chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: I had really bad reaction to it; the arm hurt,; headache; sore muscles; fever; My muscle, my jaw and my neck were extremely tight.; In my eyes it's almost black like around it.; Dizziness; My muscle, my jaw and my neck were extremely tight.; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EP754), via an unspecified route of administration, administered in Arm Left on 08Mar2021 (at the age of 55-years-old) as single dose for covid-19 immunisation. Medical history included hypothyroidism. Concomitant medications included thyroid (ARMOUR THYROID). Patient reported that she took the Pfizer vaccine on 08Mar and had really bad reaction to it. On 18Mar2021, her arm hurt, the headache, the sore muscles, the fever she had all that but then it continued. She did not not expect that maybe last a day or 2 but then she continued to had extremely bad headache, and then her muscle, her jaw and her neck were extremely tight and headache was really bad, in her eyes it was almost black like around it, it would not go away and she had dizziness also. She tried all medicine. She took anacin, aspirin, ibuprofen, Tylenol. She took tension headache medicine, migraine medicine. She took muscle relaxers. She took more advanced Ibuprofen extended release that the doctor has given her. She put heat on her, she put ice on her. She went for chiropractor 3-4 times. She tried to exercise like trying to loosen the muscle, she did a lot of stuff for it and then they gave her a shot in doctor's office. She don't know what that was, they supposed to relieve the headache it didn't and then the only thing that relieved her headache finally has been the steroid pack that's the prednisone pack and that was kind of like allergic reaction, like a high information of body allergic reaction, that's why she gave that to her. She went to chiropractor, and they tried to give her a shock to stop her headache that didn't work she thought that using work in 20 minutes, since then, now they finally put her on steroid pack massive a prednisone a pack. She called to asked if she should supposed to get her second shot. She felt like she had really bad reaction to it and she don't feel like I she should get the second shot. The outcome of all the events was unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Ocular hyperaemia, Pain
Clinical narrative: Sore, aches and pains; Eyes are red, glazed; Back spasms; Her head feels like it's going to explode; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program support. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 05Apr2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 05Apr2021, the patient reported that her eyes were red, glazed, her head felt like it was going to explode, she was sore, she had aches and pains. She took an allergy pill and decongestant, but it didn't work. She had back spasms. She took a half of a narco. No unaddressed medical questions referred or forwarded to medical information. The outcome of all the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Cough, Fatigue, Headache
Clinical narrative: Fatigue; Body ache; fever (100F )/low grade temperature (99.6/99.8); Slight headache; Dry cough; This is a spontaneous report from a contactable consumer (patient).   A 72-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EP7534, Expiry Date: Not Reported), via an unspecified route of administration, administered in Arm Left on 01Apr2021 at 13:15 (age at vaccination was 72-year-old), as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included Monitoring Thyroid Nodule and penicillin allergy. The patient previously took penicillin b and experienced rash. The concomitant medication included atorvastatin (ATORVASTATIN), and acetylsalicylic acid (ASPIRIN 81) taken for an unspecified indication, start and stop date were not reported. The patient received these medications within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6203, Expiry Date: Not Reported), via an unspecified route of administration in arm left on 11Mar2021 at 13:30 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID-19 since the vaccination. On 02Apr2021, at 19:00 the patient received fatigue, body ache and fever (100F) on the first and second days after the second dose vaccination. Thereafter low-grade temperature (99.6/99.8) in the early evenings accompanied by slight headache for the past week which goes down late evenings. Taking Acetamenphane 500mg before bedtime. Running a temperature every evening for the last 15 days after the 2nd dose vaccination. Highest temp 100.8. Normal temp in the mornings. Dry cough for the last 4 days. The patient underwent lab tests and procedures which included body temperature: 99.6/99.8 Fahrenheit (Low grade temperature (99.6/99.8) in the early evenings) on 02Apr2020, body temperature: 100 Fahrenheit on 02Apr2021, sars-cov-2 test (Nasal Swab): negative on 06Apr2021 and blood test and urine test on an unspecified date. The patient took Acetamenphane 500mg before bedtime as a treatment for the events fever (100f)/low grade temperature (99.6/99.8) and dry cough. The adverse event fever (100F)/low grade temperature (99.6/99.8) and cough led to physician office visit. The patient did not receive any treatment for fatigue and body ache. Outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Urine analysis
Clinical narrative: Fatigue; Body ache; fever (100F )/low grade temperature (99.6/99.8); Slight headache; Dry cough; This is a spontaneous report from a contactable consumer (patient).   A 72-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EP7534, Expiry Date: Not Reported), via an unspecified route of administration, administered in Arm Left on 01Apr2021 at 13:15 (age at vaccination was 72-year-old), as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included Monitoring Thyroid Nodule and penicillin allergy. The patient previously took penicillin b and experienced rash. The concomitant medication included atorvastatin (ATORVASTATIN), and acetylsalicylic acid (ASPIRIN 81) taken for an unspecified indication, start and stop date were not reported. The patient received these medications within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6203, Expiry Date: Not Reported), via an unspecified route of administration in arm left on 11Mar2021 at 13:30 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID-19 since the vaccination. On 02Apr2021, at 19:00 the patient received fatigue, body ache and fever (100F) on the first and second days after the second dose vaccination. Thereafter low-grade temperature (99.6/99.8) in the early evenings accompanied by slight headache for the past week which goes down late evenings. Taking Acetamenphane 500mg before bedtime. Running a temperature every evening for the last 15 days after the 2nd dose vaccination. Highest temp 100.8. Normal temp in the mornings. Dry cough for the last 4 days. The patient underwent lab tests and procedures which included body temperature: 99.6/99.8 Fahrenheit (Low grade temperature (99.6/99.8) in the early evenings) on 02Apr2020, body temperature: 100 Fahrenheit on 02Apr2021, sars-cov-2 test (Nasal Swab): negative on 06Apr2021 and blood test and urine test on an unspecified date. The patient took Acetamenphane 500mg before bedtime as a treatment for the events fever (100f)/low grade temperature (99.6/99.8) and dry cough. The adverse event fever (100F)/low grade temperature (99.6/99.8) and cough led to physician office visit. The patient did not receive any treatment for fatigue and body ache. Outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Right on 10Mar2021 (age at vaccination: 57 Years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced diarrhoea on Mar2021.Therapeutic measures were taken as a result of diarrhoea was Imodium (Loperamide 2mg). The outcome of the event diarrhoea was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: nausea; headache; fever; chills; injection site pain; This is a spontaneous report from a non-contactable male consumer (patient) reported for himself that male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller had the dose 1 of the Pfizer covid vaccine on an unspecified date, quite a few symptoms, what he heard that they normally didn't get them until after the second dose. He had nausea, headache, fever, chills, injection site pain. The patient asked what it would be like, the second dose for him. The side effects were gone at the time of report. Everybody he talk to the first shot was not bad, the second shot was supposed to be worse, he thought wow, what was the second one going to be like, or what. He had that nausea which was bad, he tried to figure it out, he never threw up, felt like it but didn't. Might be he would have felt better if he did threw up. He did not report to safety department. If he had more time, he had been on hold for 45 minutes, and he did not have any more time. Caller also refused to provide any more demographic information for this agent to report on his behalf. Caller stated that might be he should just wait to report after the second dose and see what happens. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Inflammation, Joint swelling, Pain in extremity
Clinical narrative: I had terrible inflammatory reaction; my right injection arm was sore; then site was swollen up; numbness and I couldn't put my arm or hand down, it throbbed, literally; I had right wrist swelled up; fingers turned into bluish; I don't feel right; This is a spontaneous report from a non-contactable consumer (patient). A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 18Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included varicos veins. Reported that patient had lots of inflammation in me, varicose veins, during covid, I haven't been to have them cut and redirected during Covid. My heart doctor said I have inflammation in me, he didn't know if I had a massive mold inflammation, or if it was from my heart or mold infection. The next vaccine scheduled on Thursday, I really want to have this protection, I don't know if I am having a stress attack over this. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced i had terrible inflammatory reaction, my right injection arm was sore, then site was swollen up, numbness and i couldn't put my arm or hand down, it throbbed, literally, i had right wrist swelled up, fingers turned into bluish, i don't feel right. It was reported that patient was fine the day after right injection arm was sore, like normal, then site was swollen up and then I had the 3rd day after I had right wrist swelled up and I couldn't use it, and I couldn't put my arm or hand down, it throbbed, literally unusual. I got supports for wrists and oh no, that was worse. I actually massaged it to get vaccine around and got it going. It lasted 4 to 5 days and along with that I had some, once in a while, 2 or 3 times where is happened, I got up from the chair and stepped down and my right foot gave out. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Vaccination site swelling
Clinical narrative: I had terrible inflammatory reaction; my right injection arm was sore; then site was swollen up; numbness and I couldn't put my arm or hand down, it throbbed, literally; I had right wrist swelled up; fingers turned into bluish; I don't feel right; This is a spontaneous report from a non-contactable consumer (patient). A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 18Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included varicos veins. Reported that patient had lots of inflammation in me, varicose veins, during covid, I haven't been to have them cut and redirected during Covid. My heart doctor said I have inflammation in me, he didn't know if I had a massive mold inflammation, or if it was from my heart or mold infection. The next vaccine scheduled on Thursday, I really want to have this protection, I don't know if I am having a stress attack over this. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced i had terrible inflammatory reaction, my right injection arm was sore, then site was swollen up, numbness and i couldn't put my arm or hand down, it throbbed, literally, i had right wrist swelled up, fingers turned into bluish, i don't feel right. It was reported that patient was fine the day after right injection arm was sore, like normal, then site was swollen up and then I had the 3rd day after I had right wrist swelled up and I couldn't use it, and I couldn't put my arm or hand down, it throbbed, literally unusual. I got supports for wrists and oh no, that was worse. I actually massaged it to get vaccine around and got it going. It lasted 4 to 5 days and along with that I had some, once in a while, 2 or 3 times where is happened, I got up from the chair and stepped down and my right foot gave out. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: a 2 inch round, red area on her arm; This is a spontaneous report from a non-contactable consumer or other non hcp. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown), via an unspecified route of administration on an unspecified date as dose one, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced a 2 inch round, red area on her arm. The caller has stated the red spot went away went away in a couple days and also she checked with my HCP and got the 2nd dose anyway. The outcome of the event was considered as recovered..  Patient states the vaccinator "told to take Benedryl or Claritan. Patient was asking whether is it ok to take after receiving Pfizer vaccine. Patient states that she had read that taking Ibuprofen or Tylenol post vaccination will affect vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: diagnosis swollen lymph nodes; Pronounced swelling at neck on left side starting 4 days post vaccination; This is a spontaneous report from a contactable consumer (patient). A 43-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8729) via an unspecified route of administration on 05Apr2021 at 10:45 (at the age of 43-years-old) in left arm as a single dose for covid-19 immunization. Medical history included aortic aneurysm from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had not been tested for covid-19. The patient had no allergies to medications, food, or other products. The patient's concomitant medications received within 2 weeks of vaccination were reported as none. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number: EN6207) on 14Mar2021 at 10:45 for covid-19 immunization. The patient experienced pronounced swelling at neck on left side starting 4 days post vaccination on 09Apr2021 and swollen lymph nodes on an unspecified date. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient was recommended ibuprofen. The outcome of both the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Oxygenation index
Clinical narrative: I experienced mild shortness of breath; fatigue; headache; This is a spontaneous report from a non-contactable consumer or other non-HCP (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 08Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021 the patient experienced mild shortness of breath, fatigue, headache. It was reported that caller stated "she received the first dose of the Pfizer vaccine 24 hours ago. She experienced mild shortness of breath, fatigue and headache. She works on a boat she checked her 02 level it was between 99 to 100 % Sometimes it's her cycle. It could be she had mild shortness of breath due to her mensuration." The patient underwent lab tests and procedures on an unspecified date which included oxygenation index: it was between 99 to 100 %. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Myalgia, Pyrexia
Clinical narrative: He is experiencing pain in his bones, in his muscles and a little fever; He is experiencing pain in his bones, in his muscles and a little fever; He is experiencing pain in his bones, in his muscles and a little fever; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Apr2021, patient experienced pain in his bones, in his muscles and a little fever. Reporter want to know if he can take ibuprofen after having taken the covid vaccine and what pills he can take for his side effects from the covid vaccine. Outcome of the events was Unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dysphagia, Flushing, Gastrooesophageal reflux disease
Clinical narrative: Tightness in the Chest; Increased Reflux; Flushing of the face; Itchy all over; Difficulty Swallowing; Pain in chest; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).  A 75-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; (Batch/Lot Number: Unknown) via an unspecified route of administration, administered in Arm Left (reported as Left Upper Arm) on 17Mar2021 (at the age of 75-years-old) as dose 1, single for covid-19 immunization. Medical history included ongoing stomach Issues and she has had stomach issues for about 4 years and was being treated for them and patient took Flu Vaccine on an unknown date in 2020. The patient's concomitant medications were not reported. Patient took Flu Vaccine and had similar symptoms as she experienced after the Covid Vaccine with the Flu Vaccine and said they were milder though, reported as AE prior vaccination. Family history reported as None. No prior vaccinations taken within 4 weeks of vaccination. No additional vaccines administered on same date of the Pfizer Suspect. It was reported that, patient wanted to report some severe side effects that she had with her first dose of the vaccine. she was fine immediately after the vaccine but once it got into her system these symptoms began and all of her symptoms began about 4 days after her vaccine. On 21Mar2021, the patient experienced tightness in the chest, increased reflux, flushing of the face, itchy all over, difficulty swallowing, pain in chest. Events were all improving slowly and the most concerning one to her was the difficulty swallowing. On an unspecified date, it was reported that she was not going to get the second dose of the vaccine which was scheduled for safety reasons. No doctor or emergency room visits related to patient reported events and she stated that she called her doctor and discussed her side effects. No Investigation Assessment was provided. Outcome of the events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Tightness in the Chest; Increased Reflux; Flushing of the face; Itchy all over; Difficulty Swallowing; Pain in chest; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient).  A 75-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; (Batch/Lot Number: Unknown) via an unspecified route of administration, administered in Arm Left (reported as Left Upper Arm) on 17Mar2021 (at the age of 75-years-old) as dose 1, single for covid-19 immunization. Medical history included ongoing stomach Issues and she has had stomach issues for about 4 years and was being treated for them and patient took Flu Vaccine on an unknown date in 2020. The patient's concomitant medications were not reported. Patient took Flu Vaccine and had similar symptoms as she experienced after the Covid Vaccine with the Flu Vaccine and said they were milder though, reported as AE prior vaccination. Family history reported as None. No prior vaccinations taken within 4 weeks of vaccination. No additional vaccines administered on same date of the Pfizer Suspect. It was reported that, patient wanted to report some severe side effects that she had with her first dose of the vaccine. she was fine immediately after the vaccine but once it got into her system these symptoms began and all of her symptoms began about 4 days after her vaccine. On 21Mar2021, the patient experienced tightness in the chest, increased reflux, flushing of the face, itchy all over, difficulty swallowing, pain in chest. Events were all improving slowly and the most concerning one to her was the difficulty swallowing. On an unspecified date, it was reported that she was not going to get the second dose of the vaccine which was scheduled for safety reasons. No doctor or emergency room visits related to patient reported events and she stated that she called her doctor and discussed her side effects. No Investigation Assessment was provided. Outcome of the events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Oropharyngeal pain, Pain
Clinical narrative: Achy; headache in sinus region; Chills; Dry cough; fever is worse; sore throat; This is a spontaneous report received from a contactable consumer (patient) reported that: A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 05Apr2021 14:50 (Batch/Lot Number: ER8733) as DOSE 1 SINGLE for covid-19 immunization (Age at vaccination 23 years). The patient past  Medical history included heart disease from an unknown date and unknown if ongoing his mother has heart disease and anemia from an unknown date and unknown if ongoing there is a family history of Anemia. Concomitant medication(s) included ascorbic acid (VITAMIN C ACID) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 05Apr2021 the patient experienced dry cough is not as bad it got worse, Headache and chills Caller stated this started when he went to sleep on Monday evening and got worse on Tuesday 6Apr2021 and last night was bad but as of now since Tuesday so on Monday to Tuesday it got worse and this morning, he had a significantly high fever and Achy. Caller stated he took a Tylenol this morning and it has lessened considerably but he feels the fever is coming back and has chills which is an indicator. Caller stated he does not feel that he has recovered completely. The event did not result in Emergency Room and No Physician Office. The patient received Treatment with Tylenol and Mucinex. The event outcome was Not recovered for dry cough, headache in sinus region and Chills, unknown for fever and Chills recovering for Achy.  Additional Communication: Informed caller that this RA agent has a serious of questions to ask in regards to patient details and symptoms the caller has experienced after the vaccine and may be able to answer questions regarding side effects to the COVID 19 vaccine. Provided caller report reference number. Provided caller hours and number. Due to high call volume caller was placed in the queue for details.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Achy; headache in sinus region; Chills; Dry cough; fever is worse; sore throat; This is a spontaneous report received from a contactable consumer (patient) reported that: A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 05Apr2021 14:50 (Batch/Lot Number: ER8733) as DOSE 1 SINGLE for covid-19 immunization (Age at vaccination 23 years). The patient past  Medical history included heart disease from an unknown date and unknown if ongoing his mother has heart disease and anemia from an unknown date and unknown if ongoing there is a family history of Anemia. Concomitant medication(s) included ascorbic acid (VITAMIN C ACID) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 05Apr2021 the patient experienced dry cough is not as bad it got worse, Headache and chills Caller stated this started when he went to sleep on Monday evening and got worse on Tuesday 6Apr2021 and last night was bad but as of now since Tuesday so on Monday to Tuesday it got worse and this morning, he had a significantly high fever and Achy. Caller stated he took a Tylenol this morning and it has lessened considerably but he feels the fever is coming back and has chills which is an indicator. Caller stated he does not feel that he has recovered completely. The event did not result in Emergency Room and No Physician Office. The patient received Treatment with Tylenol and Mucinex. The event outcome was Not recovered for dry cough, headache in sinus region and Chills, unknown for fever and Chills recovering for Achy.  Additional Communication: Informed caller that this RA agent has a serious of questions to ask in regards to patient details and symptoms the caller has experienced after the vaccine and may be able to answer questions regarding side effects to the COVID 19 vaccine. Provided caller report reference number. Provided caller hours and number. Due to high call volume caller was placed in the queue for details.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: body aches; Headache; Fatigue; fever is 101.2; This is a spontaneous report received from a contactable consumer or other non-health care professional (Husband) reporting on behalf of a Patient (Wife). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number, NDC number and Expiry Date are not provided), via an unspecified route of administration on 06Apr2021 at 13:00 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on an unspecified date as single dose for covid-19 immunisation. The reporter was calling about the Pfizer covid vaccine, he was calling on behalf of his wife. The patient had the second dose of the vaccine on 06Apr2021 at 1:00 pm. The patient was 48 years old and was never ever sick, she has a strong immune system. That day on 07Apr2021, the patient had body aches, a headache, fatigue, and her fever was 101.2. The reporter was looking at the website and saw that a fever of around 100 degrees would be expected, but is this normal or common to have a fever greater than that? The patient underwent lab tests and procedures which included Fever (Body temperature): 101.2 degrees Fahrenheit fever on 07Apr2021. Reporter seriousness for body aches, Headache, Fatigue and fever is 101.2 was Unspecified. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Cough, Fatigue, Malaise
Clinical narrative: recently experiencing severe malaise; fatigue; confusion; cough; This is a spontaneous report received from contactable Other HCP from a Pfizer Sponsored Program with Regulatory Authority support. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on 24Mar2021 as Dose 1, Single for Covid-19 immunisation. The patient medical history and concomitant medications was not reported. On unspecified date in Mar2021, the patient experienced severe malaise, fatigue, confusion and cough. It was reported that Caller (MS), was calling on behalf of their patient who got the first dose. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Rash macular, Swelling
Clinical narrative: My arm was still sore/my arm is still really hurting; got a huge red blotch on my arm It was a big welt that look like a cloud; It became swollen and hot; It became swollen and hot; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and had experienced her arm did become sore. Reporter states, on an unspecified date the patient reported having really weird side effects after getting the first dose of the Pfizer BioNTech covid vaccine. The patient had received both doses of the vaccine in left arm. The patient arm was still sore when she went back to get the second dose. The second shot was really bad. The patient got a huge red blotch on arm and it was a big welt that look like a cloud. It became swollen and hot. Every time, the patient did search for a picture of Pfizer and swollen arm, a picture of Moderna Arm' would come up. The patient was concerned because she got the doses local. On an unspecified date (2 weeks later), the patient arm was still really hurting but not red, hot or swollen. Outcome of the event My arm was still sore/my arm is still really hurting was not resolved and rest all events was resolved on an unknown date.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site rash
Clinical narrative: the lump on her left arm had developed some rash, swelling and itching; the lump looked like a teenager skin blemish; redness rash and itchy at injection site after second dose; She also noticed that on the exterior of the skin, there is still minute reddish purplish discoloration; redness rash and itchy at injection site after second dose; the lump on her left arm had develop some rash, swelling and itching; redness rash and itchy at injection site after second dose; the lump on her left arm had develop some rash, swelling and itching; the lump on her left arm had develop some rash, swelling and itching; This is a spontaneous report from a contactable consumer reported for herself. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6208; Expiration date: Jun2021; NDC and dosages unknown), via an unspecified route of administration, administered in Arm Left on 19Mar2021 (at the age of 77-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications included none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) on an unspecified date for covid-19 immunisation and experienced lump surrounded by black and blue discolorations on the injection site of her left arm. On an unspecified date, the patient experienced redness rash and itchy at injection site after second dose, after her second dose (date not captured/stated), the lump on her left arm had developed some rash, swelling and itching and just went away after a week. On the day of this report, the lump looked like a teenager skin blemish that looked close to a large pimple. She also noticed that on the exterior of the skin, there was still minute reddish purplish discoloration and that the little lump was still there. She mentioned that she did not feel alerted and concerned because initially when she asked a nurse in the vaccination center, they mentioned that they have already seen side effects that looks like this. Now, consumer was just wondering if there were any reported events about this. Referred to physician or HCP for proper clinical diagnosis and clinical recommendation. Investigation assessment included none. The events were not serious. Clinical outcome of event the lump on her left arm had develop some rash, swelling and itching was recovered on an unspecified date and outcome of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: the lump on her left arm had developed some rash, swelling and itching; the lump looked like a teenager skin blemish; redness rash and itchy at injection site after second dose; She also noticed that on the exterior of the skin, there is still minute reddish purplish discoloration; redness rash and itchy at injection site after second dose; the lump on her left arm had develop some rash, swelling and itching; redness rash and itchy at injection site after second dose; the lump on her left arm had develop some rash, swelling and itching; the lump on her left arm had develop some rash, swelling and itching; This is a spontaneous report from a contactable consumer reported for herself. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6208; Expiration date: Jun2021; NDC and dosages unknown), via an unspecified route of administration, administered in Arm Left on 19Mar2021 (at the age of 77-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications included none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) on an unspecified date for covid-19 immunisation and experienced lump surrounded by black and blue discolorations on the injection site of her left arm. On an unspecified date, the patient experienced redness rash and itchy at injection site after second dose, after her second dose (date not captured/stated), the lump on her left arm had developed some rash, swelling and itching and just went away after a week. On the day of this report, the lump looked like a teenager skin blemish that looked close to a large pimple. She also noticed that on the exterior of the skin, there was still minute reddish purplish discoloration and that the little lump was still there. She mentioned that she did not feel alerted and concerned because initially when she asked a nurse in the vaccination center, they mentioned that they have already seen side effects that looks like this. Now, consumer was just wondering if there were any reported events about this. Referred to physician or HCP for proper clinical diagnosis and clinical recommendation. Investigation assessment included none. The events were not serious. Clinical outcome of event the lump on her left arm had develop some rash, swelling and itching was recovered on an unspecified date and outcome of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills; Muscle aches; Fever; Nausea; This is a spontaneous report from a contactable consumer was received via a sales representative.  A 48-year-old patient of unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via intramuscular on 07Apr2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included covid-19 vaccine for COVID-19 immunization. It was reported that on an unspecified date the patient experienced chills, muscle aches, fever, nausea. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Headache, Pain
Clinical narrative: vomiting; dizziness; severe headache; very tired; chest pain; achy everywhere; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer reported for a 24-year-adult female consumer (daughter, patient). A 24-year-old female patient received first dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection), via an unspecified route on 04Apr2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced vomiting, dizziness, severe headache, very tired, chest pain and achy everywhere. The clinical outcome of the events was unknown.   Information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021393498 Same drug , different patient and AE
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; dizziness; severe headache; very tired; chest pain; achy everywhere; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer reported for a 24-year-adult female consumer (daughter, patient). A 24-year-old female patient received first dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection), via an unspecified route on 04Apr2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced vomiting, dizziness, severe headache, very tired, chest pain and achy everywhere. The clinical outcome of the events was unknown.   Information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021393498 Same drug , different patient and AE
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Hypersensitivity, Illness, Nasopharyngitis
Clinical narrative: She felt sick; Headache; Colds; Fever; Diarrhea; Allergic reaction; Caller asked if it was possible that she had Covid; This is a spontaneous report from a contactable consumer (patient) from a female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 05Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient felt sick. She had a head-ache, colds, fever, diarrhea, and allergic reaction. Patient asked if it was possible that she had COVID. Outcome of the events was unknown.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19
Clinical narrative: She felt sick; Headache; Colds; Fever; Diarrhea; Allergic reaction; Caller asked if it was possible that she had Covid; This is a spontaneous report from a contactable consumer (patient) from a female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 05Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient felt sick. She had a head-ache, colds, fever, diarrhea, and allergic reaction. Patient asked if it was possible that she had COVID. Outcome of the events was unknown.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cough, Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: Stomach ache, cramps sometimes, after second vaccine; Sneezing, after second vaccine; Runny nose, after second vaccine; Cough, after second vaccine; Sore throat, after second vaccine; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 19-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8733, Expiration date: Unknown) via an unspecified route of administration, administered in arm left on 02Apr2021 (age at vaccination 19 years) as dose 2, single for COVID-19 immunization. The patient medical history and family medical history related to adverse events was reported as no. The patient's concomitant medications were none. Additional vaccines administered on same date of the Pfizer suspect was reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. AE(s) following prior vaccinations was reported as no. The patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6208) via an unspecified route of administration, administered in arm left on 12Mar2021 19:00 as dose 1, single for COVID-19 immunization. The patient experienced cough, after second vaccine on 03Apr2021 07:00, stomach ache, cramps sometimes, after second vaccine on 05Apr2021, sneezing, after second vaccine on 05Apr2021 07:00, runny nose, after second vaccine on 05Apr2021 07:00, sore throat, she stated that she woke up with the stomach ache yesterday on 06Apr2021 12:00. It was reported that patient got the second shot last Friday and she started having side effects on Saturday. Caller stated, the effects, have lasted almost a week. She was having coughing, sneezing and a runny nose. Caller asked if these, side effects, were normal to have. Adverse events did not result in physician office visit or Emergency room visit. Investigation assessment and relevant tests was reported as no. The outcome of the event cough, after second vaccine was resolving, sneezing, after second vaccine was not resolved, runny nose, after second vaccine was resolved with sequel on 07Apr2021, Sore throat, after second vaccine was resolved on 07Apr2021 and stomach ache, cramps sometimes, after second vaccine was not resolved.  No follow-up attempts are needed. No further information is expected