chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: patient tested positive for COVID-19; patient tested positive for COVID-19; This is a spontaneous report from a contactable nurse (reporting for herself), via a Pfizer sponsored program.  A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient tested positive for COVID-19.  The patient underwent lab tests and procedures which included COVID-19: positive on an unspecified date.  The outcome of the event was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dizziness postural, Fatigue, Vertigo
Clinical narrative: vertigo; Extreme dizziness/ vertigo. To the point of falling.; feel lightheaded; extreme exhaustion; This is a spontaneous report from a contactable consumer (patient).   A 54-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, lot # Ek9231) at single dose at right arm on 07Jan2021 12:00 AM for Covid-19 immunisation, administered at hospital.  Medical history included non-Hodgkin's lymphoma, allergy to penicillin. Concomitant medication included amlodipine (AMLODIPINE), lisinopril (LISINOPRIL), escitalopram (ESCITALOPRAM). The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.  The patient experienced feel lightheaded on 08Jan2021 around 4 pm, extreme exhaustion on 08Jan2021 around 4 pm, vertigo to the point of falling on 08Jan2021 around 8 pm and feel lightheaded, and he was still feel lightheaded, not badly. No treatment received. Post vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered with sequelae (recovered with lasting effects).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arms; This is a spontaneous report from a contactable Other HCP. This 35-year-old female Other HCP (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Dec2020 for covid-19 immunization. Medial history and concomitant drug were not reported. Patient experienced sore arms, no other symptoms after received 1st dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: severe chills, fatigue, fever 100.7F, nausea; severe chills, fatigue, fever 100.7F, nausea; severe chills, fatigue, fever 100.7F, nausea; severe chills, fatigue, fever 100.7F, nausea; This is a spontaneous report from a non contactable   physician reporting for herself.  A 28-years-old female patient received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 19Dec2020 17:00 at  single dose for Covid-19 immunisation .  The patient medical history  and concomitant medications were not reported.  The patient experienced severe chills, fatigue, fever 100.7°F, nausea on an unknown date with outcome of recovering.  The patient underwent lab tests and procedures which included body temperature: 100.7 Fahrenheit on an unspecified.  Unspecified therapeutic measures were taken as a result of the reported events.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: Lymph node swelling unilaterally in the armpit on the side of the injection; Sore arm; some fatigue; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EL3246) via an unspecified route of administration at left arm on 06Jan2021, at 04:30 PM (dose number: 2) for COVID-19 immunization. Medical history included depression and anxiety. No known allergies. Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, Lot number: EH9899) via an unspecified route of administration at left arm on 17Dec2020 at 04:45 PM at a single dose (dose number: 1) for COVID-19 immunization. No other vaccine in four weeks. Other medications in two weeks included fluoxetine, ibuprofen, acetaminophen, cefixime (FLEXERIL). Facility type vaccine was at hospital. The patient was not pregnant. The patient experienced adverse events included lymph node swelling unilaterally in the armpit on the side of the injection, sore arm and some fatigue. The adverse event start date was reported as 08Jan2021 at 04:45 AM. No treatment received for events. The outcome of events was resolving. No COVID prior vaccination. No COVID tested post vaccination.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: patient received the second dose of the vaccine on 06Jan2021 and tested positive for the COVID virus 09Jan2021; patient received the second dose of the vaccine on 06Jan2021 and tested positive for the COVID virus 09Jan2021; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age ((Age: 50; Unit: Unknown; as reported) received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), 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.  The patient received the second dose of the vaccine on 06Jan2021 and tested positive for the COVID virus 09Jan2021 (medically significant). The clinical course was reported as follows: The patient received the second dose of the vaccine on 06Jan2021 and tested positive for the COVID virus on 09Jan2021. The patient stated that she had signs and symptoms and had exposure to the COVID virus. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 09Jan2021.  The clinical outcome of the events: drug ineffective and COVID-19 virus test positive, was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: patient received the second dose of the vaccine on 06Jan2021 and tested positive for the COVID virus 09Jan2021; patient received the second dose of the vaccine on 06Jan2021 and tested positive for the COVID virus 09Jan2021; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age ((Age: 50; Unit: Unknown; as reported) received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), 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.  The patient received the second dose of the vaccine on 06Jan2021 and tested positive for the COVID virus 09Jan2021 (medically significant). The clinical course was reported as follows: The patient received the second dose of the vaccine on 06Jan2021 and tested positive for the COVID virus on 09Jan2021. The patient stated that she had signs and symptoms and had exposure to the COVID virus. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 09Jan2021.  The clinical outcome of the events: drug ineffective and COVID-19 virus test positive, was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, first dose on an unspecified date and second dose on 06Jan2021 (at the age of 50-years-old), at a single dose for COVID-19 immunization. Medical history included blood pressure high, high cholesterol, and sugar. Concomitant medications included rosuvastatin calcium (CRESTOR), amlodipine besilate, olmesartan medoxomil (AZOR), metformin (MANUFACTURER UNKNOWN) taken for sugar, and escitalopram oxalate (LEXAPRO). The patient experienced positive COVID-19 test on 09Jan2021. The patient underwent lab tests and procedures which included COVID-19 test: positive on 09Jan2021. The patient did not receive any treatment for the event. The clinical outcome of positive COVID-19 test was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, first dose on an unspecified date and second dose on 06Jan2021 (at the age of 50-years-old), at a single dose for COVID-19 immunization. Medical history included blood pressure high, high cholesterol, and sugar. Concomitant medications included rosuvastatin calcium (CRESTOR), amlodipine besilate, olmesartan medoxomil (AZOR), metformin (MANUFACTURER UNKNOWN) taken for sugar, and escitalopram oxalate (LEXAPRO). The patient experienced positive COVID-19 test on 09Jan2021. The patient underwent lab tests and procedures which included COVID-19 test: positive on 09Jan2021. The patient did not receive any treatment for the event. The clinical outcome of positive COVID-19 test was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Sore at injection site.; This is a spontaneous report from a contactable other healthcare professional (patient). A 22-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at site of left arm on an unspecified date at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced sore at injection site on an unspecified date. Facility type vaccine was in hospital. No other vaccine received in four weeks. No other medications received in two weeks. No treatment for adverse event. No covid prior vaccination. Covid (Nasal Swab, Rapid test) was tested with negative result post vaccination. No known allergies. The outcome of event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Product use issue, Vaccination site pain
Clinical narrative: Soreness at the injection site/arm; Soreness at the injection site/arm; I am currently breastfeeding at time of vaccination; I am currently breastfeeding at time of vaccination; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. This consumer (mother) reported for herself that: a 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ek9231), via an unspecified route of administration in Left arm on 08Jan2021 11:15 at single dose for COVID-19 immunization. Medical history included ongoing breast feeding. There were no Known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination and did not have covid-19 tested post vaccination. The patient was currently breastfeeding at time of vaccination and would continue to do so. The patient experienced soreness at the injection site/arm starting a couple hours after administration on 08Jan2021 13:15 and lasting 1 day. The patient did not receive any treatment for events soreness at the injection site/arm. The outcome of events soreness at the injection site/arm was Recovered in Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021022052 Same reporter/drug, different patient/event (baby/mother case)
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations, Throat tightness, Vaccination site pain, Vaccination site rash
Clinical narrative: Mild feeling of throat constricting; dizziness; palpitations; Left arm sore; Circular rash next to injection site; This is a spontaneous report from a contactable other hcp (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ELO140), via an unspecified route of administration in left arm on 06Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included high blood pressure and brachial radial puritis. Concomitant medication included metoprolol succinate (TOPROL) and estrogens conjugated (PREMARIN). No COVID prior vaccination. No other vaccine in four weeks. The patient experienced mild feeling of throat constricting, dizziness, and palpitations, left arm sore, Circular rash next to injection site on 06Jan2021 14:45 (for about 20 minutes), left arm sore for about 4 days. No treatment received. No COVID tested post vaccination. The outcome of events was recovered in Jan2021.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea
Clinical narrative: bad migraine; headache; nauseous; This is a spontaneous report from a contactable healthcare professional (patient).  A 36-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 06Jan2021 07:00 to 06Jan2021 07:00 at 0.3 mL, single (SINGLE DOSE) for an unspecified indication.  Medical history included polycystic ovaries (PCOS), endometriosis, irritable bowel syndrome (IBS), and known allergies:  melons, all from unknown dates.  Concomitant medication included amoxicillin, clavulanic acid (AUGMENTIN), ethinylestradiol, etonogestrel (NUVARING), acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL), cetirizine hydrochloride (ZYRTEC), diphenhydramine hydrochloride (BENADRYL).  The patient experienced bad migraine, headache and was nauseous on 06Jan2021.  Details were as follows: the patient had a bad migraine for three days after. On the  Wednesday night (13Jan2021) after the injection, the migraine was so bad, that therapeutic measures taken; the patient took an unspecified medication and went to bed. The patient woke up three times in the night with a headache bad enough to make the patient nauseous. The second day was bad but manageable; on the third day it came and went.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: received the Vaccine on 31Dec and on 04Jan was tested positive; received the Vaccine on 31Dec and on 04Jan was tested positive; Low-grade fever; slight loss of smell and taste; slight loss of smell and taste; This is a spontaneous report from a contactable Consumer. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient received the Vaccine on 31Dec2020 and on 04Jan2021 was tested positive prior to having surgery. Minimal symptoms. Low-grade fever, slight loss of smell and taste. Outcome of events was recovering.   Information on the Lot/Batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Pain, Pain in extremity
Clinical narrative: fever; Sore arm; body aches; headache; chills; Administration date=09Jan2021/Administration date=21Dec2020; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received second dose of BNT162B2 (Pfizer, lot number: EL1284), via an unspecified route of administration in left arm on 09Jan2021 18:00 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (lot number: E51685) in left arm on 21Dec2020 13:45 for COVID-19 immunization. On 10Jan2021 07:00, patient experienced sore arm, body aches, headache, chills, and fever. Treatment was not received for these events. Patient was not recovered from these events.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; Sore arm; body aches; headache; chills; Administration date=09Jan2021/Administration date=21Dec2020; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received second dose of BNT162B2 (Pfizer, lot number: EL1284), via an unspecified route of administration in left arm on 09Jan2021 18:00 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (lot number: E51685) in left arm on 21Dec2020 13:45 for COVID-19 immunization. On 10Jan2021 07:00, patient experienced sore arm, body aches, headache, chills, and fever. Treatment was not received for these events. Patient was not recovered from these events.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: terrible headache/bad headache; body aches; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient) and another consumer (Wife). A 79-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 at single dose for COVID-19 immunization. Patient was experiencing body aches and terrible headache after 2nd dose of vaccine. Patient wanted to know if he could use analgesics after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The patient's wife further reported that her husband had his second dose of Covax on 09Jan2021. Today (10Jan2021) he was experiencing body aches and a bad headache and wondering if he can take pain reliever. The outcome of the events was not recovered at the time of the reporting.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Neuralgia, Pain of skin
Clinical narrative: Experience skin nerve pain all over my body; Experience skin nerve pain all over my body; Extreme cold sensation after bowel movements; This is spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not provided), via an unspecified route of administration on 04Jan2021 10:15 at single dose for covid-19 immunization. Patient is not pregnant. Medical history included severe post concussion syndrome (5 major concussions), anxiety, depression, raynaud's syndrome, pineal gland cyst (last MRI Oct2020 reveal cyst was 12mm). The known allergies included Cipro, sensitive to many food, high allergy to mold, grasses, trees. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), fluoxetine hydrochloride (PROZAC), rizatriptan benzoate (MAXALT), montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL) , lactulose (LACTUL), ongoing medications included mometasone furoate (FLONASE), budesonide (BUDESONIDE), olopatadine (OLOPATADINE), ipratropium (IPRATROPIUM) , fremanezumab (AJOVY), allergy shots. 48 hours after injection on 06Jan2021 13:00, patient began to experience skin nerve pain all over body accompanied with extreme cold sensation after bowel movements, has been 6 days and getting worse. She will be going to urgent care tomorrow. She was between primary care physicians until 13Jan2021. Patient didn't receive treatment for the adverse events. The outcome of events was not recovered.   Information about lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Discomfort, Pain
Clinical narrative: extreme discomfort; sharp pain in my upper back primary on the right side of my body; sharp pain in my upper back primary on the right side of my body; Most of the sharp pain was when coughing; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer PAA156051; lot number: EK9231) via an unspecified route of administration at right arm on 08Jan2021 at 09:30 AM at a single dose (dose number: 1) for COVID-19 immunization. Medical history was reported as none. No known allergies. No other vaccine in four weeks. Other medications in two weeks included birth control. Facility type vaccine was other. The patient was not pregnant. The patient felt extreme discomfort and sharp pain in her upper back primary on the right side of her body starting Friday 08Jan2021 evening until late Saturday night 09Jan2021. Most of the sharp pain was when coughing or inhaling and while sitting and laying down only. I did not have extreme plain when standing up. The start date of events was reported as 08Jan2021 at 05:30 PM. Treatment received included OTC Bayer for the pain. The outcome of events was resolved on 09Jan2021. No covid prior vaccination and no covid tested post vaccination.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal stiffness, SARS-CoV-2 test, Skin discolouration
Clinical narrative: Several toes on my right foot and one toe on my left became purple in color and looked like "COVID toes."; Stiff Neck noted in correlation with discoloration; This is a spontaneous report from a contactable Nurse reported for herself. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at right arm on 28Dec2020 15:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included Factor V, Behcet's disease, Hypertension, and allergy to PCN. Prior to vaccination, the patient was not diagnosed with COVID-19  The patient's concomitant medication was not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's past drug history included steriod Injection to left shoulder 23Dec2020. On 09Jan2021 11:30, Approximately 12 days after receiving vaccine, several toes on my right foot and one toe on my left became purple in color and looked like "COVID toes." I was seen in the ED, unsure of what is causing this, will be seen by MD next week. Lighter purple on second day, seems to be resolving. Stiff Neck noted in correlation with discoloration. Adverse event resulted in: Emergency room/department or urgent care. No treatment received for the events. The patient underwent lab tests and procedures which included Nasal Swab 2019 Novel Coronavirus SARSCOV-2 by PCR was negative on 09Jan2021. The outcome of the events was recovering.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody, Inflammatory marker test, Laboratory test, SARS-CoV-2 test negative, Skin discolouration
Clinical narrative: Several toes on my right foot and one toe on my left became purple in color and looked like "COVID toes."; Stiff Neck noted in correlation with discoloration; This is a spontaneous report from a contactable Nurse reported for herself. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at right arm on 28Dec2020 15:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included Factor V, Behcet's disease, Hypertension, and allergy to PCN. Prior to vaccination, the patient was not diagnosed with COVID-19  The patient's concomitant medication was not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's past drug history included steriod Injection to left shoulder 23Dec2020. On 09Jan2021 11:30, Approximately 12 days after receiving vaccine, several toes on my right foot and one toe on my left became purple in color and looked like "COVID toes." I was seen in the ED, unsure of what is causing this, will be seen by MD next week. Lighter purple on second day, seems to be resolving. Stiff Neck noted in correlation with discoloration. Adverse event resulted in: Emergency room/department or urgent care. No treatment received for the events. The patient underwent lab tests and procedures which included Nasal Swab 2019 Novel Coronavirus SARSCOV-2 by PCR was negative on 09Jan2021. The outcome of the events was recovering.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: Several toes on my right foot and one toe on my left became purple in color and looked like "COVID toes."; Stiff Neck noted in correlation with discoloration; This is a spontaneous report from a contactable Nurse reported for herself. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at right arm on 28Dec2020 15:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included Factor V, Behcet's disease, Hypertension, and allergy to PCN. Prior to vaccination, the patient was not diagnosed with COVID-19  The patient's concomitant medication was not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's past drug history included steriod Injection to left shoulder 23Dec2020. On 09Jan2021 11:30, Approximately 12 days after receiving vaccine, several toes on my right foot and one toe on my left became purple in color and looked like "COVID toes." I was seen in the ED, unsure of what is causing this, will be seen by MD next week. Lighter purple on second day, seems to be resolving. Stiff Neck noted in correlation with discoloration. Adverse event resulted in: Emergency room/department or urgent care. No treatment received for the events. The patient underwent lab tests and procedures which included Nasal Swab 2019 Novel Coronavirus SARSCOV-2 by PCR was negative on 09Jan2021. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Lymphadenopathy
Clinical narrative: headache; swollen lymph nodes; back pain; This is a spontaneous report from a contactable pharmacist (patient).  A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced delayed reactions of headache, and back pain and swollen lymph nodes started on 07Jan2021 and continue to this day (4 days as well) on 07Jan2021 with outcome of not recovered. Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for COVID after first dose; Patient tested positive for COVID after first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number/expiration date unknown) via an unspecified route of administration on 22-Dec-2020 (19 days before 10-Jan-2021)  at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient tested positive for COVID after first dose. Reporter would like to know how he should proceed for second dose. The outcome of the events was unknown.   Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal faeces, Decreased appetite, Diarrhoea, Malaise, Nausea
Clinical narrative: injection site pain; nausea; feeling unwell; reduced appetite; loose stools with an off odor; loose stools with an off odor; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 07Jan2021 (Thursday) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He stated that at first he had injection site pain in Jan2021 which has now gotten better but was currently experiencing nausea, feeling unwell, reduced appetite, loose stools with an off odor in Jan2021. He was asking how long these symptoms usually last. The patient wondered if he can get the second dose since he had these symptoms with the first dose. The outcome of event injection site pain was recovering, the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; nausea; feeling unwell; reduced appetite; loose stools with an off odor; loose stools with an off odor; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 07Jan2021 (Thursday) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He stated that at first he had injection site pain in Jan2021 which has now gotten better but was currently experiencing nausea, feeling unwell, reduced appetite, loose stools with an off odor in Jan2021. He was asking how long these symptoms usually last. The patient wondered if he can get the second dose since he had these symptoms with the first dose. The outcome of event injection site pain was recovering, the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Neck pain
Clinical narrative: she had pressure headaches; she had pressure headaches and it extends to the back of her head and neck; she had pressure headaches and it extends to the back of her head and neck; This is a spontaneous report from a contactable Other HCP(patient). A 37-year-old female patient received BNT162B2 (lot number E13246) , Intramuscular at Arm Left on 07Jan2021 09:30 at the 37 years old at single dose for COVID-19 immunization. The medical history included Shellfish allergy. The concomitant medications were none. Since taking the vaccine on Thursday morning, starting Friday morning on 08Jan2021 she had pressure headaches and it extends to the back of my head and neck. There was no treatment received for all the adverse events. There was no other vaccine in four weeks. There was no covid prior vaccination. The outcome of the event was not recovered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Tiredness; headache; chills; fever; muscle pain; This is a spontaneous report from a contactable Nurse(patient).  The 54-year-old female patient (not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ES1655) , via an unspecified route of administration at right arm on 09Jan2021 10:00AM at single dose for covid-19 immunisation.  Medical history included arthritis, asthma, sjogren, eczema.  The patient's concomitant medications were not reported.  The patient previously took cefotaxime sodium (OMNICEF) and "Bactria" and both experienced drug allergy.  The patient experienced tiredness, headache, chills, fever, muscle pain, all on 10Jan2021 at 12:00 AM with outcome of not recovered. There was no treatment received, no covid prior vaccination, no covid tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Insomnia, Nausea, Pain
Clinical narrative: body aches; insomnia; chills; bouts of nausea; This is a spontaneous report from a non-contactable Other healthcare professional (patient). A 34-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EL3246), intramuscular on left arm on unspecified date in Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received his first dose of BNT162B2 intramuscularly on left arm on unknown date for COVID-19 immunization. 10hrs after his second vaccination on 09Jan2021, the patient developed body aches, insomnia and chills, he also had been bouts of nausea. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any treatment for events. The outcome of events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Flatulence, Headache
Clinical narrative: extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; fever/low grade fever; nausea; gas which lead to vomiting; gas which lead to vomiting; extreme joint and muscle aches even after 1gm of Tylenol (ankles, elbows, hips, lower back, calves were the worst)/ lower back pain; chest similar to what one would experience during hyperventilation; tingling feeling in hands/fingers, lips; tingling feeling in hands/fingers, lips; headache; Slept most of the day evening; This is a spontaneous report from a contactable nurse (reported for herself). A 37-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 08Jan2021 10:15 at single dose at right arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication received in two weeks included lisdexamfetamine mesilate (VYVANSE) in two weeks (did not take on vaccine days). The patient previously received the first dose of bnt162b2 (lot number: EJ1685) on 18Dec2020 10:00 at single dose at right arm for COVID-19 immunization. No other vaccine in four weeks. On 09Jan2021 12:00, 12hrs after injection extreme joint and muscle aches even after 1gm of Tylenol (ankles, elbows, hips, lower back, calves were the worst), fever, nausea/gas which lead to vomiting (even after 25mg phenergan) and headache this last 6hrs. The aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent. Tylenol did not relieve symptoms, but was able to sleep. Slept most of the day evening in Jan2021. 48/60hrs after injection the lower back pain remains intense as well as low grade fever (Jan2021). Also have a tingling feeling in hands/fingers, lips, chest similar to what one would experience during hyperventilation on 09Jan2021 12:00. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient didn't have Covid prior vaccination and didn't have Covid tested post vaccination. The outcome of Arthralgia and Pain in extremity was recovering, of Pyrexia and Low back pain was not recovered, of the other events was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperventilation, Myalgia, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; fever/low grade fever; nausea; gas which lead to vomiting; gas which lead to vomiting; extreme joint and muscle aches even after 1gm of Tylenol (ankles, elbows, hips, lower back, calves were the worst)/ lower back pain; chest similar to what one would experience during hyperventilation; tingling feeling in hands/fingers, lips; tingling feeling in hands/fingers, lips; headache; Slept most of the day evening; This is a spontaneous report from a contactable nurse (reported for herself). A 37-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 08Jan2021 10:15 at single dose at right arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication received in two weeks included lisdexamfetamine mesilate (VYVANSE) in two weeks (did not take on vaccine days). The patient previously received the first dose of bnt162b2 (lot number: EJ1685) on 18Dec2020 10:00 at single dose at right arm for COVID-19 immunization. No other vaccine in four weeks. On 09Jan2021 12:00, 12hrs after injection extreme joint and muscle aches even after 1gm of Tylenol (ankles, elbows, hips, lower back, calves were the worst), fever, nausea/gas which lead to vomiting (even after 25mg phenergan) and headache this last 6hrs. The aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent. Tylenol did not relieve symptoms, but was able to sleep. Slept most of the day evening in Jan2021. 48/60hrs after injection the lower back pain remains intense as well as low grade fever (Jan2021). Also have a tingling feeling in hands/fingers, lips, chest similar to what one would experience during hyperventilation on 09Jan2021 12:00. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient didn't have Covid prior vaccination and didn't have Covid tested post vaccination. The outcome of Arthralgia and Pain in extremity was recovering, of Pyrexia and Low back pain was not recovered, of the other events was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pyrexia, Somnolence, Vomiting
Clinical narrative: extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; fever/low grade fever; nausea; gas which lead to vomiting; gas which lead to vomiting; extreme joint and muscle aches even after 1gm of Tylenol (ankles, elbows, hips, lower back, calves were the worst)/ lower back pain; chest similar to what one would experience during hyperventilation; tingling feeling in hands/fingers, lips; tingling feeling in hands/fingers, lips; headache; Slept most of the day evening; This is a spontaneous report from a contactable nurse (reported for herself). A 37-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 08Jan2021 10:15 at single dose at right arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication received in two weeks included lisdexamfetamine mesilate (VYVANSE) in two weeks (did not take on vaccine days). The patient previously received the first dose of bnt162b2 (lot number: EJ1685) on 18Dec2020 10:00 at single dose at right arm for COVID-19 immunization. No other vaccine in four weeks. On 09Jan2021 12:00, 12hrs after injection extreme joint and muscle aches even after 1gm of Tylenol (ankles, elbows, hips, lower back, calves were the worst), fever, nausea/gas which lead to vomiting (even after 25mg phenergan) and headache this last 6hrs. The aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent. Tylenol did not relieve symptoms, but was able to sleep. Slept most of the day evening in Jan2021. 48/60hrs after injection the lower back pain remains intense as well as low grade fever (Jan2021). Also have a tingling feeling in hands/fingers, lips, chest similar to what one would experience during hyperventilation on 09Jan2021 12:00. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient didn't have Covid prior vaccination and didn't have Covid tested post vaccination. The outcome of Arthralgia and Pain in extremity was recovering, of Pyrexia and Low back pain was not recovered, of the other events was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: body aches; fevers; nausea; This is Spontaneous report from a contactable consumer. A 30-year-old female patient received second dose BNT162B2, via an unspecified route of administration on 07Jan2021 at the 30 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The Historical Vaccine included BNT162B2 for COVID-19 immunization (dose number 1). The patient was a nurse and she and several of her colleagues received the second dose of COVID-19 vaccine on Thursday 07Jan2021. On Friday 08Jan2021, she and many of her colleagues woke up with body aches, fevers, and nausea. She said the side effects went away within 12- 24 hours. There was no treatment received for all the adverse events. The outcome of the event was recovered in Jan2021.  Information on lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on upper body; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2, intramuscularly in right arm on 08Jan2021 15:30 at single dose for COVID-19 immunization. Medical history was none. Concomitant medications were unspecified. On 10Jan2021 15:00, patient experienced rash on upper body. Treatment was not received for this event. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: Fever; difficulty breathing; fast heartbeat; This is a spontaneous report from a contactable Other HCP (patient). This 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 12:30 at single dose on the left arm for COVID-19 immunization. Medical history included allergies: PCN. Concomitant medications included galcanezumab (EMGALITY) received in two weeks. No other vaccine received in four weeks. Patient was not pregnant. Facility type vaccine was hospital. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 09Jan2021 18:00, the patient experienced fever, difficulty breathing, fast heartbeat. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered.  Information about Lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Fatigue, Headache
Clinical narrative: LUE pain; bone pain; mialgia/muscle aches; all over joint pain; fatigue; chills; sore Left deltoid; body aches/all over body aches; Headache; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK5730), intramuscular on 19Dec2020 07:00 am at single dose at left arm for covid-19 immunization. Medical history included hypertension, covid-19 (prior vaccination). No known allergies. Concomitant medications in two weeks included amlodipine besilate (NORVASC), ascorbic acid (VIT C), ergocalciferol (VIT D), magnesium chloride (MAG), zinc and daily multivitamins. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, patient had not been tested for COVID-19. The patient experienced sore left deltoid, body aches, headache all on 19Dec2020 16:00, all over body aches, headache, fatigue and chills all on 20Dec2020, mialgia/muscle aches, fatigue, headache and all over joint pain all on 21Dec2020, headache, LUE pain, muscle and bone pain, fatigue all on 22Dec2020, patient finally felt better with decreased symptoms on 23Dec2020. Outcome of all events was recovered on unspecified date. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient received paracetamol (TYLENOL), motrin for events.