chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Oral candidiasis
Clinical narrative: Oral thrush; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 intramuscular, administered in left arm, on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunisation. Patient's relevant medical history was reported as no. Patient did not have COVID prior to vaccination. Concomitant medications included pantoprazole taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported; and an unspecified BP med;  all these as other medications in two weeks. Patient did not have any other vaccines in 4 weeks. The patient historically took first dose of BNT162B2 (lot number: Ek9231) intramuscular on the left arm, at age 63 years, on 19Jan2021 at 08:30 AM for COVID-19 immunisation. Patient previously took paracetamol,  tramadol hydrochloride (ULTRACET) on an unspecified date and had known allergies. The patient experienced oral thrush on 15Feb2021. AE treatment was an antifungal mouth wash. Facility type vaccine was at a hospital. COVID was not tested post-vaccination. The outcome of the event was recovering at the time of reporting.   Follow-up attempts completed. Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: i can feel the site where they gave me the shot, not terribly sore; I'm tired.; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable female consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Feb2021 11:40 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included back pain from an unknown date and unknown if ongoing. Concomitant medication was not reported. The patient previously took Tylenol for back pain, at approximately 9pm, the night before vaccine dose. The patient asked if the Tylenol is going to affect vaccine. The patient reported that she received 1st dose yesterday (20Feb2021) at approximately 11:40am. "Today, morning after dose, caller says, i can feel the site where they gave me the shot, not terribly sore, but I'm tired.  I'm worried that I don't have a lot of side effect, is it working? " The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Next day had a headache and extremely tired,  Lasted 24 hours; extremely tired; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 12:45 (Batch/Lot Number: EN9581) as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no covid prior to vaccination and was not tested post vaccination. It was reported that the patient next day had a headache and extremely tired, lasted 24 hours and extremely tired on 17Feb2021. No treatment was received for the events. The outcome of the events was recovered on unspecified date.  Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic, Urticaria
Clinical narrative: Itchy bumpy rash welts on chest stomach abdomen; Itchy bumpy rash welts on chest stomach abdomen; Itchy bumpy rash welts on chest stomach abdomen; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration administered in arm left on 30Jan2021 12:45 as 1st dose, single for covid-19 immunisation. Medical history included asthma. Concomitant medications included topiramate and; venlafaxine (VENLAFAXINE) - both taken for unspecified indications, start and stop dates were not reported. The patient did not have covid prior vaccination. The patient experienced itchy bumpy rash welts on chest stomach abdomen on 05Feb2021. No treatment was received for the adverse events. The patient had not recovered from the adverse events at the time of the report. The patient was vaccinated with the 2nd dose of BNT162B2 on 20Feb2021 09:45 administered in the left arm. The patient has not been tested for covid post-vaccination.  Follow-up attempts are completed; information about the lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: UL9762 and expiration date not provided), via an unspecified route of administration, administered in Arm Right on 16Feb2021 12:30 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history included psoriasis, psoriatic arthritis, hypertension, and high cholesterol. The patient's concomitant medications included losartan, indapamide, rosuvastatin, and finasteride.  The patient previously took Cipro and experienced allergy. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318) administered in in Left arm first dose on 27Jan2021. On 19Feb2021, the patient experienced dizziness. No treatment was given for the event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea
Clinical narrative: diarrhea; feels kind of of weak; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's wife) reported that a 77-year-old male patient received received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, on the day of his scheduled second dose, the patient experienced diarrhea and feels kind of of weak. The events were reported as non-serious. The outcome of the events was recovering (reported as symptoms were "a little bit now"). It was reported that the patient's area/city was under boil advisory for water, and was unsure if the patient's symptoms might be from bad water. The reporter was querying if the patient should get the second dose (reported as scheduled today) with symptoms.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: sore back; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A male patient of an unspecified age (age: 65, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took 2 Tylenols about 8 hours prior to second dose of the Pfizer vaccine due to sore back from shoveling on an unspecified date. The Tylenol was not related to the first dose. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: My left arm is red where the shot; my arm is also sore; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 19Feb2021 13:30 (at the age of 66-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included multiple sclerosis (MS) from an unknown date. The patient was not pregnant at the time of vaccination. The patient has no known allergies. Concomitant medications included modafinil, anastrozole, colecalciferol (D3), calcium ascorbate (ESTER C), baclofen and pantoprazole sodium sesquihydrate (PANTOPRA) all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On 20Feb2021 00:00, the patient experienced my left arm is red where the shot was given and my arm is also sore. Since the vaccination the patient has been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This is a spontaneous report from a contactable consumer. (patient) A 45-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 via an unspecified route of administration in the left arm on 19Feb2021 11:15 A.M (Batch/Lot Number: En6200) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has no known allergies. The patient received 1st dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 45-year-old on 29Jan2021 (lot number: En5318) at 11:00 AM for covid-19 immunisation. The patient did not receive other vaccine in four weeks. On 19Feb2021 04:00 PM, the patient had a sore arm. No treatment was received for the adverse event. The patient has not been covid tested post vaccination. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: fatigue; dizziness; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCIN), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single (at the age of 67 years) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. After the first dose of the vaccine, 3 days after experienced fatigue and dizziness. She was on the sofa all day. The dizziness and fatigue lasted on and off for 2 days but not the same degree. It was also reported that the patient received the 2nd dose of the Pfizer vaccine on 12Feb2021 (lot: EL9267). The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Fever; headache; swollen lymph node- left armpit; This is a spontaneous report from a contactable other health professional (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 19Feb2021 14:45 (Lot Number: EN5318) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included allergy to red dye. Concomitant medications included amoxicillin, clavulanic acid (AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]) and birth control pills. The patient previously took tylenol with codeine and experienced allergy and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) in the left arm on 29Jan2021 at 12:30 pm (age: 39 years) for COVID-19 immunization. On 20Feb2021 06:00, the patient experienced fever, headache, and swollen lymph node- left armpit. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, SARS-CoV-2 test, Vaccination site movement impairment
Clinical narrative: feeling of sharp pain, felt in the upper back-outer side of shoulder; pain starts at the top of the shoulder, and extends to the lower outer neck area; pain occurs if patient raise, or stretch arm(s) straight out or above the shoulder, or hold the outstretched arm up for more than a few seconds; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Jan2021 10:00 (Batch/Lot Number: ER4176) as 1st dose, single,   then on the right arm on 09Feb2021 (lot number: EL9267), 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccines were received in four weeks. The patient received first dose in left arm, and the second dose in right arm. The adverse effect, which was still being felt in left arm that started on 19Jan2021 17:00, led the patient to get second dose in other arm. The adverse event was still being experienced, and at the time of report, it was felt on both sides. It was a feeling of sharp pain, felt in the upper back-outer side of shoulder, above the location of each administered dose. The pain starts at the top of the shoulder, and extends to the lower outer neck area. The pain occurs if patient raise, or stretch arm(s) straight out or above the shoulder, or hold the outstretched arm up for more than a few seconds. The pain also occurs if patient contort his arm(s), such as putting on a dress shirt, or taking off a sweater. The pain will subside a few seconds after the arm has lowered back into a natural position. The sharp pangs of pain have continued, even over a month past the first dose. No treatment was given for the events. Outcome was not recovered. Patient did not had covid prior to vaccination and had undergone covid test: negative on 26Jan2021.  Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Vaccination site pain
Clinical narrative: little soreness in his right arm; right elbow was swollen profusely; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 19Feb2021 (Lot Number: EL9264) as 1st dose, single for covid-19 immunisation. Medical history included diabetic. The patient's concomitant medications were not reported. The patient had a little soreness in his right arm on unknown date and yesterday (20Feb2021), when he was lying in bed, he noticed his right elbow was swollen profusely in the arm where he had got the shot on. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: Dry Mouth; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Feb2021 15:45 (03:45 PM) (Batch/Lot Number: EM9809) as 2nd DOSE, SINGLE for covid-19 immunisation. The patient is not pregnant at the time of vaccination. The patient had no other vaccine in four weeks and taking other medications in two weeks (unspecified medications). The patient has no covid prior vaccination and not covid tested post vaccination. Medical history included Osteoporosis, pre-COPD and allergy to dye used in treadmill test all from an unknown date and unknown if ongoing. The patient previously took vicodin and experienced allergies. The patient also previously took bnt162b2 (Lot: EL9262) first dose on 27Jan2021 15:45 (03:45 PM) administered in Arm Left for covid-19 immunisation. It was reported that the patient experienced Dry Mouth on 19Feb2021 12:00 PM. No treatment was given for the reported event. The outcome of the event was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oesophagitis
Clinical narrative: My esophagus is inflamed and food is having a harder time going down. I have a diagnosis of Ineffective esophageal motility disorder; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old non-pregnant  female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 28Jan2021 11:30 (Batch/Lot number was not reported) as 1st dose, single ( at the age of 55 years) for covid-19 immunisation. The patient's medical history included ineffective esophageal motility disorder, GERD and known allergies to  numbing agent for upper endoscopy. The patient has not had covid prior to vaccination. Concomitant medications included cimetidine (TAGAMET [CIMETIDINE]) and Multi-vitamin taken for an unspecified indication, start and stop date were not reported. On 28Jan2021, 11:30, the patient experienced my esophagus was inflamed and food was having a harder time going down. She have a diagnosis of ineffective esophageal motility disorder. It was further reported that as soon as she was given the vaccine, her esophagus had a reaction. Her esophagus was inflamed and food was having a harder time going down. She had a diagnosis of ineffective esophageal motility disorder, and still having issues it has not cleared up, since the vaccination. It was reported that the event was treated with Carafate. The patient was not tested for Covid post vaccination. The outcome of the event was not recovered.  Information on the Lot/Batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash, inner thigh, both legs; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 20Feb2021 at 10:30 (at the age of 64 years old) (Lot Number: EL9267, unknown expiration) as 1st dose, single for COVID-19 immunisation.  Medical history included pre-diabetic and high cholesterol. No known allergies. Concomitant medications included rosuvastatin and metformin.  The patient experienced rash, inner thigh, both legs on 20Feb2021 at 20:00. The patient did not receive treatment for the event. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. No other vaccine in four weeks. The patient had not yet recovered from the event.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Bad Chills; headache; This is a spontaneous report from a non-contactable consumer. An elderly female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose via an unspecified route of administration on 17Feb2021 (Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in Jan2021 for covid-19 immunisation. She had no COVID prior to vaccination and was not COVID tested post vaccination. It was unknown if patient received other vaccine in four weeks. On 17Feb2021, the patient experienced bad chills and headache. Treatment was not given. The patient recovered from the events.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, Urinary tract infection
Clinical narrative: UTI; bladder infection; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer Sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. The patient reported that she may have a UTI or bladder infection. She wanted to know if she can take nystatin. She got the first shot and will be getting the second shot and she doesn't want to mess it up. She also wanted to know if she can get the antibiotic after the 2nd shot. She stated she also read about immunosuppressants. The outcome of the events was unknown.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: big black and blue mark where they gave me the shot,  I don't know if its from me taking off the bandage.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as 1 st dose, single for covid-19 immunisation. Medical history included cancer. The patient's concomitant medications were not reported. The patient got her first dose of vaccine "on the 3rd or 4th" (did not verify date before disconnecting call). Second dose was scheduled for 04March2021. After the first dose (on an unspecified date), she has big black and blue mark where they gave her the shot, she didn't know if its from her taking off the bandage. The patient took warfarin sodium (COUMADIN), "no pain with it at all". Asked if that was from the vaccine. The patient asked if she could get her "lung cancer shot" and the vaccine the following day. The patient did not know the lung cancer injection medication name or type. The patient's son that lived with her, tested positive for covid without symptoms. Asking, "could I get covid after vaccine? First dose?" Also asked if a person, who unknowingly has covid and got dose, if it would be safe or cause issues. Further asked if someone gets covid infection after the vaccine, if that would mean it didn't protect them. The patient stated, "why is it recorded where we are talking over each other-its driving me nuts. Its a shot in dark". The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: felt "achy"; This is a spontaneous report from a non-contactable consumer. A elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the COVID-19 shot and he felt "achy" on unspecified date. It was unknown if treatment was received. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. It was unknown if the patient has been tested for COVID-19. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip pain, Pain in jaw
Clinical narrative: Sudden sensitivity; mild pain in jaws and lower lip area; mild pain in jaws and lower lip area; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL9264, expiry date not reported), via an unspecified route of administration, administered in left arm on 19Feb2021 11:00 as first dose, single for covid-19 immunisation. Medical history included high blood pressure, low thyroid, and essential tremor. The patient had no known allergies. Concomitant medications included levothyroxine, hctz, trazodone, propranolol, and pravastatin, all taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination and of the report. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. On 21Feb2021 16:30, the patient experienced sudden sensitivity and mild pain in jaws and lower lip area. No treatment received in response to the events reported. The patient was not tested for covid post vaccination. The patient was recovering from the events.   Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling face
Clinical narrative: I had swelling on my forehead, between my eyebrows, down the bridge of my nose, and,  both sides of the bridge of my nose.; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 12Jan2021 09:30 (Batch/Lot Number: EJ1686) (at the age of 49 years old) as 1st dose, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included penicillin allergy. No other vaccine in four weeks and no other medications in two weeks. The patient experienced swelling on forehead between eyebrows, down the bridge of my nose, and both sides of the bridge of my nose on 13Jan2021 06:30. No treatment for the event. No COVID prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab: negative on 12Feb2021. The outcome of the event was recovered on unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: a non-raised red rash appeared on chest and stomach area...also partially on my back; As the rash faded, I have an itch everywhere the rash existed; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267) at the age of 73-years-old, via an unspecified route of administration in right arm on 15Feb2021 at 12:15 at 1st dose, single for COVID-19 immunization. Medical history included being asthmatic. She has no other chronic health conditions, no known allergies, and has no COVID prior to vaccination. Concomitant medications included ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+) and acetylsalicylic acid (ASPIRIN). There were no other vaccines in four weeks. The facility where the vaccine was administered was reported as other. On Feb2021 (also reported as 11Feb2021 at 08:30), a non-raised red rash appeared on her chest and stomach area and also partially on her back; as the rash faded, she had an itch everywhere the rash existed. No treatment was given in response to the events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node on left collar bone.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 17:05 (at 39 years old, not pregnant) (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included losartan. On 10Feb2021 17:00, patient experienced Swollen lymph node on left collar bone. The outcome of the event was recovering. No treatment for the event. No covid prior vaccination. Not covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Hint aches throughout body; very fatigued; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 12:30 (at 76 years old) (Batch/Lot Number: EN6201) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 16Feb2021, patient experienced Hint aches throughout body and very fatigued. No treatment for the events. The outcome of the events was not recovered. No other vaccine_in_four weeks. No covid_prior_vaccination. Not covid tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hypoaesthesia, Paraesthesia
Clinical narrative: fast heart rate that lasted for 5 to 6 hours.; he felt a numb, tingling sensation down his arm, hands, palms, and fingers; he felt a numb, tingling sensation down his arm, hands, palms, and fingers; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Immediately after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, he experienced a fast heart rate that lasted for 5 to 6 hours. Then with the last 3 days, he felt a numb, tingling sensation down his arm, hands, palms, and fingers. He wants to know if this is a normal reaction to the vaccine, and if it is still safe for him to receive the 2nd dose of the vaccine. Outcome of the event fast heart rate was recovered; other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on back, stomach, wrists, ankles. Appeared about 36 hours post shot.; This is a spontaneous report from a contactable consumer  A 43 -year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200) on 19Feb2021 at 09:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included migraines, depression, reynaud's syndrome, seasonal allergies, animal allergies and dust allergy. Concomitant medications included montelukast, escitalopram oxalate (LEXAPRO), trazodone, levocetirizine dihydrochloride (XYZAL). On 20Feb2021 at 17:00 the patient experienced itchy rash on back, stomach, wrists, ankles, appeared about 36 hours post shot. At the time of the reporting the patient had not yet recovered from the event    Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: tired; cold; head was in a fog; Staggering; Diarrhea; ears were ringing; arm was sore; body ache; neck was painful; back of head pain; This is a spontaneous report from a contactable consumer (Patient).  A 79-year old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140, Expiration Date Mar2021) into the left arm on 11Feb2021 at 4:00pm (at the age of 79-years-old) at single dose for COVID-19 immunization. Concomitant drugs included ciclosporin (RESTASIS) twice daily both eyes taken for dry eye; bimatoprost (LUMIGAN) one daily both eyes taken for glaucoma for 5-6 years, vitamin B complex 1 daily taken as supplement for 15-20 years; colecalciferol (D3) 2 daily during the winter and 1 daily in the summer taken as supplement for 3-4 years. She use to get a lot of sore throats. Her doctor suggested she take vitamins. Some that she took didn't help. On 11Feb2021 the patient experienced arm was sore not recovered, body ache recovered on 13Feb2021 and on 12Feb2021 she experienced tired recovered on 13Feb2021, cold recovered on 12Feb2021, head was in a fog not recovered, staggering recovered on 13Feb2021, ears were ringing recovered on 13Feb2021, Diarrhea recovered on 12Feb2021. Further reported the back of her head and neck was painful that was gone by 13Feb2021. Her arm was sore if she lays on it she can feel it. Unable to answer outcome of event for being tired,if she sits long enough she falls asleep.  Her head still feels tender. She is no longer staggering. She feels comfortable going up and down stairs. The next dose is scheduled for 04Mar2021. She is considering not taking the second dose.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasopharyngitis, Neck pain, Pain, Pain in extremity, Tinnitus
Clinical narrative: tired; cold; head was in a fog; Staggering; Diarrhea; ears were ringing; arm was sore; body ache; neck was painful; back of head pain; This is a spontaneous report from a contactable consumer (Patient).  A 79-year old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140, Expiration Date Mar2021) into the left arm on 11Feb2021 at 4:00pm (at the age of 79-years-old) at single dose for COVID-19 immunization. Concomitant drugs included ciclosporin (RESTASIS) twice daily both eyes taken for dry eye; bimatoprost (LUMIGAN) one daily both eyes taken for glaucoma for 5-6 years, vitamin B complex 1 daily taken as supplement for 15-20 years; colecalciferol (D3) 2 daily during the winter and 1 daily in the summer taken as supplement for 3-4 years. She use to get a lot of sore throats. Her doctor suggested she take vitamins. Some that she took didn't help. On 11Feb2021 the patient experienced arm was sore not recovered, body ache recovered on 13Feb2021 and on 12Feb2021 she experienced tired recovered on 13Feb2021, cold recovered on 12Feb2021, head was in a fog not recovered, staggering recovered on 13Feb2021, ears were ringing recovered on 13Feb2021, Diarrhea recovered on 12Feb2021. Further reported the back of her head and neck was painful that was gone by 13Feb2021. Her arm was sore if she lays on it she can feel it. Unable to answer outcome of event for being tired,if she sits long enough she falls asleep.  Her head still feels tender. She is no longer staggering. She feels comfortable going up and down stairs. The next dose is scheduled for 04Mar2021. She is considering not taking the second dose.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: tired; cold; head was in a fog; Staggering; Diarrhea; ears were ringing; arm was sore; body ache; neck was painful; back of head pain; This is a spontaneous report from a contactable consumer (Patient).  A 79-year old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140, Expiration Date Mar2021) into the left arm on 11Feb2021 at 4:00pm (at the age of 79-years-old) at single dose for COVID-19 immunization. Concomitant drugs included ciclosporin (RESTASIS) twice daily both eyes taken for dry eye; bimatoprost (LUMIGAN) one daily both eyes taken for glaucoma for 5-6 years, vitamin B complex 1 daily taken as supplement for 15-20 years; colecalciferol (D3) 2 daily during the winter and 1 daily in the summer taken as supplement for 3-4 years. She use to get a lot of sore throats. Her doctor suggested she take vitamins. Some that she took didn't help. On 11Feb2021 the patient experienced arm was sore not recovered, body ache recovered on 13Feb2021 and on 12Feb2021 she experienced tired recovered on 13Feb2021, cold recovered on 12Feb2021, head was in a fog not recovered, staggering recovered on 13Feb2021, ears were ringing recovered on 13Feb2021, Diarrhea recovered on 12Feb2021. Further reported the back of her head and neck was painful that was gone by 13Feb2021. Her arm was sore if she lays on it she can feel it. Unable to answer outcome of event for being tired,if she sits long enough she falls asleep.  Her head still feels tender. She is no longer staggering. She feels comfortable going up and down stairs. The next dose is scheduled for 04Mar2021. She is considering not taking the second dose.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Incomplete course of vaccination, Nasopharyngitis, Neck pain, Pain
Clinical narrative: tired; cold; head was in a fog; Staggering; Diarrhea; ears were ringing; arm was sore; body ache; neck was painful; back of head pain; This is a spontaneous report from a contactable consumer (Patient).  A 79-year old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140, Expiration Date Mar2021) into the left arm on 11Feb2021 at 4:00pm (at the age of 79-years-old) at single dose for COVID-19 immunization. Concomitant drugs included ciclosporin (RESTASIS) twice daily both eyes taken for dry eye; bimatoprost (LUMIGAN) one daily both eyes taken for glaucoma for 5-6 years, vitamin B complex 1 daily taken as supplement for 15-20 years; colecalciferol (D3) 2 daily during the winter and 1 daily in the summer taken as supplement for 3-4 years. She use to get a lot of sore throats. Her doctor suggested she take vitamins. Some that she took didn't help. On 11Feb2021 the patient experienced arm was sore not recovered, body ache recovered on 13Feb2021 and on 12Feb2021 she experienced tired recovered on 13Feb2021, cold recovered on 12Feb2021, head was in a fog not recovered, staggering recovered on 13Feb2021, ears were ringing recovered on 13Feb2021, Diarrhea recovered on 12Feb2021. Further reported the back of her head and neck was painful that was gone by 13Feb2021. Her arm was sore if she lays on it she can feel it. Unable to answer outcome of event for being tired,if she sits long enough she falls asleep.  Her head still feels tender. She is no longer staggering. She feels comfortable going up and down stairs. The next dose is scheduled for 04Mar2021. She is considering not taking the second dose.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: tired; cold; head was in a fog; Staggering; Diarrhea; ears were ringing; arm was sore; body ache; neck was painful; back of head pain; This is a spontaneous report from a contactable consumer (Patient).  A 79-year old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140, Expiration Date Mar2021) into the left arm on 11Feb2021 at 4:00pm (at the age of 79-years-old) at single dose for COVID-19 immunization. Concomitant drugs included ciclosporin (RESTASIS) twice daily both eyes taken for dry eye; bimatoprost (LUMIGAN) one daily both eyes taken for glaucoma for 5-6 years, vitamin B complex 1 daily taken as supplement for 15-20 years; colecalciferol (D3) 2 daily during the winter and 1 daily in the summer taken as supplement for 3-4 years. She use to get a lot of sore throats. Her doctor suggested she take vitamins. Some that she took didn't help. On 11Feb2021 the patient experienced arm was sore not recovered, body ache recovered on 13Feb2021 and on 12Feb2021 she experienced tired recovered on 13Feb2021, cold recovered on 12Feb2021, head was in a fog not recovered, staggering recovered on 13Feb2021, ears were ringing recovered on 13Feb2021, Diarrhea recovered on 12Feb2021. Further reported the back of her head and neck was painful that was gone by 13Feb2021. Her arm was sore if she lays on it she can feel it. Unable to answer outcome of event for being tired,if she sits long enough she falls asleep.  Her head still feels tender. She is no longer staggering. She feels comfortable going up and down stairs. The next dose is scheduled for 04Mar2021. She is considering not taking the second dose.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache
Clinical narrative: a little bit of a Headache; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Eisai (manufacturer control number: EC-2021-088274). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single dose (unknown if first or second dose) for COVID-19 immunisation and lenvatinib mesilate (LENVIMA) via an unspecified route of administration from 15Feb2021 at 20 mg daily for endometrial uterine cancer. Relevant medical history included ongoing malignant hypertension (blood pressure still runs high), 2 brain aneurysms, left thyroid lobe enlarged a number of years and endometrial uterine cancer. Concomitant medications were not reported. On 18Feb2021, the patient experienced a little bit of a headache. The patient stated she got a "COVID vaccine" last week (before starting LENVIMA) and patient's Doctor told her the "headache" cold be from the vaccine too. Cause unknown but occurred while on LENVIMA. The patient reported that her blood pressure was 149/82 on 18Feb2021 and it was 132/66 on 17Feb2021, which was low for her. The patient was instructed by her Doctor to notify her Doctor if blood pressure was ever "160/100, or higher." At the time of the report, the action taken with lenvatinib mesilate and  the outcome of the event were unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: After the 1st shot, the muscle under my left thumb started to hurt; This is a spontaneous report from a non-contactable consumer. A 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247) via an unspecified route of administration in left arm on 12Feb2021 03:00PM at single dose for COVID-19 immunisation. Relevant medical history was not reported, the patient did not receive any vaccine in four weeks and had allergy to codeine. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. Concomitant medications were not reported. On 23Jan2021, after the first shot, the muscle under her left thumb started to hurt. The event was not treated, was non-serious and not resolved.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021218557 same  patient/reporter, different AE/second dose
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This is a spontaneous report from a non-contactable Other HCP (patient herself).  This 26-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN5318), via an unknown route in the left arm, on 26Jan2021 (at the age of 26-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included COVID-19 (before vaccine). No relevant concomitant medications were provided. On 26Jan2021, the patient had sore arm. The event was reported as non-serious. No treatment was given for the event. Pre and Post vaccination COVID tests were not performed. The patient recovered from the event on unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: I experienced mild joint/muscle aches the day after receiving the 2nd shot.  The side effect lasted for only 1 day.; I experienced mild joint/muscle aches the day after receiving the 2nd shot.  The side effect lasted for only 1 day.; This is a spontaneous report from a non-contactable consumer. A 57-years-old, non-pregnant, female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on 19Feb2021 (Batch/Lot Number: EL3247) as for COVID-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID after vaccination. The patient reported that, the day after receiving the 2nd shot, on 20Feb2021 08:00, she experienced mild joint/muscle aches. The side effect lasted for only 1 day. The events recovered on an unspecified date in Feb2021 without any treatment.  No follow up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: 24 hrs after vaccination I began to have a speckled rash; itchy skin on chest, back,arms; This is a spontaneous report from a Non-contactable consumer.   A 75 year old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302) on 20Feb2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 21Feb2021 24 hours after vaccination patient began to have a speckled rash and itchy skin on chest, back, arms. No treatment received. At the time of the reporting the patient had not yet recovered from the events.   No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: After the second dose, her platelet count dropped.; This is a spontaneous report from a contactable Nurse reporting for herself. A female patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history included idiopathic thrombocytopenic purpura (ITP). Concomitant medications were not reported. After the second dose, her platelet count dropped. Because of that, she was taking prednisone. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes under right arm; This is a spontaneous report from a contactable Healthcare Professional reporting for herself. A 53-years-old, non-pregnant, female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine in Hospital, via an unspecified route of administration, administered in right arm on 20Feb2021 09:30 (Batch/Lot Number: EN6200) as single dose for COVID-19 immunization. The patient's medical history was not reported. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine in right arm on 25Jan2021 06:00 PM (Batch/Lot Number: EL8982) as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID post vaccination. Concomitant medication included omeprazole taken for an unspecified indication, start and stop date were not reported. The patient experienced swollen lymph nodes under right arm on 22Feb2021 06:00. No treatment was administered for the event. The event had not resolved yet at the time of the report.  No follow-up attempts are possible. No further information is expected.