chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Infectious mononucleosis
Clinical narrative: mononucleosis; This is a spontaneous  report from a contactable consumer.   A 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced mononucleosis on an unspecified date with outcome of unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Feeling abnormal, Headache
Clinical narrative: Caller reports having a Covid infection after receiving the first dose of the Pfizer Covid vaccine/diagnosed with COVID-19 virus; Headache; Cough; feeling ill; Fatigue; feeling bad; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program COVAX Support. A58-year-old male patient received first dose BNT162B2 (Solution for injection, Pfizer-Biontech Covid-19 Vaccine, lot number: EN6208, expiry date: 30Jun2021) via an unspecified route of administration in left arm on 20Mar2021 at 10:05 AM at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Reports having a Covid infection after receiving the first dose of the Pfizer Covid vaccine on 25Mar2021. He wants to know if he should get the second dose of the vaccine. He states he got the first shot and then he got the COVID virus. He says he doesn't know if he got the virus before or after shot. He states he contracted the virus 4 or 5 days after getting the shot. He started feeling bad on an unspecified date in Mar2021. He has gone through the 14 days of quarantine and is suppose to get his second shot. He wants to know was it smart to get second shot on top of getting COVID? He states he was 6 foot or 72 inches. States he got the first shot 3 weeks ago, on Saturday 20Mar2021. He states that he started feel ill on the 25Mar2021 and went and got a COVID test. His results came back positive on Thursday 26Mar2021. On 25Mar2021, he states that he has a cough and a headache, and a few other symptoms as far as fatigue and things like that. He does not have a fever. He states that he has gone through the 14 day quarantine and was planning on going back to work tomorrow. He states that he was due to take the second shot this Saturday and he doesn't want to get sick all over again. He doesn't want to feel like this after being gone for two weeks. His headache, cough, and feeling ill started on 25Mar2021. He states that his symptoms are improving everyday seems like it is a little better. He left his vaccine card in his truck because he figured he would need it when he went back, and it was better than putting it in his wallet and loosing it. He got the vaccine because he didn't want to get the virus and then he got it anyway. He was tested for COVID on 25Mar2021 and got a positive result on 26Mar2021. Reported, as he had 1st shot 20Mar2021, but was diagnosed with COVID-19 virus. He was concerned about getting the 2nd shot scheduled on 10Apr2021. He was not yet getting better, and the caller still has the symptoms. (Name) calling also about his wife, named (Name) was in quarantine and also experiences an adverse reaction after the 2nd shot. Outcome of events was recovering.    No follow up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: Caller reports having a Covid infection after receiving the first dose of the Pfizer Covid vaccine/diagnosed with COVID-19 virus; Headache; Cough; feeling ill; Fatigue; feeling bad; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program COVAX Support. A58-year-old male patient received first dose BNT162B2 (Solution for injection, Pfizer-Biontech Covid-19 Vaccine, lot number: EN6208, expiry date: 30Jun2021) via an unspecified route of administration in left arm on 20Mar2021 at 10:05 AM at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Reports having a Covid infection after receiving the first dose of the Pfizer Covid vaccine on 25Mar2021. He wants to know if he should get the second dose of the vaccine. He states he got the first shot and then he got the COVID virus. He says he doesn't know if he got the virus before or after shot. He states he contracted the virus 4 or 5 days after getting the shot. He started feeling bad on an unspecified date in Mar2021. He has gone through the 14 days of quarantine and is suppose to get his second shot. He wants to know was it smart to get second shot on top of getting COVID? He states he was 6 foot or 72 inches. States he got the first shot 3 weeks ago, on Saturday 20Mar2021. He states that he started feel ill on the 25Mar2021 and went and got a COVID test. His results came back positive on Thursday 26Mar2021. On 25Mar2021, he states that he has a cough and a headache, and a few other symptoms as far as fatigue and things like that. He does not have a fever. He states that he has gone through the 14 day quarantine and was planning on going back to work tomorrow. He states that he was due to take the second shot this Saturday and he doesn't want to get sick all over again. He doesn't want to feel like this after being gone for two weeks. His headache, cough, and feeling ill started on 25Mar2021. He states that his symptoms are improving everyday seems like it is a little better. He left his vaccine card in his truck because he figured he would need it when he went back, and it was better than putting it in his wallet and loosing it. He got the vaccine because he didn't want to get the virus and then he got it anyway. He was tested for COVID on 25Mar2021 and got a positive result on 26Mar2021. Reported, as he had 1st shot 20Mar2021, but was diagnosed with COVID-19 virus. He was concerned about getting the 2nd shot scheduled on 10Apr2021. He was not yet getting better, and the caller still has the symptoms. (Name) calling also about his wife, named (Name) was in quarantine and also experiences an adverse reaction after the 2nd shot. Outcome of events was recovering.    No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; some kind of rash in her torso; This is a spontaneous report from a contactable consumer. This 45-Year-old female consumer (patient) received the second dose of the Pfizer-BioNTech COVID-19 Vaccine BNT162B2 on 29Mar2021 at single dose for covid-19 immunization. Nine days after (07Apr2021), Patient reported to have had shingles (suspected, but not confirmed) or some kind of rash in her torso. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Pain, Respiratory tract congestion, Sputum increased
Clinical narrative: normal body aches/body pain is getting worse pretty quickly; difficulty breathing; a lot of mucus and congestion in his chest.; a lot of mucus and congestion in his chest.; coughing a lot; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer. A 28-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced normal body aches, difficulty breathing, coughing a lot, body pain was getting worse pretty quickly. He did not have a temperature, but hard time breathing, a lot of mucus and congestion in his chest. Outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Back pain
Clinical narrative: back pain; feeling bloated; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for herself that a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient said that she was on her period right now and she was experiencing back pain and feeling bloated in Apr2021. Patient asked if she could take Midol. The outcome of the events were unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Seasonal allergy
Clinical narrative: seasonal allergies; she received her first dose of the Pfizer BioNTech COVID-19 vaccine on 23MAR2021 and reports that this past Sunday on 4APR2021 she tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 24-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 11:00 (Batch/Lot Number: ER2613; Expiration Date: Jul2021) as SINGLE DOSE for covid-19 immunisation.  Medical history included none.  There were no concomitant medications reported. It was reported that patient received her first dose of the Pfizer BioNTech COVID-19 vaccine on 23Mar2021 and reports that this past Sunday on 04Apr2021 she tested positive for COVID-19. Caller states she did have an exposure at work and knows that she got COVID-19 from someone she works with. She states that she is in her 10 day quarantine currently and heard that she has to be retested and have 2 negative tests. Caller would like to know when she would be able to get her second dose of the vaccine. She mentions possibly having to cancel her second dose appointment at this time. She knows she had the Covid 19 exposure from someone at work. She had no side effects with the Covid 19 vaccine except for a sore arm the first day. Her sore arm only lasted 24 hours. Friday, 02Apr2021, she started having cold like symptoms. Friday was her worst day. Every day has been getting better. She started off having a runny nose but she has seasonal allergies so she thought her runny nose was related to her seasonal allergies. She used to take Allegra every day and she was really good at taking it. She thought it was a continuation of her allergies. She did take Benadryl 2-3 tablets throughout Friday. She had chills, a headache and a potential fever. She didn't actually check her temperature for a fever. She had the runny nose and a cough. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Apr2021. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Muscle tightness, Muscular weakness, Myalgia
Clinical narrative: Muscle pain; muscle pain, they felt tense; Weakness in her legs; She feels "anguish" in the chest; Headache; Felt pricking on her legs; Nausea; This is a spontaneous report from contactable consumer. This 42-year-old female consumer (patient) reported that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Apr2021 14:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included covid-19 one year ago (feeling the pricking on the legs). The patient's concomitant medications were not reported.  Patient had "too much" muscle pain, they felt tense, and she felt weakness in her legs. Besides, she felt "anguish" in the chest. She reported it had been six days. She also had a headache, felt pricking on her legs and nausea with outcome of unknown.    No follow-up attempts were needed. Information on Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia
Clinical narrative: Muscle pain; muscle pain, they felt tense; Weakness in her legs; She feels "anguish" in the chest; Headache; Felt pricking on her legs; Nausea; This is a spontaneous report from contactable consumer. This 42-year-old female consumer (patient) reported that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Apr2021 14:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included covid-19 one year ago (feeling the pricking on the legs). The patient's concomitant medications were not reported.  Patient had "too much" muscle pain, they felt tense, and she felt weakness in her legs. Besides, she felt "anguish" in the chest. She reported it had been six days. She also had a headache, felt pricking on her legs and nausea with outcome of unknown.    No follow-up attempts were needed. Information on Lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He has since been exposed to, and tested positive for Covid19 illness/tested positive after 1st dose; Tested positive for Covid19 illness/tested positive after 1st dose; This is a spontaneous report from a contactable consumer (patents wife) and Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1st via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received his first dose of Pfizer-Biontech Covid19 vaccine and was scheduled for a 4-week return date. He has since been exposed and tested positive for Covid19 illness. Reporter asked about do they have for him for receiving his second dose since he was positive. As by the time he completes quarantine/isolation, it may be outside the 42-day interval before he receives his second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vomiting
Clinical narrative: rashes all over both legs and both arms; vomiting; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (nurse) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 Tuesday (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced vomiting on Wednesday, the day after 23Mar2021 and on Thursday, patient had rashes all over both legs and both arms. Outcome of vent was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: got a rash on his legs; This is a spontaneous report received from a contactable consumer. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient got eh first dose as well a week before and he's got a rash on his legs on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic
Clinical narrative: got a rash on his legs; This is a spontaneous report received from a contactable consumer. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient got eh first dose as well a week before and he's got a rash on his legs on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Feeling hot, Pyrexia, Vision blurred
Clinical narrative: fever/ 101 fever; very hot; dizziness/ dizzy; Diarrhea; can't even see straight; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in right arm on 05Apr2021 (Batch/Lot Number: ER8729; Expiration Date: 31Jul2021) as single dose for COVID-19 immunization. Medical history included breast cancer diagnosed about a year ago and it was not ongoing and lung cancer diagnosed 15 or 20 years and it was not ongoing, it stopped 20 years ago. Patient took a lot of medications. Patient stated she experienced every single side effect listed including fever and dizziness after receiving the first dose of the Pfizer COVID vaccine. Patient stated was it possible that she had COVID-19, she had a 101 fever (07Apr2021), diarrhea (05Apr2021), was very hot (07Apr2021), dizzy (06Apr2021), and had everything that was on the paper. Patient stated she had a fever and couldn't even see straight (Apr2021). She had diarrhea from 05Apr2021, 06Apr2021, 07Apr2021, 08Apr2021 and still has it. Stated it was bad and had to throw underwear out, that's how bad it was. Stated she started feeling very hot last night 07Apr2021 and it was the same. When she got up she was dizzy and that had stayed the same. Patient stated she hasn't used anything for treatment. Outcome of the events was not recovered. No investigation assessment.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: She felt like she had the flu; extreme fatigue; This is a spontaneous report form a contactable consumer (patient daughter). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 first dose on unspecified date for COVID-19 immunisation. Consumer stated her mother who had received both doses of Pfizer's COVID vaccine has still not recovered from her second dose. It has been well over a month. Caller states She felt like she had the flu for 3 weeks and she's still suffering from extreme fatigue and is not able to get on with her regular activities. She has not recuperated. The outcome of the events was not recovered.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dysgeusia, Erythema, Fatigue
Clinical narrative: slight body aches; headache; chills; cold; upset stomach; itchy and red blotch to injection site; itchy and red blotch to injection site; fatigue/exhausted; metallic taste in her mouth; soreness around injection site; redness; itchiness; unable to to go to work due to side effects; just not feeling well enough to get up/felt sick; This is spontaneous report from Pfizer-sponsored program COVAX US Support. A contactable consumer (patient) reported for herself that a 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Mar2021 at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient historically received first single dose of BNT162B2 on an unspecified date for COVID-19 immunisation. Patient reported that had second dose and was experiencing side effects like, soreness, body aches, headache chills, cold, upset stomach. She had been unable to go to work due to side effects. Body aches, itchy and red blotch to injection site, fatigue, and metallic taste. Her first shot she said, didn't have any problems. After the second however, she said was "feeling sicker". Stated trying going to work, but couldn't; and has missed a couple of days now. Experiencing symptoms: soreness around injection site, redness and itchiness, a headache, slight body aches, metallic taste in her mouth, no chest pains; but just exhausted, and just not feeling well enough to get up. Patient wanted to know how long this was supposed to last. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Malaise, Nasopharyngitis, Pain
Clinical narrative: slight body aches; headache; chills; cold; upset stomach; itchy and red blotch to injection site; itchy and red blotch to injection site; fatigue/exhausted; metallic taste in her mouth; soreness around injection site; redness; itchiness; unable to to go to work due to side effects; just not feeling well enough to get up/felt sick; This is spontaneous report from Pfizer-sponsored program COVAX US Support. A contactable consumer (patient) reported for herself that a 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Mar2021 at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient historically received first single dose of BNT162B2 on an unspecified date for COVID-19 immunisation. Patient reported that had second dose and was experiencing side effects like, soreness, body aches, headache chills, cold, upset stomach. She had been unable to go to work due to side effects. Body aches, itchy and red blotch to injection site, fatigue, and metallic taste. Her first shot she said, didn't have any problems. After the second however, she said was "feeling sicker". Stated trying going to work, but couldn't; and has missed a couple of days now. Experiencing symptoms: soreness around injection site, redness and itchiness, a headache, slight body aches, metallic taste in her mouth, no chest pains; but just exhausted, and just not feeling well enough to get up. Patient wanted to know how long this was supposed to last. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: slight body aches; headache; chills; cold; upset stomach; itchy and red blotch to injection site; itchy and red blotch to injection site; fatigue/exhausted; metallic taste in her mouth; soreness around injection site; redness; itchiness; unable to to go to work due to side effects; just not feeling well enough to get up/felt sick; This is spontaneous report from Pfizer-sponsored program COVAX US Support. A contactable consumer (patient) reported for herself that a 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Mar2021 at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient historically received first single dose of BNT162B2 on an unspecified date for COVID-19 immunisation. Patient reported that had second dose and was experiencing side effects like, soreness, body aches, headache chills, cold, upset stomach. She had been unable to go to work due to side effects. Body aches, itchy and red blotch to injection site, fatigue, and metallic taste. Her first shot she said, didn't have any problems. After the second however, she said was "feeling sicker". Stated trying going to work, but couldn't; and has missed a couple of days now. Experiencing symptoms: soreness around injection site, redness and itchiness, a headache, slight body aches, metallic taste in her mouth, no chest pains; but just exhausted, and just not feeling well enough to get up. Patient wanted to know how long this was supposed to last. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Platelet count, Platelet count decreased, Platelet disorder, Pyrexia
Clinical narrative: flu-like symptoms with fever after second covid vaccine; flu-like symptoms with fever after second covid vaccine; platelet count was low; platelet count was low and some had change in shape; This is a spontaneous report from a contactable reporter reported and a consumer. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.  Medical history included breast cancer. The patient's concomitant medications were not reported.  The patient experienced flu-like symptoms with fever after second covid vaccine on an unspecified date.  The patient had to delay palbociclib start 5 days. The patient will have lab work in 2 weeks. MD said platelet count was low and some had change in shape, not sure if due to the vaccine or the medication (palbociclib). The outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: she had a positive covid 19 test done; she had a positive covid 19 test done; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer Sponsored Program.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot number and Expiration date: UNKNOWN), via an unspecified route of administration on 13Mar2021 at SINGLE DOSE for COVID-19 immunisation.The patient medical history and concomitant medications were  not reported.   On 29Mar2021, patient had a positive COVID-19 test done. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 29Mar2021.The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: broke out into rash; looks like could be shingles; This is a spontaneous report from a Pfizer-sponsored program  from a contactable consumer reported for self. This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient had 1st dose of Covid vaccine. Last Sunday (in 2021), patient broke out into rash, looked like could be shingles. The 2nd dose of vaccine was this Wednesday. Patient wanted to know if she should get the 2nd dose. HCP told patient to get vaccine but she wanted suggestion. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: one-sided moderate tinnitus; This is a spontaneous report received from a contactable physician. The physician reporting for a patient (son) that a male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. The physician reported that patient started experiencing one-sided moderate tinnitus one day after receiving vaccine. In searching, it likes like 0.6% of people experience this. Please advise on the appropriate treatment. Outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Pain
Clinical narrative: had a urine drug screen done which came back positive for cocaine; the pain continues; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: unknown), first dose via an unspecified route of administration, administered in Left Arm on 08Mar2021 as a single dose for COVID-19 immunization. The patient medical history included pinched nerve. concomitant medications were not reported. On 10Mar2021 the patient stated that a urine drug screen was done which came back positive for cocaine and pain on an unknown date. The patient was treated for the pain with steroid shots in her back. The outcome of the events was Unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, COVID-19, Chest X-ray, Drug ineffective, Malaise
Clinical narrative: I found out that I have covid/Tested positive for Covid 19; I found out that I have covid/Tested positive for Covid 19; my anxiety's pretty high about it; I haven't been feeling well; This is a spontaneous report from two contactable consumers (one is patient) via medical information team. A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EP6955), via an unspecified route of administration in right arm on 23Mar2021 08:20 as single dose for allergies. Medical history included ongoing asthma diagnosed 30 years ago, ongoing obese and ongoing allergies which he always had for as long as patient can remember especially during this time of year. Family history included Asthma and Diabetes on both side of family. Concomitant medications included ongoing montelukast sodium (SINGULAIR) at 10 mg daily) for allergies (has been taking forever; for a long time), and fexofenadine hydrochloride (ALLEGRA ALLERGY) at 10 mg daily for allergies. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks). Patient got the firs dose of the Pfizer BioNTech covid vaccine on 23Mar2021 and am scheduled to get the second dose on 13Apr2021. He was not feeling well and went to the ER this morning. He found out that he had covid and anxiety was pretty high about it. Patient wasn't feeling well which started on Easter 04Apr2021. He took a test today and found out he has Covid 19. He had his first dose on 23Mar2021 of the Covid Vaccine. He is scheduled to get his second on 13Apr2021. He has to be in quarantine for 10 days so how would that work. On 06Apr2021 he lost his sense of taste. Then on 07Apr2021 he picked up a candle held it to his nose and could not smell it. He presented to the emergency room on 08Apr2021 (today as reported) where they tested him for Covid 19 and it was positive. Tested positive for Covid 19 after first dose of Covid Vaccine. Chest x-ray at the emergency room was done and it was good; also states his lungs were clear. He was not admitted into the hospital. States that at first he thought his symptoms were due to the time of year, change of weather, and allergies. Says he was alarmed that his symptoms would be like that when he has been taking his medication religiously. This prompted him to go and get tested for Covid 19. Visit to emergency room was required for events not feeling well, loss of taste, loss of smell. The outcome of events not feeling well, Lost sense of taste, Lost sense of smell was not recovered; for event anxiety was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary function test, SARS-CoV-2 test
Clinical narrative: I found out that I have covid/Tested positive for Covid 19; I found out that I have covid/Tested positive for Covid 19; my anxiety's pretty high about it; I haven't been feeling well; This is a spontaneous report from two contactable consumers (one is patient) via medical information team. A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EP6955), via an unspecified route of administration in right arm on 23Mar2021 08:20 as single dose for allergies. Medical history included ongoing asthma diagnosed 30 years ago, ongoing obese and ongoing allergies which he always had for as long as patient can remember especially during this time of year. Family history included Asthma and Diabetes on both side of family. Concomitant medications included ongoing montelukast sodium (SINGULAIR) at 10 mg daily) for allergies (has been taking forever; for a long time), and fexofenadine hydrochloride (ALLEGRA ALLERGY) at 10 mg daily for allergies. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks). Patient got the firs dose of the Pfizer BioNTech covid vaccine on 23Mar2021 and am scheduled to get the second dose on 13Apr2021. He was not feeling well and went to the ER this morning. He found out that he had covid and anxiety was pretty high about it. Patient wasn't feeling well which started on Easter 04Apr2021. He took a test today and found out he has Covid 19. He had his first dose on 23Mar2021 of the Covid Vaccine. He is scheduled to get his second on 13Apr2021. He has to be in quarantine for 10 days so how would that work. On 06Apr2021 he lost his sense of taste. Then on 07Apr2021 he picked up a candle held it to his nose and could not smell it. He presented to the emergency room on 08Apr2021 (today as reported) where they tested him for Covid 19 and it was positive. Tested positive for Covid 19 after first dose of Covid Vaccine. Chest x-ray at the emergency room was done and it was good; also states his lungs were clear. He was not admitted into the hospital. States that at first he thought his symptoms were due to the time of year, change of weather, and allergies. Says he was alarmed that his symptoms would be like that when he has been taking his medication religiously. This prompted him to go and get tested for Covid 19. Visit to emergency room was required for events not feeling well, loss of taste, loss of smell. The outcome of events not feeling well, Lost sense of taste, Lost sense of smell was not recovered; for event anxiety was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Lymphadenopathy, Malaise
Clinical narrative: he experiences a lot of pain due to his bone cancer/been worse recently/pain has increased; more tired/tiredness; more headaches/headache; slight nausea/light nausea that is not very severe; feels very sick/not feeling well; muscle pain; joint pain; injection site swelling and redness; injection site swelling and redness; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (at the age of 63 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  Medical history included ongoing bone cancer, ongoing pain from bone cancer, and nausea (has had nausea with the cancer). The patient's concomitant medications were not reported. The patient called about COVID-19 vaccine and mentioned that he received the 1st dose of COVID-19 vaccine on 25Mar2021 and experienced side effects not right away but shortly thereafter. He mentioned that he has bone cancer and he experience a lot of pain due to his bone cancer. He does not have an easy life as he experiences a lot of pain due to his bone cancer. He has a lot of pain to begin with because of the cancer that he has and now pain has been worse recently.  He does not know if it just the progression of the pain or if it is coming from the injection.  The patient confirmed that he experienced lists of side effects of more tired/tiredness, more headaches/headache, muscle pain, joint pain, injection site swelling and redness, slight nausea, feeling unwell, and swollen lymph nodes. He still feels very sick, is in a lot of pain, and not feeling well. He confirmed this list is from the paperwork he was given and adds that the only thing that he feels is light nausea that is not very severe.  He added that he has had nausea with the cancer, so this nausea would be very light.  But, he also he has a headache and tiredness. The patient added that his pain has increased, and the pain is the worst. The patient did not know how long it will take before feeling side effects from the vaccine or how that works.  The patient asked if the side effects is same for everyone or if it is different for everybody. He added that reporting the event is not going to help in finding out where he is going with this.  He stated he is at a crossroads, trying to determine if he needs to increase his pain medication since he now has more pain. He understands that Pfizer does not provide medical advice.  He states that he was asking Pfizer to see if Pfizer has an understanding of when these side effects might show themselves or when they would and how severe they would come. His second vaccination is due on 15Apr2021. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Vaccination site erythema, Vaccination site swelling
Clinical narrative: he experiences a lot of pain due to his bone cancer/been worse recently/pain has increased; more tired/tiredness; more headaches/headache; slight nausea/light nausea that is not very severe; feels very sick/not feeling well; muscle pain; joint pain; injection site swelling and redness; injection site swelling and redness; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (at the age of 63 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  Medical history included ongoing bone cancer, ongoing pain from bone cancer, and nausea (has had nausea with the cancer). The patient's concomitant medications were not reported. The patient called about COVID-19 vaccine and mentioned that he received the 1st dose of COVID-19 vaccine on 25Mar2021 and experienced side effects not right away but shortly thereafter. He mentioned that he has bone cancer and he experience a lot of pain due to his bone cancer. He does not have an easy life as he experiences a lot of pain due to his bone cancer. He has a lot of pain to begin with because of the cancer that he has and now pain has been worse recently.  He does not know if it just the progression of the pain or if it is coming from the injection.  The patient confirmed that he experienced lists of side effects of more tired/tiredness, more headaches/headache, muscle pain, joint pain, injection site swelling and redness, slight nausea, feeling unwell, and swollen lymph nodes. He still feels very sick, is in a lot of pain, and not feeling well. He confirmed this list is from the paperwork he was given and adds that the only thing that he feels is light nausea that is not very severe.  He added that he has had nausea with the cancer, so this nausea would be very light.  But, he also he has a headache and tiredness. The patient added that his pain has increased, and the pain is the worst. The patient did not know how long it will take before feeling side effects from the vaccine or how that works.  The patient asked if the side effects is same for everyone or if it is different for everybody. He added that reporting the event is not going to help in finding out where he is going with this.  He stated he is at a crossroads, trying to determine if he needs to increase his pain medication since he now has more pain. He understands that Pfizer does not provide medical advice.  He states that he was asking Pfizer to see if Pfizer has an understanding of when these side effects might show themselves or when they would and how severe they would come. His second vaccination is due on 15Apr2021. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: intermittent chest pain; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on an unspecified date in 2021 (60-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (unknown age at time of vaccination), at single dose, for COVID-19 immunization. Patient reports that she received second dose of vaccine on the day of reporting and has started to experience intermittent chest pain. Patient would like to know what she should do about the chest pain. 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: Fatigue, Femur fracture, Pain, Upper limb fracture
Clinical narrative: tired; pain; broken femur and busted up shoulder; broken femur and busted up shoulder; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 19Mar2021 as single dose for COVID-19 immunization. Medical history included vertigo; allergies to penicillin, corticosteroids, nitrofurantion derivatives, statins, paraphenylenediamine, molds and smuts. The patient stated that she had gentamycin toxicity four years ago which cause her to have vertigo 24/7.  The patient's concomitant medications were not reported. The patient previously took gentamycin and experienced toxicity; patient also had allergy to penicillin G, sodium hyaluronate (AVIAN), dicloxacillin, formaldehyde, clarithromycin (MACROBID), pravastin, quaternium-15, restylane.  The patient experienced broken femur and busted up shoulder on 03Apr2021, tired on an unspecified date, pain on an unspecified date. The patient stated she received the first dose of the PFIZER-BIONTECH COVID-19 VACCINE on 19Mar2021. She stated that her second dose would be on 09Apr2021. She is concerned about ingredients that might cause her problems. She stated that she had an injury after the first dose of the vaccine this past Saturday (03Apr2021) and has a broken femur and busted up shoulder. At the time of the report, she is in a wheelchair, is very tired and takes vicodin for the pain. Therapeutic measures were taken as a result of pain. Outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report from a contactable Physician. A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose intramuscular, administered in Arm Left on 31Jan2021 (at 66 years old), singe dose for covid-19 immunisation. Medical history included lymphoma, hypertension, polycystic kidneys. Concomitant medications included losartan potassium. The patient had first dose of bnt162b2 vaccine on 10Jan2021 (at the age of 66 years old) for Covid-19 Immunisation, via intramuscular route on left arm. No other vaccine in four weeks. The patient experienced stroke on 21Feb2021 with outcome of recovering. The patient was hospitalized for stroke for 4 days.  Information on the lot/batch number has been requested.; Sender's Comments: The event of stroke is assessed as possibly related to the suspect vaccine based on strong temporal association, but consider also possible contributory effects from patient's medical history of hypertension and polycystic kidney disease.  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.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a Pfizer-sponsored program . A contactable female consumer (patient) of an unspecified age received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced headache. The patient was scheduled for second dose and wanted to know whether she can take Tylenol prior to her second dose. The outcome of event was unknown.  Information about Lot/Batch number is not provided. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Vomiting
Clinical narrative: she is feeling lightheaded; diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 20Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer BioNTech COVID-19 vaccine on 20Mar2021. The patient reported that on the second day, she had diarrhea and vomiting on 21Mar2021. Should we like to know if this is a normal side effect with the vaccine. She also mentions that today she was feeling lightheaded in Apr2021. Spoke from the full emergency use authorization (EUA) prescribing information PFIZER-BIONTECH COVID-19 VACCINE prescribing information tables 1-4 to let caller know that vomiting and diarrhea were commonly reported side effects in the clinical trial. The patient reported that today she was feeling lightheaded and would like to know if she was okay to take Tylenol since her second dose of the Pfizer BioNTech COVID-19 vaccine was coming up this Saturday. After giving the patient the available information, she stated "You've been very helpful." The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.