chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Joint swelling
Clinical narrative: Extremely Swollen and extremely red left elbow; Extremely Swollen and extremely red left elbow; This is a spontaneous report from a non-contactable consumer.   This 76-year-old male patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route in the left arm, on 11Feb2021 12:00 (at the age of 76-year-old) at single dose for COVID-19 immunisation. No relevant medical history was provided. Relevant concomitant medications included methotrexate and calcium folinate (LEUCOVORINE). On 11Feb2021, the patient developed extremely swollen and extremely red left elbow. The events were assessed as non-serious. Both events required emergency room visit. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: Muscle aches; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 40-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 12:45 (Batch/Lot Number: EL3247),  age at vaccination of 40-years-old, as single dose, for covid-19 immunisation.  Medical history was none; patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 12:45 (Batch/Lot Number: EL3247) for covid-19 immunisation. There were no concomitant medications. The patient had not received other vaccine in four weeks. The patient experienced muscle aches and fatigue on 13Feb2021 at 05:45 AM (around 16 hours after injection of the second dose). No treatment was administered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Feb2021. The patient was not tested for covid prior vaccination. Muscle aches started to feel better as the day progressed. The patient was considered to be recovering from the events.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Movement disorder
Clinical narrative: lower back pain; walking on the slower pace; her arm was not husting anymore; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267; Expiration Date: 31May2021), via an unspecified route of administration on 11Feb2021 as 1st dose, single for COVID-19 immunisation.  Medical history included stenosis and stiffness in the back, both ongoing. The patient's concomitant medications were not reported.  The patient experienced lower back pain on an unspecified date in Feb2021. Patient reported that she had stenosis but had different kind of stiffness in the back. She was walking on the slower pace; her arm was not husting anymore. The outcome of events was unknown.    Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a severe rash; This is a spontaneous report from a contactable consumer. A 74-year-old male consumer (patient himself) reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. Seven days after vaccine administration the patient developed a severe rash. He did not think it was an allergic reaction because it did not occur right away after receiving the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Crying
Clinical narrative: Crying spell; This is a spontaneous report from a contactable consumer (patient). This is the first of 2 cases  A 21-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration, administered in Arm Left on 25Jan2021 11:15 (Lot Number: GL9262) as single dose for covid-19 immunisation. Second dose (Lot Number: EL2202) was administered on 11Feb2021 01:00PM left arm.  Medical history included chronic migraine, inflammatory arthritis and ANA titer, thin basement membrane disease, asthma exercise induced, eczema, penicillin hypersensitivity. Concomitant medications included diclofenac potassium (CAMBIA), ondansetron (ZOFRAN), salbutamol (ALBUTEROL HFA), drospirenone, ethinylestradiol betadex clathrate (YAZ). The patient experienced crying spell on an unspecified date. The outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysphagia, Dyspnoea, Fatigue
Clinical narrative: faintly feeling; got nauseated; rapid heart beat; shortness of breath; swelling tongue; hard to swallow; fatigue; no energy; That night felt numb all over, hands feet face; severe headache; This is a spontaneous report from a contactable consumer (patient).   A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.   Medical history included cardiac operation in 2008. The patient's concomitant medications were not reported.   The patient experienced faintly feeling (dizziness) (non-serious) on an unspecified date with outcome of unknown , got nauseated on an unspecified date with outcome of unknown , that night felt numb all over, hands feet face (hypoaesthesia) (non-serious) on 06Feb2021 with outcome of unknown , severe headache (non-serious) on 06Feb2021 with outcome of unknown , rapid heart beat (heart rate increased) (non-serious) on an unspecified date with outcome of unknown , shortness of breath (non-serious) on an unspecified date with outcome of unknown , swelling tongue (swollen tongue) (non-serious) on an unspecified date with outcome of unknown , hard to swallow (dysphagia) (non-serious) on an unspecified date with outcome of unknown , fatigue on an unspecified date with outcome of unknown , no energy (asthenia) (non-serious) on an unspecified date with outcome of unknown.      Information on Lot /Batch Number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Hypoaesthesia, Nausea, Swollen tongue
Clinical narrative: faintly feeling; got nauseated; rapid heart beat; shortness of breath; swelling tongue; hard to swallow; fatigue; no energy; That night felt numb all over, hands feet face; severe headache; This is a spontaneous report from a contactable consumer (patient).   A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.   Medical history included cardiac operation in 2008. The patient's concomitant medications were not reported.   The patient experienced faintly feeling (dizziness) (non-serious) on an unspecified date with outcome of unknown , got nauseated on an unspecified date with outcome of unknown , that night felt numb all over, hands feet face (hypoaesthesia) (non-serious) on 06Feb2021 with outcome of unknown , severe headache (non-serious) on 06Feb2021 with outcome of unknown , rapid heart beat (heart rate increased) (non-serious) on an unspecified date with outcome of unknown , shortness of breath (non-serious) on an unspecified date with outcome of unknown , swelling tongue (swollen tongue) (non-serious) on an unspecified date with outcome of unknown , hard to swallow (dysphagia) (non-serious) on an unspecified date with outcome of unknown , fatigue on an unspecified date with outcome of unknown , no energy (asthenia) (non-serious) on an unspecified date with outcome of unknown.      Information on Lot /Batch Number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Eye oedema, Eye pain, Eye swelling
Clinical narrative: Swelling of outer area of both eyes; Left eye worse: sore, tender to touch and feels like a little fluid buildup.; Left eye worse: sore, tender to touch and feels like a little fluid buildup.; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old female patient not pregnant patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 11Feb2021 13:00 (Lot Number: EN5318) as single dose (at age of 51-year-old), for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient had no known allergies (NKA) nor food allergies. First dose of bnt162b2 (BNT162B2), was received via an unspecified route of administration, administered in Arm Left on 21Jan2021 13:00 (Lot Number: EL1283) (at age of 51-year-old), for covid-19 immunisation. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and the patient has not been tested for COVID-19 post vaccination. On 12Feb2021 at 16:00 patient experienced swelling of outer area of both eyes. Left eye worse: sore, tender to touch and feels like a little fluid buildup. No treatment was received. Patient had not recovered from the events, at the time of the report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Also noticed increase in sense of smell persistent after both vaccine doses and still occurring; This is a spontaneous report from a contactable consumer (patient) who reported events after first and second dose of the vaccine. This case is for event after the first dose. A 43-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 18Jan2021 at 14:00 (at 43 years)at single dose for covid-19 immunisation . Medical history was none. Concomitant medication included metformin taken for an unspecified indication, start and stop date were not reported. On an unspecified date in 2021, the patient noticed increase in sense of smell persistent after vaccine and still occurring. The outcome of the event was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021194810 same  patient/reporter, different AE/second dose
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: Hair loss began 1 week after first vaccine; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 19Jan2021 at 2nd dose, single and the first dose intramuscularly, administered in left arm, on 29Dec2020 at 14:30 at 1st dose, single, both at the age of 57-years-old for COVID-19 immunization. Medical history included hypothyroidism and COVID prior vaccination. The patient was not pregnant and had no known allergies. Other medications in two weeks included levothyroxine taken at 100 mcg, estradiol 0.1mg/g cream, multivitamin, vitamin D3 taken at 50 mcg, chondroitin sulfate sodium, glucosamine sulfate potassium chloride, methylsulfonylmethane (GLUCOSAMINE & CHONDROITIN & MSM). No other vaccines received on the same date of product and/or in four weeks. The patient experienced hair loss began 1 week after first vaccine, on 05Jan2021 at 12:00 AM. Second dose was on 19Jan2021, and the hair loss continued. The patient saw her doctor on 22Jan2021 and 05Feb2021 and she saw the physician assistant certified (PA-C) at advanced dermatology on 11Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the adverse event and included treatment with triamcinolone began on 25Jan2021 and ended on 10Feb2022; on 11Feb2021 the patient began ketoconazole 2% shampoo, and prednisone. COVID was tested post vaccination through nasal swab (quick test), on 10Feb2021: negative. The patient had not recovered from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: experienced some pain the site; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). An 8-decade male patient (Patient Age reported as late 70s) received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date patient experienced some pain in the site, it was mild and it went away. He wanted to know if he can continue with his daily medication, aspirin 81 mg and muscle rub. Outcome of the event was recovered.  The information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 11Feb2021 (on Thursday, as reported) at 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient would like to know what the normal side effects of BNT162B2 were and if her side effects were considered usual or unusual. She received 1st dose of BNT162B2 on Thursday and she was reporting not feeling well, very fatigued and tired, stomach pain and diarrhea, in Feb 2021. Patient would like to know more information about the demographics of the participants who experienced side effects from BNT162b2 and what to do about her side effects from it. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Nausea, Oral herpes, Pain in extremity
Clinical narrative: brain fog; sore arm; mild queasiness; diarrhea; cold sores on lips; This is a spontaneous report from a contactable consumer (patient). An 83-year-old patient of an unspecified gender received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 25Jan2021 15:45 (Lot number was not reported) as single dose (at age of 83-year-old) for covid-19 immunisation. Medical history included fibromyalgia, irritable bowel syndrome (IBS), high blood pressure, allergies to shellfish. It was reported that patient received concomitant medications within two weeks of vaccination, no details reported. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and the patient has not been tested for COVID-19 post vaccination. On 26Jan2021 10:00 patient experienced Sore arm, mild queasiness and diarrhea, brain fog, and cold sores on lips. No treatment was received. Patient was recovering from the events, at the time of the report.  The batch/lot number number is not available despite the follow-up attempts made.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Vomiting, Weight, Weight decreased
Clinical narrative: lost 10 lbs; I vomited for three nights; lost my appetite; had diarrhea the first week; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in right arm, on 02Jan2021 at 08:30 AM (at the age of 78-years-old) at 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. No COVID prior vaccination and no COVID tested post vaccination. The patient had no known allergies. No other vaccines received in four weeks and no other medications taken in two weeks. The patient lost 10 lbs in 4 days, he vomited for three nights, lost the appetite and had diarrhea the first week, all occurred on 03Jan2021 at 12 AM. No treatment was received for the events. The patient had recovered with sequel from lost 10 lbs on 07Jan2021, from vomited for three nights on 06Jan2021, from lost the appetite and had diarrhea the first week on 10Jan2021.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Swollen armpit on left side (same as injection) lymph node swollen to about the size of a tennis ball; Swollen armpit on left side (same as injection) lymph node swollen to about the size of a tennis ball; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient not pregnant received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 11Feb2021 13:30 (Lot Number: EL9261) as single dose (at age of 34-year-old) for covid-19 immunisation. Medical history was not reported. Concomitant medications included montelukast sodium (MONTELUKAST SODIUM), sertraline hydrochloride (ZOLOFT) and cetirizine hydrochloride (ALLERTEC). The patient previously took amoxicillin and experienced drug hypersensitivity. First dose of bnt162b2 (BNT162B2), was received via an unspecified route of administration, administered in Left arm on 19Jan2021 02:30 PM (Lot Number: EL8982) (at age of 34-year-old), for covid-19 immunisation. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and the patient has not been tested for COVID-19 post vaccination. On 13Feb2021 02:00 AM patient experienced Swollen armpit on left side (same as injection) lymph node swollen to about the size of a tennis ball. Events resulted in Emergency room/department or urgent care. No treatment was received for the events. Patient had not recovered from the events, at the time of the report.  Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: 3 hours after 2nd vaccination I found that all of my standard routines were effortless, and I could add 20-30 lbs of added resistance before they felt normal.; This is a spontaneous report from a contactable consumer (patient himself).  This 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN 6201), via an unknown route in the left arm, on 13Feb2021 09:45 (at the age of 73-year-old) at single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in the left arm on 23Jan2021 for COVID-19 immunisation. No other vaccine was received in four weeks. The patient did not have a relevant medical history. Relevant concomitant medications included cefalexin (CEPHALEXINE). The patient stated ''I've been going to gym 3x weekly for over 10 years doing the exact same resistance machine routine; 3 hours after 2nd vaccination I found that all of my standard routines were effortless, and I could add 20-30 lbs of added resistance before they felt normal; I'm wondering if the vaccine stimulates adrenaline production (at least short term); I've never had this happen before; even doing free chin-ups I normally struggle to do one, but 3 hrs after vaccine, I could do 4 with little effort''. The patient was not treated for the event. The outcome of the event was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Rhinorrhoea, Sneezing
Clinical narrative: runny nose; watering eyes; sneezing; This is a spontaneous report from a contactable consumer (patient).  A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 12:15 (Batch/Lot number was not reported), age at vaccination of 73-years-old, as single dose,for covid-19 immunisation.  Medical history included lung neoplasm malignant from an unknown date and unknown if ongoing, autoimmune thyroiditis from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing (shrimp). The patient was not pregnant and was not pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, administered in Arm Left on 21Jan2021 12:00 (Batch/Lot number was not reported) for covid-19 immunisation. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported; alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported.  The patient had not received other vaccine in four weeks. The patient experienced runny nose, watering eyes, sneezing, all on 13Feb2021 1645. No treatment was administered for the events. The patient was not tested for covid prior vaccination nor post vaccination. The patient was considered to be recovering from the events.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Tenderness on left collarbone and tenderness under left arm pit; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 05Feb2021 15:00 (at the age of 50-years-old) as 1st dose, single for COVID-19 immunisation.  Medical history included type 2 diabetes, allergy to penicillin, COVID and allergy. Concomitant medication included cetirizine hydrochloride taken for allergy, start and stop date were not reported. The patient experienced tenderness on left collarbone and tenderness under left arm pit on 06Feb2021 13:00. Tenderness was treated with topical steroids then oral steroids and it was resolved on an unspecified date in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a rash appeared on parts of my body including torso, left foot, right wrist and thighs.; This is a spontaneous report from a contactable consumer. An 81-year-old female consumer (patient herself) reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration in right arm on 05Feb2021 09:30AM (at the age of 81-year-old) at single dose for COVID-19 immunisation. The patient received first dose of BNT162b2 (Lot number unknown) on 15Jan2021 09:30 for COVID-19 immunisation. Relevant medical history included high cholesterol and high blood pressure. The patient had not COVID prior to vaccination. The patient was taking other medicines (unspecified) but concomitant medications were not reported. Four days after the second vaccination, on 09Feb2021 at 10:00PM a rash appeared on parts of her body including torso, left foot, right wrist and thighs. After seeking medical attention, she took the prescribed medication but had to go to ER on 12Feb2021 due the rash becoming discolored more of bluish-purple. The patient was treated with topical steroids then oral steroids. The event was not resolved. The patient was not tested for COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After first dose--slightly sore arm for 3 days.; This is a spontaneous report from a non-contactable non-healthcare professional. A 48-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: Unknown), via unspecified route on left arm on 19Jan2021 at 11:45 (at the age of 48 years) as 1st single dose for COVID-19 immunisation. The patient's medical history included allergies to freshwater prawns. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in 2021, the patient experienced slightly sore arm for 3 days. The patient has not receive any treatment. The outcome of the event was recovered on 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: shortness of breath; chest hurts when I breathe; This is a spontaneous report from a contactable consumer (patient).  This 66-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9269), via an unspecified route of administration in the left arm, on 02Feb2021 11:45 (at the age of 66-year-old) at single dose for COVID-19 immunisation.  Relevant medical history included rheumatoid arthritis (RA). Relevant concomitant medications included herbal supplements.  No other vaccine was received in four weeks. On 07Feb2021 12:00, the patient stated 'chest hurts when I breathe, and she had shortness of breath. No treatments were given. Pre-vaccination and post-vaccination COVID tests were not performed. The patient had not recovered from the events.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Headache, Vaccination site pain
Clinical narrative: Upset stomach; loose bowels; headache; arm sore around injection site; fatigue; This is a spontaneous report from a contactable consumer (patient).   A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 07:45 (Batch/Lot number was not reported), age at vaccination of 70-years-old as single dose for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing, drugs hypersensitivity from an unknown date and unknown if ongoing known allergies (penicillin and erythromycin). Concomitant medications included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported.  The patient experienced upset stomach, loose bowels, headache, arm sore around the injection site and fatigue, all on 11Feb2021 1900. The patient had not received other vaccine in four weeks. The patient was not tested for covid prior vaccination nor post vaccination.  No treatments were given for the events. The patient was considered to be recovering from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Injection site rash; This is a spontaneous report from a non-contactable Other HCP. A 46-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL8982) via an unspecified route of administration in right arm on 21Jan2021 12:00AM (at the age of 46-year-old) at single dose for COVID-19 immunisation. Relevant medical history included environmental allergies as well as topical product allergies in soaps and cosmetics but no medications. Concomitant medications were not reported. The patient experienced injection site rash on first dose on an unspecified date. The event was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Fatigue, Headache, Pain in extremity
Clinical narrative: Left arm increasing painful; headache; back pain; temp of 99.6; Tired; This is a spontaneous report from a contactable Consumer (patient).  A 65-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 12Feb2021 09:15 AM (Lot Number: EN6201) (at the age of 65) as single dose for covid-19 immunisation. First dose (lot#EN5318) was administered on 23Jan2021, 04:00 PM, left arm. Medical history included vitiligo, hypothyroidism, knee arthroplasty, drug hypersensitivity (sulfa and penicillin). Concomitant medications included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC ALLERGY), biotin, ergocalciferol (VIT D), collagen. The patient experienced left arm increasing painful, headache, back pain, temp of 99.6, tired all on 12Feb2021 21:30. The events outcome was not recovered.    No follow-up attempts are possible. No further information is expected
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Left arm increasing painful; headache; back pain; temp of 99.6; Tired; This is a spontaneous report from a contactable Consumer (patient).  A 65-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 12Feb2021 09:15 AM (Lot Number: EN6201) (at the age of 65) as single dose for covid-19 immunisation. First dose (lot#EN5318) was administered on 23Jan2021, 04:00 PM, left arm. Medical history included vitiligo, hypothyroidism, knee arthroplasty, drug hypersensitivity (sulfa and penicillin). Concomitant medications included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC ALLERGY), biotin, ergocalciferol (VIT D), collagen. The patient experienced left arm increasing painful, headache, back pain, temp of 99.6, tired all on 12Feb2021 21:30. The events outcome was not recovered.    No follow-up attempts are possible. No further information is expected
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Slight fever; Chills; Headache; Exhaustion; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male received the BNT162B2 (BNT162B2, Formulation: Solution for injection, Batch/Lot no: EL3247) second dose via unspecified route of administration in left arm on 12Feb2021 11:00( at the age of 35-years-old) as 2nd dose single for COVID-19 immunization. The first dose via unspecified route of administration in left arm on 21Jan2021 01:45 (batch/Lot no: EL3247) 1st dose as single for COVID-19 immunization. The patient medical history included the allergies to the sulfa drugs were reported. Patient received Sertraline within 2 weeks of vaccination as concomitant medications were reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 13Feb2021 10:00 AM, the patient experienced with slight fever (100F) and chills for 1 day, headache for 2 days and exhaustion for 2 days. Treatment received for the adverse event headache which included Acetaminophen. Outcome of the events slight fever (100F) and chills was recovered for 1 day on 14Feb2021 and headache, exhaustion recovered for 2 days on 15Feb2021.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Musculoskeletal stiffness
Clinical narrative: Stiff injection arm; stiff neck; Chills; This is a spontaneous case from a contactable consumer.   A 66-years-old female patient received first dose of bnt162b2 (BNT162B2,Formulation: Solution for injection, Lot Number: EL9265), via an unspecified route of administration, administered in Left arm on 10Feb2021 08:30 at a single dose for covid-19 immunisation. Medical history included ulcerative colitis and known allergies: Seasonal hayfever. Concomitant medication included balsalazide, cyanocobalamin (B12-VITAMIIN) and calcium, ergocalciferol (calcium plus D). No covid tested post vaccination. No covid prior vaccination. The patient experienced stiff injection arm, stiff neck and chills on 11Feb2021 at 03:00 AM. No treatment was given for the events. No other vaccine in four weeks. The outcome of the events was recovered on an unspecified date 2021.  Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site swelling
Clinical narrative: The shot was not given in the muscle the way it should have been. It was given way below the muscle in the fatty area; I still have swelling, about 2.5 inches of swelling from the second dose; This is a spontaneous report from a contactable consumer (patient herself). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EN6201, Expiry date not reported), unspecified route of administration in left arm on 11Feb2021 16:00 ( at age of 68-years) as 2nd dose, single for COVID-19 immunization. The patients did not have any history and concomitant medication were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283, Expiry date not reported) via unspecified route of administration in left arm on 19Jan2021 as 1st dose, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The caller stated that she received the second dose of the COVID-19 vaccine on Thursday 11Feb2021. The shot was not given in the muscle the way it should have been. It was given way below the muscle in the fatty area. I still have swelling (unspecified date in Feb2021), about 2.5 inches of swelling from the second dose, does that mean it was given in correctly. Is there anything she should do, not sure it was effective. Shot may not be effective because it was given way below the muscle in the fatty area. The clinical outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Somnolence
Clinical narrative: feeling very tired; nauseated on the stomach; sleepy; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number/Expiry date: unknown) via an unspecified route of administration as a single dose for COVID-19 immunization on 11Feb2021. The NDC number of Pfizer BioNTech vaccine was not provided. The past medical history and concomitant medication was not provided. On 13Feb2021, the patient experienced feeling very tired, nauseated on the stomach, and sleepy for 3 days now and it was worst today. The patient reported that tiredness prompted her to go back to bed. The clinical outcome for the events was unknown. Caller is trying to see if this last Pfizer BioNTech vaccine is causing her to feel so tired and nauseous on the stomach.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Paranoia
Clinical narrative: Behaving differently like paranoid; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received first  dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 22Jan2021 as a single dose for COVID-19 immunization. The patient's medical history included macular degeneration that are shots in the eye. The patient's concomitant medication included saffron. On the same day of vaccination after a while, the patient started behaving differently like paranoid that her daughter and grandson where stealing from her, out of the blue and the patient had not been behaving like that before. The patient got the second dose on 12Feb2021. The patient got the physician performed CT scan and blood work, but they came good. The patient wanted to know if that was something that has been reported. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Left arm/ shoulder pain; Left arm/ shoulder pain; This is a spontaneous report received from a Non-contactable other health care professional (patient).  A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: ELO140), via an unspecified route of administration, administered in Arm Left on 24Dec2020 (age at the time of vaccination was 33-year-old) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. Patient had no known allergies. Patient has not received any other vaccines in four weeks and not received any other vaccines prior to vaccination. On 15Feb2021 (post vaccination) The patient underwent lab tests and procedures which included sars-cov-2 test and resulted as negative. On 24Dec2020 the patient experienced left arm/ shoulder pain (pain in extremity), left arm/ shoulder pain (arthralgia) persisting since the first vaccination it has never gone away. Patient had no other injury to that arm other than the vaccine which resulted in doctor or other healthcare professional office/clinic visit. The outcome of event was not recovered. No follow up attempts are Possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Discomfort, Fatigue, Feeling cold, Musculoskeletal chest pain
Clinical narrative: muscle pain in my chest and going down my rib cage; feet felt like ice; Calf muscle also hurt; could not find a comfortable way to sit or lie down; muscles still tingle a little bit; lost my appetite; tired; This is a spontaneous report from a contactable consumer or other non hcp. A 81-year-old male patient received first dose bnt162b2 (BNT162B2,  Formulation: solution for injection, Batch/Lot Number: EL9262 and Expiration date was not provided), via an unspecified route of administration, administered in Arm Right on 02Feb2021 15:30 ((age at vaccination 81-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included myelitis transverse. I had Transverse Myelitis 70 Years ago at age 12. No other allergies were reported. No covid was reported prior to vaccination. The patient's concomitant medications were not reported. No other vaccination in four weeks and no other medications in two weeks. On 11Feb2021 20:30, the patient experienced muscle pain in my chest and going down my rib cage, feet felt like ice, calf muscle also hurt, could not find a comfortable way to sit or lie down, muscles still tingle a little bit, lost my appetite, tired. The patient underwent lab tests and procedures which included sars-cov-1 test: unknown on 14Feb2021. Therapeutic measures were taken as a result of muscle pain in my chest and going down my rib cage, feet felt like ice, calf muscle also hurt, could not find a comfortable way to sit or lie down, muscles still tingle a little bit, lost my appetite, tired. The outcome of event was Not recovered/Not resolved.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, SARS-CoV-1 test
Clinical narrative: muscle pain in my chest and going down my rib cage; feet felt like ice; Calf muscle also hurt; could not find a comfortable way to sit or lie down; muscles still tingle a little bit; lost my appetite; tired; This is a spontaneous report from a contactable consumer or other non hcp. A 81-year-old male patient received first dose bnt162b2 (BNT162B2,  Formulation: solution for injection, Batch/Lot Number: EL9262 and Expiration date was not provided), via an unspecified route of administration, administered in Arm Right on 02Feb2021 15:30 ((age at vaccination 81-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included myelitis transverse. I had Transverse Myelitis 70 Years ago at age 12. No other allergies were reported. No covid was reported prior to vaccination. The patient's concomitant medications were not reported. No other vaccination in four weeks and no other medications in two weeks. On 11Feb2021 20:30, the patient experienced muscle pain in my chest and going down my rib cage, feet felt like ice, calf muscle also hurt, could not find a comfortable way to sit or lie down, muscles still tingle a little bit, lost my appetite, tired. The patient underwent lab tests and procedures which included sars-cov-1 test: unknown on 14Feb2021. Therapeutic measures were taken as a result of muscle pain in my chest and going down my rib cage, feet felt like ice, calf muscle also hurt, could not find a comfortable way to sit or lie down, muscles still tingle a little bit, lost my appetite, tired. The outcome of event was Not recovered/Not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling more fatigued than normal after receiving the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 85-Year-old male patient received the second dose of bnt162b2 (COMIRNATY; Solution for injection; Lot number and Expiration date not reported) via an unspecified route of administration on 15Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient is usually fatigued however is feeling more fatigued than normal after receiving the vaccine. The outcome of the event was not reported.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache
Clinical narrative: his pressure went up to 168/90; headaches; This is a spontaneous report from a contactable consumer.   An 81-year-old male 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 08Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for hypertension and carvedilol hcl taken for hypertension. Patient reported that he had his vaccine on 08Feb2021 and 2 days later his pressure went up to 168/90 and it has stayed up. Caller reports that he usually takes Carvedilol and Lipitor for his blood pressure and asks if elevated blood pressure is a side effect of the covid vaccine. Caller states he got the Pfizer vaccine on 8Feb2021, everything was great and the next day it was good, on the second day after the vaccine, clarifies 10Feb2021, states his blood pressure went up and got headaches. States tomorrow he has an appointment with cardiology. States Second dose is scheduled on 3Mar2021.Caller wants to know if this is normal. The caller gave additional Information for Concomitant Products Lipitor as couple years. The caller provided the dates for blood pressure went up and has headaches as 10Feb2021 to Ongoing. The patient underwent lab tests and procedures which included blood pressure measurement: 168/90 on 10Feb2021 Caller reports that he had his vaccine on Feb 8th and 2 days later his pressure went up to 168/90 and it has stayed up. The outcome of the events was not recovered/not resolved.  Information of lot/batch number have been requested  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; This is a spontaneous report from a non-contactable consumer (patient's spouse) from via Medical information team.  A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 15Feb2021 as 2nd dose, single and dose 1 via an unspecified route of administration on an unspecified date as 1st dose, for COVID-19 immunization. Consumer reported that her husband received the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine today and is having issues with his back. She wants to know if he can take the steroid injection that his doctor prescribed him with for his back pain. She also mentioned that her husband previously took the steroid injection 2 days after his 1st dose, but now they want to be safe. She wants to know how long her husband has to wait before taking the steroid injection after receiving the 2nd dose of the vaccine. The outcome of the event was unknown. The patients' wife wants to know if her husband should receive a 3rd dose of the Pfizer-BioNTech Covid-19 Vaccine since he took a steroid injection after the 1st dose and if there is a test that her husband can take to assess the Pfizer-BioNTech Covid-19 Vaccine's effect on him.   No follow-up attempts are possible. Information about lot/batch number could not be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9264), via an unspecified route of administration in right arm on 02Feb2021 at 10:30 AM (at the age of 59-year-old) as a single dose for COVID-19 immunization. The patient did not receive other vaccine in four weeks. There was none known allergies. Patient did not have covid prior vaccination. The patient's medical history included type II diabetes mellitus. The patient's concomitant medication (other vaccine in two weeks) included metformin, lisinopril, jardiance, atorvastatin. On 15Feb2021 at 10:15 AM, the patient experienced severe headache. The patient did not receive any treatment for the event. The patient had not tested for covid post vaccination The outcome of the event was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected