event was recovered in Jan2021. Patient was not tested for COVID post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site hypersensitivity, Vaccination site induration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Delayed allergic reaction at injection site - red, raised, hard, warm to touch, and itchy. Not painful.; red; raised, hard; warm to touch; itchy; This is a spontaneous report from a contactable other health professional (HCP). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on arm left on 04Jan2021 at a single dose for COVID-19 immunization. Medical history included obesity and known allergies to penicillin, both from an unknown date and unknown if ongoing. Concomitant medication included phentermine. The patient experienced a delayed allergic reaction at injection site - red, raised, hard, warm to touch, and itchy, not painful on 12Jan2021. Therapeutic measures were taken as a result of delayed allergic reaction at injection site - red, raised, hard, warm to touch, and itchy. The outcome of the events was recovering.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Severe rigors involving core and extremities, making it difficult to breathe.; Severe rigors involving core and extremities, making it difficult to breathe.; muscle pain; joint pain noted in hips; loss of appetite; profound fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), via an unspecified route of administration on 11Jan2021 11:45 on the left arm at a single dose for COVID-19 immunization. The patient received the vaccine in a hospital. The patient had no other vaccine in four weeks. Medical history included clinical depression. The patient has no known allergies. The patient was not tested for COVID prior and post vaccination. Concomitant medications included bupropion and multivitamin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK5730, expiry: unknown) on 21Dec2020 at 11:00 in the right arm for COVID-19 immunization. On 12Jan2021 at 01:00, the patient experienced severe rigors involving core and extremities, making it difficult to breathe. Flexeril 10 mg was taken to help relieve rigors. Rigors stopped and ease of breathing resumed in 1 hour. Other symptoms include muscle pain, joint pain noted in hips, loss of appetite, and profound fatigue x48 hrs. The events difficult breathing, muscle pain, joint pain noted in hips, loss of appetite and profound fatigue were not treated. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of "severe rigors involving core and extremities, making it difficult to breathe". 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Severe rigors involving core and extremities, making it difficult to breathe.; Severe rigors involving core and extremities, making it difficult to breathe.; muscle pain; joint pain noted in hips; loss of appetite; profound fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), via an unspecified route of administration on 11Jan2021 11:45 on the left arm at a single dose for COVID-19 immunization. The patient received the vaccine in a hospital. The patient had no other vaccine in four weeks. Medical history included clinical depression. The patient has no known allergies. The patient was not tested for COVID prior and post vaccination. Concomitant medications included bupropion and multivitamin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK5730, expiry: unknown) on 21Dec2020 at 11:00 in the right arm for COVID-19 immunization. On 12Jan2021 at 01:00, the patient experienced severe rigors involving core and extremities, making it difficult to breathe. Flexeril 10 mg was taken to help relieve rigors. Rigors stopped and ease of breathing resumed in 1 hour. Other symptoms include muscle pain, joint pain noted in hips, loss of appetite, and profound fatigue x48 hrs. The events difficult breathing, muscle pain, joint pain noted in hips, loss of appetite and profound fatigue were not treated. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of "severe rigors involving core and extremities, making it difficult to breathe". 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash maculo-papular
Clinical narrative: maculopapular rash on abdomen; redness covering trunk and extremities, sparing head, hands, and feet; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL246 and expiry date: unknown), via an unspecified route of administration, left arm on 11Jan2021 09:45 at a single dose for COVID-19 immunization. The first dose was received on 21Dec2020 10:30 (lot number: EJ1685) on the left arm. Medical history included mild asthma GERD (gastrooesophageal reflux disease, and allergies to certain antibiotics causing a rash. Patient was not pregnant. Concomitant medication included montelukast sodium, omeprazole, and colecalciferol (VITAMIN D). The adverse events began as maculopapular rash on abdomen now redness covering trunk and extremities, sparing head, hands, and feet on 12Jan2021. Outcome of the events was not recovered. No treatment for the events was received. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: He mentioned that he took the first dose of the COVID-19 vaccine on 29Dec2020. Then, after a few days, tested positive for COVID-19.; He mentioned that he took the first dose of the COVID-19 vaccine on 29Dec2020. Then, after a few days, tested positive for COVID-19.; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a male patient of an unspecified age received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He mentioned that he took the first dose of the COVID-19 vaccine on 29Dec2020. Then, after a few days, tested positive for COVID-19. He is scheduled for his second dose this weekend (16Jan2021-17Jan2021). He wants more information about his safety. What happens next, the do's and don'ts. He is asking if there is any information on this. The outcome of the event was unknown.  Information about the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Sex: F
Vaccine: COVID19
Symptoms: Infection parasitic
Clinical narrative: Paratrex to kill of parasites; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 12Jan2021 at a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included bismuth subsalicylate, calcium carbonate (PEPTO BISMOL). The patient reported that she and her husband got the vaccination yesterday (12Jan2021) and she was taking Paratrex to kill of parasites. She was also taking Pepto Bismol. The patient inquired if this will interfere with the vaccine. The outcome of the event was unknown.  The following information on the batch/lot number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Headache, Pain, Pyrexia
Clinical narrative: fever; dizziness; head hurts feeling like it is going to split/headache; medicine taste in her mouth; aches all over; This is a spontaneous report from a contactable consumer (patient) via the Medical Information Team. This consumer reported same events for different patients. This is the first of two reports.  A female patient of unspecified age (reported as 56 [units unspecified]) received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unknown route of administration on unknown date at a single dose for COVID-19 immunization. The patient reported that she got her second vaccine and her friend got the vaccine same day and her friend was feeling the same way as the reporter was feeling: had fever, dizziness, headache (also reported as head hurts feeling like it is going to split), aches all over, medicine taste in her mouth, and has been in bed all day; all on unspecified dates. The patient reported that she has taken acetaminophen (TYLENOL) but no diphenhydramine (BENADRYL). The outcome of the events was unknown.  The following information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021031286 same reporter/drug/events, different patient
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive COVID-19; tested positive COVID-19; This is a spontaneous report from a contactable healthcare professional, reporting for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose of the COVID-19 vaccine on 28Dec2020, 9 days later tested positive COVID-19. She requested information on the recommendations for getting her second dose of the vaccine. The patient underwent lab tests and procedures which included Covid test: positive on Jan2021. The outcome of the events was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Comirnaty's effectiveness is documented after 7 days from the second dose
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: His nose has been dripping; This is a spontaneous report from a contactable consumer, reporting for himself. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. Medical history included allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had his COVID-19 vaccine three days ago and since then his nose has been dripping. He wanted to know why he was not allowed to take his allergy test. He also said that he thinks his allergy is to cortisone but was not that serious. He was going to the doctor to get a cortisone shot and he wanted to know if he was able to do that or not. He said it was an allergy shot, he guessed it was going to be cortisone, but he doesn't know for sure he just knows it was an allergy shot. He says he was supposed to get his second shot 31Jan2021, so he was trying to see if he has enough time in between to take his allergy shot. He was going to go as soon as he can to go get the allergy shot, he thinks it will be plenty of time because his second shot should be the 31Jan2021. No, he does not have time he was not sick he just doesn't want it to get worse and he just does wants to know if he can take the allergy shot. If not, it was fine, but he wants to know if it was alright to take it. He just wanted to know if he can take the allergy shot or not. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: his mother's temperature rise to 98.1/ she had temperature of 99.0; headache; chills; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Consumer said he was calling for his mother who received the 1st dose of the Covid-19 Vaccine. He said that after receiving the vaccine, his mother's temperature rose to 98.1 and also experienced headache and chills on an unspecified date. Consumer wants to know if these side effects have been reported. Today, he was looking at pamphlet that they gave her when she got the shot. She called them and they said they had to look for the # number. He sees on here that there may be injection site pain tenderness, muscle pain, joint pain, fever and chills. He says right now, she had temperature of 99.0 and she took Aspirin or Tylenol at 12. He says he was just checking on her health to make sure what do they do. She also said she had a headache and she took Aspirin. He clarified that she took Tylenol, she did not take Aspirin. He has been hearing if there were side effects to just rest. She was saying she had some chills and she took Tylenol 325 mg.  He says he would have thought that the hospital where she got the vaccine would have explained to them what to do if she experienced anything but he was thinking that this was just side effects. He asks if he should just call the physician talk with them. He would like to know how often these side effects have been reported with the vaccine. He pretty much understands the process, he was just looking out for his mom and just wanted to know if she needs to go into the hospital or if she was fine. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Chills, Muscle spasms, Neck pain
Clinical narrative: Shivering; muscle cramps; Extreme Neck and back pain; Extreme Neck and back pain; Left armpit pain with tinglingly sensation down left arm; Left armpit pain with tinglingly sensation down left arm; This is a spontaneous report from a contactable nurse. A 26-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283, expiry date not reported), via an unspecified route of administration on 11Jan2021 at a single dose in the left arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient had no other vaccine in four weeks. The patient had the first dose of bnt162b2 (brand: Pfizer, lot number: Ej1685, expiry date not reported) on 21Dec2020, intramuscular in the left arm for COVID 19 immunization. On 12Jan2021, patient experienced shivering and muscle cramps the first day; extreme neck and back pain x2 days post injection. On third day post injection, patient experienced left armpit pain with tinglingly sensation down left arm. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the events shivering, muscle cramps, extreme neck and back pain and left armpit pain with tinglingly sensation down left arm was unknown.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Shivering; muscle cramps; Extreme Neck and back pain; Extreme Neck and back pain; Left armpit pain with tinglingly sensation down left arm; Left armpit pain with tinglingly sensation down left arm; This is a spontaneous report from a contactable nurse. A 26-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283, expiry date not reported), via an unspecified route of administration on 11Jan2021 at a single dose in the left arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient had no other vaccine in four weeks. The patient had the first dose of bnt162b2 (brand: Pfizer, lot number: Ej1685, expiry date not reported) on 21Dec2020, intramuscular in the left arm for COVID 19 immunization. On 12Jan2021, patient experienced shivering and muscle cramps the first day; extreme neck and back pain x2 days post injection. On third day post injection, patient experienced left armpit pain with tinglingly sensation down left arm. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the events shivering, muscle cramps, extreme neck and back pain and left armpit pain with tinglingly sensation down left arm was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular
Clinical narrative: Erratic heart beat; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: lot number: Elo140), via an unspecified route of administration on left arm on 11Jan2021 13:00 (first dose) at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. No other vaccine in four weeks. Patient had no COVID prior vaccination and no known allergies. Concomitant medications included other medication (taken other medication in two weeks). The patient experienced erratic heart beat on 11Jan2021 14:00. The event resulted in doctor or other healthcare professional office/clinic visit. There was no treatment for the event. The patient was not COVID tested post vaccination. The outcome of the event was not recovered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: there was a little sensation but it may have been in her head; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number, expiration date unknown) , via an unspecified route of administration in her arm on 13Jan2021 at a single dose for  COVID-19 immunisation .  The patient's medical history and concomitant medications were not reported. On 13Jan2021, the patient reported that she received the COVID vaccine today and did not feel a thing, she did not feel the needle or the shot. She said other people have sore arm so she wanted to check if she should be feeling anything. She said she removed the bandaid to see the needle puncture but she did not see it. She felt like the nurse didn't give it to her in her arm. Her arm is not sore. She had to wait 15 minutes after she got the vaccine. There was a little sensation from it but maybe it was in her head on 13Jan2021. The nurse pinched her arm when she gave it. The patient  stated her next dose is scheduled on 03Feb2021. The outcome of the event was unknown.  Information on Lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Migraine, Nausea
Clinical narrative: severe arthralgias; migraine headache; mild nausea; This is a spontaneous report from a contactable nurse. A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142/expiration date unknown) dose number 2, via an unspecified route of administration on 08Jan2021 09:00 at a single dose on the right arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included asthma, arrhythmia, sulfonamide allergy, and latex allergy. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post vaccination. Historical vaccine included BNT162B2 (COVID-19, lot number EJ1685, dose number 1) on 18Dec2020 06:30 on the right arm. There were no other vaccinations within 4 weeks. Concomitant medications included ASA, acetylsalicylic acid, caffeine, paracetamol, salicylamide (EXCEDRIN), cyanocobalamin (VIT B12), ergocalciferol (VIT D), and cetirizine hydrochloride (ZYRTEK). The patient experienced severe arthralgias, migraine headache, and mild nausea on 08Jan2021 20:00. The outcome of the events was recovered in Jan2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Muscle pain; Joint pain; Headache; This is a spontaneous report from a non-contactable other health care professional.  A 46-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3246), via an unspecified route of administration on 11Jan2021 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID19 vaccine bnt162b2 for COVID-19 immunization on 21Dec2020; lot number: EL0140 on left arm at 46 years old. On 12Jan2021, the patient experienced muscle pain, joint pain, and headache. The patient did not receive treatment for the events. The outcome of the events was unknown.    No follow up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oropharyngeal pain, Vaccination site pain
Clinical narrative: Left arm pain at rest and with movement; headache; full body myalgias; sore throat; This is a spontaneous report from a contactable physician (patient).  A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231 expiration date unknown), intramuscular in left arm on 12Jan2021 at 08:00  at a single dose for COVID-19 immunization.  Medical historywas reported as none. The patient had no known allergies. The patient's concomitant medications were not reported.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899) on 22Dec2020 at 12:30 PM for COVID-19 immunization. The patient has not had COVID prior to vaccination. The patient had no other vaccines within four weeks. On 13Jan2021 at 14:00, the patient experienced left arm pain at rest and with movement, headache, full body myalgias, and sore throat.  Therapeutic measures were taken as a result of the events and included treatment with ibuprofen. The patient was not tested for COVID post vaccination. The outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), 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. On an unspecified date, the patient experienced migraine that has lasted for almost one week since receiving the vaccine. The reporter did not know if the vaccine that the patient received was from Pfizer or Moderna. Outcome of event was unknown.  Information on lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Fatigue; Chills; Brain fog; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (left arm) on 13Jan2021 16:15 at single dose for covid-19 immunisation. There were no medical history and concomitant medications. On 13Jan2021 17:45, the patient experienced Fatigue, chills, brain fog, headache. No treatment was given for the events. The outcome of the events was recovering. The patient has no Covid prior vaccination and was not tested post vaccination.  Information on the Batch/Lot number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Pyrexia, Vaccination site pain
Clinical narrative: chills; achy back; low fever; injection site pain; This is a spontaneous report from a contactable other health care professional. A 59-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el 3248 and expiration date not provided), intramuscular (right arm) first dose on 12Jan2021 12:00 at single dose for covid-19 immunisation. The patient's medical history included psoriasis, seasonal allergies, and If COVID prior vaccination: Yes. The patient's concomitant medication included oxymetazoline hydrochloride (CLARITIN EYE ALLERGY RELIEF), ergocalciferol (VIT D), vitamin c [ascorbic acid], and zinc. On 13Jan2021 07:00, the patient experienced chills, achy back, low fever, injection site pain. No treatment was given to the events. The outcome of the events was not recovered. No other vaccine was taken within four weeks and not tested for Covid post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: first dose of the COVID-19 vaccine on 23Dec2020, and testing positive to COVID on 01Jan2021; first dose of the COVID-19 vaccine on 23Dec2020, and testing positive to COVID on 01Jan2021; This is a spontaneous report from a non-contactable Other HCP. A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient received the first dose of the COVID-19 vaccine on 23Dec2020, and testing positive to COVID on 01Jan2021. She mentioned that her "last recorded symptoms" were on 06Jan2021 and has been "symptom less" for 8 days, now. She specified that her second dose was due today but she didn't receive it at her workplace, as planned (due to isolation measures). She asked what was the allowed window to receive the second dose of the vaccine? She also asked what were the criteria to receive the second dose, after testing positive. She then asked if she would need to repeat the vaccination series.  Patient also mentioned testing positive to COVID on 13Jan2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given. However, a causal relationship between event "first dose of the COVID-19 vaccine on 23Dec2020, and testing positive to COVID on 01Jan2021" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: chills; injection site soreness; fever; headache; fatigue; This is a spontaneous report from a non-contactable consumer. A 35-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4176, expiration date not reported) via an unspecified route of administration on the left arm on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included hepatitis B and patient had tested positive for Covid in May2020 and had recovered. Concomitant medications included hepatitis B experimental medicine. On 13Jan2021, the patient experienced injection site soreness, chills, fever, headache, fatigue. No treatment was received for the events. Post vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: slight headache; low grade fever and chills for approx 10 hours post injection; low grade fever and chills for approx 10 hours post injection; This is a spontaneous report from a contactable other healthcare professional (HCP). A 65-year-old female patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscular on 08Jan2021 18:00 (reported as 06:00 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. There were no other medical history. No known allergies. The patient's concomitant medications were not reported. No other vaccine in four weeks. Facility type vaccine was hospital. No COVID prior vaccination. The patient experienced slight headache, low grade fever and chills for approximately 10 hours post injection on 09Jan2021 02:00 PM. No treatment for the events. Outcome of the events was recovered in Jan2021. Patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Malaise
Clinical narrative: Hives; itching; swelling of feet, hands; swelling of axilla, buttocks; redness on hips, worsening after 1 week after second dose; administration date: 17Dec2020 / administration date: 05Jan2021; fever; chills; fatigue; malaise; body aches; headache; tinnitus; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration in the right arm, on 05Jan2021 at 16:00, at a single dose, for COVID-19 immunization. Relevant medical history included known allergies to poison ivy/ poison oak. Concomitant medications included finasteride. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 05Jan2021, at 20:00, after second dose, the patient experienced hives with itching and swelling of feet, hands, axilla, buttocks, redness on hips, worsening after 1 week after second dose. On an unspecified date in Jan2021, for a 3-day period after second dose, patient had fever, chills, fatigue, malaise, body aches, headache, tinnitus, all since resolved except hives worsening. The patient did not receive therapy for the events. Outcome of the event hives was not recovered, for event "administration date: 17Dec2020 / administration date: 05Jan2021" was unknown, while for the other events was recovered. The patient has not been tested for COVID-19 since vaccination.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pruritus, Pyrexia, Swelling
Clinical narrative: Hives; itching; swelling of feet, hands; swelling of axilla, buttocks; redness on hips, worsening after 1 week after second dose; administration date: 17Dec2020 / administration date: 05Jan2021; fever; chills; fatigue; malaise; body aches; headache; tinnitus; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration in the right arm, on 05Jan2021 at 16:00, at a single dose, for COVID-19 immunization. Relevant medical history included known allergies to poison ivy/ poison oak. Concomitant medications included finasteride. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 05Jan2021, at 20:00, after second dose, the patient experienced hives with itching and swelling of feet, hands, axilla, buttocks, redness on hips, worsening after 1 week after second dose. On an unspecified date in Jan2021, for a 3-day period after second dose, patient had fever, chills, fatigue, malaise, body aches, headache, tinnitus, all since resolved except hives worsening. The patient did not receive therapy for the events. Outcome of the event hives was not recovered, for event "administration date: 17Dec2020 / administration date: 05Jan2021" was unknown, while for the other events was recovered. The patient has not been tested for COVID-19 since vaccination.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Urticaria
Clinical narrative: Hives; itching; swelling of feet, hands; swelling of axilla, buttocks; redness on hips, worsening after 1 week after second dose; administration date: 17Dec2020 / administration date: 05Jan2021; fever; chills; fatigue; malaise; body aches; headache; tinnitus; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration in the right arm, on 05Jan2021 at 16:00, at a single dose, for COVID-19 immunization. Relevant medical history included known allergies to poison ivy/ poison oak. Concomitant medications included finasteride. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 05Jan2021, at 20:00, after second dose, the patient experienced hives with itching and swelling of feet, hands, axilla, buttocks, redness on hips, worsening after 1 week after second dose. On an unspecified date in Jan2021, for a 3-day period after second dose, patient had fever, chills, fatigue, malaise, body aches, headache, tinnitus, all since resolved except hives worsening. The patient did not receive therapy for the events. Outcome of the event hives was not recovered, for event "administration date: 17Dec2020 / administration date: 05Jan2021" was unknown, while for the other events was recovered. The patient has not been tested for COVID-19 since vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node on left side of neck that is oblong in shape, measuring 2.5in x 1.5in; This is a spontaneous report from a contactable consumer. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date not reported), via an unspecified route of administration (reported: left arm), on 30Dec2020 at 20:30 at a single dose, for COVID-19 immunization. Medical history was not reported. Concomitant medication includes unspecified multivitamins. The patient experienced swollen lymph node on left side of neck that is oblong in shape, measuring 2.5in x 1.5in, on 08Jan2021 at 5 AM. The patient has not recovered from the event.