chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: have a fever of 99.9; This is a spontaneous report from a contactable consumer (patient).  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date in left deltoid in Jan2021 at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient had a fever of 99.9 on unknown date in Jan2021 with outcome of unknown.  Information on Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 15:00 single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache in Jan2021. Caller asked if she could take OTC medication after receiving her vaccine first dose on Friday 08Jan2021 at 3:00 pm. She was c/o "a headache". The outcome of event was unknown.  Information on Lot/Batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: swollen lymph nodes behind left ear, tender to touch; swollen lymph nodes behind left ear, tender to touch; This is a spontaneous report from a non-contactable nurse. A 34-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL0410, intramuscular in the right arm, from 04Jan2021 16:00 at SINGLE DOSE for COVID-19 immunization. Medical history reported as none. The patient was not pregnant. There were no concomitant medications. The patient experienced swollen lymph nodes behind left ear, tender to touch on 07Jan2021 14:00. The patient underwent lab tests and procedures on 08Jan2021 which included Nasal swab with negative result. The outcome of events was recovering. No treatment was received/required due to the events.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: feel a tiny bit of soreness; This is a spontaneous report from a contactable female consumer (patient) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) Intramuscular on 09Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Caller stated: "I received my first dose of COVID-19 vaccine today at noon. I did not know I had to Tell the vaccination provider about being on a blood thinner until After I received the IM injection. I feel a tiny bit of soreness but that's all." Outcome of the event was unknown.  Information about lot/batch number is requested.
Age: 25.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Nausea & stomach pain; Nausea & stomach pain; This is a spontaneous report from a contactable other health professional.  A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via an unspecified route of administration, in the left arm from 08Jan2021 10:00 to 08Jan2021 10:00 at a SINGLE DOSE for covid-19 immunization; propanolol hcl, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. Medical history included long QT syndrome and latex allergy. Concomitant medications included mexiletine, bupropion and duloxetine hydrochloride (CYMBALTA).  The patient experienced nausea & stomach pain on 09Jan2021 09:00. The outcome of events was recovering. No treatment was received/required due to the events.  Information on Lot/Batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable physician (patient). A 54-year-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EH9H99), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date after 1st shot. The outcome was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Body aches; temperature 99.7; Chills; This is a spontaneous report from a non-contactable nurse (patient herself). A 36-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140), via intramuscular on 08Jan2021 09:45 in right arm at single dose for COVID-19 immunization. Medical history included thyroid cancer, appendectomy, tonsillectomy and asthma. The patient was known allergies: PCN and Sulfa. Concomitant medication included levothyroxine sodium (SYNTHROID), ibuprofen (MOTRIN), paracetamol (TYLENOL), naproxen sodium (ALEVE) and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). The patient previously took the first dose of BNT162B2 (lot# lot: EL0140) via intramuscular on 18Dec2020 09:45 in right arm at single dose for COVID-19 immunization. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The patient experienced body aches, temperature 99.7 and chills on 08Jan2021 20:00. Outcome of events were recovered in Jan2021. No treatment was received for events.   No follow up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Severe back pain; This is a spontaneous report from a contactable nurse (patient). This 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 14:15 at single dose for COVID-19 immunization. Medical history included exercise induced asthma and COVID. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type of vaccine was hospital. No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID. Since the vaccination, the patient hasn't been tested for COVID. On 31Dec2020 07:00, patient experienced severe back pain that started the day after receiving the vaccine when she had never had back pain in the past. Woke her up through the night for about 5 days after receiving the vaccine. It has been 10 days and the back pain was easing up but still clearly present. No treatment received for the adverse event. Outcome of the event was not recovered.  Information of lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: With my first injection I did have arm pain; This is a Follow-up spontaneous report from a contactable Other healthcare professional. A 64-year-old female patient received BNT162B2 (Pfizer BioNTech, lot number: EH9899) first dose on 18Dec2020 07:30 AM on left arm at single dose for COVID-19 immunization. Medical history included Elevated Blood Pressure and Atrial Septal Defect repair in 2008. No Known allergies. Concomitant medications in two weeks included Olmesartan Medox/HCTZ40-12.5 MG TAB. Patient is not pregnant. Facility type vaccine was Hospital. No other vaccine in four weeks. With her first injection she did have arm pain, but otherwise resumed normal activity. No treatment for the event. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the event was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: fever; headache; Tiredness; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL#246) second dose, via an unspecified route of administration on 08Jan2021 12:00 at single dose at right arm for COVID-19 immunisation. Medical history was none. No known allergies. Historical vaccine included bnt162b2 first dose on 18Dec2020 18:00 at single dose on left arm for COVID-19 immunisation. Concomitant medication included ascorbic acid (VITAMIN C).  The patient experienced tiredness started on 08Jan2021 at 15:00, headache on 09Jan2021 at 14:00, fever on 09Jan2021 at 20:00. Patient received treatment ibuprofen for the events. Outcome of the events was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: maybe she could have COVID too; maybe she could have COVID too; a rash on her leg; some shortness of breath; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 06Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her first dose of COVID-19 vaccine on Wednesday, 06Jan2021 and today, on 09Jan2021, the patient started having a rash on her leg, some shortness of breath. She used an asthma inhaler. She experienced some of the symptoms before Wednesday. The reporter was concerned that maybe the patient could have COVID, too. The reporter heard that with COVID, sometimes rashes and/or shortness of breath can come, too. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph Nords; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3246, via an unspecified route of administration at left arm on 08Jan2021 12:00 at single dose for COVID-19 immunization. Facility type vaccine was at military base. The patient medical history was not reported. Concomitant drugs was none. No other vaccine in four weeks or other medications in two weeks. The patient experienced swollen lymph nodes on 09Jan2021 15:00. No treatment received, no COVID prior vaccination and COVID was not tested post vaccination. The outcome of the event was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Night sweats, Pain
Clinical narrative: Headache; fever; body aches; chills; night sweats; loss of appetite; This is a spontaneous report from a contactable Nurse (patient). A 24-year-old non-pregnant female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), intramuscular on 07Jan2021 at 11:45 at single dose in left arm for covid-19 immunization. Medical history included birth control. Concomitant medication included fluoxetine hydrochloride (PROZAC), and ethinylestradiol, norgestimate (TRI LINYAH) for birth control. The patient previously received the first dose bnt162b2 (lot number: Et1a899), intramuscular on 16Dec2020 at 11:45 in left arm for covid-19 immunization. The patient experienced headache, fever, body aches, chills, night sweats, loss of appetite; all on 07Jan2021 at 12:00. The patient did not receive treatment for the events, all events were reported as non-serious. The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination, and the patient was not tested for covid post vaccination. The outcome of all the events was resolved in Jan2021.   No follow-up attempts are possible. No further information are expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; fever; body aches; chills; night sweats; loss of appetite; This is a spontaneous report from a contactable Nurse (patient). A 24-year-old non-pregnant female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), intramuscular on 07Jan2021 at 11:45 at single dose in left arm for covid-19 immunization. Medical history included birth control. Concomitant medication included fluoxetine hydrochloride (PROZAC), and ethinylestradiol, norgestimate (TRI LINYAH) for birth control. The patient previously received the first dose bnt162b2 (lot number: Et1a899), intramuscular on 16Dec2020 at 11:45 in left arm for covid-19 immunization. The patient experienced headache, fever, body aches, chills, night sweats, loss of appetite; all on 07Jan2021 at 12:00. The patient did not receive treatment for the events, all events were reported as non-serious. The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination, and the patient was not tested for covid post vaccination. The outcome of all the events was resolved in Jan2021.   No follow-up attempts are possible. No further information are expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold
Clinical narrative: experienced extreme cold; fatigue; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received other medications in two weeks. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19 since the vaccination. After the 2nd dose of BNT162B2, the patient experienced extreme cold and fatigue on 08Jan2021 with outcome of unknown. The events were reported as non-serious.  Information about lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: severe headache behind the eyes; Initially extreme fatigue; started to have shortness of breath; muscle aches; cough; second dose on 05Jan2021 08:30; This is a spontaneous report from a contactable physician (patient). A 39-year-old female patient received second dose of BNT162B2 (Lot number: EL3246), intramuscularly on 05Jan2021 08:30 in left arm at single dose for COVID-19 immunization. Medical history included known allergies: latex and asthma. Patient did not have COVID prior vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), drospirenone/ethinylestradiol (YASMIN), melatonin, and ibuprofen (MOTRIN). Patient previously took montelukast sodium (SINGULAIR) and experienced allergy. Patient received first dose of BNT162B2 (Lot number: EK5730), intramuscularly on 18Dec2020 09:00 in left arm at single dose for COVID-19 immunization. Patient experienced initially extreme fatigue, then muscle ached all within 12-24 hours, severe headache behind the eyes. Then when thought was getting better, she started to have shortness of breath, worsening fatigue, and cough; all on 05Jan2021 12:00. These events were resulted in emergency room/department or urgent care. COVID was tested post vaccination. COVID test type post vaccination was nasal swab. COVID test name post vaccination was COVID 19 nasopharyngeal swan. COVID test date was on 08Jan2021. Test result was pending. Treatment received included nebulizer treatment, and steroid course. Patient was not recovered from these events.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile, causality between events severe headache and extreme fatigue and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: severe headache behind the eyes; Initially extreme fatigue; started to have shortness of breath; muscle aches; cough; second dose on 05Jan2021 08:30; This is a spontaneous report from a contactable physician (patient). A 39-year-old female patient received second dose of BNT162B2 (Lot number: EL3246), intramuscularly on 05Jan2021 08:30 in left arm at single dose for COVID-19 immunization. Medical history included known allergies: latex and asthma. Patient did not have COVID prior vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), drospirenone/ethinylestradiol (YASMIN), melatonin, and ibuprofen (MOTRIN). Patient previously took montelukast sodium (SINGULAIR) and experienced allergy. Patient received first dose of BNT162B2 (Lot number: EK5730), intramuscularly on 18Dec2020 09:00 in left arm at single dose for COVID-19 immunization. Patient experienced initially extreme fatigue, then muscle ached all within 12-24 hours, severe headache behind the eyes. Then when thought was getting better, she started to have shortness of breath, worsening fatigue, and cough; all on 05Jan2021 12:00. These events were resulted in emergency room/department or urgent care. COVID was tested post vaccination. COVID test type post vaccination was nasal swab. COVID test name post vaccination was COVID 19 nasopharyngeal swan. COVID test date was on 08Jan2021. Test result was pending. Treatment received included nebulizer treatment, and steroid course. Patient was not recovered from these events.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile, causality between events severe headache and extreme fatigue and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: extreme fatigue a few hours after receiving the vaccine to where she couldn't keep her eyes open; Slight headache; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0142), via intramuscular on 05Jan2021 10:00 AM in right arm at single dose for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. Facility type vaccine was workplace clinic. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The patient previously took nitrofurantoin and experienced allergies: nitrofurantoin. The patient experienced extreme fatigue a few hours after receiving the vaccine to where she couldn't keep her eyes open and light headache on 05Jan2021 14:00. Outcome of events were recovering. No treatment was received for events.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: Fever 101 degrees Fahrenheit; chills; muscle aches; This is a spontaneous report from a contactable other Health Professional (patient). A 27 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) at his 26 years old, via an unspecified route of administration at left arm on 08Jan2021 19:15 at single dose for COVID-19 immunization. Medical history included depression, bipolar, dental implants, sinus surgery. No known allergies. Concomitant medication included vortioxetine hydrobromide (TRINTELLIX), bupropion (BUPROPION), acetylsalicylic acid, caffeine, salicylamide (EXCEDRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever 101 degrees fahrenheit, chills, muscle aches on 09Jan2021 09:00 with outcome of not recovered. No treatment received for the adverse events. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: 06/09/20 heart palpitations; dizziness; This is a spontaneous report from a contactable Other HCP (patient). A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Ek5730), via an unspecified route of administration in right arm on 06Jan2021 at 2nd single dose for COVID-19 immunization. Medical history included hoshimotos. No Covid prior vaccination. No known allergies. Historical vaccine included BNT162B2 on 16Dec2020 (1st dose) for COVID-19 immunization. Concomitant medication included levothyroxine, bupropion, desvenlafaxine succinate (PRISTIQ), topiramate (TOPIMAX). No other vaccine was received in four weeks. The patient experienced 06/09/20 heart palpitations and dizziness, both on 09Jan2021 11:15 with outcome of unknown. No Covid tested post vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Malaise, Pain in extremity
Clinical narrative: Bleeding at left arm injection site; Flu like symptoms; feeling unwell; fatigue; mild headache; injection site pain; injection site pain, increased soreness in 24 hrs; This is a spontaneous report from a contactable nurse.  A 51-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), intramuscular into the left arm on 17Dec2020 at 02:45 PM at single dose for COVID-19 immunization. Medical history included Childhood asthma, NIDDM and known allergies to Latex. Concomitant drugs included Metformin, Glyburide, Lisinopril, Jardiance, Januvia, Atorvastatin, Proventil, Advair, Tylenol, MVI, D3, Diosmin, Niacin, Flonase, Vit C. On 17Dec2020 after first dose administered, at 03:00 PM, the patient experienced injection site pain, increased soreness in 24 hrs, bleeding at left arm injection site; flu like symptoms at the 12th hour of vaccination despite of tylenol and ibuprofen alternate medication. Generalized feeling unwell, fatigue, mild headache. At the time of reporting, the patient was recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: Bleeding at left arm injection site; Flu like symptoms; feeling unwell; fatigue; mild headache; injection site pain; injection site pain, increased soreness in 24 hrs; This is a spontaneous report from a contactable nurse.  A 51-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1685), intramuscular into the left arm on 17Dec2020 at 02:45 PM at single dose for COVID-19 immunization. Medical history included Childhood asthma, NIDDM and known allergies to Latex. Concomitant drugs included Metformin, Glyburide, Lisinopril, Jardiance, Januvia, Atorvastatin, Proventil, Advair, Tylenol, MVI, D3, Diosmin, Niacin, Flonase, Vit C. On 17Dec2020 after first dose administered, at 03:00 PM, the patient experienced injection site pain, increased soreness in 24 hrs, bleeding at left arm injection site; flu like symptoms at the 12th hour of vaccination despite of tylenol and ibuprofen alternate medication. Generalized feeling unwell, fatigue, mild headache. At the time of reporting, the patient was recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills
Clinical narrative: severe chills, body shook and would not stop for about 2 hours; stomach hurt; This is a spontaneous report from a contactable Other Healthcare Professional (HCP, patient).  This 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH 9899), on Dec2020 (provided both as 19Dec2020 and 129Dec2020) at 10:00 PM at single dose, and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL 3248), on 09Jan2021 at 11:00 PM at single dose ,both for COVID-19 immunisation and via an unspecified route of administration. Age at vaccination was 36-years-old. Vaccine location was left arm for both doses. No other vaccine was received in four weeks. Medical history and concomitant medications were none. The patient had severe chills that started about 12 hours after the first vaccine (as reported). Her body shook and would not stop for about 2 hours. However onset was also reported as 09Jan2021 at 10:00PM (to be clarified). Treatment included Pepto bismol because her stomach hurt and she had ''dia'' (as reported). Outcome was recovering.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout in my left toe; This is a spontaneous report from a contactable patient. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Right arm on 06Jan2021 06:30 PM as a single dose for COVID-19 immunization, lot number: EJI685. Patient had no known allergies and had COVID prior vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Jan2021 07:00 AM patient experienced gout in his left toe, event resulted in emergency room/department or urgent care. Treatment received included colchicine (COLCRYS). Patient had not been tested for COVID-19 post vaccination. At the time of the report patient was recovering from the event.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: could not move my arm; it was like glued to the side of my arm/such pain; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age  (reported as 78: unknown unit) received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for Covid-9 immunisation. Medical history included hip replacement last year (2020) and informed that it was that much pain. The patient's concomitant medications were not reported. The patient reported that she could not move her arm. It was like glued to the side of her arm and informed that she never had such pain on an unspecified date. At the slightest touch she would scream. Her neighbor put her arm in a sling. She took Tylenol also as treatment. She was scheduled for her 2nd shot and was asking if this will happen again. The outcome of event was recovering (today was a little better).   Information on the Lot/Batch number has been requested
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Jaundice
Clinical narrative: Jaundice; This is a spontaneous report from a contactable healthcare professional (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular in right arm on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included almonds and apples allergy, Sulfa drugs allergy, and antibiotics allergy. The patient's concomitant medications were not reported. The patient previously took oxycodone hydrochloride;oxycodone terephthalate;paracetamol (PERCOCET) and VALIUM and experienced allergies. The patient experienced jaundice on 07Jan2021. Patient does not have COVID-19 prior vaccination. COVID-19 was not tested post vaccination. No treatment was received for the event. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: arm hurts a lot; his arm hurts a lot and it is hard for him to lift up his arm; put heat or ice on his injection site to relieve pain.; This is a spontaneous report from a contactable consumer (patient).   A 76-year-old male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on 09Jan2021 for Covid-19 immunisation.   The patient medical history and concomitant medications were not reported.  The patient experienced injection site pain and his arm hurts a lot and it is hard for him to lift up his arm. He placed an ice gel pack on the injection site to relieve pain in Jan2021. The outcome of events was unknown.   He wanted to know if it matters which arm he receives the 2nd dose of the Covid vaccine in. He wanted confirmation that he is to receive the second dose of the vaccine in 3 weeks.  Information on Lot/Batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fever(highest 103.8); Chills; body aches; Muscle soreness; Headache; extreme fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 35-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 08Jan2021 at 11:00 at single dose in left arm for COVID-19 immunisation. Age at vaccination was 35 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient was vaccinated at hospital. Historical vaccine included first dose of BNT162B2 administered on 18Dec2020 at 10:00 at single dose in left arm. Medical history included autoimmune thyroiditis (Hashimotos hypothyroidism), migraine, tachycardia/ palpitations. The patient has known allergies to tioconazole. Concomitant medications included sumatriptan succinate (IMITREX), propranolol (PROPANOLOL), levothyroxine sodium (SYNTHROID) and birth control. On 08Jan2021 at 07:00 PM, the patient experienced fever (highest 103.8), chills, body aches, muscle soreness, headache and extreme fatigue. No treatment was received for the events. The patient did not have COVID prior to vaccination and was not tested positive post vaccination. The events resolved on an unspecified date in Jan2021.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever(highest 103.8); Chills; body aches; Muscle soreness; Headache; extreme fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 35-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 08Jan2021 at 11:00 at single dose in left arm for COVID-19 immunisation. Age at vaccination was 35 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient was vaccinated at hospital. Historical vaccine included first dose of BNT162B2 administered on 18Dec2020 at 10:00 at single dose in left arm. Medical history included autoimmune thyroiditis (Hashimotos hypothyroidism), migraine, tachycardia/ palpitations. The patient has known allergies to tioconazole. Concomitant medications included sumatriptan succinate (IMITREX), propranolol (PROPANOLOL), levothyroxine sodium (SYNTHROID) and birth control. On 08Jan2021 at 07:00 PM, the patient experienced fever (highest 103.8), chills, body aches, muscle soreness, headache and extreme fatigue. No treatment was received for the events. The patient did not have COVID prior to vaccination and was not tested positive post vaccination. The events resolved on an unspecified date in Jan2021.  Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; This is a spontaneous report from a contactable Nurse.   A 30 Years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 07Jan2021 at 03:15 PM at single dose on right arm for COVID-19 immunization. Relevant medical history were not reported.  Concomitant medication included unspecified multivitamins. The patient experienced fatigue on 09Jan2021 and headache on 10Jan2021. No treatment was received for the events. At the time of the reporting the patient had not yet recovered from the events.   The information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Headache, Nausea
Clinical narrative: Shaking chills; Significant headache 8/10 pain; temp of 101.5; Nausea; Emesis; Energy not quite back; This is a spontaneous report from a contactable Other-HCP (patient).  This 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via an unknown route, on 07Jan2021 (at 15:15) at single dose at left arm for COVID-19 immunisation, administered at hospital. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899) on 18Dec2020. No other vaccine was received in four weeks. Relevant medical history included mild seasonal allergies. Patient allergies included erythromycin-hives. Relevant concomitant medications included colecalciferol (VITAMIN D), and cetirizine hydrochloride (ALLERTEC) as antihistamine therapy. Pre-vaccination and post-vaccination COVID tests were not performed. On 08Jan2021, after 12 hours of receiving the 2nd dose, the patient had shaking chills followed by significant headache 8/10 pain, temp of 101.5 and significant nausea with emesis, very difficult to take  paracetamol (TYLENOL) or get in fluids. She was absolutely fitful for 30 hours. In bed wondering if it would stop, then after fever broke rest of symptoms slowly let up. Day three low grade temp of 98.9, energy not quite back but feeling better. The patient was not treated for the events. She was recovering from the events.
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Pyrexia, Vomiting
Clinical narrative: Shaking chills; Significant headache 8/10 pain; temp of 101.5; Nausea; Emesis; Energy not quite back; This is a spontaneous report from a contactable Other-HCP (patient).  This 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via an unknown route, on 07Jan2021 (at 15:15) at single dose at left arm for COVID-19 immunisation, administered at hospital. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899) on 18Dec2020. No other vaccine was received in four weeks. Relevant medical history included mild seasonal allergies. Patient allergies included erythromycin-hives. Relevant concomitant medications included colecalciferol (VITAMIN D), and cetirizine hydrochloride (ALLERTEC) as antihistamine therapy. Pre-vaccination and post-vaccination COVID tests were not performed. On 08Jan2021, after 12 hours of receiving the 2nd dose, the patient had shaking chills followed by significant headache 8/10 pain, temp of 101.5 and significant nausea with emesis, very difficult to take  paracetamol (TYLENOL) or get in fluids. She was absolutely fitful for 30 hours. In bed wondering if it would stop, then after fever broke rest of symptoms slowly let up. Day three low grade temp of 98.9, energy not quite back but feeling better. The patient was not treated for the events. She was recovering from the events.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Angiogram cerebral abnormal, Cerebrovascular accident, Deafness unilateral, Dizziness
Clinical narrative: Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test, Viral test negative, Vomiting
Clinical narrative: Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chest discomfort, Chest pain, Chills
Clinical narrative: Pregnant at the time of vaccination; Pregnant at the time of vaccination; Pregnant at the time of vaccination; bilateral nerve like pain; small headache; temp 100.3; enlarged axillary lymph nodes; pain in both shoulder joints; chest soreness; feel exhausted/feel tired; Braxton Hicks contractions; slight chills; injection site soreness/arm pain radiates around seems like nerve like pain with chest tightness; injection site soreness/arm pain radiates around seems like nerve like pain with chest tightness; arm pain radiates around seems like nerve like pain; This is a spontaneous report from a contactable other HCP.  A 31-year-old female other HCP reported for herself that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EKS730) into the left arm at single dose on 22Dec2020 at 05:30 PM  and received the second dose of BNT162B2 (Lot number EKS730) into the left arm on 08Jan2021 at 08:00 AM at single dose for COVID-19 immunization. The patient  is pregnant, last menstrual date 29Apr2020, gestational period 35 and estimated delivery date 07Feb2021. Concomitant drug included Prenatal vitamin. The patient reported that on 08Jan2021 she experienced injection site soreness at 20:00, the arm pain radiates around seems like nerve like pain with chest tightness. Temperature 97.7, she took Tylenol 1000 mg. On 09Jan2021 at 00:15 she had slight chills, at 01:20/01:30 chills, arm pain, chest more tight, Braxton Hicks contractions for about 1 hour,  temperature 99.9, she took Tylenol 1000mg and went to sleep. At 08:00 she had no chills temperature 98.8, pain in both shoulder joints, chest soreness- feel exhausted.  At 09:00 1000mg Tylenol, at 14:15 temperature 98.0, at 17:45 temperature 99.8, she took 750mg Tylenol. At 18:20 temperature 100.3, she took 250mg Tylenol, at 18:50 temperature 99.0 after shower, at 19:08 temp 98.8 and at 22:00 feeling slightly better, she had bilateral nerve like pain, chest pain, small headache. On 10Jan2021 at 02:45 temp 98.2 she took 1000mg Tylenol, at 09:00 temp 97.9, bilateral nerve like pain and enlarged axillary lymph nodes, chest sore, slight headache. At 17:00 temp 96.6 bilateral nerve/lymph node pain and felt tired. The patient did  not have Covid prior vaccination and she was not Covid tested post vaccination. At the time of reporting the patient was recovering.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Maternal exposure during pregnancy, Neuralgia
Clinical narrative: Pregnant at the time of vaccination; Pregnant at the time of vaccination; Pregnant at the time of vaccination; bilateral nerve like pain; small headache; temp 100.3; enlarged axillary lymph nodes; pain in both shoulder joints; chest soreness; feel exhausted/feel tired; Braxton Hicks contractions; slight chills; injection site soreness/arm pain radiates around seems like nerve like pain with chest tightness; injection site soreness/arm pain radiates around seems like nerve like pain with chest tightness; arm pain radiates around seems like nerve like pain; This is a spontaneous report from a contactable other HCP.  A 31-year-old female other HCP reported for herself that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EKS730) into the left arm at single dose on 22Dec2020 at 05:30 PM  and received the second dose of BNT162B2 (Lot number EKS730) into the left arm on 08Jan2021 at 08:00 AM at single dose for COVID-19 immunization. The patient  is pregnant, last menstrual date 29Apr2020, gestational period 35 and estimated delivery date 07Feb2021. Concomitant drug included Prenatal vitamin. The patient reported that on 08Jan2021 she experienced injection site soreness at 20:00, the arm pain radiates around seems like nerve like pain with chest tightness. Temperature 97.7, she took Tylenol 1000 mg. On 09Jan2021 at 00:15 she had slight chills, at 01:20/01:30 chills, arm pain, chest more tight, Braxton Hicks contractions for about 1 hour,  temperature 99.9, she took Tylenol 1000mg and went to sleep. At 08:00 she had no chills temperature 98.8, pain in both shoulder joints, chest soreness- feel exhausted.  At 09:00 1000mg Tylenol, at 14:15 temperature 98.0, at 17:45 temperature 99.8, she took 750mg Tylenol. At 18:20 temperature 100.3, she took 250mg Tylenol, at 18:50 temperature 99.0 after shower, at 19:08 temp 98.8 and at 22:00 feeling slightly better, she had bilateral nerve like pain, chest pain, small headache. On 10Jan2021 at 02:45 temp 98.2 she took 1000mg Tylenol, at 09:00 temp 97.9, bilateral nerve like pain and enlarged axillary lymph nodes, chest sore, slight headache. At 17:00 temp 96.6 bilateral nerve/lymph node pain and felt tired. The patient did  not have Covid prior vaccination and she was not Covid tested post vaccination. At the time of reporting the patient was recovering.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Product use issue, Pyrexia, Uterine contractions during pregnancy
Clinical narrative: Pregnant at the time of vaccination; Pregnant at the time of vaccination; Pregnant at the time of vaccination; bilateral nerve like pain; small headache; temp 100.3; enlarged axillary lymph nodes; pain in both shoulder joints; chest soreness; feel exhausted/feel tired; Braxton Hicks contractions; slight chills; injection site soreness/arm pain radiates around seems like nerve like pain with chest tightness; injection site soreness/arm pain radiates around seems like nerve like pain with chest tightness; arm pain radiates around seems like nerve like pain; This is a spontaneous report from a contactable other HCP.  A 31-year-old female other HCP reported for herself that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EKS730) into the left arm at single dose on 22Dec2020 at 05:30 PM  and received the second dose of BNT162B2 (Lot number EKS730) into the left arm on 08Jan2021 at 08:00 AM at single dose for COVID-19 immunization. The patient  is pregnant, last menstrual date 29Apr2020, gestational period 35 and estimated delivery date 07Feb2021. Concomitant drug included Prenatal vitamin. The patient reported that on 08Jan2021 she experienced injection site soreness at 20:00, the arm pain radiates around seems like nerve like pain with chest tightness. Temperature 97.7, she took Tylenol 1000 mg. On 09Jan2021 at 00:15 she had slight chills, at 01:20/01:30 chills, arm pain, chest more tight, Braxton Hicks contractions for about 1 hour,  temperature 99.9, she took Tylenol 1000mg and went to sleep. At 08:00 she had no chills temperature 98.8, pain in both shoulder joints, chest soreness- feel exhausted.  At 09:00 1000mg Tylenol, at 14:15 temperature 98.0, at 17:45 temperature 99.8, she took 750mg Tylenol. At 18:20 temperature 100.3, she took 250mg Tylenol, at 18:50 temperature 99.0 after shower, at 19:08 temp 98.8 and at 22:00 feeling slightly better, she had bilateral nerve like pain, chest pain, small headache. On 10Jan2021 at 02:45 temp 98.2 she took 1000mg Tylenol, at 09:00 temp 97.9, bilateral nerve like pain and enlarged axillary lymph nodes, chest sore, slight headache. At 17:00 temp 96.6 bilateral nerve/lymph node pain and felt tired. The patient did  not have Covid prior vaccination and she was not Covid tested post vaccination. At the time of reporting the patient was recovering.