chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: tongue kept flicking out; This is a spontaneous report from a Pfizer-sponsored program. A Non-contactable consumer reported that a patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date, as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose. A Non-contactable consumer reported that a patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date, as 1st dose, single for COVID-19 immunization. Unspecified time later, on an unknown date the patient mentioned that preacher was claiming that vaccination may alter your DNA and turn you into a reptile. The patient's tongue kept flicking out after second dose. 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: Malaise
Clinical narrative: Friend not feeling great after second dose; This is a spontaneous report from a non-contactable consumer reporter for his friend. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 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 medical history and concomitant medications were not reported. The reporter stated that his friend not feeling great after second dose on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021238689 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: his mom isn't feeling great after her second dose; This is a spontaneous report from a non-contactable consumer reporter for his mom. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 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 medical history and concomitant medications were not reported.  The reporter stated that his mom isn't feeling great after her second dose on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021238643 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a non-contactable consumer (patient). An elderly male of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 27Feb2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient had not experienced Covid-19 prior vaccination. On an unspecified date, the patient experienced dizziness. No treatment received. Post the vaccination, the patient has not been tested for COVID-19. Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Moderate headache; fatigue; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received (PFIZER-BIONTECH COVID-19 mRNA 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 immunisation. Medical history included heart attack (4 years ago). The patient's concomitant medications were not reported. On an unspecified date, the patient experienced moderate headache and fatigue. Event took place after use of product. The outcome of the events was unknown.  No follow up attempts are possible. Information about lot/ batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: severe headache; Dizziness; weakness; fever; chills; muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6202), dose 2 via an unspecified route of administration, administered in arm left on 02Mar2021 18:45 as 2nd dose, single for covid-19 immunisation. Medical history included covid-19, hypothyroidism, hypertension and rheumatoid arthritis. Concomitant medications included levothyroxine sodium (SYNTHROID), acetylsalicylic acid (ASPRIN) and lisinopril (LISINOPRIL). Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: EL9267), via an unspecified route of administration in left arm on 09Feb2021 at 06:45 PM for covid-19 immunisation. On 03Mar2021 06:00 am, patient experience dizziness, weakness, fever, chills, muscle aches and severe headache. Patient was not pregnant. She did not receive any other vaccine in four weeks. The patient did not received treatment for to the events. she had COVID prior vaccination and did not tested for covid post vaccination. The patient did not had any known allergies. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: severe headache; Dizziness; weakness; fever; chills; muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6202), dose 2 via an unspecified route of administration, administered in arm left on 02Mar2021 18:45 as 2nd dose, single for covid-19 immunisation. Medical history included covid-19, hypothyroidism, hypertension and rheumatoid arthritis. Concomitant medications included levothyroxine sodium (SYNTHROID), acetylsalicylic acid (ASPRIN) and lisinopril (LISINOPRIL). Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: EL9267), via an unspecified route of administration in left arm on 09Feb2021 at 06:45 PM for covid-19 immunisation. On 03Mar2021 06:00 am, patient experience dizziness, weakness, fever, chills, muscle aches and severe headache. Patient was not pregnant. She did not receive any other vaccine in four weeks. The patient did not received treatment for to the events. she had COVID prior vaccination and did not tested for covid post vaccination. The patient did not had any known allergies. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate, Heart rate increased, Myalgia
Clinical narrative: Chest pain; Increase heart rate; Muscle aches; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient (reported as unknown if pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202), via an unspecified route of administration in right arm, on 01Mar2021 at 09:30 AM (at the age of 31 years), as second dose, single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included sertraline hydrochloride (SERTRALINE HCL) and ascorbic acid/ betacarotene/ calcium sulfate/ colecalciferol/ cyanocobalamin/ ferrous fumarate/ folic acid/ nicotinamide/ pyridoxine hydrochloride/ retinol acetate/ riboflavin/ thiamine mononitrate/ tocopheryl acetate/ zinc oxide (PRENATAL VITAMINS). The patient previously received the first dose of BNT162B2 for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. On 01Mar2021 (reported as 12:00 AM), the patient experienced chest pain, increase heart rate, and muscle aches. No treatment was administered for the events. The patient has not been tested for COVID-19 post vaccination. The patient had not recovered from the events.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date (at the age of 64-years) as single dose for COVID-19 immunization. Patient's medical history included: known allergies. It was unknown if patient had received any other vaccine in four weeks. The patient's concomitant medications were not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. On an unspecified date in Feb2021, the patient experienced headache and fatigue. The patient did not receive treatment for adverse events. Since the vaccination the patient had not been tested for COVID-19. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. information about lot/batch number could not be obtained. No further information is expected
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Headache; nausea; tiredness; This is a spontaneous report from a contactable consumer or other non hcp. A 65-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Right on 03Mar2021 11:30 (Batch/Lot Number: EN6206) as single dose for covid-19 immunisation. The patient's medical history was not reported. The patient stated that in Mar2020, his wife was tested positive for covid. The patient's concomitant medications included Vyvanse, Duloxetine, Divalproex, Tamsulosin, Levotab. The patient did not have covid prior to the vaccination nor been tested post vaccination. The patient had no Known allergies. On 04Mar2021 at 18:30, the patient experienced Headache, nausea and tiredness. All symptoms were mild and lasted. The patient did not receive any treatment for the events. On an unknown date in Mar2021, patient had recovered from all events.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported for a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced headache and nausea. 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: Fatigue, Headache
Clinical narrative: Moderate headache; Mild fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 39-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Lot Number: El3247) solution for injection, dose 1 via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:30 as 1st dose, single for covid-19 immunisation. The patient's medical history not reported. Concomitant medications included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D), ibuprofen and minerals nos, quercetin,thioctic acid, vitamins nos (EMERGEN-C). On 01Mar2021 11:30 am, patient experience moderate headache and mild fatigue. Patient did not received treatment for the adverse event. The patient was not diagnosed with covid-19 prior to vaccination and since the vaccination, patient had not been tested for covid-19. She is not pregnant at the time of vaccination. She did not have other medical history and allergies to medications, food, or other products. She did not receive any other vaccines within 4 weeks prior to the covid vaccine. The start date of the symptoms was 01Mar2021 and ended the afternoon of 02Mar2021. The outcome of the event was recovered on 02Mar2021.   No follow-up are needed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Fever (99.2 fahrenheit); missed his second dose on 01Mar2021 due to fever; This is a spontaneous report from a contactable consumer (patient)  A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation  .  Medical history:none  There were no concomitant medications.  The patient missed his second dose on 01mar2021 due to fever .The patient underwent lab tests and procedures which included body temperature: 99.2 fahrenheit on 01Mar2021 .    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Vaccination site erythema, Vaccination site pain
Clinical narrative: soreness and redness around injection site; soreness and redness around injection site; This is a spontaneous report from a contactable consumer (patient)   A 70 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 10:58 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation  . Age at vaccination 69 years Medical history included osteoporosis from 2002 to an unknown date , herpes in her eye, Blood pressure high from 2010 to an unknown date , High cholesterol from 2010 to an unknown date.     The patient experienced soreness and redness around injection site on an unspecified date with outcome of recovered , The patient underwent lab tests and procedures which included blood thyroid stimulating hormone: 4.94  on 03Feb2021  .  The reporter stated that She says she had no symptoms after the first dose other than soreness and redness around injection site that went away within 2-3 days. The patient get the second shot on second dose 25Feb2021 at 12:27PM, and both were given in her left arm.She developed several issues upon second shot.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021229265 same patient and drug, different dose and event.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain, Pyrexia
Clinical narrative: fever; feeling very sick; aches; feels very tired daily; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program.  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 23Feb2021 (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  Historical vaccine includes dose 1 of BNT162B2 received on 02Feb2021. The patient experienced fever, feeling very sick, aches, feels very tired daily and stayed in bed all day. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-1 test
Clinical narrative: having a little headache; This is a spontaneous report from a contactable other hcp.A 65-years-old male patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 24Feb2021 (at the age of 65 years) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included rheumatoid arthritis from 1996 having swollen joint, stiff tendons, arm, and legs, and liquid in his knee, stress being a factor of rheumatoid arthritis.The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and Expiration date not reported) via an unspecified route of administration, on 21Jan2021 (at the age of 65 years) as a single dose for COVID-19 immunisation. Concomitant medication(s) included tofacitinib citrate (XELJANZ XR, 11mg, oral) taken for rheumatoid arthritis from 2017 and ongoing; methotrexate (METHOTREXATE) taken for an unspecified indication, start and stop date were not reported; adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported; etanercept (ENBREL) taken for an unspecified indication, start and stop date were not reported. On an unspecified date in 2021,the patient experienced having a little headache. Patient reported stress being a factor of rheumatoid arthritis. Patient reported having pain, but it was not unbearable. Patient reported having discomfort in his wrist when it was cloudy, and when it snows.The patient underwent lab tests and procedures which included sars-cov-1 test: negative on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: severe headache and nausea that came on about 4 hours after the vaccination; severe headache and nausea that came on about 4 hours after the vaccination; This is a spontaneous report from a contactable Other Hcp. This 47-Year-old Other Hcp (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: 3247) via an unspecified route of administration on 05Mar2021 at 09:00 AM on left arm at 1st dose, single for COVID-19 immunization (at the age of 47-year-old). The patient's medical history included hypertension, hypothyroidism and migraine, all from an unknown date and it was unknown if ongoing. The patient's concomitant medications included amlodipine, levothyroxine and naproxen sodium (Anaprox), all taken for an unspecified indication and start and stop date were not reported. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination and since the vaccination, she was not tested for COVID-19. The patient had no allergies to medications, food, or other products. Four hours after the vaccination on 05Mar2021 at 01:00 PM the patient experienced severe headache and nausea. No treatment was received for the events. On an unknown date in Mar2021 the events recovered.  No follow-up attempts were needed. No further information was expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back injury
Clinical narrative: back injury; This is a spontaneous report from a Pfizer. A contactable male consumer (patient) reported for himself. A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL8982 and Expiration date: unknown), via unspecifies route, administered in left arm (left upper arm bicep) on 18Jan2021 (at the age of 66-year-old) as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 08feb2021, the patient missed the second dose of vaccination which was scheduled due to a back injury. The patient did not receive treatment. The patient stated had his first dose of the vaccine last 18th of Jan. Supposedly, his second dose of the covid vaccine was 8th of Feb but couldn't do it because he had a back injury. On 08Feb2021 but missed his appointment because he was incapacitated from his back being shot. The patient stated he has been trying to reschedule his second dose on 09feb2021 with no success. The reported assessed the event as non-serious. The outcome of the event was unknown.  Information about lot/batch number was available. No follow-up attempts are needed.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Urticaria
Clinical narrative: Hives All Around Neck; Dull Headache; Indication/Chronic Bronchitis and COPD; Soreness in right arm; This is a spontaneous report from a contactable Nurse (patient herself). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: BN6205, Expiration date: 30Jun2021) via an unspecified route of administration in right arm on 03Mar2021 at 10:00 AM (at the age of 64-year-old) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation (reported indication as chronic bronchitis and COPD) and the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown, Expiration date: Unknown) via an unspecified route of administration in right upper arm on 10Feb2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history included Chronic bronchitis and COPD from an unknown date and unknown if ongoing and concomitant medications were not reported. Prior Vaccinations within 4 weeks was none. Family medical history included that her son has a kidney diagnosis and immunosuppression and didn't develop a response to the measles, meningitis, or diphtheria vaccines, he did not develop an immune response. On 03Mar2021 (after the vaccination), the patient experienced soreness in right arm, dull headache on 04Mar2021, on 05Mar2021 at 1:30 AM hives all around her neck when she woke up and has had them all day which reported that she still had hives and worsened and Indication/Chronic Bronchitis and COPD on 03Mar2021 at 10:00 AM. The events didn't require a visit to emergency room/physician office. Caller stated that she wore a necklace but has worn it for 30 years and thought maybe she had been sweating and figured it'll go away in a couple of hours. The reported assess the relatedness of drug to reaction as unknown for dull headache, hives around neck and related for soreness in right arm. The reporter assessed all events as non-serious. The outcome of the events dull headache reported as recovered/resolved on 04Mar2021, soreness in right arm as recovering /resolving, hives around neck as not recovered/not resolved and Indication/Chronic Bronchitis and COPD as unknown.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Influenza, Nasal congestion, Pyrexia
Clinical narrative: but tested positive for covid; fever of 101 Fahrenheit/100 Fahrenheit fever; flu symptoms; nasal congestion; chest congestion; fatigue; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she had her Pfizer Covid Shot on 28Feb2021 and after 24 hours of no problem she had 2 days (01Mar2021) of 101 Fahrenheit fever and other flu symptoms. After that a few days (Mar2021) of 100 Fahrenheit fever with nasal and chest congestion, and fatigue, the patient has no fever now for about a week but tested positive for covid on 9Mar2021. She was hoping her chest congestion will dissipate in a few more days. She inquired if she should go for her scheduled 2nd Covid shot on 21Mar2021. The outcome of the event fever was recovered on Mar2021 while the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: but tested positive for covid; fever of 101 Fahrenheit/100 Fahrenheit fever; flu symptoms; nasal congestion; chest congestion; fatigue; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she had her Pfizer Covid Shot on 28Feb2021 and after 24 hours of no problem she had 2 days (01Mar2021) of 101 Fahrenheit fever and other flu symptoms. After that a few days (Mar2021) of 100 Fahrenheit fever with nasal and chest congestion, and fatigue, the patient has no fever now for about a week but tested positive for covid on 9Mar2021. She was hoping her chest congestion will dissipate in a few more days. She inquired if she should go for her scheduled 2nd Covid shot on 21Mar2021. The outcome of the event fever was recovered on Mar2021 while the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID 13Mar2021; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program COVAX US Support. A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 05Mar2021 (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 23 years). Medical history included hypoglycaemia from Jul2019 and ongoing. There were no concomitant medications. The patient stated that she had tested positive for COVID on 13Mar2021. The patient underwent lab tests and procedures which included Covid-19 Test: negative on 11Mar2021 and Covid-19 Test: positive on 13Mar2021. The event was reported as non-serious by the reporter. Outcome of the event was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: raised bumps under both arms; Cough; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration, in the right arm on 11Mar2021 (at the age of 56-years-old) as a single dose for COVID-19 Immunisation. Medical history included asthma, sinus issues and sore throat. Prior to the vaccination, the patient was not diagnosed with COVID-19 and tested negative for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included doxycycline (Manufacturer unknown) for an unspecified indication. The patient was allergic to amoxicillin. On 12Mar2021, the patient experienced raised bumps under both arms. It was reported that the bumps looked like hives but they're not itchy for the patient. It was reported that these bumps started to appear the day after the shot. On an unspecified date in Mar2021, the patient had cough but unsure if it's from my sinus cold or from the vaccine. The patient did not receive any treatment for the events. The clinical outcome of the raised bumps under both arms was not recovered and the outcome of cough was unknown. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for a few days; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 48-year-old non-pregnant (at the vaccination) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EN 5318 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm right on 28Jan2021 at 16:45 as 1st dose, single, and dose 2 via an unspecified route of administration, administered in arm right on 18Feb2021 (lot number was EN 5318 and expiration date was not reported) as 2nd dose, single for COVID-19 immunisation. The patient medical history included attention deficit hyperactivity disorder (ADD) and the patient did not have known allergies. The patient concomitant medications included amfetamine aspattate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), escitalopram oxalate (LEXAPRO), and amlodipine. The patient had not COVID prior vaccination. The patient did not receive other vaccine in four weeks. It was reported that, on 29Jan2021 at 21:00 the patient experienced sore arm for a few days. The patient reported that this was the only reaction she experienced from the vaccine. It occurred approximately 8 hours after receiving the shot and subsided completely approximately 48-60 hours later. The patient did not receive treatment for the event. It was confirmed that the 1st shot was on 28Jan2021, but sore arm occurred next day 29Jan2021. The patient was not COVID tested post vaccination. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymph node pain, Lymphadenopathy, Musculoskeletal stiffness, Pain
Clinical narrative: lymph node in base of neck on left side painful; Left shoulder stiff; Left shoulder was swollen; Lymph node in base of neck on left side very swollen; Painful to move left arm or neck to the side; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) solution for injection via an unspecified route of administration in left arm 05Mar2021, 12:00 (at the age of 28 years old) as a single dose for COVID-19 immunisation. The patient had no history of allergies for food and drugs. Patient medical history included asthma. Concomitant medications included Montelukast sodium 10 mg daily for unknown indication. The patient has not had symptoms associated with COVID-19. Patient did not receive any other vaccine 4 weeks prior to COVID-19 vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. On 11Mar2021 the patient experienced lymph node in base of neck on left side very swollen and painful. Left shoulder was swollen and stiff and painful to move left arm or neck to the side. The patient did not receive any treatment for the event. Clinical outcome of the events of pain neck, stiffness shoulder, pain arm and lymphadenopathy were unknown. Since the vaccination, has the patient was not tested for COVID-19. Information about lot/batch number cannot be obtained. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Peripheral swelling, Vaccination site bruising, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site has bruise; swelling in upper arm; redness appeared at base of swelling about 4 inches below injection; injection site tender; injection site is swollen; This is a spontaneous report from a contactable consumer (patient). A 49-years-old non-pregnant female patient received second dose BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot/batch no: EN6208) as a single dose on an unspecified route of administrated in right arm on 12Mar2021 at 12:30 PM for COVID-19 vaccination. Medical history included diabetes and Polycystic ovary syndrome (PCOS). The patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH; Lot/batch no: EN6201) as a single dose on an unspecified route of administrated in right arm on 19Feb2021 at 12:15 PM for COVID-19 vaccination. Concomitant medication includes atenolol (MANUFACTURER UNKNOWN), metformin  (MANUFACTURER UNKNOWN), spironolactone l(MANUFACTURER UNKNOWN), humalog (MANUFACTURER UNKNOWN) and lant(MANUFACTURER UNKNOWN). Patient was allergic to penicilin, vicodin, moraphine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 13Mar2021 patient experienced Injection site has bruise, swelling in upper arm, redness appeared at base of swelling about 4 inches below injection site, injection site was swollen and tender. The patient reported that Injection site has bruise. Day two noticed swelling in upper arm.  Day three redness appeared at base of swelling about 4 inches below injection site. Day 4 redness has more than doubled and tenderness has increased at the area of redness. The entire upper arm below injection site was swollen and tender. The events resulted in Doctor or other healthcare professional office/clinic visit, however it was unknown if treatment received for the adverse event. The clinical outcomes for Injection site has bruise, swelling in upper arm, redness appeared at base of swelling about 4 inches below injection site, injection site is swollen and tender was Not recovered. No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: chills; Headache; Injection site pain; Tiredness; Muscle pain; This is a spontaneous report from a contactable Other Healthcare professional, the patient. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration, in left arm as 2nd dose, single, on 15Mar2021 at 10:15 (at the age of 48-years-old) for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient past drug history include BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration, in left arm as 1st dose, single, on 22FEB2021 at 13:15 for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received Symbicort, Nasacort and Allegra within 2 weeks of vaccination. On 16Mar2021 after vaccination, the patient experienced injection site pain, tiredness, headache and chills. Patient was treated with Tylenol for events. Clinical outcome of the event injection site pain, tiredness, headache and chills was reported as recovering/resolving. No follow up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Fatigue, Nausea, Vertigo
Clinical narrative: Nausea; Dizziness; vertigo like symptoms; Not able to stand; vomiting; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6201), via an unspecified route of administration in the left arm on 13Mar2021 at 13:15 (at the age of 58-year-old), at single dose for COVID-19 immunization. The patient's medical history included high blood pressure. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not have any allergies to medications, food or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); zolpidem tartrate (AMBIEN); Amlodipine; Benazepril. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced extreme nausea, vomiting, extreme fatigue, dizziness, unable to stand without help, vertigo like symptoms, on 15Mar2021 at 18:00. Events were resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient was not tested for COVID-19. It was unknown if any treatment received for events. The clinical outcomes of reported events were not recovered. The report was reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; Dizziness; vertigo like symptoms; Not able to stand; vomiting; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6201), via an unspecified route of administration in the left arm on 13Mar2021 at 13:15 (at the age of 58-year-old), at single dose for COVID-19 immunization. The patient's medical history included high blood pressure. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not have any allergies to medications, food or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); zolpidem tartrate (AMBIEN); Amlodipine; Benazepril. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced extreme nausea, vomiting, extreme fatigue, dizziness, unable to stand without help, vertigo like symptoms, on 15Mar2021 at 18:00. Events were resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient was not tested for COVID-19. It was unknown if any treatment received for events. The clinical outcomes of reported events were not recovered. The report was reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Palpitations, Wheezing
Clinical narrative: heart began 4acing and pounding; problems breathing; wheeze; asthma attack; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot no.: EN6204) via unspecified route of administration at single dose on 10Mar2021 10: 00 AM at left arm for Covid-19 Immunization. Medical history included splenectomy from 2002. The patient has not reported any allergies. Concomitant medication within 2 weeks included 10 mg of fluoxetine hydrochloride (PROZAC) every other day. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not tested positive for COVID-19 after vaccination. On 11Mar2021 after 4 hours of sleep patient woke up and went to urinate, returned to bed at that time (reported as 3hich time) her heart began 4acing and pounding like nothing she had never experienced before. Event start time was 11Mar2021 12:45 AM. The patient slept another 12 hours. At hour 16 after cardio event, she had problems breathing and began to wheeze and had an asthma attack. No therapeutic measures were not taken for the events. Patient had recovered from the events on an unknown date in 2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.  No follow-up attempts possible. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Polymerase chain reaction
Clinical narrative: Cannot take a deep breath; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch Number: EL9266) via an unspecified route of administration in right arm in Feb2021 at 9:45 (at the age of 66-years-old) as a single dose for COVID-19 Immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested negative for COVID-19. The patient did not receive any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 21Feb2021, the patient could not take a deep breath. On 02Mar2021, the patient underwent lab tests and procedures which included nasal swab where the results found to be negative. It was reported that the patient had not received any treatment for the event. The clinical outcome of the event could not take a deep breath was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Felt sick to stomach; Headache; Bodyache; Tired; This is a spontaneous report from a contactable consumer, the patient. A 67-Years-old elderly non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: EN6200 and expiration date not provided) dose 1 on right arm via an unspecified route on Mar2021 at 14:00 (at the age of 67-years-old) as a single dose for COVID-19 vaccination (COVID-19 Immunisation). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Past medical history included High blood pressure, Thyroid, allergy to antibiotics, morphine and codeine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications received within 2 weeks of vaccination included Vitamin D, sertraline, Vitamin A, Olmesartan, Esterol and Levothi. The first day and the next patient had headache and was tired. One week later to the day and time of the Covid shot the patient felt sick to stomach, headache, body aches, and tired. The onset date of the events was 15Mar2021 at 14:30. No therapeutic measures were taken in response to the event. The clinical outcome of the events Headache, stomach discomfort, General body pain, tiredness was resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pharyngeal swelling
Clinical narrative: Throat started swelling on one side (side of injection); Face turned red; This is a spontaneous report received from a non-healthcare professional, contactable patient. A 63-year-old non-pregnant female patient received the single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch number: EN6119), via an unspecified route of administrated in the right arm on 11Mar2021 at 1:00 PM (at the age of 63- years old) for COVID-19 Immunisation. The patients medical history included breast cancer, asthma and past drug history included allergic to codeine and morphine. The concomitant medications included fenofibrate (MANUFACTURER UNKNOWN) dose of 145 mg, pravastatin (MANUFACTURER UNKNOWN) dose of 20 mg and vitamin-D (MANUFACTURER UNKNOWN) of an unspecified dose used within 2 weeks of vaccination for an unknown indication. The patient did not receive any other vaccine with in four weeks prior to the vaccine. Prior and since the vaccination the patient was not diagnosed with COVID-19. On 11Mar2021 the patient experienced throat started swelling on one side (side of injection as reported) and face turned red. The clinical outcome of throat swelling and face red was recovered at the time of this reporting (Mar2021). No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling of the  left supraclavivular lymphnode; This is a spontaneous report from a non-contactable other healthcare professional. A 41-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular first dose on 21Feb2021 10: 30 am at single dose (Lot Number not reported), and second dose on 14Mar2021 11:30 am (Lot Number: en6204) as single dose, both at site of left arm at the age of 41-year-old for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The patient experienced swelling of the left supraclavivular lymphnode on an unspecified date with outcome of unknown.    No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Fatigue, Headache, Lacrimation increased, Nasal pruritus
Clinical narrative: Watery itchy eyes; Watery itchy eyes; Itchy nose; itchy nose and throat; itchy head, neck, and body; headache; Tiredness; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received first single dose of BNT162B2 (lot Number: PFIZER BION TECH MANUFACTURING) via an unspecified route of administration into left arm on 13Mar2021 at 09.30 AM for COVID-19 Immunisation. Medical history included allergy to salmon, carbamazepine (TEGRETOL), ketorolac tromethamine (TORADOL), lithium, morphine (MORFINE), nova cane, ciprofloxacin (CIPRO), Sulfa, hyoscyamine sulfate methenamine methylthioninium chloride phenyl salicylate phosphoric acid sodium (URELLE), and contrast media allergy. Prior to vaccination patient was not diagnosed with covid-19, and since the vaccination the patient had not been tested positive for COVID-19. Concomitant medications were not reported. The patient experienced watery itchy eyes, itchy nose and throat, itchy head, neck, and body, headache and tiredness on 13Mar2021 at 09.45 am. The adverse events resulted in doctor or other healthcare professional office/clinic visit]. The patient was administered with 2 diphenhydramine hydrochloride (BENADRYL) as a therapeutic measure on an unspecified date. The patient was recovering from all the adverse events at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat irritation
Clinical narrative: Watery itchy eyes; Watery itchy eyes; Itchy nose; itchy nose and throat; itchy head, neck, and body; headache; Tiredness; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received first single dose of BNT162B2 (lot Number: PFIZER BION TECH MANUFACTURING) via an unspecified route of administration into left arm on 13Mar2021 at 09.30 AM for COVID-19 Immunisation. Medical history included allergy to salmon, carbamazepine (TEGRETOL), ketorolac tromethamine (TORADOL), lithium, morphine (MORFINE), nova cane, ciprofloxacin (CIPRO), Sulfa, hyoscyamine sulfate methenamine methylthioninium chloride phenyl salicylate phosphoric acid sodium (URELLE), and contrast media allergy. Prior to vaccination patient was not diagnosed with covid-19, and since the vaccination the patient had not been tested positive for COVID-19. Concomitant medications were not reported. The patient experienced watery itchy eyes, itchy nose and throat, itchy head, neck, and body, headache and tiredness on 13Mar2021 at 09.45 am. The adverse events resulted in doctor or other healthcare professional office/clinic visit]. The patient was administered with 2 diphenhydramine hydrochloride (BENADRYL) as a therapeutic measure on an unspecified date. The patient was recovering from all the adverse events at the time of reporting.   No follow-up attempts are needed. No further information is expected.