chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia, Vaccination site pain
Clinical narrative: Fever of 103.1; Cold Chills; Body Ache; Pain At Injection Site; Very Tired, Extremely exhausted; Delusional off/On; Mild/Sever Diarrhea; Headache On/Off; Upset stomach; Loss of appetite; Lazy Feeling(Extremely exhausted); Left arm swelling arm & Injection Site; Left arm swelling arm & Injection Site; left arm pain, very red tender to touch; Very red tender to touch; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient received bnt162b2 via an unspecified route of administration, administered in left arm on 10Jun2021 11:00 (Lot Number: Ew0180) as 2nd dose, single dose at the age of 27-year-old for covid-19 immunization. The patient was not pregnant. Historic vaccine was bnt162b2 via an unspecified route of administration, administered in left arm on 17May2021 13:45 (Lot Number: Ewv172) as 1st dose, single dose at the age of 27-year-old for covid-19 immunization. Medical history included Lung disease- Histoplasmosis, Stress Seurizes, chronic back pain, and Known allergies: Adhesive tape from an unknown date. Past drug event included ibuprofen and doxycycline and experienced allergies. Concomitant medication included cetirizine hydrochloride (CETIRIZINE HCL); oxycodone hydrochloride, paracetamol (PERCOCET, 5 mg); women vitamins (OLLY), all taken for an unspecified indication within 2 weeks of vaccination. The patient experienced left arm swelling arm & injection site, very red tender to touch/left arm pain, cold chills, body ache, pain at injection site, very tired, delusional off/on, mild/sever diarrhea, headache on/off, upset stomach, loss of appetite, lazy feeling (Extremely exhausted) on 10Jun2021. The patient also experienced fever of 103.1 on 10Jun2021 11:00 am. The patient underwent lab tests and procedures which included body temperature: 103.1 on 10Jun2021 11:00 am. Therapeutic measures were not taken as a result of events. The patient did not 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 not been tested for COVID-19. The outcome of events was not recovered.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Fever of 103.1; Cold Chills; Body Ache; Pain At Injection Site; Very Tired, Extremely exhausted; Delusional off/On; Mild/Sever Diarrhea; Headache On/Off; Upset stomach; Loss of appetite; Lazy Feeling(Extremely exhausted); Left arm swelling arm & Injection Site; Left arm swelling arm & Injection Site; left arm pain, very red tender to touch; Very red tender to touch; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient received bnt162b2 via an unspecified route of administration, administered in left arm on 10Jun2021 11:00 (Lot Number: Ew0180) as 2nd dose, single dose at the age of 27-year-old for covid-19 immunization. The patient was not pregnant. Historic vaccine was bnt162b2 via an unspecified route of administration, administered in left arm on 17May2021 13:45 (Lot Number: Ewv172) as 1st dose, single dose at the age of 27-year-old for covid-19 immunization. Medical history included Lung disease- Histoplasmosis, Stress Seurizes, chronic back pain, and Known allergies: Adhesive tape from an unknown date. Past drug event included ibuprofen and doxycycline and experienced allergies. Concomitant medication included cetirizine hydrochloride (CETIRIZINE HCL); oxycodone hydrochloride, paracetamol (PERCOCET, 5 mg); women vitamins (OLLY), all taken for an unspecified indication within 2 weeks of vaccination. The patient experienced left arm swelling arm & injection site, very red tender to touch/left arm pain, cold chills, body ache, pain at injection site, very tired, delusional off/on, mild/sever diarrhea, headache on/off, upset stomach, loss of appetite, lazy feeling (Extremely exhausted) on 10Jun2021. The patient also experienced fever of 103.1 on 10Jun2021 11:00 am. The patient underwent lab tests and procedures which included body temperature: 103.1 on 10Jun2021 11:00 am. Therapeutic measures were not taken as a result of events. The patient did not 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 not been tested for COVID-19. The outcome of events was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Lymphadenopathy on left clavicle; Chills/rigors; Fever; Headache; Nausea; Muscle aches; Extreme fatigue; Pain in collar bone on left side; This is a spontaneous report from a contactable other health care professional (HCP) (patient). A 38-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 09Jun2021 18:00 (Lot Number: EW0182) as dose 2, single for covid-19 immunization at the age of 38-year-old. The patient medical history and concomitant medications were none. The patient did not have any known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19May2021 17:00 (Lot Number: EW0182) as dose 1, single for covid-19 immunization at the age of 38-year-old. On 10Jun2021, the patient woke up to pain in collar bone on left side, she felt a small jelly like bump. On 11Jun2021, the jelly like bump doubled in size and pain. The patient went to Urgent Care and was diagnosed with Lymphadenopathy on left clavicle. The patient would follow-up with family physician if swelling doesn't go down for further testing. It was reported that patient also had symptoms of chills, fever, headache, rigors, nausea, muscle aches, and extreme fatigue on the day after receiving 2nd dose. The outcome of the events was not recovered. The patient did not receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Lymphadenopathy on left clavicle; Chills/rigors; Fever; Headache; Nausea; Muscle aches; Extreme fatigue; Pain in collar bone on left side; This is a spontaneous report from a contactable other health care professional (HCP) (patient). A 38-year-old female patient received BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 09Jun2021 18:00 (Lot Number: EW0182) as dose 2, single for covid-19 immunization at the age of 38-year-old. The patient medical history and concomitant medications were none. The patient did not have any known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19May2021 17:00 (Lot Number: EW0182) as dose 1, single for covid-19 immunization at the age of 38-year-old. On 10Jun2021, the patient woke up to pain in collar bone on left side, she felt a small jelly like bump. On 11Jun2021, the jelly like bump doubled in size and pain. The patient went to Urgent Care and was diagnosed with Lymphadenopathy on left clavicle. The patient would follow-up with family physician if swelling doesn't go down for further testing. It was reported that patient also had symptoms of chills, fever, headache, rigors, nausea, muscle aches, and extreme fatigue on the day after receiving 2nd dose. The outcome of the events was not recovered. The patient did not receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not been tested for COVID-19 since the vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss and hair thinning at the top of her head; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported, NDC/UPC number: Unknown, Expiry date: Unknown) as single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 (Batch/Lot number was not reported) (at the age of 64-year-old) as single dose for Covid-19 immunisation. The patient stated that, she was experiencing hair loss. Her hairdresser was noticing those who had the Pfizer vaccines had on top of the head hair loss. The patient received both doses of the Pfizer covid vaccine. It was her hairdresser who mentioned it to me. Patient was losing a lot of hair it was thinning. It was shedding while shampooing. In order not to go bald on top; the patient was thinning on the top she need to see a hair loss specialist. This was the major hair loss. She also reported that her hairdresser told her that others who received the Pfizer vaccine she had noticed that her other clients had hair loss as well, hair loss and hair thinning at the top of her head on 12May2021.The patient stated regarding the LOT number Moderna COVID 19 Vaccine vial then it was LOT 048A21A that was one LOT. Consumer stated regarding the expiration date was no. The patient saw was the LOT and she had the date they were administered. The patient stated that, "Moderna COVID 19 that was what she saw, were Moderna. So, Moderna was a different company. Oh, patient was told she was getting the Pfizer vaccine, she thought it was Pfizer Moderna. They told her it was a Pfizer Vaccine, they told me she was getting a Pfizer Vaccine. It says Moderna COVID 19. Pfizer and Moderna that was a one vaccine she thought Pfizer/Moderna. Patient stated, Ok, first she was trying to determine if Pfizer Moderna, it was a Pfizer and Moderna vaccine. Consumer was informed if this was the Moderna vaccine then you had to reach out to Modena for the concern. When paraphrased the concern, consumer stated, she took both (first dose and second dose) and her hairdresser said that she was seeing that the patient that took Covid vaccine (Covid-19 Vaccine) that they had a hair loss on the top of their head. She would like whether it was that a reported side effect. Outcome of the event was not resolved.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: COVID-19 virus test positive/lost sense of taste and smell but that was it; COVID-19 virus test positive; Vaccination site pain/Sore arm; This is a solicited report from a Pfizer-sponsored program received from a non-contactable consumer (patient) based on information received by Pfizer from(Manufacturer Control number 21K-163-3938265-00).  A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular in 2021 (Lot number was not reported) at the age of 62-year-old as single dose and dose 2 via an unspecified route of administration in 2021 (Lot number was not reported) at the age of 62-year-old as single dose for COVID-19 Vaccination; risankizumab (SKYRIZI), via subcutaneous from an unspecified date, at unspecified dose for Moderate to severe chronic plaque psoriasis. The patient medical history and concomitant medications were not reported. The patient experienced vaccination site pain in Jan2021. It was reported that the patient with events of non-serious Covid positive and sore arm after Covid vaccine with risankizumab. There was no reported medical history. On an unknown date, the patient experienced Sore arm after Covid Vaccine. In Jan2021, the patient experienced Covid positive. In 2021, the Covid positive resolved. On an unknown date, Sore arm after Covid vaccine resolved. Covid-19 Vaccine was also considered suspect. In Jan2021, patient had covid positive and lost sense of taste and smell but that was it. In 2021, he took two doses of Pfizer vaccine. His arm was a little sore. They just heard that people that had covid could not get the vaccine because there were antibodies in their bone marrow. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the events for risankizumab was unknown. The outcome of the events was recovered on an unspecified date in 2021. The reporter's causality for the event of Covid positive with Skyrizi(RISANKIZUMAB) was a reasonable possibility. The reporter's causality for the event of Sore arm after Covid vaccine was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Information about lot/batch number has been requested.; Sender's Comments: Whatever the efficacy of a product, lack of effect can occur and it is an expected finding. Based on the limited information currently available in this case, this occurrence cannot be excluded. Vaccination site pain is possibly related due to a plausible temporal relationship.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headache after that happened otw home lasting several hours; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration, administered in arm left on 22May2021 as 1st dose, single (age at vaccination was 48 years and was not pregnant) for COVID-19 immunisation. Medical history included migraines, arthritis, and fibromyalgia (chronic pain), and had known allergies to Codine, Theoflyine, Minocycoline, Bactrim DS, Flexril, and latex. The patient's concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced severe headache after that happened otw home lasting several hours on 22May2021. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Blood test, Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: My arm was hurting; It's not as bad but it's still red and swelling is still there; I have been having Temperature; Swelling and redness in my arm; Arm is still sore; Swelling in my arm in both areas at the injection site and in my lymph nodes; Swelling in my arm in both areas at the injection site and in my lymph nodes; Been very tired for last several days; My appetite is not normal; This is a spontaneous report from a contactable consumer or other non hcp.    A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via intramuscular route of administration, administered in Deltoid Left on 10Jun2021 09:40 (at the age of 68-year-old) as single dose for covid-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing, Patient stated I am allergy type person with some medicines, I tend to have reactions from insect bites and different things like that, multiple allergies from an unknown date and unknown if ongoing. Concomitant medication included verapamil (Verapamil) taken for blood pressure measurement, start and stop date were not reported. The patient experienced swelling in my arm in both areas at the injection site and in my lymph nodes on 10Jun2021, patient stated been very tired for last several days and my appetite is not normal on Jun2021. Patient want to inquire How long would these last? Any recommendations on what to do? During the day on Thursday it was ok but later in the evening by Friday am at 3am I woke up and my arm was hurting. Patient stated It has lasted for 3 days now and it's not as bad but it's still red and swelling is still there. "Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. Patient stated "I just received my first COVID shot on Thursday. I have been having Temperature and swelling and redness in my arm it seems to be going away, but today the arm is still sore, it still feels warm on 10Jun2021. Date for Second COVID shot: Consumer stated "Supposed to get 01Jul2021.Therapeutic measures were taken with "Tylenol" as a result of the events swelling in my arm in both areas at the injection site and in my lymph nodes, been very tired for last several days, it's not as bad but it's still red and swelling is still there, i have been having temperature swelling and redness in my arm, arm is still sore. The patient underwent lab tests and procedures which included blood test: unknown on 08Jun2021. Outcome of event was unknown for event Swelling in my arm in both areas at the injection site and in my lymph nodes and for all events outcome was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: My arm was hurting; It's not as bad but it's still red and swelling is still there; I have been having Temperature; Swelling and redness in my arm; Arm is still sore; Swelling in my arm in both areas at the injection site and in my lymph nodes; Swelling in my arm in both areas at the injection site and in my lymph nodes; Been very tired for last several days; My appetite is not normal; This is a spontaneous report from a contactable consumer or other non hcp.    A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via intramuscular route of administration, administered in Deltoid Left on 10Jun2021 09:40 (at the age of 68-year-old) as single dose for covid-19 immunisation. Medical history included blood pressure from an unknown date and unknown if ongoing, Patient stated I am allergy type person with some medicines, I tend to have reactions from insect bites and different things like that, multiple allergies from an unknown date and unknown if ongoing. Concomitant medication included verapamil (Verapamil) taken for blood pressure measurement, start and stop date were not reported. The patient experienced swelling in my arm in both areas at the injection site and in my lymph nodes on 10Jun2021, patient stated been very tired for last several days and my appetite is not normal on Jun2021. Patient want to inquire How long would these last? Any recommendations on what to do? During the day on Thursday it was ok but later in the evening by Friday am at 3am I woke up and my arm was hurting. Patient stated It has lasted for 3 days now and it's not as bad but it's still red and swelling is still there. "Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. Patient stated "I just received my first COVID shot on Thursday. I have been having Temperature and swelling and redness in my arm it seems to be going away, but today the arm is still sore, it still feels warm on 10Jun2021. Date for Second COVID shot: Consumer stated "Supposed to get 01Jul2021.Therapeutic measures were taken with "Tylenol" as a result of the events swelling in my arm in both areas at the injection site and in my lymph nodes, been very tired for last several days, it's not as bad but it's still red and swelling is still there, i have been having temperature swelling and redness in my arm, arm is still sore. The patient underwent lab tests and procedures which included blood test: unknown on 08Jun2021. Outcome of event was unknown for event Swelling in my arm in both areas at the injection site and in my lymph nodes and for all events outcome was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Pain
Clinical narrative: Friday after shot entire body began aching, severe pain; Headache; chills; raynaulds acting up; 101 degree fever; Very fatigued; shaking; Sore in am; put on sweats; This is a spontaneous report from a contactable nurse (patient). A 63-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: unknown and expiry date was not provided) via an unspecified route of administration, in the Left arm, on 11Jun2021 at 16:00 (at the age of 63-years-old) as a dose number unknown, single for COVID-19 immunisation. Medical history included lupus, scleroderma crest and migraines. Concomitant medication included Prevnar in left deltoid on 11Jun2021 at 16:00, Cellcept and Plaquenil. Patient has not been tested for COVID, Since the vaccination. Patient was not diagnosed with COVID, prior vaccination. On 11Jun2021 at 16:45, Friday after shot entire body began aching, severe pain, headache, began having chills and raynaulds acting up, 101 degrees fever, very fatigued, shaking, put on sweats and sore in arm. Patient took 2 650mg Tylenol helped slightly with 101 degrees fever. Felt slightly better, then began to have all symptoms slowly reoccur over day. By seven had fever again 101, chill, shaking, put on sweats and electric blanket. Repeat paracetamol (TYLENOL) and laid down. Patient went to bed. By noon symptoms all returned, treatment repeated nap was ensued. Patient received home treatment for adverse events, as she was nurse so far treated self. The outcome of all events was not resolved.  Information about lot/batch has been requested. Additional information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Raynaud's phenomenon, Tremor, Vaccination site pain
Clinical narrative: Friday after shot entire body began aching, severe pain; Headache; chills; raynaulds acting up; 101 degree fever; Very fatigued; shaking; Sore in am; put on sweats; This is a spontaneous report from a contactable nurse (patient). A 63-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: unknown and expiry date was not provided) via an unspecified route of administration, in the Left arm, on 11Jun2021 at 16:00 (at the age of 63-years-old) as a dose number unknown, single for COVID-19 immunisation. Medical history included lupus, scleroderma crest and migraines. Concomitant medication included Prevnar in left deltoid on 11Jun2021 at 16:00, Cellcept and Plaquenil. Patient has not been tested for COVID, Since the vaccination. Patient was not diagnosed with COVID, prior vaccination. On 11Jun2021 at 16:45, Friday after shot entire body began aching, severe pain, headache, began having chills and raynaulds acting up, 101 degrees fever, very fatigued, shaking, put on sweats and sore in arm. Patient took 2 650mg Tylenol helped slightly with 101 degrees fever. Felt slightly better, then began to have all symptoms slowly reoccur over day. By seven had fever again 101, chill, shaking, put on sweats and electric blanket. Repeat paracetamol (TYLENOL) and laid down. Patient went to bed. By noon symptoms all returned, treatment repeated nap was ensued. Patient received home treatment for adverse events, as she was nurse so far treated self. The outcome of all events was not resolved.  Information about lot/batch has been requested. Additional information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling hot, Hyperhidrosis, Menstrual disorder
Clinical narrative: Nasal congestion; shaking chills; Momentary feeling of a lot of heat; sweat; burning throat; No menstrual period; Cough; This is a spontaneous report from a contactable consumer or other health care professional (patient). A 37-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0177) via an unspecified route of administration, administered in Arm Left on 12May2021 19:30 (at the age of 37 years old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient did not receive any other vaccines within four weeks and within 2 weeks of vaccination. On 15May2021 10:00am, the patient experienced shaking chills, momentary feeling of a lot of heat, sweat, cough, nasal congestion, burning throat and no menstrual period. The patient was treated with Tylenol Flu, Antibiotic for the adverse events caused. The patient underwent lab tests and procedures which included oral swab test results negative on 25May2021. The clinical outcome of the events was recovered with sequelae on an unspecified date in May2021.  Follow up attempts are needed. Further information has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal discomfort, SARS-CoV-2 test
Clinical narrative: Nasal congestion; shaking chills; Momentary feeling of a lot of heat; sweat; burning throat; No menstrual period; Cough; This is a spontaneous report from a contactable consumer or other health care professional (patient). A 37-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0177) via an unspecified route of administration, administered in Arm Left on 12May2021 19:30 (at the age of 37 years old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient did not receive any other vaccines within four weeks and within 2 weeks of vaccination. On 15May2021 10:00am, the patient experienced shaking chills, momentary feeling of a lot of heat, sweat, cough, nasal congestion, burning throat and no menstrual period. The patient was treated with Tylenol Flu, Antibiotic for the adverse events caused. The patient underwent lab tests and procedures which included oral swab test results negative on 25May2021. The clinical outcome of the events was recovered with sequelae on an unspecified date in May2021.  Follow up attempts are needed. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: little bit of body pain.; Tiredness; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received (COMIRNATY, Lot number and expiry date was unknown) via an unspecified route of administration on 14May2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, it was reported that after getting the first shot of vaccine, the patient experienced a little bit of body pain and tiredness like for two days and then it went away. The patient was recovered from events on an unspecified date in 2021.   Information about lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Pollakiuria
Clinical narrative: Painful and frequent urination; Painful and frequent urination; This is a spontaneous report from a contactable consumer(patient). A 38-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Jun2021 (at the age of 38-year-old) as 2nd dose, single dose for covid-19 immunization. Medical history included high BP. Concomitant medication included amlodipine besilate (AMLOPRES) 5 mg taken for hypertension, start and stop unknown. The patient previously took Varicella for chicken pox in the left shoulder near the armpit on 22Apr2021, BNT162B2 (BNT162B2, solution for injection, Batch/Lot: EW0173) administered in left arm on 09May2021 as 1st dose, single dose for covid-19 immunization. On 04Jun2021, after 2 days of vaccination actually patient experienced side effect of painful and frequent urination. She wanted to understand is this normal, how long the side effects be like that only or she has to check with her doctor. Lab tests: patient stated, "Not recently, last month actually, before the vaccination, before the first shot, just preventive checkups, like to check our immunity.". Outcome of the events was unknown.   Follow up attempts are needed. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Peripheral swelling, Vein disorder
Clinical narrative: my left arm it is just a little swollen; my right arm and my forearm, like my veins through like kind of bruising up my forearm; vein is like pop up kind of bruising in my right arm; my right arm and my forearm, like my veins through like kind of bruising up my forearm; vein is like pop up kind of bruising in my right arm/vein is pushing out of my arm; This is a spontaneous report from a contactable consumer, the patient. A patient of an unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date, UPC number and NDC number was unknown), via an unspecified route of administration, administered in left arm on 11Jun2021 as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got the vaccine today in the left arm, it was just a little swollen but in the right arm and forearm, it seemed like the veins through like kind of bruising up the forearm, that's never happened ever. Patient did not know if it was serious. Patient need to go and get checked out because the vein was like 'pop up' kind of bruising in my right arm. Patient's vein was pushing out of the arm. Patient had very deep vein, which patient meant that was my skin, and thought they had like an emergency. The outcome of all the events was unknown.  Follow-up attempts are possible. Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic
Clinical narrative: Allergy on skin; This is a spontaneous report from a contactable consumer (daughter). A female patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 10Jun2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a little bit allergic on the skin and she at her home. The reporter stated that she did not know how to speak English and wondering what was happening or what can she do and if this reaction was normal or not. The reporter hung up the call abruptly, so limited information available over the call. The outcome of the event was unknown.  Information on Batch/Lot number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Eructation, Malaise, Pain, Somnolence, Vomiting
Clinical narrative: he didn't feel good; felt like he had to burp; vomiting; feels groggy; Always freaked out when he feels pain; This is a spontaneous report received from a contactable consumer, the patient (reported for himself). A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0173; Expiration Date: 31Aug2021) via an unspecified route of administration, administered in Arm Left on 11Jun2021 09:15 as 2nd dose, single for covid-19 immunization. The patient medical history was reported as none. Concomitant medications were not reported. Family history was reported as no. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot no: EW0175) received on 20MAY2021 08:05 AM in right side upper arm and experienced arm pain. Patient reported that he was the only one in the family that got the vaccinated. On 11Jun2021, patient didn't feel good, experienced vomiting, felt groggy, he always freaked out when he feels pain. The first dose was on 20th of May and the second dose was on this morning around 09:15 AM. Patient received second dose today at 9:15am and an hour and a half later he didn't feel good, felt like he had to burp and ended up vomiting once, and feels groggy but not tired. He dint had headache, fever, or chills. His temperature was 98.6. He had to leave work today. He stated he always "freaked out" when he feels pain or something that was not normal in his body. He asked, should he just wait it out for a couple of days and then go to the ER. No treatment was received to treat events. The outcome was unknown.  Follow-up actions are needed. Further information has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching on the hands; This is a spontaneous report from a contactable consumer (parent). A 12-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0168; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Arm Right at 4:10-4:5pm on 18May2021 as SINGLE DOSE for covid-19 immunisation. Reporter states the patient got 1st dose was 18May2021, lot EW0168, in her right arm before tennis practice at 4:10-4:5pm that on the sticker she had to wear it said 4:35 to leave after dose. States the expiry date is 31Aug2021. Caller does not have the NDC or dose to provide. Medical history included meningitis at 7 years old. she had meningitis and went through a whole lot with that and doesn't think that has a bearing on this. There were no concomitant medications. Patient had not taken other products. Patient's historical vaccine include Flu shot. Patient does the flu shot every year. Vaccines administered on same date of the Pfizer suspect reported as none. Patient was not received any other vaccine prior four weeks of vaccination. On an unspecified date the patient experienced itching on the hands. Reporter states her school gave her the 1st dose on 18May2021. Caller reported with her first does of the vaccine, she had itching on the hands but didn't thought about it and perhaps that was a sign after the first dose. Reporter relays her daughter didn't have anything weird after her 1st dose. After her 1st dose her hands itched, and she didn't pay it any mind. States she had no face swelling. Reporter states she is wondering if those little hand itches after the 1st dose she didn't talk about till now was that a little bit of a sign that something else was there. States she didn't mention it after the 1st dose and was good to go. States after the 2nd dose she said reporter that her hands itched after the 1st dose, her lip didn't swell, and she told the doctor it's not conditions on the list of symptoms and she didn't have breathing issues. Caller states it's a non-severe reaction and is assuming to dose and said yesterday if she gets a booster what does Pfizer advise. Caller states she doesn't over react but she is aware and if she had told her about her hands she would have thought allergic reaction, mild one and brought her to the doctor or at the 2nd vaccine and she didn't say anything until after the fact. Patient visited to physician's office for the events. The outcome of the events was reported as unknown.   Follow up attempts are needed; further information was requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest pain, Limb mass
Clinical narrative: Lump like ball in the arm for almost two weeks; For the first 4 or 5 days, after receiving the first dose Pfizer Covid Vaccine, had chest pains; her heart literally had chest pains for 4 or 5 days; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).  A 40-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in arm right on 08Apr2021 13:30 as 1st dose, single for COVID-19 immunization. Medical history included Chronic pain from 2004 and ongoing, high blood pressure from 2010 and ongoing, asthma from 2004 and ongoing. The concomitant medications were not reported. The patient did not receive prior vaccination within four weeks and other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse events reported prior vaccinations. The patient has not received the second dose Pfizer Covid Vaccine yet because the she was scared.On 08Apr2021, at night the patient experienced chest pain. It was reported that for the first 4 or 5 days, after receiving the first dose Pfizer Covid Vaccine, had chest pains. The patient had high blood pressure because of chronic pain issues. The patient stated that her heart literally had chest pains for 4 or 5 days. The patient was reading about inflammation of the heart. The patient knows that inflammation of the heart happens in young people, the patient was wondering if this happened to her. The patient stated that few hours after first dose there was a lump like ball started forming and it went away but took almost two weeks to go away. When the patient pressed on it, the lump like ball felt like a bruise more like. She stated that she also had chest pains which began at the night when she received the first dose Pfizer Covid Vaccine on 08Apr2021, and this went away about 5 days later. The outcome for the events lump like ball started forming was reported as recovered on an unspecified date in 2021 while for had chest pains and her heart literally had chest pains for 4 or 5 days was reported as recovered on 13Apr2021.  Information on the lot/ batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia, Maternal exposure during pregnancy, Uterine contractions during pregnancy
Clinical narrative: Had strong contractions (20 weeks pregnant) 10 minutes after injection (2nd dose). Contractions on and off all day; Had strong contractions (20 weeks pregnant) 10 minutes after injection (2nd dose). Contractions on and off all day.; chest pains on and off along with heartburn sensation.; chest pains on and off along with heartburn sensation.; This is a spontaneous report from a non-contactable consumer (reporting on herself). A 24-years-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via intramuscular, administered in Arm Left on 11Jun2021 as dose 2, single for COVID-19 immunization. Medical history included anaemia, anxiety disorder, arrhythmia all from an unknown date and unknown if ongoing. Concomitant medication(s) included iron (IRON) taken for supplementation therapy, start and stop date were not reported and prenatal vitamins.  The patient previously took augmentin [amoxicillin;clavulanic acid] and experienced drug hypersensitivity and  BNT162B2 for COVID-19 immunization and experienced maternal exposure during pregnancy.  Patient did not receive other vaccines within 4 weeks prior to the COVID vaccine and Prior to vaccination, patient was not diagnosed with COVID-19. It was reported that had strong contractions (20 weeks pregnant) 10 minutes after injection (2nd dose). Contractions on and off all day. Also reporting chest pains on and off along with heartburn sensation.  The mother was 21 Weeks pregnant at the onset of the event.  The mother was due to deliver on 25Oct2021.  The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: a red puffy eye/puffy right eye; a red puffy eye/redness to right eye; right eye dry; right eye sensitive/has yuck shit around her right eye; rash around right eye; she cannot stop itching; rash on right arm/rash on her arm/right arm is engulfed with rash/swollen rash on her arm/yuck shit around her right eye and her arm; right eye swelling/eye swelling; This is a spontaneous report from a contactable consumer (patient) reported for herself. An adult female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1st dose, single for COVID-19 immunization. On an unknown date, the patient experienced rash on right arm, redness to right eye, had yuck around her right eye, right eye swelling, right eye dry, right eye sensitive, a red puffy eye/puffy right eye and rash around right eye and she could not stop itching. The patient stated that she had a reaction to the Pfizer shot. Stated that she had the vaccine completed a month ago. Stated that the first time she got rash on her arm at the same place where she got the shot. Stated that she had some eye swelling with it. Stated that she was told to take Benadryl and it went away 5 days later. Stated that two weeks later she had the rash again and it went away. Stated that she got the second shot and it went haywire. Stated that she had a red puffy eye, dry, sensitive and a rash around it. Stated that her right arm was engulfed with rash. Stated that it would go away and came back away. Stated that she had went to the ER three times. Stated that got up in morning and had a swollen rash on her arm. Stated that went back there again and woke up that morning and had redness and yuck shit around her right eye and her arm. Stated that she was that told could not do anything with the reaction to the shot. Stated that it was driving her crazy. Stated that she could not stop itching. Stated was told to call CDC and report it. She wanted to know if anyone had heard of anyone with that reaction or was it just targeting her. She wanted to know what to do. Stated that she worked with the public and did not like looking the way that she looked. The outcome of the events was unknown.  Information about lot/batch number has been requested. Additional information has been requested.  Follow up (14Jun2021): New information received from a contactable consumer (patient) reported for herself included: Added the patient's name.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 67-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173) via an unspecified route of administration, administered in Arm Left on 11May2021 at 13:39 (at the age of 67 years old) as single dose for COVID-19 immunisation. Medical history included ongoing high cholesterol. She does not take it more than that because it causes her back pain and sciatic pain. Her doctor told her she had to take it because her cholesterol is 225. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) twice a week taken for high blood cholesterol. Historical vaccine includes flu vaccine and had a reaction, her throat started closing. That was years ago, it had to be 2014. Before she got the Covid 19 vaccine she checked to make sure she didn't have the Covid 19 virus. No other vaccines were administered on same date with the Pfizer vaccine nor four weeks prior to the vaccination. On an unspecified date, with the first Covid 19 vaccine the patient experienced a sore arm. Adverse event did not require visit to emergency room nor physician office. The lab tests and procedures included blood cholesterol was 225 on an unspecified date. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Injection site irritation, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: arm became sore; it feels like a little pain; under my arm pretty swollen where I had took this shot; its swollen and it's very irritating and little painful; I felt like little pain under my armpit; I saw that it was real swollen under my armpit on the left hand side I took a shot at; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received BNT162B2(CONMITARY, Solution of injection, Lot Number: ER8729; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Arm Left on 09Jun2021 (at the age of 53-years-old), as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm became sore, it feels like a little pain, under my arm pretty swollen where she had took this shot, its swollen and it's very irritating and little painful, she felt like little pain under my armpit, the patient saw that it was real swollen under my armpit on the left hand side she took a shot at on an unspecified date. Therapeutic measures were taken as a result of arm became sore, it feels like a little pain, under my arm pretty swollen where she had took this shot, its swollen and it's very irritating and little painful, she felt like little pain under my armpit, she saw that it was real swollen under my armpit on the left hand side she took a shot at. The outcome of the events was unknown.  Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021695222 Same reporter/ drug, different AE/ patient