chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Poor quality sleep
Clinical narrative: his arm also hurt/pain in my arm; couldn't sleep enough/could not sleep well; felt more and more ill; whole body hurts/body hurts; chills; very tired; his head hurts too; This is a spontaneous report from a non-contactable consumer reported for the patient (brother) via medical information team. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that yesterday the patient got the vaccine around 10:00, was fine, but moved his arm and it hurt a lot, couldn't sleep enough because of the pain in arm, today went out for a walk but felt more and more ill, came back and whole-body hurts, have chills, very tired and head hurts a little on 10Mar2021. Experienced pain before, but it accentuated. The patient inquired what can he taken as a treatment and what should he do. His body temperature is 97.7 ° F. His brother considers taking Ibuprofen to relieve symptoms. The reporter inquires if the patient can take Ibuprofen to relieve the symptoms experienced. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Sore muscle; A bit tired; This is a spontaneous report from a contactable consumer reporting for herself. A 62-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on 10Mar2021 09:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines in four weeks and any other medications in two weeks. Patient was not tested for covid prior or post vaccination. On 10Mar2021 16:00 the patient experienced sore muscle, and a bit tired. Patient did not receive any treatment. The clinical outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This is a spontaneous report from a contactable consumer or other non hcp. Consumer reported for himself that a 41-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 09:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient did not had any medical history. Concomitant medication(s) included collagen marine, methylsulfonylmethane (MARINE COLLAGEN PEPTIDES WITH MSM); ascorbic acid, euterpe oleracea fruit (ACAI BERRY [ASCORBIC ACID;EUTERPE OLERACEA FRUIT]); vitamin c [ascorbic acid] and vitamin b complex. Patient had no known allergies. On 10Mar2021 07:00, the patient experienced chills. Patient did not received any treatment. It was reported that patient started getting chills almost 24 hrs after getting the first dose, they have lasted for the past 10 hrs. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Very tired; headache; chills; This is a spontaneous report from a contactable consumer or other non-healthcare professional.  A 43-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration in left arm on an unknown date in Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at Clinic/facility. Medical history included hypertension, high blood pressure, asthma, known allergies: Amoxicillin, Bactrim, Flagyl and lactose. The patient's concomitant medications were not reported. The patient did not receive any other vaccination in four weeks before covid vaccine administration. The patient did not have covid prior to vaccination and covid was not tested post vaccination. On an unknown date in Mar2021, after administration of first dose of vaccine, the patient experienced very tired, headache and chills. Outcome of the events very tired, headache and chills were reported as recovering at the time of this report.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Feeling abnormal, Pharyngeal swelling, Swollen tongue
Clinical narrative: throat started to hurt like it was swollen; It felt more muscular.; a couple episodes of trouble swallowing.; it felt like the very back of my tongue was also swollen.; This is a spontaneous report from a contactable consumer. This 53-year-old female consumer (patient) reported that who received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: En6198 and expiry date was unknown) via an unspecified route of administration on 04-MAR-2021 19:00 as a single dose for COVID-19 immunisation. Medical history was Psoriatic arthritis, osteoarthritis, fibromyalgia, asthma, allergic to Several Antibiotics, deet. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08-MAR-2021 17:00 her throat started to hurt like it was swollen. Did not have a sore(irritated) throat. It felt more muscular. She had a couple episodes of trouble swallowing. Tuesday night it felt like the very back of my tongue was also swollen. This problem was not constant. She have episodes of it happening. No treatment was received due to events. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling hot, Nausea, Vomiting
Clinical narrative: nausea; dizzy; vomiting; sometimes I feel hot; I feel chilled; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: 9NG198), dose 1 via an unspecified route of administration administered in Arm Left on 09Mar2021 at 11:30 (at 49-years age) as single dose of covid-19 immunisation. Medical history included seizure, endometriosis and had known Allergies: antibiotics sulfa medicines. Concomitant medications included zonisamide (ZONEGRAN) and levetiracetam (KEPPRA). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Other vaccine was not received in four weeks. On 09Mar2021 at 12:00, patient experienced nausea and dizzy and vomiting after first dose sometimes she feel hot and other times she feel chilled. No treatment was received for events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration in Arm on 08Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced headache on an unspecified date on Mar2021. Reporter reported as, He was told by the vaccination site "don't take advile if your arm gets store, tylenol is fine but not advil." He states that he doesn't have arm soreness but has a headache from his job today and only has Advil to take for it. He feels this is not vaccine related. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Myalgia, Pain, Pain in extremity
Clinical narrative: Dull continuous pain in left arm where shot was administered; Painful to lift arm above head; too weak to hold things.; Felt pain in veins in arm and muscle, down to my finger; Felt pain in veins in arm and muscle, down to my finger; Felt pain in veins in arm and muscle, down to my finger; Some chest pain on the left side; This is a spontaneous report from a contactable consumer reported for herself. A 27-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration in arm left on 25Feb2021 as 1st dose, single dose for COVID-19 immunisation. Medical history included as none. Concomitant medications included sertraline (SERTRALINE) 100 mg taken for an unspecified indication, start and stop date were not reported in two weeks. No other vaccine in four weeks. No covid prior vaccination and tested covid post vaccination known allergies were none. On 26Feb2021 12:00 AM, patient experienced dull continuous pain in left arm where shot was administered, painful to lift arm above head and too weak to hold things, felt pain in veins in arm and muscle, down to my fingers. Some chest pain on the left side happened a few days later. The patient underwent lab tests and procedures which included sars-cov-2 test resulted as negative on an unspecified date. Covid test type post vaccination was nasal swab. No treatment received. The clinical outcome of the event was resolving.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vascular pain
Clinical narrative: Dull continuous pain in left arm where shot was administered; Painful to lift arm above head; too weak to hold things.; Felt pain in veins in arm and muscle, down to my finger; Felt pain in veins in arm and muscle, down to my finger; Felt pain in veins in arm and muscle, down to my finger; Some chest pain on the left side; This is a spontaneous report from a contactable consumer reported for herself. A 27-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number was not reported) via an unspecified route of administration in arm left on 25Feb2021 as 1st dose, single dose for COVID-19 immunisation. Medical history included as none. Concomitant medications included sertraline (SERTRALINE) 100 mg taken for an unspecified indication, start and stop date were not reported in two weeks. No other vaccine in four weeks. No covid prior vaccination and tested covid post vaccination known allergies were none. On 26Feb2021 12:00 AM, patient experienced dull continuous pain in left arm where shot was administered, painful to lift arm above head and too weak to hold things, felt pain in veins in arm and muscle, down to my fingers. Some chest pain on the left side happened a few days later. The patient underwent lab tests and procedures which included sars-cov-2 test resulted as negative on an unspecified date. Covid test type post vaccination was nasal swab. No treatment received. The clinical outcome of the event was resolving.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Transient diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 85-years-old female (not pregnant) patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no and expiration date was not reported), via unspecified route of administration in left arm on 09Mar2021 at 12:30 as 1st dose, single for COVID-19 immunization (at the age of 85-years). Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took bactrim and experienced drug hypersensitivity. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, she has not been tested for COVID-19. On 10Mar2021 at 10:00, the patient experienced transient diarrhea. The patient did not receive any treatment for the events. The clinical outcome for the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Rash
Clinical narrative: The first shot caused soreness in my arm where the injection was made; a rash on both inner thighs/rash on the left side of my face; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 14:00 (Batch/Lot Number: EN6201) as 1st dose, single dose for covid-19 immunisation. Medical history included high blood pressure, cholesterol, diverticulosis (it is not active at this time). Concomitant medication included AMLODIPINE and ROSUVASTATIN. The patient was not tested positive prior vaccination. The patient did not have covid prior vaccination. The patient did not have known allergies. The patient experienced the first shot caused soreness in my arm where the injection was made and a rash on both inner thighs/rash on the left side of my face. It was reported that, the first shot caused soreness in patient arm where the injection was made, which went away after about three days. After about 10 days, patient developed a rash on both inner thighs. It cleared up in about 3 days. Patient also had a rash on the left side of my face about the same time. Patient took prescription medicine for high blood pressure and cholesterol. Patient had diverticulosis, but it was not active at this time. No treatment was received. The outcome for the event first shot caused soreness in my arm where the injection was made was recovered on unknown date while for the other event was unknown.  No follow up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, SARS-CoV-2 test
Clinical narrative: Global amnesia 24 hrs after the vaccination; This is a spontaneous report from a contactable consumer or other non HCP (patient herself).  A 23-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Mar2021 (at the age of 23-years-old) as unknown, single dose for covid-19 immunisation. The patient medical history included colitis ulcerative. The patient had covid-19 prior vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. On 10Mar2021, at 07:00 pm, 24 hours after the vaccination the patient experienced global amnesia. The patient was tested for covid post vaccination. The nasal swab was collected, and polymerase chain reaction (PCR) test was done which resulted as negative. The patient did not receive treatment for the event. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Thirst
Clinical narrative: Very mild arm soreness; felt dehydrated; mild headache; fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247) via an unspecified route of administration, administered in left arm, on 10Mar2021 at 10:45 (at the age of 35 years old) as 1st dose, single dose, for COVID-19 immunization; ethinylestradiol, etonogestrel (ETONOGESTREL/ETHINYLESTRADIOL MYLAN; batch/lot number and dose were not reported) vaginal ring via unspecified route of administration, from unspecified date, at an unknown dose and frequency, for an unspecified indication. The patient's medical history included exercise induced asthma and chronic bronchitis. Concomitant medications were not reported. The patient previously took aspartame and experienced headaches and nausea; and PERCOTCET and experienced vomiting, nausea and hives. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021 at 11:15 A.M., it was reported that the patient experienced very mild arm soreness, felt dehydrated starting about 30 minutes after the vaccine dose through the end of the day, very thirsty despite drinking a lot of water, mild headache and fatigue, moderate in the afternoon and more extreme towards the end of the day. The patient did not receive a treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The action taken in response to the events for etonogestrel/ ethinylestradiol was unknown. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Mobility decreased, Nausea
Clinical narrative: nausea; stomach pain; dry heaving; feel arm pain and was unable to lift my arm and move it normally; feel arm pain and was unable to lift my arm and move it normally; felt very fatigued and tired; a minor headache; This is a spontaneous report from a non-contactable consumer or other non hcp (patient, self-reporting). A 21-years-old female (non-pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in arm left on 04Mar2021 at 08:00 as 1ST dose, single for COVID-19 immunisation. It was reported that the patient had no allergies, Patient Medical history and concomitant were not reported. The patient did not receive any other vaccine in four weeks and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that on 04Mar2021 at 13:00 several hours after the 1st dose, began to feel arm pain and was unable to lift her arm and move it normally. That evening, felt very fatigued and tired with a minor headache. Exactly 48 hours after the vaccine, she developed nausea and stomach pain that resulted in dry heaving for approximately 3-4 hours. No treatment was received for the events. Facility where the most recent COVID-19 vaccine administered was public health clinic/Veterans Administration facility. On an unspecified date, patient was recovered in the year of 2021.   No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Retching
Clinical narrative: nausea; stomach pain; dry heaving; feel arm pain and was unable to lift my arm and move it normally; feel arm pain and was unable to lift my arm and move it normally; felt very fatigued and tired; a minor headache; This is a spontaneous report from a non-contactable consumer or other non hcp (patient, self-reporting). A 21-years-old female (non-pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in arm left on 04Mar2021 at 08:00 as 1ST dose, single for COVID-19 immunisation. It was reported that the patient had no allergies, Patient Medical history and concomitant were not reported. The patient did not receive any other vaccine in four weeks and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that on 04Mar2021 at 13:00 several hours after the 1st dose, began to feel arm pain and was unable to lift her arm and move it normally. That evening, felt very fatigued and tired with a minor headache. Exactly 48 hours after the vaccine, she developed nausea and stomach pain that resulted in dry heaving for approximately 3-4 hours. No treatment was received for the events. Facility where the most recent COVID-19 vaccine administered was public health clinic/Veterans Administration facility. On an unspecified date, patient was recovered in the year of 2021.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Sudden worsening on day 4; fever; chills; muscle pain; wheezing; loss of appetite; diarrhea; fatigue; nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration in left arm on 07Mar2021 at 00:30 (age at vaccination 56-year-old) at single dose for covid-19 immunisation. Patient's medical history was not reported. No known allergies were reported. Concomitant medications included clonazepam (KLONOPIN) at 0.5mg, trazodone and diphenhydramine hydrochloride (BENADRYL). Patient did not receive other vaccines in four weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. On 10Mar2021 at 16:00, patient experienced Sudden worsening on day 4, fever, chills, muscle pain, wheezing, loss of appetite, fatigue, diarrhoea and nausea. No treatment was given for the events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Wheezing
Clinical narrative: Sudden worsening on day 4; fever; chills; muscle pain; wheezing; loss of appetite; diarrhea; fatigue; nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration in left arm on 07Mar2021 at 00:30 (age at vaccination 56-year-old) at single dose for covid-19 immunisation. Patient's medical history was not reported. No known allergies were reported. Concomitant medications included clonazepam (KLONOPIN) at 0.5mg, trazodone and diphenhydramine hydrochloride (BENADRYL). Patient did not receive other vaccines in four weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. On 10Mar2021 at 16:00, patient experienced Sudden worsening on day 4, fever, chills, muscle pain, wheezing, loss of appetite, fatigue, diarrhoea and nausea. No treatment was given for the events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Oxygen consumption, Oxygen saturation, Palpitations
Clinical narrative: L sided heart palpitations; This is a spontaneous report from a non-contactable pharmacist. A 84-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810), via intramuscular on 08Feb2021 (at the age of 84-years-old) as a single dose for covid-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 01Mar2021 (at the age of 84-years-old) as a single dose for covid-19 immunization. It was unknown, whether the patient had other vaccine within four weeks; prior to the vaccination, the patient was diagnosed with COVID-19 or since the vaccination, the patient had been tested for COVID-19. The patient medical history was not reported. Concomitant medication(s) included rivaroxaban (XARELTO); tamsulosin hydrochloride (FLOMAX); metoprolol tartrate; docusate sodium (STOOL SOFTENER); levothyroxine; furosemide; omeprazole; potassium. On 24Feb2021, the patient experienced L sided palpitations after COVID-19 vaccine 08Feb2021. First episode lasted 4-5 hours: Blood pressure -113/78 mmhg, Heart rate- 78, O2 consumption - 96 and oxygen saturation: 96 %. Happened a few hours after second dose of vaccine as well (01MAR2021). The patient visited to doctor or other healthcare professional office/clinic visit for adverse event. He visited PCP and was stable. It was unknown, whether patient recevied any treatment. Outcome of the event was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: left are sore; mild headache; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non pregnant female patient received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, administered in Arm Left on 05Mar2021 11:45(at the age 0f 34-year-old) as, single for covid-19 immunisation. The patient Medical history included psoriatic arthropathy and had allergies to sulfadrugs from an unknown date and unknown if ongoing. Concomitant medication included etanercept (ENBREL), paracetamol (TYLENOL), omeprazole (OMEPRAZOLE), buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), ibuprofen taken for an unspecified indication and received within 2 weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the vaccine. Prior and since the vaccination the patient was not diagnosed with COVID-19. On 05Mar2021 13:00 the patient experienced left are sore and mild headache.  Therapeutic measures were taken as a result of left are sore, mild headache and included treatment with ibuprofen and Tylenol. The outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore muscle at injection site; This is a spontaneous report from a non-contactable Consumer or other non HCP (patient, self-reporting). A 36-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported) via an unspecified route of administration, in left arm on an unspecified date (at the age of 36-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication(s) included escitalopram oxalate (LEXAPRO) on n unknown date for unknown indication. The patient was not pregnant at the time of vaccination. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date, the patient experienced sore muscle at injection site. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Circumoral swelling
Clinical narrative: patient developed a swelling under her lip; t felt like a wad of cotton between her lip and gum; This is a spontaneous report received. A contactable consumer (patient) reported a non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unknown route of administration on 09Mar2021 (batch/lot number: not reported) as 1st dose, single dose for COVID-19 immunisation. Patient's medical history included myocardial bridging (myocardial bridge). Concomitant medications included ranolazine (RANEXA), meloxicam, diltiazem hydrochloride (CARTIA), metoprolol and sertraline for unspecified indications. It was reported that the patient had an allergy to ACE inhibitors. Approximately 3 hours after administration of BNT162B2, the patient developed a swelling under her lip. The patient stated that it felt like a wad of cotton between her lip and gum. She wasn't sure if it was related but she felt it should be reported as it was very strange. The patient visited the physician's office for consultation regarding her condition. She was treated with steroid and diphenhydramine (BENADRYL) shots. The patient was able to recover from the reported event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: really bad metallic taste in her mouth; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration, administered in the left arm on 09Mar2021, 13:15 (at the age of 36 years old), as first dose, single dose for COVID-19 immunisation. Medical history included bipolar disorder, anxiety disorder, and hepatic adenomatosis. The patient was not pregnant on the time of the report. Concomitant medications included lithium, quetiapine fumarate (SEROQUEL), dicyclomine, fexofenadine hydrochloride (ALLEGRA), alprazolam (XANAX). The patient did not receive other vaccines within four weeks prior to vaccination. The patient had a really bad metallic taste in her mouth starting approximately one hour after vaccination and lasted for 10 hours on 09Mar2021, 14:15. The patient had no COVID prior vaccination and was not COVID tested post-vaccination. No treatment was received for the event. The outcome of the event was recovered on 10Mar2021, 00:15.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Facial pain, Rash pustular, Swelling face
Clinical narrative: cheek feels bruised and is very swollen and hurts to touch; cheek feels bruised and is very swollen and hurts to touch; cheek feels bruised and is very swollen and hurts to touch; oozing rash on my chest that burns; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1, via unspecified route of administration, administered on the left arm on 08Mar2021 (Batch/Lot Number: not reported) as 1st dose, single dose for COVID-19 immunization. The patient's medical history included allergies on peaches and apples and patient had filler in both cheeks and lips. The patient's concomitant medication was not reported. On 10Mar2021, the patient reported that her left cheek felt bruised, very swollen and hurt to touch. The patient had filler in both cheeks and lips and only one cheek was swollen. The patient also reported that she had oozing rash on chest that burns. Treatment received was unknown. The outcome of the events was not recovered.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: I feel like uncomfortable today; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received unspecified dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Mar2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had vaccine yesterday and felt like uncomfortable today. Patient would like to know if can take Advil. The outcome of the events unknown.  Limited information available on call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Giant cell arteritis, Platelet count, Tenderness
Clinical narrative: possible Sx of Temporal arteritis; left side only- Tenderness,  peri- temporal area; fatigue; Blurry vision; joint pain (bone on bone feeling); This is a spontaneous report from a contactable nurse (patient herself). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200, expiration date not reported), via an unspecified route of administration, administered in the left arm on 26Feb2021 11:30 (at the age of 68-years-old) as second dose, single dose for COVID-19 immunisation. Relevant medical history included allergy to NSAIDs, cephalosporin, and bee stings, Epstein-Barr virus infection (EBV), chronic obstructive pulmonary disease (COPD), drug induced immune thrombocytopenia (ITP with NSAIDs and Rebetol/Interferon), "T&A", tubal ligation, cholecystectomy, and osteoporosis. Concomitant medications included Zinc, Vit D3, probiotics, and calcium, all taken for an unspecified indication, start and stop dates were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiration date not reported), via an unspecified route of administration, administered in the left arm on 05Feb2021 15:30 (at the age of 68-years-old) as first dose, single dose for COVID-19 immunisation. After first dose, on an unspecified date in Feb2021, the patient experienced platelets down to 140k, (Hx of drug induced ITP), and splenic discomfort/pain.  Patient also previously received NSAIDs, Interferon and Rebetol and experienced immune thrombocytopenia (drug induced ITP). The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced possible sx of temporal arteritis, left side only- tenderness, peri- temporal area , fatigue, blurry vision, and joint pain (bone on bone feeling) on 28Feb2021 00:00. The patient underwent lab tests and procedures which included platelet count: down to 140k on an unspecified date in Feb2021. Patient waiting on CBC & sediment rate (ESR) bloodwork results. No treatment was received as a result of the events. Patient seek consult of physician as a result of the events. The outcome of all events was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: possible Sx of Temporal arteritis; left side only- Tenderness,  peri- temporal area; fatigue; Blurry vision; joint pain (bone on bone feeling); This is a spontaneous report from a contactable nurse (patient herself). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200, expiration date not reported), via an unspecified route of administration, administered in the left arm on 26Feb2021 11:30 (at the age of 68-years-old) as second dose, single dose for COVID-19 immunisation. Relevant medical history included allergy to NSAIDs, cephalosporin, and bee stings, Epstein-Barr virus infection (EBV), chronic obstructive pulmonary disease (COPD), drug induced immune thrombocytopenia (ITP with NSAIDs and Rebetol/Interferon), "T&A", tubal ligation, cholecystectomy, and osteoporosis. Concomitant medications included Zinc, Vit D3, probiotics, and calcium, all taken for an unspecified indication, start and stop dates were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiration date not reported), via an unspecified route of administration, administered in the left arm on 05Feb2021 15:30 (at the age of 68-years-old) as first dose, single dose for COVID-19 immunisation. After first dose, on an unspecified date in Feb2021, the patient experienced platelets down to 140k, (Hx of drug induced ITP), and splenic discomfort/pain.  Patient also previously received NSAIDs, Interferon and Rebetol and experienced immune thrombocytopenia (drug induced ITP). The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced possible sx of temporal arteritis, left side only- tenderness, peri- temporal area , fatigue, blurry vision, and joint pain (bone on bone feeling) on 28Feb2021 00:00. The patient underwent lab tests and procedures which included platelet count: down to 140k on an unspecified date in Feb2021. Patient waiting on CBC & sediment rate (ESR) bloodwork results. No treatment was received as a result of the events. Patient seek consult of physician as a result of the events. The outcome of all events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Herpes zoster
Clinical narrative: However found out today a friend's brother had the same issue after 1st shot. He also started feeling bad 5 days after 1st shot and broke out with Shingles at 10 days; feeling bad 5 days after 1st shot; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (friend's brother). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced shingles. It was reported by the consumer that Reporter found out today a friend's brother had the same issue after 1st shot. he also started feeling bad 5 days after 1st shot and broke out with shingles at 10 days. The outcome of the events were unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021265079 same reporter/product/event, different patient
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Severe stomach cramps; diarrhea; This is a spontaneous report from a contactable other hcp (patient herself). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6203, expiration date not reported), intramuscularly, administered in the left arm on 06Mar2021 12:30 (at the age of 31-years-old), as first dose, single dose for COVID-19 immunisation. Patient 's medical history was not reported and there were no concomitant medications. The patient was not pregnant at the time of vaccination. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced severe stomach cramps and diarrhea on 08Mar2021 00:00. No treatment was received as a result of the events. Patient did not seek consult to physician or urgent care. The outcome of event was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaginal haemorrhage
Clinical narrative: Irregular Vaginal bleeding; Nausea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ENG206; Expiration date were not reported), via unspecified route of administration in the left arm on 10Mar2021 03:15 PM (at the age of 50-years-old) as second dose, single dose for COVID-19 immunisation at a School or Student Health Clinic. Medical history included asthma and thyroid from an unknown date and unknown if ongoing. The patient was taking other medications in two weeks. The patient previously took Vitamin B12 (reported as B12) and experienced drug allergy. The patient was previously vaccinated with BNT162B2 (Batch/Lot Number: ENG201) in the left arm on 09Feb2021 03:15 PM as first dose, single dose for COVID-19 immunisation. Patient was also previously vaccinated with Tetanus vaccine in the left arm on 20Jan2021 as first dose for tetanus immunization and experienced Shingles. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. On 10Mar2021, the patient experienced irregular vaginal bleeding and nausea. No treatment was given as a result of the events. The outcome of the event was not recovered  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Paraesthesia, Pyrexia
Clinical narrative: tingling in finger tips; pain; swelling; fever; chills; tiredness; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 09Mar2021 at 10:00 (Batch/Lot Number: EL3247) (at the age of 51-years-old) as first dose, single dose for COVID-19 immunisation. Medical history included high blood pressure and Covid-19 prior to vaccination. Concomitant medications included amlodipine and carvedilol; both taken for an unspecified indication, start and stop date were not reported. On 10Mar2021 at 08:00, patient experienced tingling in finger tips, pain, swelling, fever, chills, tiredness. Patient did not received any treatment for the events. Patient had not tested for Covid post vaccination. Outcome of the events was recovering.   No follow-up attempts needed. No further information expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: tingling in finger tips; pain; swelling; fever; chills; tiredness; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 09Mar2021 at 10:00 (Batch/Lot Number: EL3247) (at the age of 51-years-old) as first dose, single dose for COVID-19 immunisation. Medical history included high blood pressure and Covid-19 prior to vaccination. Concomitant medications included amlodipine and carvedilol; both taken for an unspecified indication, start and stop date were not reported. On 10Mar2021 at 08:00, patient experienced tingling in finger tips, pain, swelling, fever, chills, tiredness. Patient did not received any treatment for the events. Patient had not tested for Covid post vaccination. Outcome of the events was recovering.   No follow-up attempts needed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: minor sore arm; This is a spontaneous report from a contactable consumer. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  It was unknown if there are other vaccine administered in four weeks. There was no COVID prior vaccination, and patient was also not COVID tested post vaccination. The patient experienced minor sore arm on 10Mar2021 with outcome of unknown. It was unknown if there was any treatment for the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is very sore; This is a spontaneous report from a contactable consumer (patient reporting for herself). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247) via an unspecified route of administration, administered in left arm, on 10Mar2021 at 09:30 (at the age of 39 years old) as 1st dose, single dose, for COVID-19 immunisation. The patient's medical history was not reported. The patient has no known allergies. The patient was not pregnant at the time of report. Concomitant medications included cyanocobalamin (VIT B12); iron; vitamin b complex (VITAMIN B); magnesium; loratadine (ALAVERT), all were taken for an unspecified indication, start and stop date were not reported, and an over the counter allergy medication. Historical vaccine included flu shot and experienced a very sore arm. The patient has no other vaccine in four weeks. On 10Mar2021 at 09:30 A.M, it was reported that the patient's arm was very sore, and no other sign occurred. She also experienced the same thing when she got the same flu shot every year. The patient did not receive a treatment for the adverse event. The patient had no COVID prior vaccination and she was not tested post-vaccination.  No Follow-up attempts are possible: No Further information is excepted.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: "Cut body" (Flu-like symptoms); fever; This is a spontaneous report from a contactable healthcare professional (patient himself). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Mar2021 at 05:00 (Batch/Lot number was not reported) (at the age of 37-years-old) as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not received any vaccines within 4 weeks prior to Covid vaccine. On 11Mar2021 at 12:15, patient experienced "cut body" (flu-like symptoms) and fever. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Callers mom received first dose and was diagnosed with shingles a few days later.; This is a spontaneous report from a contactable consumer reporting for Mother via medical information team. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and Expiration date: Not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter asked whether her mother can get the second dose of the vaccine. After receiving first dose of vaccine, patient was diagnosed with shingles a few days later. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.