chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Persistent and severe headache since day after vaccination.; Some nausea starting day 4; This is a spontaneous report from a contactable consumer (patient). A 45-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via an unspecified route of administration on 12Feb2021 09:30 as SINGLE DOSE (at the age of 45-years) in Arm Left for covid-19 immunization. Medical history included: high blood pressure. The patient had no known allergies. The patient did not receive any other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: atenolol and amlodipine, taken for an unspecified indication. On 13Feb2021 at 15:00, the patient had persistent and severe headache since day after vaccination and some nausea starting day 4. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was Not recovered.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Device leakage, Fatigue, Headache, SARS-CoV-2 test, Underdose
Clinical narrative: vaccine leaked out and ran down her arm. She does not think that she had full dose; vaccine leaked out and ran down her arm. She does not think that she had full dose; severe headache; fatigue; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration in right arm on 20Jan2021 at 17:30 PM (at the age of 68-years-old) as a single dose for COVID-19 immunisation at hospital. The patient's medical history included asthma and breast cancer. Patient had allergies to latex, Penicillin, IVP dye, shellfish. The patient previously took codeine, mepivacaine hydrochloride (CARBOCAINE, dental anesthetic) and articaine hydrochloride, epinephrine bitartrate (SEPTOCAINE). Patient was not pregnant at the time of vaccination. Concomitant medications included anastrozole (ARIMIDEX), famotidine, ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC) and AREDS2, all received in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no COVID prior vaccination. On 20Jan2021, the patient experienced severe headache and fatigue for 7 days after though, which resulted in Doctor or other healthcare professional office/clinic visit. Patient reported that when vaccine was injected, she thought that vaccine leaked out and ran down her arm. She does not think that she had full dose. No treatment received for adverse events. On 28Jan2021, post vaccination, PCR test performed from nasal swab and received a negative result. On 04Feb2021, post vaccination, COVID test performed from saliva sample and received negative result. Outcome of the events headache and fatigue was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Trigger finger
Clinical narrative: experienced joint pain in my pinky of my left hand that was diagnosed as trigger finger; experienced joint pain in my pinky of my left hand that was diagnosed as trigger finger; back spasm on my left side; This is a spontaneous report from a contactable other Health Professional (Patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 08Feb2021 16:30 (Lot Number: Unknown) and dose 1 via an unspecified route of administration on 11Jan2021 14:00 (Lot Number: Unknown), both as SINGLE DOSE (at the age of 43-years) in arm left for covid-19 immunization. Patient was not pregnant at the time of vaccination. Patient's medical history was not reported. Patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unspecified date, the patient experienced joint pain in her pinky of her left hand that was diagnosed as trigger finger. It happened very suddenly and had it before. She also experienced a back spasm on her left side. She went to urgent care and they told her that they are seeing many people with spasming. Patient received an unspecified anti-inflammatory injection, and muscle relaxer as treatment for the event. Since the vaccination, the patient was not tested for COVID-19. Outcome of the event back spasm on my left side was unknown and for all other events, it was recovered with sequel on an unknown date.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Nausea
Clinical narrative: chills; Fatigue; Some shortness of breath; Very slight headache; slight nausea; This is a spontaneous report received from a contactable consumer. This 85-year-old female consumer (patient) reported in response to Non-HCP letter sent in cross reference case. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot: EN6203, Expiration date not reported) via intramuscular route on upper Left arm on 24Feb2021 at 07:15 A.M single dose for COVID-19 immunisation. Patients medical history included Pain, swelling in left wrist from 15Nov2020 (ongoing, doctor suggested wrist brace and ibuprofen when needed) and on 15Feb2021, the patient had Pain still in wrist (ongoing, was given injection of 40mg, Kenalog eased pain immediate). Patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot: EL9264) via intramuscular route on upper Left arm on 03Feb2021 at 09:40 A.M as single dose for Covid-19 immunization and experienced pain in wrist. The patient's concomitant medications were not reported. Patient experienced in reaction to vaccine was chills, fatigue, some shortness of breath, very slight headache, slight nausea on unspecified date. Outcome of event was reported was reported as unknown.  Follow-up (15Mar2021): The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (15Mar2021), this case now contains all required information to be considered valid.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration in left arm on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated with her first dose, she had nothing, just some soreness at the injection site. The patient further stated she got her vaccine, clarifies it was the second dose (Lot number: EL9265, Expiration date: May2021) on Friday, 02Feb2021, states she has redness (in left arm) at the injection site on 06Feb2021 and states it was swollen yesterday with a red rash around it, states it is not as swollen today. Patient stated yesterday she could feel the thickness of the bump at the site but today it is not as bad. Patient is wondering if this is something she should be concerned about, is it an allergic reaction. The outcome of the event was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: sharp pain in right shoulder; Headache; Chills; Fever; This is a spontaneous report from a contactable consumer (reported for herself). A 73-years-old female patient received BNT162B2 (BNT162B2, Solution for injection, Lot Number: ES9261), via intramuscular route of administration in left arm on 02Feb2021 at 08:45 am as single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient had pain in her right shoulder hit her, then it went up into her head and it was horrible. The pain in her right shoulder in her joint went away when the pain moved to her head. Between 430-5pm the pain started in her head. It was the worst headache she ever experienced. She could not even clear her throat since it felt like the top of her head was going to come off. By 9pm her headache was subsiding, and she had a good night's sleep and had fever and chills. The patient received Tylenol. The outcome of the events sharp pain in right shoulder and Chills was recovered on 05Feb2021.The outcome of the other events was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Bed rest, Chest pain, Chills
Clinical narrative: Intense tingling on palms and bottom; chills; weakness; stomach pain; chest pain; low grade fever; needed bed rest; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received first dose of BNT162B2 (BNT162B2), Via an unspecified route of administration, administered in Arm Right on 09Jan2021 08:30 (Batch/Lot Number: EK9231) as single, dose 2 via an unspecified route of administration, administered in Arm Right on 30Jan2021 (Batch/Lot Number: EL9262) as single for covid-19 immunisation. The patient Medical history included glaucoma, asthma, hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications included simvastatin (SIMVASTATIN); atropine (ATROPINE); dorzolamide (DORZOLAMIDE); escitalopram oxalate (LATA) taken for an unspecified indication, start and stop date were not reported. The patient experienced intense tingling on palms and bottom (paraesthesia), chills (chills), weakness (asthenia), stomach pain (abdominal pain upper), chest pain (chest pain), low grade fever (pyrexia), needed bed rest (bed rest) on 09Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Feb2021. Therapeutic measures were taken as a result of intense tingling on palms and bottom (paraesthesia), chills (chills), weakness (asthenia), stomach pain (abdominal pain upper), chest pain (chest pain), low grade fever (pyrexia), needed bed rest (bed rest). The outcome of events was recovering.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Intense tingling on palms and bottom; chills; weakness; stomach pain; chest pain; low grade fever; needed bed rest; This is a spontaneous report from a contactable consumer (Patient). A 58-years-old male patient received first dose of BNT162B2 (BNT162B2), Via an unspecified route of administration, administered in Arm Right on 09Jan2021 08:30 (Batch/Lot Number: EK9231) as single, dose 2 via an unspecified route of administration, administered in Arm Right on 30Jan2021 (Batch/Lot Number: EL9262) as single for covid-19 immunisation. The patient Medical history included glaucoma, asthma, hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications included simvastatin (SIMVASTATIN); atropine (ATROPINE); dorzolamide (DORZOLAMIDE); escitalopram oxalate (LATA) taken for an unspecified indication, start and stop date were not reported. The patient experienced intense tingling on palms and bottom (paraesthesia), chills (chills), weakness (asthenia), stomach pain (abdominal pain upper), chest pain (chest pain), low grade fever (pyrexia), needed bed rest (bed rest) on 09Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Feb2021. Therapeutic measures were taken as a result of intense tingling on palms and bottom (paraesthesia), chills (chills), weakness (asthenia), stomach pain (abdominal pain upper), chest pain (chest pain), low grade fever (pyrexia), needed bed rest (bed rest). The outcome of events was recovering.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, SARS-CoV-2 test, Vertigo
Clinical narrative: dizziness; vertigo; nausea; This is a spontaneous report from a contactable consumer (reporting herself). This 51 year old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9810), via an unspecified route of administration in left arm on 09Feb2021 at 14:45 as a single dose for COVID-19 immunisation. The patient did not received any other vaccine in 4 weeks of COVID vaccination. The patient did not received any other medication in two weeks of COVID vaccination. On 28Jan2021, the patient underwent Nasal Swab COVID test post vaccination which resulted as negative. On 10Feb2021, the patient did not feel sore arm until around 9pm. Approximately 5 hours later at 05:00, after sleep, upon waking, experienced intense dizziness, vertigo, nausea. Dizziness and nausea was currently present while lying, sitting & standing. The patient did not received any treatment for the events. The patient had no COVID before vaccination. On 28Jan2021, the patient underwent Nasal Swab COVID test post vaccination which resulted as negative. The patient received fist dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 20Jan2021 at 13:00 as a single dose for COVID-19 immunization previously. The outcome of dizziness and nausea was not recovered and vertigo was unknown.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pyrexia, Sinus headache
Clinical narrative: Fever; Chills; Mild injection site soreness; Sinus headache; This is a spontaneous report received from a contactable consumer (patient). A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EL3247 via an unspecified route of administration in left arm on 17Feb2021 at 14:00 (at the age of 27-year-old) as a single dose for COVID-19 immunization. Patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: Unknown) as a single dose on an unspecified date. On 18Feb2021 at 03:00, the patient experienced fever, chills, mild injection site soreness and sinus headache. The patient did not receive any treatment for the events. The outcome for the events was recovering.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Insomnia
Clinical narrative: sleep was restless; chills; This is a spontaneous report from a contactable consumer.(patient himself) in response to Non HCP follow-up letter sent in cross referenced case .   A 68-year old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9810,), via an Arm left on 03Feb2021 at 10:00 am as a single dose (Age at Vaccination: 68 years) and was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3249), via Arm left on 13Jan2021 as single dose for Covid-19 immunization. Medical history included: Hypothyroidism on an unspecified date in 1990 treated with low dose levothyroxine. Concomitant medications include: Levothyroxine which the patient have been taking for many years and is still ongoing.  Dose #2 also resulted in chills 14 hours after injection on 04Feb2021. Chills lasted longer and sleep was restless on 04Feb2021, on by next day. patient felt fine. Admission to hospital due to the event was no. No Problems following initial minor side effect of chills. Second dose received 03Feb2021 at 10:00 am. During the following night sleep was fitful and chills were again experienced and they were more severe. During the day (04Feb2021). Patient  felt fine and as of 05Feb2021. there are no problems. The reported issue occur after use of a Pfizer Product was yes Therapeutic measures were none. Outcome of the events was recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pyrexia
Clinical narrative: Fever & chills; enlarged lymph node under right arm; Fever & chills; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 17Feb2021 12:00 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL). Concomitant medication(s) included vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 27Jan2021 13:45 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies. Since 18Feb2021 01:45, the patient experienced Fever & chills, enlarged lymph node under right arm. No treatment received for AE. Outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm pain and swelling; Arm pain and swelling; This is a spontaneous report from a contactable consumer(patient himself) or other non hcp. A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection),via an unspecified route of administration on 17Feb2021 01:45 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation .The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm pain and swelling. The outcome of event was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Cough, Headache, Nausea
Clinical narrative: severe pain; joint pain; headache; fever; nausea plus heavy chest feeling; Have persistent cough; Heavy chest feeling; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 13:15 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunisation.  Medical history included gastrooesophageal reflux disease. Concomitant medication(s) included vitamin d3 (VITAMIN D3) taken for an unspecified indication, vitamin b complex (B COMPLEX [vitamin b complex]) taken for an unspecified indication, fish oil (fish oil) taken for an unspecified indication, biotin (BIOTIN) taken for an unspecified indication, start and stop date were not reported; famotidine (PEPCID [FAMOTIDINE]) taken for an unspecified indication.  The patient previously took covid-19 vaccine for covid-19 immunisation. On 15feb2021, at 18:30 the patient experienced severe pain, joint pain, headache, fever, nausea plus heavy chest feeling and have persistent cough. The patient was recovering from the events. The action taken in response to the event(s) for bnt162b2 was not applicable.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: severe pain; joint pain; headache; fever; nausea plus heavy chest feeling; Have persistent cough; Heavy chest feeling; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 13:15 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunisation.  Medical history included gastrooesophageal reflux disease. Concomitant medication(s) included vitamin d3 (VITAMIN D3) taken for an unspecified indication, vitamin b complex (B COMPLEX [vitamin b complex]) taken for an unspecified indication, fish oil (fish oil) taken for an unspecified indication, biotin (BIOTIN) taken for an unspecified indication, start and stop date were not reported; famotidine (PEPCID [FAMOTIDINE]) taken for an unspecified indication.  The patient previously took covid-19 vaccine for covid-19 immunisation. On 15feb2021, at 18:30 the patient experienced severe pain, joint pain, headache, fever, nausea plus heavy chest feeling and have persistent cough. The patient was recovering from the events. The action taken in response to the event(s) for bnt162b2 was not applicable.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Lethargy
Clinical narrative: Slight dizziness within 1 hour of injection; Lethargy; This is a spontaneous report from a contactable consumer (patient). A 64-Year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration date were unknown), via an unspecified route of administration on 17Feb2021 at 11:15 (at the age of 64-years-old) via unspecified route as a single dose in left arm for COVID-19 immunisation at workplace clinic. The patient's medical history included Urothelial carcinoma. The patient had no known allergies. Concomitant medications in two weeks were atenolol, Ascorbic Acid (VIT C), Ergocalciferol (VIT D). The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient received first dose (historical vaccine) of BNT162B2 (Lot Number: Unknown) on 21Jan2021, at 10:00 AM, in left arm, facility type for dose 1 was workplace clinic. On 17Feb2021 at 13:00, the patient experienced slight dizziness within 1 hour of injection and lethargy 10 hours after vaccine. Patient received no treatment for the adverse events. Patient received second vaccine on 17Feb2021, submitted report on 18Feb2021 and adverse events occurred on 17Feb2021. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was recovering. Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: I had a minor headache and fatigue; I had a minor headache and fatigue; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247 and expiry date were not reported), via an unspecified route of administration at left arm on 16Feb2021 at 13:30, as single dose for COVID-19 immunization. The patient did not have any allergies to medications, food or other products. Patient medical history was not reported. Concomitant medications included birth control pill, cetirizine hydrochloride (ZYRTEC) and womens multivitamin. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccina-tion. Patient has not been tested for COVID, post vaccination. On 16Feb2021 at 23:30, patient experienced minor headache and fatigue. Patient received treatment as 500 mg paracetamol (ACETA-MINOPHEN). The headache pain was alleviated by taking paracetamol (ACETAMINOPHEN). The out-come of events was recovered on 18Feb2021.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Nasal congestion, Pyrexia
Clinical narrative: stuffy nose; Low grade fever of 99.1; felt extremely fatigued about 6 hours later; minor headache; This is a spontaneous report from a contactable consumer. A 23-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3247) via an unspecified route of administration on 15Feb2021 at 12:30 PM on Left arm as a single dose (at the age of 23-years) for COVID-19 immunization at a workplace clinic. Medical history included: sore arm from first dose of BNT162B2 (Lot number: EL3247) via an unspecified route of administration on 25Jan2021 at 12:00 PM on left arm. Patient had known allergies of Amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Feb2021 (night of the 15th into the 16th), the patient experienced low grade fever of 99.1, felt extremely fatigued about 6 hours later, minor headache and stuffy nose. No treatment was provided for the events. Events persisted for 24 hours. The patient was not tested for COVID-19 post vaccination. The outcome of events was recovered on an unspecified date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had my first Pfizer vaccine and few days later I tested positive for COVID; Had my first Pfizer vaccine and few days later I tested positive for COVID; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration, administered. The patient medical history and concomitant medications were not reported. Caller received her first dose of Pfizer's COVID vaccine and a few days later, she tested positive for COVID. She will have gone through her isolation of quarantine period and will be symptom free by the time she gets her second dose. Caller is wondering if she should be receiving her second dose. At the time of reporting the outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Myalgia, Secretion discharge
Clinical narrative: vertigo; Fatigue; muscle pain; stomach cramps; Diarrhea; mucus from sinus; This is a spontaneous report from a contactable other Non- HCP. A 82-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL9261) via unspecified route of administration in left arm on 06Feb2021 (at the age of 82-Year-old) for COVID-19 immunization. Medical history included diabetes, high blood pressure, overweight. The patient was not pregnant. Concomitant medication included ezetimibe 10 mg once daily; metformin 1000 mg twice daily; acetylsalicylic acid (ASPIRIN) 81 mg once daily; chromium picolinate, cinnamomum verum bark, colecalciferol (CINSULIN ADVANCED STRENGTH) (medications in two weeks). No other vaccine in four weeks. The patient previously took first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL1283) in left arm on 16Jan2021 for COVID-19 immunization. On 06Feb2021, patient experienced muscle pain, fatigue, stomach cramps and diarrhea, mucus from sinus, vertigo. No treatment was received for events. No COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; Fatigue; muscle pain; stomach cramps; Diarrhea; mucus from sinus; This is a spontaneous report from a contactable other Non- HCP. A 82-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL9261) via unspecified route of administration in left arm on 06Feb2021 (at the age of 82-Year-old) for COVID-19 immunization. Medical history included diabetes, high blood pressure, overweight. The patient was not pregnant. Concomitant medication included ezetimibe 10 mg once daily; metformin 1000 mg twice daily; acetylsalicylic acid (ASPIRIN) 81 mg once daily; chromium picolinate, cinnamomum verum bark, colecalciferol (CINSULIN ADVANCED STRENGTH) (medications in two weeks). No other vaccine in four weeks. The patient previously took first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL1283) in left arm on 16Jan2021 for COVID-19 immunization. On 06Feb2021, patient experienced muscle pain, fatigue, stomach cramps and diarrhea, mucus from sinus, vertigo. No treatment was received for events. No COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Fever; Nausea; sore muscles; This is a spontaneous report received from a contactable consumer (patient). A 71-years-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: E19267), via an unspecified route of administration in the left arm on 17Feb2021 at 14:30 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included high blood pressure and high cholesterol. The patient did not have any known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Post the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medication patient received within 2 weeks of vaccination included hydrochlorothiazide, triamterene (DYAZIDE) and simvastatin. On 17Feb2021 at 22:00, the patient experienced fever, nausea and sore muscles. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Information on the lot/batch number is captured.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Oropharyngeal pain, Pain
Clinical narrative: Sore throat; I have had a terrible cough and it is so bad that my body aches when I cough; I have had a terrible cough and it is so bad that my body aches when I cough; Headache; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 62-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Dose number: unknown, Lot number: EN5318, Expiry date: May2021) via an unspecified route of administration, administered in left arm on 30Jan2021 (age at vaccination was unknown) at a single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included lisinopril (LISINOPRIL). The patient received the vaccine on 30Jan2021(not clarified) and on the 4th (not clarified), she got a sore throat and then on the 5th (not clarified) and since then she has had a terrible cough and it was so bad that her body aches when she coughs. The patient did not go to any Physician Office/ Emergency Room and was going to go as soon as after she had a talk. That's what she wanted to know if she should go or not. The patient has been taking cough medicine and Tylenol for the headache as a treatment. The outcome of all the events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pruritus
Clinical narrative: I started to get itchy everywhere; cough; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route of administration on unknown date in Feb2021 at single dose for covid-19 immunization. Patient also received Benadryl (manufacturer unknown, formulation unknown, lot number not reported (It doesn't say lot, it just says SJF001) and expiration Mar2022) on an unspecified date via unknown route for unknown indication. The patient's medical history included migraine. The patient's concomitant medications include adalimumab, Methotrexate, omeprazole, Olmesartan, Folic acid, Promethazine and bupropion hydrochloride. On an unknown date 2021, the night of that day, patient got a reaction, that evening, she started to get itchy everywhere, that would not stop. So, she took Benadryl but that did not help and saw her doctor in the morning, and he gave her an injection of steroid (treatment). So, she was wondering if she should go ahead and get second one or not. The other thing was she did develop a cough that lasted for about a week. Date for next shot was 10Feb2021. She took Wellbutrin, 300 mg because it was the extended release. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on her trunk and head; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Right on 12Feb2021 (Batch/Lot Number: EL9267) as single dose for covid-19 immunisation. Medical history included diabetes which was also a family history of patient. Concomitant medications included metformin 1000 mg once daily for diabetes mellitus, Januvia 100 mg once daily for diabetes mellitus. The patient previously took iron infusion and got a reaction and had allergic to sulfur. On 13Feb2021, patient woke up with hives on her trunk and head. Patient called her doctor in the morning and asked if she could take the Benadryl, he said she could but that didn't seem to work. Patient went to the MD who gave her a shot of prednisone that did work with unspecified medication and some Prednisone 20 mg tablets to take for 5 days with Zyrtec as a treatment for the event and patients hives went away within hours. Outcome of event recovered.  Call back was done to gather details of Unspecified medications and Product details for Iron infusion. However, it was not successful.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Hypoacusis, Malaise, Swelling
Clinical narrative: he was not feeling well; Really swelled up; his arthritis is getting worst; Hard of hearing; This is a spontaneous report from a contactable consumer (Patient). A 73-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 27Jan2021 (Batch/Lot Number: EL9265) as single dose for covid-19 immunisation. Medical history included none. There were no concomitant medications. On 10Feb2021, the patient experienced really swelled up, his arthritis is getting worst, hard of hearing and he was not feeling well on an unspecified date. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event he was not feeling well was unknown while for the rest of the events it was not recovered.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inflammation, Injection site erythema, Pruritus
Clinical narrative: inflamation; My left hand became very red; very servere itching; sever head pain; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 01:30 (Batch/Lot Number: EL9265) as single dose for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported. On 01Feb2021 13:00, the patient experienced inflamation, my left hand became very red and very servere itching, sever head pain. The action taken in response to the events for BNT162B2 was not applicable. Therapeutic measures were taken as a result of inflamation, my left hand became very red, very servere itching, sever head pain. The outcome of events was Recovering.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: I woke up feeling a little nauseated; My back ached slightly; chills; had a fever of 100.8; This is a spontaneous report from a contactable Consumer (Patient). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 17Feb2021 01:30 (Batch/Lot Number: EL9267) as single dose for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing (Multiple Sclerosis asymptomatic for 30 years). Concomitant medication included celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported. On 18Feb2021 07:00, the patient reported i woke up feeling a little nauseated, my back ached slightly, chills, had a fever of 100.8. I took Ibuprofin with no alleviation of symptoms. A few hours later I tried Tylenol - with no change. Later in the afternoon I took aspirin. The patient underwent lab tests and procedures which included body temperature: 100.8 on 18Feb2021 (around 100.5 at 4:00 p.m. By 6:00 pm my temp reading was 99.4.). he action taken in response to the events for BNT162B2 was not applicable. Therapeutic measures were taken as a result of had a fever of 100.8. The outcome of events was Recovering.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Dizziness, Hyperhidrosis, Pain
Clinical narrative: Fever; Chills; Body aches; abdominal pain; dizziness; sweating; This is a spontaneous report from a contactable other health professional (patient). A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 intramuscular, administered in Arm Right on 17Feb2021 14:30 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 intramuscular, administered in Arm left on 27Jan2021 15:00 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. On 17Feb2021 14:30, the patient experienced fever, chills, body aches, abdominal pain, dizziness, sweating. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; Body aches; abdominal pain; dizziness; sweating; This is a spontaneous report from a contactable other health professional (patient). A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 intramuscular, administered in Arm Right on 17Feb2021 14:30 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 intramuscular, administered in Arm left on 27Jan2021 15:00 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. On 17Feb2021 14:30, the patient experienced fever, chills, body aches, abdominal pain, dizziness, sweating. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Fatigue, Rash vesicular, Tenderness
Clinical narrative: Tender; sore to the touch or clothing; blistered rash the size of a quarter; Got pressure in the middle of my chest and both breasts; Tiredness; weakness; This is a spontaneous report from a contactable consumer (Patient). A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 12:00 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included lorazepam 1mg, metoprolol succinate 25 mg (TOPROL XL) taken for an unspecified indication, start and stop date were not reported. On 05Feb2021, the patient experienced got pressure in the middle of my chest and both breasts, tiredness and weakness, On 07Feb2021, blistered rash the size of a quarter, On an unspecified date, tender and sore to the touch or clothing. Day 1 I got pressure in the middle of my chest and both breasts. Tiredness and weakness. Day 2 it slowly eased. Day 3 I got a red blistered rash the size of a quarter directly above my right nipple. It has been 13 days and the rash has gotten smaller to the size of a dime with blisters remaining. The sight is tender and sore to the touch or clothing. The action taken in response to the event for BNT162B2 was not applicable. The outcome of events for tender and sore to the touch or clothing was unknown, for blistered rash the size of a quarter it was recovering while for the rest of the it was not recovered.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tender; sore to the touch or clothing; blistered rash the size of a quarter; Got pressure in the middle of my chest and both breasts; Tiredness; weakness; This is a spontaneous report from a contactable consumer (Patient). A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 12:00 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included lorazepam 1mg, metoprolol succinate 25 mg (TOPROL XL) taken for an unspecified indication, start and stop date were not reported. On 05Feb2021, the patient experienced got pressure in the middle of my chest and both breasts, tiredness and weakness, On 07Feb2021, blistered rash the size of a quarter, On an unspecified date, tender and sore to the touch or clothing. Day 1 I got pressure in the middle of my chest and both breasts. Tiredness and weakness. Day 2 it slowly eased. Day 3 I got a red blistered rash the size of a quarter directly above my right nipple. It has been 13 days and the rash has gotten smaller to the size of a dime with blisters remaining. The sight is tender and sore to the touch or clothing. The action taken in response to the event for BNT162B2 was not applicable. The outcome of events for tender and sore to the touch or clothing was unknown, for blistered rash the size of a quarter it was recovering while for the rest of the it was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site swelling, Lymphadenopathy
Clinical narrative: headache; swollen lymph nodes; muscle/joint pain; joint pain; tiredness; injection site soreness; injection site swelling; nausea; generally felt unwell; This is a spontaneous report from a contactable Consumer (Patient). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 13Feb2021 16:00 (Batch/Lot Number: EM9809) as single dose for covid-19 immunisation. Medical history included arthritis and overweight from an unknown date and unknown if ongoing. Concomitant medication included meloxicam and zolpidem. On 15Feb2021 08:00, the patient experienced headache, swollen lymph nodes, muscle/joint pain, joint pain, tiredness, injection site soreness, injection site swelling, nausea and generally felt unwell. The action taken in response to the events for bnt162b2 was not applicable. The outcome of event was recovering.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Vaccination site pain
Clinical narrative: headache; swollen lymph nodes; muscle/joint pain; joint pain; tiredness; injection site soreness; injection site swelling; nausea; generally felt unwell; This is a spontaneous report from a contactable Consumer (Patient). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 13Feb2021 16:00 (Batch/Lot Number: EM9809) as single dose for covid-19 immunisation. Medical history included arthritis and overweight from an unknown date and unknown if ongoing. Concomitant medication included meloxicam and zolpidem. On 15Feb2021 08:00, the patient experienced headache, swollen lymph nodes, muscle/joint pain, joint pain, tiredness, injection site soreness, injection site swelling, nausea and generally felt unwell. The action taken in response to the events for bnt162b2 was not applicable. The outcome of event was recovering.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Pain, Tremor
Clinical narrative: stomach aches; he's got the shakes; his right back, shoulder and back of his neck, his legs, his trunk of his body are sore, everywhere his muscle are sore; Diarrhea; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 25Dec2020 (Batch/Lot Number: EL9261; Expiration Date: 31May2021) as single dose for an unspecified indication. Medical history included myocardial infarction from an unknown date and unknown if ongoing (He had 2 heart attacks and open heart surgery and he is sick of this already), cardiac operation from an unknown date and unknown if ongoing (He had 2 heart attacks and open heart surgery and he is sick of this already) rhinorrhoea from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 28Dec2020, the patient experienced diarrhea, stomach aches, he's got the shakes, his right back, shoulder and back of his neck, his legs, his trunk of his body are sore, everywhere his muscle are sore. Patient says the 25th of last month, 25Dec he got his first shot, that was 14 days ago and 3 days after he got diarrhea it was pretty severe but then that cleared up and he was ok for few days and then he got stomach aches, the stomach aches woke him up at 5o'clock in the morning and then he had the stomach ache 03Feb. It was 3 times he had the stomach aches. Today he's got the shakes but he also has Parkinson's so a lot of things amplify his Parkinson's, so he is not overly concerned about the shaky thing. shaky thing happens periodically to him but it is pretty bad today. What he did to rectify is he took his normal medicine and he has taken an antacid on those days when he had the stomach ache and one other thing, the second thing was the stomach aches and also his right back, shoulder and back of his neck, his legs, his trunk of his body are sore, everywhere his muscle are sore and he is having a runny nose, the runny nose is the last thing but at the same time the runny nose was happening prior to taking the shot so that might not be related. He is calling to see if those things are associated with the vaccine. During that time period of time he took his temperature and he did not have a fever at any time. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.