chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Abnormal faeces
Clinical narrative: He wants to know if it's okay to take stool softener (colace); This is a spontaneous report from a contactable consumer (patient reported himself) via Pfizer-sponsored program. A male patient received first dose of BNT162B2 (COVID 19 VACCINE, Solution for injection) via an unspecified route of administration on 28Jan2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "caller just took his first dose of Covid 19 vaccine just today and wanted to know if it was okay to take stool softener (COLACE). Precautionary-AE. Outcome of the event was unknown.  Follow-up attempts are completed. Information about Batch/Lot number has been requested. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: started having high blood glucose readings requiring more insulin than previously; This is a spontaneous report from a contactable Other HCP (reported for herself). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Right leg on 01Jan2021 10:00 am (Batch/Lot Number: EL1284) as 1ST DOSE, SINGLE, dose 2 via an unspecified route of administration, administered in Right arm on 20Jan2021 10:00 am (Batch/Lot Number: EL9261) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history Type 1 Diabetic on an insulin pump. Patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Allergies to medications, food, or other products: NKA. Concomitant medication(s) (received within 2 weeks of vaccination) included Insulin Pump, insulin aspart (NOVOLOG) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; atorvastatin calcium (ATORVAST) taken for an unspecified indication, start and stop date were not reported. Facility where the most recent COVID-19 vaccine was administered: Other. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced started having high blood glucose readings requiring more insulin than previously (non-serious) on 01Jan2021. Treatment was received for the adverse event. Patient stated that I am a Type 1 Diabetic on an insulin pump. I have in the past month started having high blood glucose readings requiring more insulin than previously. This seems to have coincided with the Covid vaccine. This has not been temporary.  Has this been reported by other Type 1 diabetics. Vaccine Facility information available. Ethnicity information is available. Race information is available. The patient underwent lab tests and procedures which included blood glucose: high on 01Jan2021 (high blood glucose readings). The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash across stomach; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 30Jan2021 at 11:15 in right arm as single dose for COVID-19 immunisation. The patient medical history included shellfish allergy and detached retina from an unknown date and unknown if ongoing. Concomitant medication included losartan. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine. On 31Jan2021, 17:00 the patient experienced Itchy rash across stomach. The event was considered as non-serious. No treatment was received for the event. The outcome of the event was not recovered.   Follow-up attempts have been completed and no further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: injection site pain; left arm began to become sore; This is a spontaneous report from a contactable other hcp. A 50-year-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 intramuscular, administered in Arm Left on 06Jan2021 12:00 as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, type 2 diabetes mellitus, hypersensitivity, food, or other products:Yes, illness from Nov2020 to an unknown date I was sick with covid-19 in November, covid-19 from Nov2020 to an unknown date I was sick with covid-19 in November, the stiff neck was one of the first symptoms I noticed, musculoskeletal stiffness from Nov2020 to an unknown date I was sick with covid-19 in November, the stiff neck was one of the first symptoms I noticed. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced injection site pain and left arm began to become sore. I received my 1 st vaccine in my left arm and my second in my right arm. About 10 minutes or so after receiving the second vaccine, my left arm began to become sore as if it had been injected into the left arm again. That went away later that night. I started to injection site pain the next day which lasted only a few hours, while with the 1st injection it lasted 3 or 4 days. This afternoon I noted that my neck was stiff 2 days after receiving my second dose. The only reason I mention that was when I was sick with covid-19 in November, the stiff neck was one of the first symptoms I noticed. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was recovered and left arm began to become sore with outcome unknown.  Follow-up attempts have been completed and no further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza, Pain, Pain in extremity
Clinical narrative: Arm pain; tiredness; body aches; flu; chills; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 31Jan2021 at 10:45 AM, single dose for COVID-19 immunisation. The patient's medical history included Clindymycin sulfas allergy and she was diagnosed with COVID-19 Prior to vaccination. The concomitant medication was not reported. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient did not disclose other medications which she received within 2 weeks of vaccination. The patient experienced Arm pain, tiredness, body aches, feel like I have the flu, chills on 31Jan2021. She did not receive any treatment for adverse event. The outcome of events was reported as unknown. Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site itching, redness (almost circular), bump, hot to touch; Injection site itching, redness (almost circular), bump, hot to touch; Injection site itching, redness (almost circular), bump, hot to touch; Injection site itching, redness (almost circular), bump, hot to touch; This is a spontaneous report from a contactable 37-year-old female Other Health Professional reported for herself that she received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 28Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medication was not reported. Historic vaccine includes bnt162b2 (BNT162B2, Solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 7Jan2021 for covid-19 immunisation. The patient experienced injection site itching, redness (almost circular), bump, hot to touch on 31Jan2021. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021138885 mother/baby case
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nasal congestion, Pyrexia
Clinical narrative: mild headache; congestion on feb 1st; Chills; Fever on Jan 31st; This is a spontaneous report from a contactable 22-year-old (age at vaccination) male consumer reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; E19262) on 23Jan2021 at 2nd dose, single on left arm for covid-19 immunisation. Patient's medical history was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; E4284 dose number; 1 on 02Jan2021 at 12:00 pm on left arm for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced chills/Fever on 31Jan2021 at 11:00 pm and mild headache and congestion on 01Feb2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. The reported events were not considered as serious or fall under any seriousness criteria. Location of injection information is available for all vaccines received on the same date. The outcome of events was recovered on an unknown date.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: second dose is schedule outside of the 21 days; she has been waiting for so long that she is just in a brain fog dead; This is a spontaneous report from a contactable consumer. A 69-Yerars-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an 23Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On 26Jan2021, the patient received first dose of bnt162b2 (Batch/Lot number: EL9623). She had adverse event, like joint pain and headache with first dose. Her chills have went away, but was still getting a little bit of a headache. She had some pain in her arm, but it was much better now. She had waited for over an hour and a half. She was schedule for the second dose tomorrow. She had been waiting for so long that she was just in a brain fog dead, she at first stating that she was on Valacyclovir 1mg but then corrects herself stating that she was taking Valacyclovir 500mg once in the morning and once in the evening, she asks will that interfere with the covid vaccine. She also states that her second dose was schedule outside of the 21 days. The events assessed as non-serious with outcome of unknown.  Follow up (29Jan2021): This is a follow up spontaneous report from a contactable Consumer. This Consumer reported that: vaccine questions answered received.  Information about lot/batch number has been requested.  Follow-up (21Feb2021): The initial case was missing the following minimum criteria: of a true adverse event, upon receipt of follow-up information on 21Feb2021, this case now contains all required information to be considered valid.  Follow-up (22Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reporter for herself that: Patient details (age), events, clinical information were added.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She's having a little pain in her arm where the injection is; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. on an unspecified date, the patient had little pain in her arm where the injection is and was enquiring whether to take Tylenol. The outcome of events was reported as unknown.  No follow up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Pain, Pyrexia
Clinical narrative: metallic taste; fever; achy; This is a spontaneous report from a contactable pharmacist. A 45-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (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 took previously BNT162B2 dose 1 for Covid-19 immunization. The patient experienced metallic taste, fever, achy on an unspecified date. The 45-year-old man, about 6 ft 3 in. Vaccinated with Pfizer COVID Vaccine. He reported metallic taste in his mouth after Vaccination. This was his second dose - had fever and achy a few hours later. The outcome of the events was recovered/ Resolved the next day on unspecified date.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: chills; fever; body aches; This is a spontaneous report from a contactable consumer. A 34-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 18Jan2021 (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced chills and body aches on an unspecified date. The action taken in response to the event(s) for bnt162b2 was not applicable. The outcome of events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder due to a general medical condition
Clinical narrative: I was up all night scratching my head; This is a spontaneous report from a contactable consumer(patient). A 54-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on 03Feb2021 15:00 as unknown, single for covid-19 immunisation.  Medical history included allergy to allergic to fire ants from an unknown date and unknown if ongoing and Penicilin drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within a timeframe of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. The patient was up all night scratching her head on 03Feb2021 23:00 further she described just like when I took penicillin (which I am allergic to).The outcome of event is recovering. Information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Insomnia, Pain, Pyrexia
Clinical narrative: Fever at 103.9 and 101.5; About 12 hours later I experienced rigor chills; Body aches; Unable to sleep; This is a spontaneous report from a contactable Other Health Professional (patient) reported for herself that, A 35-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL 3248, Expiration date: unknown), via an intramuscular route of administration in Right arm on 03Feb2021 10:30 AM at Unknown dose, single for covid-19 immunisation. patient received other vaccine product Immunotherapy on 03Feb2021 in right arm SQ, and other vaccine product Immunotherapy on 03Feb2021 in left arm SQ. The patient medical history included asthma and allergies. Patient's concomitant medications was not reported. No Allergies to medications, food, or other products was reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since vaccination, patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered at Hospital. Patient reported that on 03Feb2021 about 12 hours later (after the vaccination) she experienced rigor chills and the start of body aches. Stated she was unable to sleep, and her temperature was 103.9 at 2am and 101.5 at 830am. Patient did not receive any treatment for the adverse event. The outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Pyrexia
Clinical narrative: Headache; Dizziness; Mild fever; This is a spontaneous report from a non-contactable consumer. A 39-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown) via an unspecified route of administration in left arm on 03Feb2021 as 2nd dose single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had no allergies to medications, food, or other products. The patient previously took comirnaty on Jan2021 for covid-19 immunization. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and List of any other medications the patient received within 2 weeks of vaccination was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient did not tested for COVID-19. On 04Feb2021, the patient experienced headache, dizziness, mild fever. The patient measured body temperature of mild fever on 04Feb2021. The patient did not received any treatment for adverse events. The events considered non serious. The clinical outcome of the events were recovering.  No follow-up attempts are possible information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Bad headache; Body aches ribs sore; Very tired; This is a spontaneous report from a contactable consumer or other non hcp. A 59-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Formulation: Solution for injection, Lot Number:EL3247), via an unspecified route of administration, administered in right arm on 02Feb2021 15:30 at a single dose (1st DOSE, SINGLE) for covid-19 immunization.Medical history included diabetic, hypertension and allergies. Allergies to medications, food, or other products included penicillin and vankomyicin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Patient received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. Patient has been not tested for COVID-19, since the vaccination. The patient experienced within 12 hours started bad headache, body aches ribs sore, very tired on 02Feb2021 at 12:00. No treatment was given for the events.  Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia, Somnolence
Clinical narrative: Extremely tired; slept on and off all day; some pain at the site of the injection; chills; fever; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown) via an unspecified route of administration on 02Feb2021 10:15 as 1st dose, single for COVID-19 immunization.  Medical history included sulfa drugs allergies, penicillin allergies and covid-19.  Concomitant medication(s) included multi vitamins, atorvastatin, lisinopril and omeprazole. The patient did not receive any recent vaccines for any other conditions prior to the event. The patient has not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient was not tested for COVID-19 since the vaccination. The patient was diagnosed with COVID-19 prior to vaccination. On 02Feb2021 9:30 PM, the patient experienced chills and fever, on 03Feb2021, the patient had fever of 102, some pain at the site of the injection and on an unspecified date, the patient experienced extremely tired, slept on and off all day. Therapeutic measures were taken with acetaminophen. The outcome of the events was recovered.   Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Extremely tired; slept on and off all day; some pain at the site of the injection; chills; fever; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown) via an unspecified route of administration on 02Feb2021 10:15 as 1st dose, single for COVID-19 immunization.  Medical history included sulfa drugs allergies, penicillin allergies and covid-19.  Concomitant medication(s) included multi vitamins, atorvastatin, lisinopril and omeprazole. The patient did not receive any recent vaccines for any other conditions prior to the event. The patient has not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient was not tested for COVID-19 since the vaccination. The patient was diagnosed with COVID-19 prior to vaccination. On 02Feb2021 9:30 PM, the patient experienced chills and fever, on 03Feb2021, the patient had fever of 102, some pain at the site of the injection and on an unspecified date, the patient experienced extremely tired, slept on and off all day. Therapeutic measures were taken with acetaminophen. The outcome of the events was recovered.   Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea; vomiting; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 28-year-old (Non-pregnant) female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL9264, Expiry date was not reported), via unspecified route of administration in left arm on 03Feb2021 at 17:45 (at age of 28-year) as 2nd dose, single for COVID-19 immunization. The patients medical history was not reported. Patient concomitant medication includes Paracetamol (TYLENOL), (LUPIN) for unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL1283, Expiry date not reported) via unspecified route of administration in left arm on 13Jan2021 17:45 (at age of 28-year-old) as single dose for COVID-19 immunization. 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. Post vaccination, the patient was not tested for COVID. On 04Feb2021,13:45 (one day after vaccination), Patient experienced diarrhea and vomiting. No treatment was received for event. The facility where the most recent COVID-19 vaccine administered was hospital. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Pain
Clinical narrative: Pain in left shoulder; shooting pain from left shoulder to chest; Felt like stabbing in my chest hurt to breathe; This is a spontaneous report from a non-contactable other hcp. A adult female patient received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3302 and Expiration date was not provided), via other, administered in Arm Left on 28Jan2021 12:00 as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included , covid-19; if covid prior vaccination: Yes, known allergies: Nuts, Patient's received single dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL0140 and Expiration date was not provided), via Intramuscular, administered in Arm Left on 06Jan2021 10:00 as 1ST DOSE, SINGLE for covid-19 immunisation. There were no concomitant medications. On 28Jan2021 18:00 the patient experienced pain in left shoulder, shooting pain from left shoulder to chest, felt like stabbing in my chest hurt to breathe. The outcome of event was Not recovered/Not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: severe headache that is not responding to Tylenol; nausea; This is a spontaneous report from a contactable consumer. This 49-year-old female consumer (patient) reported that the patient (non-pregnant) received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot: unknown) through an unspecified route in Left arm as UNKNOWN, SINGLE on 27Jan2021 for Covid-19 immunization. The patient had not tested positive for covid prior the vaccination or after the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included that the patient was allergic to aspirin and the patient also had asthma. Concomitant medications included unithroid. On 27Jan2021 11:30, The patient had severe headache that is not responding to Tylenol and some nausea. The patient had not received treatment for adverse event. The outcome of the event was reported as recovering.  Information on the Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: shoulder pain; My husband had a sore arm; This is a spontaneous report from a contactable Consumer. This Consumer reported that a 76-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 25Jan2021 as 1 ST DOSE, UNKNOWN for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. She stated that her husband experienced only shoulder pain. She stated my husband had a sore arm, he (Husband) was fine, he was good with it he just had a sore. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: the caller doesn't know the name of the medicine they have given her when she went in for them to look at her heart (after getting the first dose of Covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported that:  A female patient of an unspecified age received bnt162b2 (BNT162B2 solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for an unspecified indication. The patient medical history and concomitant was not reported. On an unspecified date, The patient experienced the caller doesn't know the name of the medicine they have given her when she went in for them to look at her heart (after getting the first dose of covid-19 vaccine with outcome of unknown.   Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Nervous reaction where I can't stop my arms and head from shaking.; This is a spontaneous report from a contactable consumer (patient).    This 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 12Feb2021 12:00 (Lot Number: EN5318) as single dose (at 45 years old) for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Concomitant medications included atorvastatin, ramipril, venlafaxine, vitamin D nos, all taken for an unspecified indication, start and stop date were not reported. Previously the patient received the first dose of BNT162B2 (Lot Number: EL1283) on 22Jan2021 in the left arm for COVID-19 immunisation. On 12Feb2021 23:30 , the patient experienced nervous reaction where I can't stop my arms and head from shaking. with outcome of not recovered. No treatment was received. The vaccine was administered at Public clinic. 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.   Follow-up attempts completed. No further information expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pain in extremity
Clinical narrative: Sore arm at first; fever at 102.0 F; chills; body aches; mild headache; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El3247) in the left arm, at single dose, on 11Feb2021 at 02:00 PM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history was unknown. The patient previously received, on 21Jan2021 at 02:00 PM, the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El3247) in the left arm, at single dose, for COVID-19 immunisation. Known allergies to cephalosporin was reported. Concomitant medications included esomeprazole sodium (NEXIUM) and fexofenadine hydrochloride (ALLEGRA). On 11Feb2021, at 07:00 PM, the patient experienced sore arm at first. Then developed fever, chills, body aches and mild headache. Fever, chills and body ache lasted approximately 12 hours. Highest temperature during fever was 102.0 Fahrenheit. No treatment was received. COVID was not tested post vaccination. The patient recovered from the events.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore arm at first; fever at 102.0 F; chills; body aches; mild headache; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El3247) in the left arm, at single dose, on 11Feb2021 at 02:00 PM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history was unknown. The patient previously received, on 21Jan2021 at 02:00 PM, the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. El3247) in the left arm, at single dose, for COVID-19 immunisation. Known allergies to cephalosporin was reported. Concomitant medications included esomeprazole sodium (NEXIUM) and fexofenadine hydrochloride (ALLEGRA). On 11Feb2021, at 07:00 PM, the patient experienced sore arm at first. Then developed fever, chills, body aches and mild headache. Fever, chills and body ache lasted approximately 12 hours. Highest temperature during fever was 102.0 Fahrenheit. No treatment was received. COVID was not tested post vaccination. The patient recovered from the events.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Pain in extremity
Clinical narrative: sore arm; nose bleeds; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced nose bleeds (non-serious) on 04Feb2021 with outcome of recovered and sore arm (non-serious) on an unspecified date with outcome of unknown.  No follow-up attempts are possible, information about batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm got a little sore; This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer. A 92-year-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after the first shot the patient's arm got a little sore. The event's outcome was unknown at the time of the report.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: Dizzy; Very swollen and very painful lymph nodes; Very swollen and very painful lymph nodes; Very nauseous; shaky; cold then hot; This is a spontaneous report from a contactable Other HCP (patient).   A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Feb2021 15:15 (Lot Number: EN6201) (at the age of 46) as single dose for covid-19 immunisation. No other vaccine was received in four weeks. No covid prior vaccination, no covid tested post vaccination. No known allergies. Medical history included fibromyalgia, chronic fatigue syndrome, depression, anxiety, I have no spleen either. Concomitant medications included melatonin, duloxetine, bupropion. The patient experienced dizzy on 13Feb2021 03:00, very swollen and very painful lymph nodes on 13Feb2021 03:00, very swollen and very painful lymph nodes in armpit of arm that received the vaccine on 13Feb2021 03:00, very nauseous on 13Feb2021 03:00, shaky on 13Feb2021 03:00, cold then hot on 13Feb2021 03:00. The outcome was not recovered.    No follow-up attempts are possible. No further information is expected
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Dizzy; Very swollen and very painful lymph nodes; Very swollen and very painful lymph nodes; Very nauseous; shaky; cold then hot; This is a spontaneous report from a contactable Other HCP (patient).   A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Feb2021 15:15 (Lot Number: EN6201) (at the age of 46) as single dose for covid-19 immunisation. No other vaccine was received in four weeks. No covid prior vaccination, no covid tested post vaccination. No known allergies. Medical history included fibromyalgia, chronic fatigue syndrome, depression, anxiety, I have no spleen either. Concomitant medications included melatonin, duloxetine, bupropion. The patient experienced dizzy on 13Feb2021 03:00, very swollen and very painful lymph nodes on 13Feb2021 03:00, very swollen and very painful lymph nodes in armpit of arm that received the vaccine on 13Feb2021 03:00, very nauseous on 13Feb2021 03:00, shaky on 13Feb2021 03:00, cold then hot on 13Feb2021 03:00. The outcome was not recovered.    No follow-up attempts are possible. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: bladder infection; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced bladder infection and was prescribed to take 2 antibiotics, one of which is fosfomycin. The patient asked if it is safe for her to get the second shot of the COVID-19 vaccine as it is scheduled on 18Feb2021 and if it would affect the vaccine. The event's outcome was unknown at the time of the report.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Since the 1st vaccine, I have experienced intermittent tingling of my fingers; This is a spontaneous report received from a contactable nurse (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), intramuscular in left arm on 03Jan2021 (at the age of 56-year-old) as 1st dose, single for COVID-19 immunisation. The patient was not pregnant. Facility vaccine type was reported as hospital. The patient's medical history included hypothyroidism, psoriasis, hyperlipidaemia (HLD), all from unspecified date. No COVID prior vaccination was reported. The patient's concomitant medications included levothyroxine sodium (SYNTHROID), from unspecified date. No other vaccines were received within 4 weeks from vaccination. The patient previously took propylthiouracil (PTU) and tapazole, both reported as known allergies. It was reported that since first vaccine, she had experienced intermittent tingling of her fingers on 10Jan2021. No treatment was received for the event. It was also reported that patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), administered in right arm on 24Jan2021. The patient had not been tested for COVID post vaccination. The outcome of the event was not resolved.  Follow-up (12MAY2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gingivitis, Tooth fracture
Clinical narrative: infection in my gums; broke my tooth; This is a spontaneous report from a non-contactable Other healthcare professional (HCP) who reported for herself. This other HCP reported events after first and second dose of the vaccine. This case is for events after the first dose. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported) on an unspecified date at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient stated she had the first dose of the vaccine and later (date unspecified) she broke her tooth and the dentist put her on the antibiotic because they saw she had an infection in her gums. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188750 same patient, same drug(different dose) and different event
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Condition aggravated
Clinical narrative: twitching in her left lower eye lid; twitching in her left lower eye lid/ she had her eye-lids twitch or spasm before but not for this long; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received BTN162B2 (PFIZER-BIONTECH COVID-19 vaccine, lot number not provided), via unspecified route of administration on 03Feb2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history included eye-lids twitch or spasm (she had her eye-lids twitch or spasm before) from unspecified date. The patient's concomitant medications were not reported. Patient stated that she was having a side effect after receiving the first dose of the Pfizer COVID-19 vaccine on 03Feb2021. She stated that she was experiencing twitching in her left lower eye lid. She stated that at first it was mostly at night, however, it was also happening during the day. She described it as pretty constant and annoying. She stated, she had her eye-lids twitch or spasm before but not for this long and the only thing she had done differently was get the COVID vaccine. The patient wanted to know if this was a commonly reported side effect. Patient wanted to know if she should get the second dose of the Pfizer COVID-19 vaccine since she had this reaction to the first dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypokinesia, Nausea, Pain, Pain in extremity
Clinical narrative: just really tired; nausea and vomiting; nausea and vomiting; incredibly sleepy; unable to move arm and soreness in left upper body; unable to move arm and soreness in left upper body; sore arm; This is a spontaneous report from a contactable Consumer (patient).  A 67-year-old female patient (not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL9296), via an unspecified route of administration  in Arm Left on 07Feb2021 at 11:30 (at 67 years) as single dose for covid-19 immunisation. Medical history included asthma; she also had allergies to penicillin, to valsartan (DIOVAN), to tetanus and to passion fruit. Concomitant medications included hydrochlorothiazide, spironolactone, amlodipine besilate, dexlansoprazole (DEXILANT) and estrogens conjugated (PREMARIN), all taken for an unspecified indication, start and stop date were not reported. The patient experienced sore arm on 07Feb2021 at 16:00 (day 1); on 08Feb2021 (day 2)patient was unable to move arm and soreness in left upper body;  on 09Feb2021 (day 3) soreness was gone but she was incredibly sleepy and on 10Feb2021 (day 4) she had sleepy, nausea and vomiting; on 11Feb2021 (day 5) nausea, on 12Feb2021 and 13Feb2021 (days 6 and 7) fairly normal, just really tired and sleepy. Events were non serious. No treatment given. The final outcome of all the events was reported as recovering.Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: just really tired; nausea and vomiting; nausea and vomiting; incredibly sleepy; unable to move arm and soreness in left upper body; unable to move arm and soreness in left upper body; sore arm; This is a spontaneous report from a contactable Consumer (patient).  A 67-year-old female patient (not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL9296), via an unspecified route of administration  in Arm Left on 07Feb2021 at 11:30 (at 67 years) as single dose for covid-19 immunisation. Medical history included asthma; she also had allergies to penicillin, to valsartan (DIOVAN), to tetanus and to passion fruit. Concomitant medications included hydrochlorothiazide, spironolactone, amlodipine besilate, dexlansoprazole (DEXILANT) and estrogens conjugated (PREMARIN), all taken for an unspecified indication, start and stop date were not reported. The patient experienced sore arm on 07Feb2021 at 16:00 (day 1); on 08Feb2021 (day 2)patient was unable to move arm and soreness in left upper body;  on 09Feb2021 (day 3) soreness was gone but she was incredibly sleepy and on 10Feb2021 (day 4) she had sleepy, nausea and vomiting; on 11Feb2021 (day 5) nausea, on 12Feb2021 and 13Feb2021 (days 6 and 7) fairly normal, just really tired and sleepy. Events were non serious. No treatment given. The final outcome of all the events was reported as recovering.Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Headache, Lethargy, Myalgia
Clinical narrative: Lethargy; swollen and painful arm and armpit; swollen and painful arm and armpit; swollen and painful arm and armpit; chills; nausea; headache; muscle aches all over body; restlessness in muscles (feel like she had to flex everything); This is a spontaneous report received from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via unspecified route of administration in left arm on 12Feb2021 12:30 PM (at the age of 25-year-old) as 2nd dose, single for COVID-19 immunisation. Vaccine facility type was reported as hospital. The patient's medical history included depression and anxiety, both from unspecified date. No known allergies and no COVID prior vaccination were reported. The patient's concomitant medications reported as within two weeks from vaccination included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (reported as generic ADDERRAL), duloxetine hydrochloride (reported as generic CYMBALTA), both from unspecified date. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via unspecified route of administration in left arm on unspecified date as 1st dose, single for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks from vaccination. On 13Feb2021 12:00 AM the patient experienced lethargy, swollen and painful arm and armpit, chills, nausea, headache, muscle aches all over body, restlessness in muscles (feel like she had to flex everything). Treatment for the events were received and reported as patient took lots of extra strength paracetamol (TYLENOL). Patient had not been tested post vaccination. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information is expected.