chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: My left side of my face went numb. Same side I got vaccine on  has been getting less numb; This is a spontaneous report from a contactable other health care professional (HCP) patient. A 61-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection (Lot Number: EN62D6) via unspecified route of administration at left arm (at the age of 61-year-old) on 05Mar2021 15:45 as a single dose for COVID-19 immunisation. Medical history was known allergies Peaches. Concomitant medications were not reported. The patient previously received amoxicillin; clavulanic acid (AUGMENTINE) and experienced allergies. Patient did not on any vaccination four weeks prior. Patient did not take other medications in two weeks. Patient did not diagnosed with COVID prior to vaccination and post COVID vaccination. On 05-MAR-2021 15:45 patient experienced left side of my face went numb. Same side she got vaccine on has been getting less numb. No treatment was received for the events. Outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: tired; sore shoulder; headache for only one evening; This is a spontaneous report from a contactable consumer (patient himself). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6201 and expiration date: unknown), via an unspecified route of administration in left arm on 04Mar2021 at 08:30 as a single for COVID-19 immunisation. The patient's medical history included allergies to any cillin. Concomitant medications were not reported. The patient has not received any other vaccinations in four weeks nor other medications in two weeks. The patient was not diagnosed with Covid prior to vaccination and has not tested for Covid post vaccination. After first dose, on an unspecified date the patient experienced tired, sore shoulder and headache for only one evening. No treatment received for the adverse events. The outcome of the events was reported as recovering.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; This is a spontaneous report from a contactable Physician. A 78-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular in arm left on 03Mar2021 as a 2nd dose, single for COVID-19 immunisation. The patient's medical history included HTN, dyslipidemia. Age at vaccination was 78 years. The patient's concomitant medications in two weeks included atorvastatin, hydrochlorothiazide, triamterene (TRIAMTERENE-HCTZ). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular in arm left on 10Feb2021 as a 1st dose, single for COVID-19 immunisation. It was reported that, no other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 05Mar2021, the patient experienced vertigo. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment medication included was meclizine. The outcome of the event was recovering.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Lymphadenopathy
Clinical narrative: Sore joints; temp 100; chills; swollen lymph nodes in right armpit; mild headache; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Right arm on 04Mar2021 14:30 (at the age of 50-years-old) as a SINGLE DOSE for COVID-19 immunisation. The patient's medical history was not reported and patient had no known allergies. Concomitant medication included atorvastatin, taken for an unspecified indication on an unspecified date received within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EC-3249), via an unspecified route of administration, administered in Left arm on 11Feb2021 at 14:30 (at the age of 50-years-old) as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 05Mar2021 at 09:00, the patient experienced Sore joints, temp 100, chills, swollen lymph nodes in right armpit, mild headache. The patient underwent lab tests and procedures which included body temperature: 100 degrees on 05Mar2021. No treatment was received for adverse events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore joints; temp 100; chills; swollen lymph nodes in right armpit; mild headache; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Right arm on 04Mar2021 14:30 (at the age of 50-years-old) as a SINGLE DOSE for COVID-19 immunisation. The patient's medical history was not reported and patient had no known allergies. Concomitant medication included atorvastatin, taken for an unspecified indication on an unspecified date received within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EC-3249), via an unspecified route of administration, administered in Left arm on 11Feb2021 at 14:30 (at the age of 50-years-old) as SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 05Mar2021 at 09:00, the patient experienced Sore joints, temp 100, chills, swollen lymph nodes in right armpit, mild headache. The patient underwent lab tests and procedures which included body temperature: 100 degrees on 05Mar2021. No treatment was received for adverse events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Migraine, Vomiting
Clinical narrative: migraine headache; weakness; I woke up the next morning approximately 6 AM violently vomiting; This is a spontaneous report from a contactable Other Health Professional (Patient). A 54-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Right on 04Mar2021 18:00 as 1st dose, single dose for covid-19 immunisation. Medical history included rheumatoid arthritis, Hashimoto's thyroiditis, sjogren's syndrome from 1992 to an unknown date, chronic back pain, previous posterior anterior surgery with placement of Harrington rods 1992. known allergies: Sulpha drugs. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN); aripiprazole; fluoxetine and trazodone. No COVID prior vaccination. No COVID tested post vaccination. No other vaccine in four weeks. Patient was not pregnant at the time of vaccination. It was reported that patient woke up the next morning approximately 6 AM violently vomiting, migraine headache and weakness on 05Mar2021. Patient did not receive any treatment for events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Achiness; 102 fever; chills.; This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 10Feb2021 05:00 as 1ST DOSE, SINGLE DOSE, dose 2 via an unspecified route of administration on 06Mar2021 01:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism. Concomitant medication included levothyroxine (LEVOTHYROXINE). The patient experienced achiness, 102 fever and chills on 05Mar2021 09:30. The patient underwent lab tests and procedures which included body temperature: 102 on. Outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (Patient). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EN6205), via an unspecified route of administration, on 04Mar2021 14:00 (at age of 72-year-old) as single, in Arm Left for Covid-19 immunization. The patient's medical history included poly myalgia rheumatica. The patient's past drug event included erythromycin with reaction included drug allergy and he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EL9269), via an unspecified route of administration, on 09Feb2021 01:30 PM (at age of 72-year-old), as single in Arm Left for, Covid-19 immunization. The patient's concomitant medications included prednisone, amitriptyline, lorazepam and ezetimibe. The patient did not have covid prior to vaccination and was not tested positive post vaccination. The patient did not receive other vaccine in four weeks. On 05Mar2021 12:00, the patient experienced diarrhea. The patient received treatment with Pepto Bismol and Immodium for the event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate, Heart rate increased
Clinical narrative: Fast heartbeat; chestpain; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 05Mar2021 13:45 (01:45 PM) (at the age of 58-year-old) as a single dose for COVID-19 immunization. The patient medical history included COPD. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient did not receive any other vaccines prior to the COVID vaccine within 4 weeks. The patient experienced fast heartbeat, chest pain on 05Mar2021 22:30 (10:30 PM). The patient underwent lab tests and procedures which included heart rate was fast on 05Mar2021. The patient had not tested for COVID-19 post vaccination. The patient did not receive any treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Myalgia, Pyrexia
Clinical narrative: face redness; Headache so bad thought my head was going to explode; fever; muscle aches; chills; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 06Mar2021 10:15 (at the age of 50-year-old), at a 2nd dose, single dose for covid-19 immunisation. Medical history included Hbp (Hypertension), hashimoto disease, asthma, patient was allergic Sulfa, penicillin, patient had covid prior vaccination. Concomitant medications included montelukast sodium (SINGULAIR); levothyroxine; propranolol; vitamins nos (MULTIVITAMINS). Historical vaccine included first dose BNT162B2 for covid-19 immunisation. On an unspecified date in Mar2021 the patient experienced Headache so bad thought her head was going to explode, fever, muscle aches, chills, face redness. Patient did not receive treatment for the adverse event. Patient did not tested covid post vaccination. Outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Sore arm; chills; body fatigue; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: En6203), via an unspecified route of administration, administered in right arm on 05Mar2021 03:00 PM (age at vaccination was 55 years) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was no known allergies. No other vaccine was received by patient in four weeks and no other medications was received by patient in two weeks. The patient was not had covid prior vaccination and not tested for covid post vaccination. On 05Mar2021 10:00 PM, the patient experienced sore arm, chills and body fatigue. No treatment received for adverse events. Outcome of the events was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male (same age at vaccination) patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot no: 59267-1000-01) via unspecified route of administration on 05Mar2021 11:30 AM in right arm for COVID-19 immunisation. other vaccine was also reported on 05Mar2021. Medical history was not reported. Concomitant medications reported was Hydrochlorothiazide 25mg and vitamins nos (MULTIVITAMIN). No COVID prior vaccination, neither patient COVID tested post vaccination and no known allergies were reported. Patient experienced Mild injection site soreness on 05Mar2021 at 03:00 PM. No treatment was received in response to the event. outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chills, Headache, Pain
Clinical narrative: Day after vaccine at 3 p.m.- chills; total body aches; headache; soreness on left side below breast bone.; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 04Mar2021 16:00, as 1st dose, single for COVID-19 immunisation. Medical history included COVID-19. The patient's concomitant medication included Multivitamin (Other medications in two weeks). Other medical history was not provided. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 15:00, patient experienced day after vaccine at 3 p.m.- chills, total body aches, headache and soreness on left side below breastbone. Therapeutic measures were taken as a result of day after vaccine at 3 p.m.- chills, total body aches, headache, soreness on left side below breastbone. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Rash, SARS-CoV-2 test
Clinical narrative: Flush face immediately after. Rash on left side of body after 14 hours. Mostly disappeared after 24 hours 48 hours rash over whole body; Flush face immediately after. Rash on left side of body after 14 hours. Mostly disappeared after 24 hours 48 hours rash over whole body; This is a spontaneous report from a contactable other hcp. A 29-years-old non-pregnant female patient received first dose of BNT162B2(Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 03Mar2021 12:00 PM at the age of 29 years as 1ST DOSE SINGLE for covid-19 immunisation. Medical history included Low blood pressure, Recurrent UTI (Urinary tract infection), Recurrent BV (Bacterial vaginosis), vitamin d deficiency, history of abnormal Pap, sensitivity to pork products. The patient had covid before vaccination. The concomitant medications included Birth control, antibiotics and topical antibiotics. Patient did not receive any other vaccines within 4 weeks. On 03Mar2021 patient experienced flush face immediately after. Rash on left side of body after 14 hours. Mostly disappeared after 24 hours 48 hours rash over whole body. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: After first and second shots, experienced a moderate burning sensation in feet and toes the first night. Lasted a couple of hours. No other side effects. I have never had that sensation before.; This is a spontaneous report received from a contactable consumer (Patient). A 67-year-old non pregnant female patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm left on 06Feb2021 15:00 (Lot Number: EN6201) as first dose single and via an unspecified route of administration, administered in arm left on 05Mar2021 (Lot Number: EL9266) as second dose single for covid-19 immunisation. Medical history included known allergies: Penicillin. Concomitant medications included losartan, atorvastatin, omeprazole and anastrozole. 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 06Feb2021 22:30, after first and second shots, patient experienced a moderate burning sensation in feet and toes the first night. Lasted a couple of hours. No other side effects. She never had that sensation before. No treatment was received. The event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Nausea
Clinical narrative: nausea; slight dizziness; muscle pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Mar2021 as single for covid-19 immunisation. The patient's medical history and concomitant medication were was not reported. After receiving the first dose, after 21 hours he experienced nausea, slight dizziness and muscle pain on an unspecified date on Mar2021. The patient wanted to know if he can get the 2nd dose of the vaccine due to these symptoms The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Hypoaesthesia, Vaccination site pain
Clinical narrative: Facial numbness left side:  cheek, eye, ear.  Skin sensitivity left top forehead at hairline.Arm soreness (left upper); Facial numbness left side:  cheek, eye, ear.  Skin sensitivity left top forehead at hairline.Arm soreness (left upper); Facial numbness left side:  cheek, eye, ear.  Skin sensitivity left top forehead at hairline.Arm soreness (left upper); This is a spontaneous report from a contactable consumer or other non hcp.A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: IN6205), via an unspecified route of administration, administered in Arm Left on 05Mar2021 08:45 as 1st dose, single dose for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. Concomitant medications includes vitamin-D and multivitamins taken for an unspecified indication, start and stop date were not reported.The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient experienced facial numbness left side: cheek, eye, ear. Skin sensitivity left top forehead at hairline. Arm soreness (left upper) on 05MAR2021 09:00. The events were assessed as non-serious. The treatment was not received for the events. The patient had no known allergies medications, food, or other products. Caller had facial numbness on left side particularly the cheek, eye, and ear which happened 20-25minutes after receiving vaccine and subsided about 5 days after injection. Caller also had skin sensitivity on left top forehead at hairline which dissipated about 5 days after the vaccine. Caller also stated she had what she thinks is normal but arm soreness in left upper arm that went away about 3 days after receiving vaccine. Caller states that the arm soreness is nothing it is the numbness she is very concerned about. Caller has a question on if she should receive the second dose. 71-year-old caller confirmed she experienced side effects after getting the first dose of the Pfizer-BioNTech COVID-19 vaccine. She asked if she should receive the second dose. She explained she has already spoken to her HCP. Caller explained the Medical Information line is very misleading as it cannot provide a treatment recommendation regarding her second dose of the Pfizer-BioNTech COVID-19 vaccine. She added she waited for almost two hours before being able to speak with an MI agent. She stated it is very disappointing and discouraging. The outcome of the event was reported as recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling cold, Peripheral coldness
Clinical narrative: B cold feeling (like stepping on cold water or ice ) at the arch of the foot/cold feeling at the R deltoid, R biceps and triceps, and R upper leg; B cold feeling (like stepping on cold water or ice ) at the arch of the foot/cold feeling at the R deltoid, R biceps and triceps, and R upper leg; Feeling less energetic but able to do ADL; This is a spontaneous report from a contactable other HCP (health care professional, who reported for herself). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot Number: EN6203, expiration date unknown) 1st dose, via an unspecified route of administration administered in Arm Right on 28Feb2021 at 11:00 am, as single dose for covid-19 immunization. Medical history included B peripheral neuropathy post op (L5- S1), urinary retention postoperative, superficial melanoma (excision required, no treatments) and seasonal allergies. Concomitant medication included estrogens esterified, methyltestosterone (ESTRATEST); progesterone (PROMETRIUM [PROGESTERONE]); tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]); cyanocobalamin (B12 [CYANOCOBALAMIN]); collagen (COLLAGEN) and Biot. The patient previously took IV Infed on which experienced anaphylaxis) and IC Feraheme on which experienced hives. The patient had not received prior covid vaccination and had not tested covid post vaccination. The caller stated that after receiving the first dose of vaccine on 03Mar2021 she experienced B cold feeling (like stepping on cold water or ice) at the arch of the foot, cold feeling at the R deltoid, R biceps and triceps, and R upper leg and was feeling less energetic but able to do ADL. The patient had not received any treatment to treat the event. The outcome of the events was not recovered.  No Follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: I had a flare up of Gout; This is a spontaneous report from a contactable consumer (patient).   A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6198) via an unspecified route of administration on 03Mar2021 at 02:45 on left arm, single dose for COVID-19 immunization. The patient's medical history included gout immediately following surgery on her foot 5 years ago. It was reported that the patient did not receive any other vaccine in four weeks, he did not have covid prior to the vaccination, he did not test for covid post vaccination and had no allergies. The concomitant medication of the patient included pravastatin taken for an unspecified indication, start and stop date were not reported. The historical vaccine of the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9269) via an unspecified route of administration on 03Feb2021 at 10:15 AM on left arm as 1st dose, single dose for COVID-19 immunization. On 04Mar2021 at 1800 hours, one day after second dose of vaccination the patient experienced a flare up of gout. No treatment was received for the event.The outcome of event was reported as recovering.    No follow-up attempts were possible; information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Dizziness; Weakness; This is a spontaneous report from a contactable consumer. A 83-years-old female patient (mother)  received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced dizziness and weakness on an unspecified date. Caller stated that her mother got her second Vaccine shot a week ago and experienced dizziness and weakness. Caller asked if this is the reported side effect 7 days post vaccination for the second shot of the vaccine. Response: Spoke as per document attached and also stated that they don't  have specific information on the difference of the side effects people have gotten for either the first or second doseThe outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Feeling abnormal, Hypoaesthesia
Clinical narrative: unsteady on feet, almost "tipsy", as if returning to land after being on boat, Have  been experiencing for 4-5 days; unsteady on feet, almost "tipsy", as if returning to land after being on boat, Have  been experiencing for 4-5 days; unsteady on feet, almost "tipsy", as if returning to land after being on boat, Have  been experiencing for 4-5 days; This is a spontaneous report from a contactable consumer. This 78-year-old male consumer (Patient) reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL 9264 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 10:15 (Batch/Lot Number: EL 9264) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included, chronic kidney disease, coronary artery disease, hypothyroidism, hypertension from an unknown date and unknown if ongoing. No known allergies were reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), dose number; 1 on 18Jan2021 at 09:30 am at left arm for covid-19 immunization. Facility type vaccine was reported as other. The patient did not receive any other vaccines within 4 weeks. Concomitant medications (Other medications in two weeks) included allopurinol taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID), eicosatetraenoic acid ethyl ester (VASCEPA), rivaroxaban (XARELTO), rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported. On 02Mar2021 the patient experienced unsteady on feet, almost "tipsy", as if returning to land after being on boat, have been experiencing for 4-5 days. 2 others, not related, with same approx schedules, experiencing same feelings. No treatment was given for the AE. If covid prior vaccination: No, If covid tested post vaccination: No. The outcome of events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain
Clinical narrative: fever, (100-102); aches; chills; nausea; vomiting; headache; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9266, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 15:00 as 2nd dose, single dose for covid-19 immunisation. Medical history included drug hypersensitivity. Concomitant medication(s) included simvastatin (SIMVASTATIN)10mg; meloxicam (MELOXICAM)75mcg; levothyroxine (LEVOTHYROXINE)15mg. Patient had history of allergy to sulpha drugs. Patient previously took 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 02:30 PM as 1st dose, single dose for covid-19 immunisation. On 13Feb2021 03:00 The patient experienced fever, (100-102), aches, chills, nausea, vomiting, headache. Patient not tested positive before vaccination and tested post vaccination. The patient underwent lab tests and procedures which included body temperature:100-102 on 13Feb2021, sars-cov-2 test negative on 17Feb2021, 24Feb2021, 03Mar2021 respectively (covid test type post vaccination was other and covid test name post vaccination was PCR pool testing). The outcome of events recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: fever, (100-102); aches; chills; nausea; vomiting; headache; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9266, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 15:00 as 2nd dose, single dose for covid-19 immunisation. Medical history included drug hypersensitivity. Concomitant medication(s) included simvastatin (SIMVASTATIN)10mg; meloxicam (MELOXICAM)75mcg; levothyroxine (LEVOTHYROXINE)15mg. Patient had history of allergy to sulpha drugs. Patient previously took 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 02:30 PM as 1st dose, single dose for covid-19 immunisation. On 13Feb2021 03:00 The patient experienced fever, (100-102), aches, chills, nausea, vomiting, headache. Patient not tested positive before vaccination and tested post vaccination. The patient underwent lab tests and procedures which included body temperature:100-102 on 13Feb2021, sars-cov-2 test negative on 17Feb2021, 24Feb2021, 03Mar2021 respectively (covid test type post vaccination was other and covid test name post vaccination was PCR pool testing). The outcome of events recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Neck pain, Pain in extremity, Sneezing
Clinical narrative: Aches in neck, arms and legs; Aches in neck, arms and legs; Severe headache; Sneezing; Congestion; This is a spontaneous report from a non-contactable consumer (patient herself). A 55-years-old female non-pregnant patient 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, administered in arm left on 03Mar2021 at 19:00 (at the age of 55-years-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history included obesity from an unknown date and unknown if ongoing. Concomitant medication(s) included magnesium citrate (MAGNESIUM CITRATE), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) and multivitamin. It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was not reported whether the patient have allergies or not. On 03Mar2021 at 20:00, the patient experienced aches in neck, arms and legs, severe headache, sneezing and congestion. No treatment was given for the events. The outcome of the events was resolved on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Headache, Muscle tightness
Clinical narrative: Brain fog; headache; tired; nausea; extremely hot feeling; itchy all over; face tightness; This is a spontaneous report from a contactable other HCP (patient reported herself). A 46-year-old non-pregnant female patient received first dose of BNT162B2 (COVID 19, PFIZER, Solution for injection) via an unspecified route of administration, administered to her left arm on 05Mar2021 02:30 PM (Lot number: EL9267) as single dose for Covid-19 immunisation. The patient's medical history included high blood pressure (BP), chronic obstructive pulmonary disease (COPD) and post-traumatic stress disorder (PTSD). Known allergies: any caine medicine. Facility type vaccine: Public Health Clinic/Veterans Administration facility. Concomitant medications included lisinopril and tramadol (other medications in two weeks). On 05Mar2021 05:30 PM, the patient experienced brain fog, headache, tired, nausea, extremely hot feeling, itchy all over and face tightness. No COVID tested prior or post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus
Clinical narrative: Brain fog; headache; tired; nausea; extremely hot feeling; itchy all over; face tightness; This is a spontaneous report from a contactable other HCP (patient reported herself). A 46-year-old non-pregnant female patient received first dose of BNT162B2 (COVID 19, PFIZER, Solution for injection) via an unspecified route of administration, administered to her left arm on 05Mar2021 02:30 PM (Lot number: EL9267) as single dose for Covid-19 immunisation. The patient's medical history included high blood pressure (BP), chronic obstructive pulmonary disease (COPD) and post-traumatic stress disorder (PTSD). Known allergies: any caine medicine. Facility type vaccine: Public Health Clinic/Veterans Administration facility. Concomitant medications included lisinopril and tramadol (other medications in two weeks). On 05Mar2021 05:30 PM, the patient experienced brain fog, headache, tired, nausea, extremely hot feeling, itchy all over and face tightness. No COVID tested prior or post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Oral herpes, Peripheral swelling, Pyrexia
Clinical narrative: After the second vaccination have/had severe right arm swelling (still icing arm) entire upper arm swollen no redness; hot to touch; Fever; chills; cold sore upper lip; This is a spontaneous report from a contactable other hcp. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6198), dose 2 via an unspecified route of administration, administered in Arm Right on 03Mar2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Patient had previously received first dose of vaccine (Lot number: EM9809) in left arm on 10Feb2021 at 12:30. Patient did not receive other vaccine in four weeks of vaccination.Patient has not been tested for COVID, post vaccination. The patient's concomitant medications were not reported. On 03Mar2021, patient experienced severe right arm swelling (still icing arm) entire upper arm swollen no redness, hot to touch, fever, chills the next day lasting 2 days. Also now have a cold sore upper lip after the vaccination. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of after the second vaccination have/had severe right arm swelling (still icing arm) entire upper arm swollen no redness, hot to touch, fever, chills, cold sore upper lip. The outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Covid arm swelling; pain; redness; itching; This is a spontaneous report from a contactable consumer or other non hcp.   A 70-years-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, lot no: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 01Mar2021 19:45 as SINGLE DOSE for covid-19 immunization. Medical history included arthritis, bulging back discs and migraine headaches. Concomitant medication included acyclovir (ACYCLOVIR); sumatriptan succinate (IMITREX); magnesium (MAGNESIUM) and multivitamin taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient didn't have COVID prior vaccination. The patient did not test COVID post vaccination. The known allergies were none. On 02Mar2021 01:00, The patient experienced Covid arm swelling, pain, redness and itching around site of injection which continues to this day (06Mar2021).  There was no treatment provided for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Sore knuckle joints opposite hand; sore shoulder same arm as injection; sore arm at injection site; This is a spontaneous report from a contactable other health professional (patient). A 65-year-old non-pregnant female patient received bnt162b2 (BNT162B2), (Batch/Lot Number: EN6200) via an unspecified route of administration, administered in Arm Left on 17Feb2021 12:30 PM (age at vaccination was 65 years old) at an unknown single, for COVID-19 immunization. The patient's Medical history included cancer. The patient was not pregnant. The patient previously took morphine, codeine, Percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol], lidocaine and had allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. The patient received other medications in two weeks prior to vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications in two weeks prior to vaccination The patient did not receive any other vaccines within four weeks prior to the vaccination.The patient's concomitant medications were not reported. The patient experienced sore knuckle joints opposite hand, sore shoulder same arm as injection, sore arm at injection site on 18Feb2021 03:00. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included Nasal Swab PCR test: negative on 03Mar2021. The outcome of the events was recovered on unspecified date  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Myalgia, Nausea, Vomiting
Clinical narrative: nausea; vomiting; joint and muscle pain; joint and muscle pain; Mild back pain is lingering; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer (patient) reported that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: En6202and Expire Date: unknown) in left arm via unspecified route of administration on 02Mar2021 at 10:30 as1st dose, single dose for Covid-19 immunisation. Facility type vaccine was reported as Pharmacy or Drug Store. Patient's medical history was not reported. Concomitant medications (other medications included in two weeks) included atenolol and atorvastatin. No other vaccination was administered in four weeks. Patient stated that 'About 28 hours after the injection I had nausea and vomiting, joint and muscle pain. Mild back pain is lingering.'' Events occurred on 03Mar2021 at 06:00 pm. No treatment was given for the AEs. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The outcome of event was Recovered/Resolved with Sequel without treatment on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Nasopharyngitis
Clinical narrative: Mid day, day after vaccine: fatigue.Entire week following the second day: Foggy brain, minor headache, felt like a head cold, tired.; Very mild Headache/minor headache; Entire week following the second day: Foggy brain, minor headache, felt like a head cold, tired.; Entire week following the second day: Foggy brain, minor headache, felt like a head cold, tired.; This is a spontaneous report from a contactable physician. A 66-years-old non-pregnant adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot Number: EL9264) via an unspecified route of administration, administered in Right Arm on 23Feb2021 at 12:00(at the age of 66years) as 2nd Dose, Single Dose for COVID-19 immunization.The patient's medical history included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Right Arm on 02Feb2021 at 12:00 as 1st Dose, Single Dose for COVID-19 immunization, Known allergies: Sulfa drugs (mouth ulcers).The patient had taken Estradiol patch, Levothyroxine 112mcg, Calcium sup within in two weeks of vaccination. The patient did not take any other vaccine within 4 weeks of vaccination. On 24Feb2021 at 12:00,the patient experienced fatigue, very mild headache/minor headache, feeling abnormal, head cold. No Treatment was received for the events. The outcome for the events was recovered/resolved.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash around the area of injection - approx. 4 inch in diameter; Itchiness; This is a spontaneous report from a contactable consumer. A 75-years-old non-pregnant female patient received BNT162B2(Solution for injection, Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 18:00 as 2nd dose, single dose for COVID-19 immunization. No other vaccine administered in four weeks. Patient did not have covid prior vaccination. Medical history included known allergies to Sulfa drugs, penicillin. Concomitant medications included in two weeks included ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER), PREVALENT, calcium citrate (CITRACAL), and estradiol. The patient previously took BNT162B2(Lot Number: EL9264), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 17:15 as 1st dose, single dose for COVID-19 immunization.  On 05Mar2021, the patient experienced rash around the area of injection - approx. 4 inch in diameter and itchiness. Patient did not have covid tested post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Pain, Pyrexia
Clinical narrative: chills with shaking; low-grade fever; headache; lethargy; body aches; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route, administered in the left arm on 04Mar2021 01:15 PM (at the age of 66-years-old) as first dose, single dose for COVID-19 immunisation at a hospital. Medical history included Mediterranean anemia, bilateral profound hearing loss, gout and mild hypothyroidism; all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium, rosuvastatin calcium and febuxostat; all taken for an unspecified indication, start and stop dates were not reported. No other vaccine was given to the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. On 05Mar2021 06:00 PM, the patient experienced chills with shaking, low-grade fever, headache, lethargy and body aches. No treatment was taken as a result of the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.