chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Dysstasia, Gait disturbance, Nausea
Clinical narrative: dizziness; disorientation; Brief episodes of vertigo; occasionally walked by keeping hands on wall; Brief episode of nausea; unable to stand without falling down; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9265), via an unspecified route of administration in right arm on 02Feb2021 at 14:00 (at the age of 74 years old) as single for covid-19 immunisation. Medical history included minor hypertension, chronic obstructive pulmonary disease. Concomitant medications in two weeks included amlodipine; simvastatin; hctz; triamterene (TRIAMTENE); chondroitin sulfate sodium, glucosamine hydrochloride (OSTEO-BI-FLEX) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 03Feb2021, at 02:00 AM, 12 hours after shot patient experienced dizziness, disorientation; unable to stand without falling down; could move by crawling on hand and knees. No loss of consciousness. Brief episodes of vertigo (room spinning). Brief episode of nausea (24 hours after shot) less dizziness, occasionally walked by keeping hands on wall. Nausea gone. (10 days after shot) still some dizziness with head movement. No problem when sitting down or driving. Dizziness seems associated with change in position of head. Only minor improvement in dizziness since 3 days after shot. Generally able to walk slowly with great attention to movement. The patient did not received treatment due to the events. The outcome of brief episode of nausea was recovered on an unspecified date in 2021, while with other events was recovering.  Follow-up (10Jun2021): Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: dizziness; disorientation; Brief episodes of vertigo; occasionally walked by keeping hands on wall; Brief episode of nausea; unable to stand without falling down; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9265), via an unspecified route of administration in right arm on 02Feb2021 at 14:00 (at the age of 74 years old) as single for covid-19 immunisation. Medical history included minor hypertension, chronic obstructive pulmonary disease. Concomitant medications in two weeks included amlodipine; simvastatin; hctz; triamterene (TRIAMTENE); chondroitin sulfate sodium, glucosamine hydrochloride (OSTEO-BI-FLEX) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 03Feb2021, at 02:00 AM, 12 hours after shot patient experienced dizziness, disorientation; unable to stand without falling down; could move by crawling on hand and knees. No loss of consciousness. Brief episodes of vertigo (room spinning). Brief episode of nausea (24 hours after shot) less dizziness, occasionally walked by keeping hands on wall. Nausea gone. (10 days after shot) still some dizziness with head movement. No problem when sitting down or driving. Dizziness seems associated with change in position of head. Only minor improvement in dizziness since 3 days after shot. Generally able to walk slowly with great attention to movement. The patient did not received treatment due to the events. The outcome of brief episode of nausea was recovered on an unspecified date in 2021, while with other events was recovering.  Follow-up (10Jun2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Rash erythematous, Rash pruritic
Clinical narrative: defined rash 8 hours later described her rash as mildly itchy,  red and limited to her "inner thighs, nowhere else on body; defined rash 8 hours later described her rash as mildly itchy,  red and limited to her "inner thighs, nowhere else on body; a sore arm, now it's better; wiped out; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 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. On an unspecified date patient experienced defined rash 8 hours post vaccination described her rash as mildly itchy, red and limited to her "inner thighs, nowhere else on body, a sore arm, now it's better, wiped out. She also said her rash is 90% gone now. She specified she didn't take anything for the rash. She added in the middle of the night, she had "a sore arm, now it's better and she also feels a "little bit wiped out" and specified it can be because she "got 5 hours of sleep". She asked was my reaction reported as a side effect of the vaccine. She added she read that the COVID-19 vaccine caused mild allergic reaction closely after the shot, in 83% of people vaccinated. What are the recommendations for someone who developed a mild rash to the vaccine, my adverse reaction be considered? should I take the second dose of the Pfizer-BioNTech COVID-19 vaccine after reacting to the first dose. Caller thanked us for our customer service and for "quickly" answering the line. There Is a medical information request. The outcome for rash red and itchy was recovering and for sore arm it was recovered and for wiped out it was unknown.  Follow-up (12Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that. Information on the batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Malaise, Pain
Clinical narrative: fever 99.01; chills; feeling unwell; achey; diarrhea; This is a spontaneous report from a contactable consumer(patient). A non-pregnant female patient (age 74, units unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Pfizer 9810), via an unspecified route of administration, administered in left arm on 11Feb2021 as dose 2, single for covid-19 immunisation in doctors office/urgent care. The patient medical history was reported as none. Patient had known allergies to morphine. The patient previously took morphine and experienced allergy. Concomitant medications in two weeks included sulfamethoxazole, trimethoprim (SULFAMETH/TRIMETH 80/160mg) taken for an unspecified indication, start and stop date were not reported. Previously the patient was administered with bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: Pfizer 4176) via an unspecified route of administration, administered in left arm on 21Jan2021 at 02:00 pm as dose 1, single for covid-19 immunisation. On 12Feb2021, the patient experienced fever 99.01, chills, feeling unwell, achey and diarrhea. The patient underwent lab tests and procedures which included fever: 99.01 on 12Feb2021. It was unknown if the patient received treatment for the events. There were no other vaccine in four weeks. There was no covid prior vaccination and was not tested for covid post vaccination. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever 99.01; chills; feeling unwell; achey; diarrhea; This is a spontaneous report from a contactable consumer(patient). A non-pregnant female patient (age 74, units unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Pfizer 9810), via an unspecified route of administration, administered in left arm on 11Feb2021 as dose 2, single for covid-19 immunisation in doctors office/urgent care. The patient medical history was reported as none. Patient had known allergies to morphine. The patient previously took morphine and experienced allergy. Concomitant medications in two weeks included sulfamethoxazole, trimethoprim (SULFAMETH/TRIMETH 80/160mg) taken for an unspecified indication, start and stop date were not reported. Previously the patient was administered with bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: Pfizer 4176) via an unspecified route of administration, administered in left arm on 21Jan2021 at 02:00 pm as dose 1, single for covid-19 immunisation. On 12Feb2021, the patient experienced fever 99.01, chills, feeling unwell, achey and diarrhea. The patient underwent lab tests and procedures which included fever: 99.01 on 12Feb2021. It was unknown if the patient received treatment for the events. There were no other vaccine in four weeks. There was no covid prior vaccination and was not tested for covid post vaccination. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Pain
Clinical narrative: generalized body aches/having general aches and pains all over his body, like arthritis; joints hurting; bones aching; This is a spontaneous report from a contactable nurse (patient) via medical information team. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 16Jan2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Investigation assessment was not provided. He got his first dose on 16Jan2021. He said after he got that dose, he has had general body aches, with his joints hurting and bones aching, he has not had any relief, he was still had general body aches like arthritis. He said something about how he went to Pfizer for an x-ray of his hip and right knee, shoulders. He has not had problems like that before, he cannot do anything, he does had problems when he gets up his from chair after sitting for a long time. He said his whole body, including his knees, every part of his body. The outcome of the events was unknown.   Information on the batch/lot number has been requested. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Pyrexia
Clinical narrative: she took Tylenol to prevent fever; one fever from other things, nothing worry about now; This is a spontaneous report from a contactable consumer.  A female patient of unspecified age received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On an unspecified date, after the vaccination, the patient took Tylenol to prevent fever and one fever from other things. The events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (11May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Musculoskeletal stiffness, Pain
Clinical narrative: COULD not Move my arm from the shoulder to the elbow. Deltoid muscle would not respond at all.; Extreme pain; fatigue; headache; chills; This is a spontaneous report received from a contactable consumer or other non hcp. A 74-years-old female patient received  1st dose of bnt162b2 (Pfizer covid19 vaccine,Batch/Lot Number: EL8982), via an unspecified route of administration, administered in Arm Right on 11Feb2021 08:00,at the age of 74 years old, as Dose 1,single for covid-19 immunization.Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included loratadine, hctz,famotidine,calcium carbonate (TUMS) taken for an unspecified indication, start and stop date were not reported.  The patient previously took clindamycin and experienced drug hypersensitivity.The patient experienced she could not move her arm from the shoulder to the elbow. deltoid muscle would not respond at all, extreme pain, fatigue, headache and chills on 11Feb2021 08:45.Therapeutic measures were taken as a result of could not move my arm from the shoulder to the elbow. deltoid muscle would not respond at all.,extreme pain,fatigue,headache and chills.The patient had not received any other vaccine within 4 weeks.The patient received Percocet: CBD cream for adverse event treatment.The patient was not diagnosed with covid prior to vaccination and not tested for covid post vaccination.The outcome of the events was recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: low grade fever; chills; diarrhea; This is a spontaneous report from a Pfizer. A contactable consumer (patient's wife) reported for a male patient (Reporter's husband)   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 20Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, 3 days after vaccination (JAN-2021) the patient experienced low grade fever (pyrexia), chills, diarrhea. The outcome for the events was unknown.   Follow-up attempts completed. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dizziness, Headache, Heart rate
Clinical narrative: Bad headache; dizziness; Nausea; Chills; tightness in chest/fast heartbeat; tightness in chest/fast heartbeat; Sore at injection site; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 29-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EL3247), dose 2 via an unknown route of administration in left arm on 11Feb2021 at 10:30 (at the age of 29-years-old) as single dose for COVID-19 immunisation at workplace clinic. The patient's medical history included fatigue, chronic rhinitis/sinus congestion, brain fog and skin rash. She was allergic to sulfonamides. Concomitant medications included valaciclovir hydrochloride (VALTREX); ethinylestradiol, norethisterone acetate (JUNEL); ergocalciferol (VIT D); polycarbophil calcium (FIBER); fluticasone propionate (FLONASE); azelastine (AZELASTIN); all were taken for an unknown indication and from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EL3247), dose 1 via an unknown route of administration in left arm on 21Jan2021 (at the age of 29-years-old) as single dose for COVID-19 immunisation. On 11Feb2021 at 19:30, the patient experienced sore at injection site 10 hrs post vaccination, chills started at about 12 hrs post vaccination (gone by AM), tightness in chest/fast heartbeat at about 12 hrs post vaccination (gone by AM), bad headache starting about 20 hrs post vaccination, would not go away took an advil about 24 hrs post vaccination which significantly helped, some dizziness and nausea 20-28 hrs post dose. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment received for the adverse event. The patient underwent lab test and procedure which included Heart rate and it was fast. The outcome of the events chills started at about 12 hrs post vaccination (gone by AM), tightness in chest/fast heartbeat at about 12 hrs post vaccination (gone by AM) was recovered on 12Feb2021, while the outcome of the remaining events was recovering.  Follow-up attempts completed. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Vaccination site pain
Clinical narrative: Bad headache; dizziness; Nausea; Chills; tightness in chest/fast heartbeat; tightness in chest/fast heartbeat; Sore at injection site; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 29-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EL3247), dose 2 via an unknown route of administration in left arm on 11Feb2021 at 10:30 (at the age of 29-years-old) as single dose for COVID-19 immunisation at workplace clinic. The patient's medical history included fatigue, chronic rhinitis/sinus congestion, brain fog and skin rash. She was allergic to sulfonamides. Concomitant medications included valaciclovir hydrochloride (VALTREX); ethinylestradiol, norethisterone acetate (JUNEL); ergocalciferol (VIT D); polycarbophil calcium (FIBER); fluticasone propionate (FLONASE); azelastine (AZELASTIN); all were taken for an unknown indication and from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EL3247), dose 1 via an unknown route of administration in left arm on 21Jan2021 (at the age of 29-years-old) as single dose for COVID-19 immunisation. On 11Feb2021 at 19:30, the patient experienced sore at injection site 10 hrs post vaccination, chills started at about 12 hrs post vaccination (gone by AM), tightness in chest/fast heartbeat at about 12 hrs post vaccination (gone by AM), bad headache starting about 20 hrs post vaccination, would not go away took an advil about 24 hrs post vaccination which significantly helped, some dizziness and nausea 20-28 hrs post dose. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment received for the adverse event. The patient underwent lab test and procedure which included Heart rate and it was fast. The outcome of the events chills started at about 12 hrs post vaccination (gone by AM), tightness in chest/fast heartbeat at about 12 hrs post vaccination (gone by AM) was recovered on 12Feb2021, while the outcome of the remaining events was recovering.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Diarrhoea, Dizziness, Dysgeusia
Clinical narrative: Local arm pain close to injection site; dizziness; back pain close to elbow to the head; Diarrhea; vomiting; headache; burping; bitter taste in mouth; body aches; weakness; farting; tiredness; This is a spontaneous report from a contactable consumer (patient herself). A 51-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269), via an unspecified route of administration, administered in left arm on 07Feb2021 15:00 (age at vaccination: 51 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included hypertension and thyroid cancer. Concomitant medication(s) included levothyroxine sodium 88 mcg; losartan potassium (LOSARTAN) 100mg and gestodene. On 09Feb2021 10:00, the patient experienced local arm pain close to injection site, dizziness, back pain close to elbow to the head, diarrhea, vomiting, headache, burping, bitter taste in mouth, body aches, weakness, farting and tiredness. The patient on 15Jan2021, underwent sars-cov-2 test (nasal swab) which was negative. There was no other vaccine in four weeks. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Eructation, Fatigue, Flatulence, Headache, Pain
Clinical narrative: Local arm pain close to injection site; dizziness; back pain close to elbow to the head; Diarrhea; vomiting; headache; burping; bitter taste in mouth; body aches; weakness; farting; tiredness; This is a spontaneous report from a contactable consumer (patient herself). A 51-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269), via an unspecified route of administration, administered in left arm on 07Feb2021 15:00 (age at vaccination: 51 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included hypertension and thyroid cancer. Concomitant medication(s) included levothyroxine sodium 88 mcg; losartan potassium (LOSARTAN) 100mg and gestodene. On 09Feb2021 10:00, the patient experienced local arm pain close to injection site, dizziness, back pain close to elbow to the head, diarrhea, vomiting, headache, burping, bitter taste in mouth, body aches, weakness, farting and tiredness. The patient on 15Jan2021, underwent sars-cov-2 test (nasal swab) which was negative. There was no other vaccine in four weeks. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain, Vomiting
Clinical narrative: Local arm pain close to injection site; dizziness; back pain close to elbow to the head; Diarrhea; vomiting; headache; burping; bitter taste in mouth; body aches; weakness; farting; tiredness; This is a spontaneous report from a contactable consumer (patient herself). A 51-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269), via an unspecified route of administration, administered in left arm on 07Feb2021 15:00 (age at vaccination: 51 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included hypertension and thyroid cancer. Concomitant medication(s) included levothyroxine sodium 88 mcg; losartan potassium (LOSARTAN) 100mg and gestodene. On 09Feb2021 10:00, the patient experienced local arm pain close to injection site, dizziness, back pain close to elbow to the head, diarrhea, vomiting, headache, burping, bitter taste in mouth, body aches, weakness, farting and tiredness. The patient on 15Jan2021, underwent sars-cov-2 test (nasal swab) which was negative. There was no other vaccine in four weeks. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: he experienced chest pain; This is a spontaneous report from a contactable other hcp (patient himself).  A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9265), via an unspecified route of administration, administered in Arm Left on 10Feb2021 as DOSE 1, SINGLE (age at vaccination was 71 years old) for covid-19 immunisation. Medical history included a breakout with Penicillin, a hand breakout, NDC, lot, expiry unknown, it has been a long time ago, maybe 10-20 years ago. There were no concomitant medications. About prior vaccination (within 4 weeks), he said he had a vaccine, he is unsure if it was 4 weeks, it was 2-3 months earlier. On 10Feb2021, the patient experienced chest pain 30 minutes after the receipt of the first dose. One day after he had slight pain for a few seconds. It stopped the same day after 2-3 minutes, it stopped, one day later, he felt slight sensation of the same thing. He asked if he should receive the second dose of the vaccine after reacting to the first one. He then mentioned he has an appointment with his cardiologist on 22Feb2021 and will talk to him about it. He is a substitute teacher but was an x-ray technician about 10 years ago. No additional vaccine was administered on the day of first dose. Second dose was supposed to be on 21Mar2021. The outcome of chest pain was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Cough, Headache
Clinical narrative: chills; coughing; upset stomach; headache; This is a spontaneous report from a contactable consumer or other non HCP. This consumer reported for a 83-year-old female patient (grandmother).  A 83-year-old female patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on 03Feb2021 (at the age of 83-year-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. As per reported, reporter brought the patient to receive the first dose of the COVID vaccine on 03Feb2021 and seemed fine that day. Patient started to experience chills, coughing, upset stomach and a headache two to three days ago on unspecified date in Feb2021. Reporter would like to know if these symptoms are normal and associated with the vaccine, how long will patient's symptoms last and what to do about side effects. At the time of this report, outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dry throat, Dysphonia, Vomiting
Clinical narrative: I had massive diarrhea; I vomited, lots of mucus; dry cough; voice started to crack; My throat became dry; This is a spontaneous report from a contactable consumer (patient herself). A 37-years-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route, administered in Arm Right on 09Feb2021 16:15 (Batch/Lot Number: EN6201) as DOSE 2, SINGLE (age at vaccination was 37 years) for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported.  Historical vaccine included bnt162b2 (BNT162B2, solution for injection), dose 1 administered in right arm on 12Jan2021 (Batch/Lot Number: EL0140) for covid-19 immunisation. The patient reported that on 09Feb2021, 05:00 PM, my throat became dry after an hour from getting my vaccine on Tuesday. On 10Feb2021, wednesday I had a dry cough and it was not continuous. Wednesday into thursday my voice started to crack and would come in and out. On 11Feb2021, Thursday, mid-afternoon (48 hours after vaccine) I had massive diarrhea and an hour later I vomited, lots of mucus. After vomiting my throat was no longer dry. Voice still coming in and out, and now had a cough. Friday morning (12Feb2021) voice is getting better, slowly, and the cough is going away. Friday afternoon (3:40pm I am filling out this form) a little more of a voice and just clearing my throat. It was reported that therapeutic measures were taken. Patient was advised to continue use of cough drops, Saline spray and rest. The outcome of all the events was recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: felt her throat tightening up; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 12Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient stated that she received the first dose of the Pfizer COVID-19 vaccine 2 hours ago on 12Feb2021. Patient stayed for 15 minutes and when she got in the car to go home, she felt her throat tightening up and wanted to know if this was a common side effect. Patient wanted to know if she can take Benadryl. 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: Abdominal discomfort, Chills, Fatigue, Headache, Malaise
Clinical narrative: experienced a sick stomach; she did not feel well; her arm hurts; chills; feels tired; slight headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 vaccine, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on 29Jan2021 as dose number unknown, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced a sick stomach, she did not feel well, her arm hurt, chills, felt tired, slight headache on an unspecified date in 2021. The reporter assessed the events as non-serious. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experienced a sick stomach; she did not feel well; her arm hurts; chills; feels tired; slight headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 vaccine, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on 29Jan2021 as dose number unknown, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced a sick stomach, she did not feel well, her arm hurt, chills, felt tired, slight headache on an unspecified date in 2021. The reporter assessed the events as non-serious. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Chest pain, Fatigue, Headache
Clinical narrative: Fatigue; Nausea; Jump in blood pressure; Pain in chest; Headache; This is a spontaneous report from a contactable consumer (Patient) reporting for himself.  A 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 27Jan2021 (age at the time of vaccination was 85-year-old) as dose 1, 0.3 ML single for COVID-19 immunization. Medical history included thyroid cancer from an unknown date and unknown if ongoing (diagnosed with thyroid cancer, in remission, paraganglioma, which he says is a benign tumor in the artery, it is maybe something that effects the vaccine. he doesn't know, hypertension and left bundle branch block), paraganglion neoplasm from an unknown date and unknown if ongoing, bundle branch block left from an unknown date and unknown if ongoing (only problem is the left bundle branch block, which is something his cardiologist told him, and that is concerning the most). The patient's concomitant medications were not reported. It was reported that on 27Jan2021 the patient underwent his first inoculation with Pfizer COVID vaccine, and developed constant fatigue, nausea, jump in blood pressure and pain in chest on an unspecified date in 2021. The blood pressure and pain in chest resolved in 3 days, left only fatigue, headache, and nausea, no chest pain anymore, his blood pressure was back to normal with medications. The symptoms lasted for three days, the patient asked should he follow up with the second inoculation. The patient underwent lab tests and procedures which included blood pressure measurement: jump in blood pressure on an unspecified date in 2021. There was no medical information request. Therapeutic measures included medications which were taken as a result of jump in blood pressure and was back to normal. Outcome of the event fatigue, nausea and headache was reported as Unknown, outcome of the event jump in blood pressure was reported as recovered on an unspecified date in 2021.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Fatigue; Nausea; Jump in blood pressure; Pain in chest; Headache; This is a spontaneous report from a contactable consumer (Patient) reporting for himself.  A 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 27Jan2021 (age at the time of vaccination was 85-year-old) as dose 1, 0.3 ML single for COVID-19 immunization. Medical history included thyroid cancer from an unknown date and unknown if ongoing (diagnosed with thyroid cancer, in remission, paraganglioma, which he says is a benign tumor in the artery, it is maybe something that effects the vaccine. he doesn't know, hypertension and left bundle branch block), paraganglion neoplasm from an unknown date and unknown if ongoing, bundle branch block left from an unknown date and unknown if ongoing (only problem is the left bundle branch block, which is something his cardiologist told him, and that is concerning the most). The patient's concomitant medications were not reported. It was reported that on 27Jan2021 the patient underwent his first inoculation with Pfizer COVID vaccine, and developed constant fatigue, nausea, jump in blood pressure and pain in chest on an unspecified date in 2021. The blood pressure and pain in chest resolved in 3 days, left only fatigue, headache, and nausea, no chest pain anymore, his blood pressure was back to normal with medications. The symptoms lasted for three days, the patient asked should he follow up with the second inoculation. The patient underwent lab tests and procedures which included blood pressure measurement: jump in blood pressure on an unspecified date in 2021. There was no medical information request. Therapeutic measures included medications which were taken as a result of jump in blood pressure and was back to normal. Outcome of the event fatigue, nausea and headache was reported as Unknown, outcome of the event jump in blood pressure was reported as recovered on an unspecified date in 2021.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac disorder, Condition aggravated, Cough, Dizziness
Clinical narrative: worsened; brown rash on her arm, face, thighs and hands; brown rash on her arm, face, thighs and hands; brown rash on her arm, face, thighs and hands; cannot catch her breath; Dizziness; heart is hurting; weakness; coughing a lot; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EL5318; Expiration date: Unknown) via an unspecified route of administration (age at vaccination 72-year) in Right Arm on 31Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took aspirin. On 31Jan2021 the patient experienced coughing a lot; on 01Feb2021 the patient experienced she cannot catch her breath, Dizziness, Weakness, her heart was hurting; on 02Feb2021 the patient experienced she has a brown rash on her face; on 03Feb the patient experienced she has a brown rash on her arms, thighs and hands; On an unspecified date the patient experienced all the adverse events was reported as worsened. Caller stated that she had the Pfizer vaccine on 31Jan, and it stated to call if she had anything pertaining to the shot she took. Stated that half the time she cannot catch her breath and that she was coughing a lot. Stated that it was hard to breath when she lies down to go to bed. Stated that she has dizziness and weakness. Stated that she has a brown rash on her face, arms and thighs. Stated that she was told to read the paper, but she was just reading it now. Clarified that it was for Pfizer Covid vaccine. Stated that she was supposed to get it at age 72. Stated that when she gets up that she was dizzy. Stated that her heart was hurting. Stated that she took two (Company name) aspirin before she took the shot. Stated that when a person was sick that they cannot think straight. Stated that she was getting the second shot on 21Feb. Stated that she has a brown rash to her hands. Wanted to know if she got Covid since she got the shot. Also stated that she has to sit down to catch her breath. Stated that the brown rash like freckles on her face started on 2-3 Feb. Stated that the brown rash on her arms started on the 03 Feb. Treatment received was reported as None. The clinical outcome of worsened was unknown, while the outcome of all other events was not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: worsened; brown rash on her arm, face, thighs and hands; brown rash on her arm, face, thighs and hands; brown rash on her arm, face, thighs and hands; cannot catch her breath; Dizziness; heart is hurting; weakness; coughing a lot; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EL5318; Expiration date: Unknown) via an unspecified route of administration (age at vaccination 72-year) in Right Arm on 31Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took aspirin. On 31Jan2021 the patient experienced coughing a lot; on 01Feb2021 the patient experienced she cannot catch her breath, Dizziness, Weakness, her heart was hurting; on 02Feb2021 the patient experienced she has a brown rash on her face; on 03Feb the patient experienced she has a brown rash on her arms, thighs and hands; On an unspecified date the patient experienced all the adverse events was reported as worsened. Caller stated that she had the Pfizer vaccine on 31Jan, and it stated to call if she had anything pertaining to the shot she took. Stated that half the time she cannot catch her breath and that she was coughing a lot. Stated that it was hard to breath when she lies down to go to bed. Stated that she has dizziness and weakness. Stated that she has a brown rash on her face, arms and thighs. Stated that she was told to read the paper, but she was just reading it now. Clarified that it was for Pfizer Covid vaccine. Stated that she was supposed to get it at age 72. Stated that when she gets up that she was dizzy. Stated that her heart was hurting. Stated that she took two (Company name) aspirin before she took the shot. Stated that when a person was sick that they cannot think straight. Stated that she was getting the second shot on 21Feb. Stated that she has a brown rash to her hands. Wanted to know if she got Covid since she got the shot. Also stated that she has to sit down to catch her breath. Stated that the brown rash like freckles on her face started on 2-3 Feb. Stated that the brown rash on her arms started on the 03 Feb. Treatment received was reported as None. The clinical outcome of worsened was unknown, while the outcome of all other events was not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: feverish/fever; Joint pain; back and shoulder muscle pain/muscle ache; feeling fatigue; arm was hurting at the injection site; sore arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration, on 09Feb2021 (at the age of 74-year-old), as dose 1, single in right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received pneumonia shot and she did not get a rash or anything like when getting pneumonia shot, but her arm was red. On 09Feb2021, after the first dose of vaccine, the patient's arm was hurting at the injection site and sore arm for 1 day. Patient thought this was normal, every time she gets something, she gets the same reaction. On 10Feb2021, 1 day after the first dose of vaccine, the patient was feeling fatigued while doing laundry, with back and shoulder muscle pain/muscle ache, the side where she got the shot had irritated her in the back. On 11Feb2021, 2 days after the first dose of vaccine, the patient woke up with fever at 03:00 AM or 04:00 AM and joint pain. Patient enquired if this was normal. The clinical outcome of the event sore arm was resolved on 10Feb2021; events fever and feeling fatigue was resolved on an unspecified date in 2021; and clinical outcome of all other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: feverish/fever; Joint pain; back and shoulder muscle pain/muscle ache; feeling fatigue; arm was hurting at the injection site; sore arm; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration, on 09Feb2021 (at the age of 74-year-old), as dose 1, single in right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received pneumonia shot and she did not get a rash or anything like when getting pneumonia shot, but her arm was red. On 09Feb2021, after the first dose of vaccine, the patient's arm was hurting at the injection site and sore arm for 1 day. Patient thought this was normal, every time she gets something, she gets the same reaction. On 10Feb2021, 1 day after the first dose of vaccine, the patient was feeling fatigued while doing laundry, with back and shoulder muscle pain/muscle ache, the side where she got the shot had irritated her in the back. On 11Feb2021, 2 days after the first dose of vaccine, the patient woke up with fever at 03:00 AM or 04:00 AM and joint pain. Patient enquired if this was normal. The clinical outcome of the event sore arm was resolved on 10Feb2021; events fever and feeling fatigue was resolved on an unspecified date in 2021; and clinical outcome of all other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chest pain, Chills, Dry throat, Dysuria
Clinical narrative: Both arms and legs were in a lot of pain/Still head and arm hurt; Felt like someone was constantly pulling hair; Throat was dry; Kept urinating all night; Stayed mostly in bed the night of the shot then for the next two days; First night have shivers; Hot; Cold; Chest pains that night; Still head and arm hurt; This is a spontaneous report from a contactable consumer (Patient). A 84-year-old non pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9262), Solution for injection, Dose 2 via an unspecified route of administration, administered in Arm Right on 08Feb2021 15:00 and dose 1 via an unspecified route of administration, administered in Arm Right on 18Jan2021 15:00 (Batch/Lot Number: EL8982) both as single dose (at the age of 84-year-old) for covid-19 immunisation. Medical history included (Long-term Previous) Neuropathy, Epstein-Bar Virus. Concomitant medications included meloxicam (MELOXICAM) and amlodipine (AMLODIPINE). The patient previously took statin [atorvastatin calcium] and experienced statin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 08Feb2021 20:00, the patient experienced both arms and legs were in a lot of pain/still head and arm hurt, felt like someone was constantly pulling hair, throat was dry, kept urinating all night, stayed mostly in bed the night of the shot then for the next two days, first night have shivers, hot, cold, chest pains that night, still head and arm hurt. It was reported that, Monday night after shot Both arms and legs were in a lot of pain, felt like someone was constantly pulling hair, throat was dry, kept urinating all night. Stayed mostly in bed the night of the shot then for the next two days. First night have shivers, hot and cold (and had to take an acetaminophen to help relieve). Felt well by Wednesday afternoon, then chest pains that night. Still head and arm hurt on Thursday. Friday feeling better.Therapeutic measures were taken as a result of first night have shivers, hot and cold. No treatment was received for other events. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.