chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-2 antibody test
Clinical narrative: Loss of taste; This is a spontaneous report from a contactable consumer.   A non-pregnant 38-year-old female patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 20:15 (Batch/Lot Number: EN6204) as dose 1, single (at the age of 38 years old) for COVID-19 immunisation.  Medical history included allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication and cetirizine hydrochloride (ZYRTEK) taken for hypersensitivity, both start and stop date were not reported.  The patient experienced loss of taste on 04Mar2021 06:00.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: unknown results on 04Mar2021 (pending). The event led to physician office visit. The patient received no treatment.  The outcome of the event was recovering.  No follow up attempts are possible. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Investigation, Metabolic function test, Pain
Clinical narrative: Fatigue; Bodyaches; This is a spontaneous report from a contactable nurse (patient himself).  A 24-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL0142; Expiration Date: Mar2021), dose 2 intramuscular, administered in Deltoid Left on 11Jan2021 18:50 (age at vaccination:24-Year-old) as DOSE 2, 0.3 ML SINGLE for covid-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date: Mar2021), intramuscular in the left arm on 21Dec2020 18:45 at 0.3 ml, single, for COVID-19 immunization and then he experienced Left arm soreness on 22Dec2020 12:00 and Left supraclavicular lymphadenopathy on 25Dec2020. Left arm soreness was Recovered on 27Dec2020 and Left supraclavicular lymphadenopathy was ongoing. Patient's family medical history included grandparents of vaccine recipient both suffered from lymphoma later in life (more than 60-year-old). Concomitant medications were not reported. No Vaccination administered at military facility. Vaccination facility Type was Hospital. On 12Jan2021 08:00, The patient experienced non serious fatigue body aches. He underwent lab tests and procedures which included CBC, CMP, DIFF which result was negative abnormalities on an unknown date in 2019. No treatment was received for the adverse event fatigue body aches. Outcome of event fatigue and body aches was recovered on 13Jan2021.  The casual relationship ((Covid-19 virus vaccine, EL0142 Mar2021) was reported as yes. Information on the lot/batch number is requested. Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: some pain in my upper left arm where the shot was given; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration on 04Mar2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, a reaction to Pfizer covid vaccine to get on the 04Mar2021. On an unspecified date Mar2021, the patient had experienced some pain in my upper left arm where the shot was given. Treatment received for the event was unknown. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site pain
Clinical narrative: Flu like symptoms; Pain in injection site; This is a spontaneous report from a contactable 50-year-old male consumer (Patient). A 50 year old female patient had received bnt162b2 (PFIZER COVID-19 VACCINE, Batch/lot number:En6203, Solution for injection) via an unspecified route of administration on 10Mar2021; 01:15 AM in left arm as DOSE 2, SINGLE for covid-19 immunization(age at the time of vaccination 50 year) at Pfizer. The patient medical history had included High Blood Pressure and Cancer. The patient's concomitant medications included Methotrexate sodium within 2 weeks of vaccination. The patient previously took BNT162B2 (PFIZER COVID-19 VACCINE, Batch/lot number:EL3247, Solution for injection) into left arm at 01:00 AM,as Dose1, Single for covid-19 immunization. It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. It was also reported that since the vaccination the patient had not been tested for COVID-19. On 11Mar2021 at 08:15 AM the patient had experienced Flu like symptoms, pain in injection site without fever. The patient had not received any treatment. The clinical outcome of the events were not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypoglycaemia, Hypotension, Rash
Clinical narrative: lightheadedness / dizziness; Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); This is a spontaneous report from a non-contactable other healthcare professional (HCP). This other HCP reported for a 71-year-old female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6206), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, waiting for 15 minutes after the vaccination, the patient experienced lightheadedness. The patient denied difficulty breathing, difficulty swallowing, itching, facial swelling, lip swelling and tongue swelling. Patient complains of dizziness (lightheaded). The differential diagnosis included systemic reaction (hypoglycemia, hypotension, generalized rash) on an unknown date. The patient was observed in the medical bay for approx. 20 minutes. The patient was able to stand from wheelchair w/o lightheadedness/dizziness. The patient states she feels much better and was ready to go home. The reporter provided handwritten instructions on monitoring her bp (blood pressure) at home and when to follow up with pcp. The patient lab test included blood pressure measurement was unknown results on an unknown date. The patient received water and snacks as treatment for the event lightheadedness / dizziness. Follow up response to treatment was excellent. The outcome of the event lightheadedness / dizziness was resolving. The outcome of the other events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypotension, Lymphadenopathy
Clinical narrative: \This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on 10Feb2021 as dose2, single for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included hydrochlorothiazide taken for blood pressure and lisinopril taken for blood pressure. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. After two weeks of second dose of COVID vaccine patient developed a side effect with a swollen lymph node, his gland was swollen (in Feb2021). He had been experiencing low blood pressure and asked if the vaccine had any ingredients in it that would cause low blood pressure, because he was diagnosed with high blood pressure. The patient underwent lab tests and procedures which included blood pressure: 105/58 on 08Mar2021 7:30 AM, blood pressure: 103/51 on 08Mar2021 12:30 PM, blood pressure: 101/56 on 08Mar2021 1:05 PM, blood pressure: 108/52 on 08Mar2021 2:10 PM, blood pressure: 114/61 on 08Mar2021 4:20 PM, blood pressure: 121/61 on 08Mar2021 8:00 PM, blood pressure: 109/61 on 08Mar2021 10:00 PM, blood pressure: 122/63 on 08Mar2021 11:45 PM, blood pressure: 106/58 on 09Mar2021 6:30 AM, blood pressure: 115/54 on 09Mar2021 7:30 AM, blood pressure: 112/65 on 09Mar2021 9:30 AM, blood pressure: 112/58 on 09Mar2021 12:40 PM, blood pressure: 110/60 on 10Mar2021 12:30 AM, blood pressure: 121/64 on 10Mar2021 5:30 AM, blood pressure: 128/69 on 10Mar2021 10:15 AM, blood pressure: 115/61 on 10Mar2021 12:15 PM. Pulse: 71 on 08Mar2021 12:30 PM, Pulse: 75 on 08Mar2021 12:30 PM, Pulse: 75 on 08Mar2021 1:05 PM, Pulse: 74 on 08Mar2021 2:10 PM, Pulse: 72 on 08Mar2021 4:20 PM, Pulse: 64 on 08Mar2021 8:00 PM, Pulse: 67 on 08Mar2021 10:00 PM, Pulse: 62 on 08Mar2021 11:45 PM, Pulse: 72 on 09Mar2021 6:30 AM, Pulse: 79 on 09Mar2021 7:30 AM, Pulse: 79 on 09Mar2021 9:30 AM, Pulse: 71 on 09Mar2021 12:40 PM, Pulse: 65 on 10Mar2021 12:30 AM, Pulse: 64 on 10Mar2021 5:30 AM, Pulse: 64 on 10Mar2021 10:15 AM, Pulse: 67 on 10Mar2021 12:15 PM. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm after the vaccine soreness was in the injection site arm; This is a spontaneous report from a non-contactable consumer or other non-hcp (patient himself). A 71-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm and soreness was in the injection site arm after the vaccine on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number is requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Herpes zoster, Pain, Rash vesicular
Clinical narrative: vesicular rash erupted; vague body aches; discomfort; shingles; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: En6198) via an unspecified route of administration in Arm Left on 08Mar2021 13:30 (age at vaccination:61 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient had received other medications within 2 weeks to vaccination. Patient was not pregnant at the time of vaccination, patient didn't had covid-19 prior to vaccination. The patient medical history and concomitant medications were not reported. Patient had no allergies. The patient experienced vague body aches on 09Mar2021, discomfort on 09Mar2021, shingles on 09Mar2021, vesicular rash erupted on 13Mar2021. No therapeutic measures were taken for the events. Patient was not tested with covid to post vaccination. The outcome of the events pain, discomfort, herpes zoster, rash vesicular was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mouth injury, Nausea
Clinical narrative: A filling pop in her mouth; Headache; Nausea; This is a spontaneous report from a contactable consumer or other non hcp (Patient) from a Pfizer sponsored program.  A 39-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Apr2021 as single dose for covid-19 immunisation. Medical history included has some allergy issues and is experiencing a runny nose and post nasal drip and an irritated sore throat, She is unsure if its allergies or a cold from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. The patient concomitant medications were not reported. It was reported that patient set to receive her first dose of the Pfizer vaccine today but has some allergy issues and is experiencing a runny nose and post nasal drip and an irritated sore throat. She is unsure if its allergies or a cold. Can she still receive the vaccine today and wanted to know it be efficacious. She is not currently taking any medications for her allergy symptoms. Upon date 12Apr2021 it was reported that patient received second dose and experienced a filling pop in her mouth and has a dentist appointment tomorrow morning. Asked if it is okay to have the appointment or in case they will give medication like Novocaine after receiving the second dose. Upon date 13Apr2021 it was reported that She has an upcoming dental appointment, and may need some fillings. She wants to know if it is safe to have the dental procedure done. Also reported she has been experiencing a headache that has been coming and going and some nausea. Neither symptom lasts long. She was asking if this could be because of the second dose, and how long the symptoms could last. The outcome for the events was reported as unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Soreness; feeling stiff; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-089449), for BNT162B2. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on unspecified date as a dose number unknown, single for COVID-19 immunization. The patient medical history included C55 uterine cancer, Shingles (she has been on Gabapentin since her Shingles outbreak). The patient started taking other medication on 25Feb2021 which included lenvatinib mesylate (LENVIMA) and pembrolizumab (KEYTRUDA). On an unspecified date the patient advised that she had been feeling stiff and sore the last few days. Patient got the COVID shot from Pfizer a few days ago. Soreness appeared after that. Patient advised some of the discomfort follows the same areas as she shingles outbreak, she had last year. Patient had been on gabapentin since her Shingles outbreak. Patient receive the treatment of tylenol and occasional a tramadol for soreness and stiffness. Patient was advised to seek healthcare care professional guidance on what to do for this issue. Patient believed that it was a combination of lenvima, keytruda, and the COVID shot that are causing patient's issues. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (Patient).  A 23-year-old non-pregnant female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EL3247) via unspecified route of administration, in left arm on 25Jan2021 12:00 PM as a dose 1, single for COVID-19 immunization. The patient medical history included amoxicillin allergy. The concomitant medication of the patient was not reported. Patient had not received any other vaccine within four weeks prior to the COVID vaccine and patient had not received any other medications in two weeks vaccination. The patient had not COVID prior to vaccination and not tested post COVID vaccination. On unspecified date patient experienced sore arm only after administration of first dose of BNT162B2. Outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Tremor, Vomiting
Clinical narrative: She was shaking all over; she was trying to throw up; She felt pretty bad; This is a spontaneous report received from a contactable consumer (patient husband). A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6204, NDC number: unknown, Expiry date: 30Jun2021), via an unspecified route of administration on 05Mar2021 (age at vaccination was 86 years) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter says he and his wife had the first shot 5 Mar, Friday and today he thought he was going to lose her. He wondered if patient had a reaction or something to the vaccine. On an unspecified date in Mar2021, the patient was shaking all over and patient was trying to throw up, felt pretty bad. The reporter was trying to see if that was a reaction to the vaccine. Primary care reported as the reporter called them and they said someone would get a hold of them but they are having the same problem, there are so many calls ahead and they are going to know the same thing, she was shaking all over. The reporter just wanted to make sure everything was on the up and up. The patient slept most of the afternoon and got up and was feeling better now. The reporter says they are looking for the phone number to the doctor's office. They are still looking for the number. The reporter says we can continue, and they will keep looking for it. No investigation assessment reported. Outcome of the events was resolved on an unspecified date in 2021.     Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer. This case is for 1st dose. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9266) via an unspecified route of administration, administered in Arm Left on 17Feb2021 16:30 (at the age of 65-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included cerebrovascular accident, blood cholesterol, blood pressure abnormal, pain. Concomitant medication(s) included warfarin (WARFARIN) 5mg; take once daily orally taken for Stroke from Oct2020 and ongoing; rosuvastatin calcium (ROSUVASTATIN CALCIUM) 40mg; take once daily orally taken for cholesterol from an unspecified start date and ongoing; amlodipine besilate (AMLODIPINE BESILATE) 2.5mg take once daily orally taken for Blood pressure from Jan2021 and ongoing; paracetamol (TYLENOL) 500mg; take as needed taken for pain from an unspecified start date and ongoing. The patient experienced sore arm on 18Feb2021. Prior Vaccinations (within 4 weeks) reported as no. Patient did not any AE(s) require a visit to emergency room and physician office. The outcome of event was recovered after 20 days on 10Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: body ache; chills; headache; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program. A female patient of unspecified age received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: not reported, expiration date: not reported) via an unspecified route of administration on an unknown date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient had mild reaction, chills, body ache and headache she wanted to know if she could take Dayquil/Nightquil. Outcome of the events was unknown.   Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in arm; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female patient reported that, a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient wanted to know if she could take pain medication after receiving the first covid vaccine due to pain in arm and wanting to take pain medicine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; This is a spontaneous report from a contactable consumer or other non-HCP (measurable supplier, patient). A patient of unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient experienced soreness in arm on an unspecified date in Mar2021. Event took place after use of product. The outcome of the event was unknown.  Follow up letter has been generated for further information.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: lower back pain; This is a spontaneous report received from a contactable consumer via Pfizer sponsored program COVAX US Support. A female patient (reporter's  mother) of an unspecified age received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) by an unspecified route of administration on 01Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lower back pain on an unspecified date on Mar2021 and the reporter wants to  know more about the side effects. The outcome of the event unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: 1st dose of Covid 19 Vaccine (03/09/21) within a minute after the Vaccine she felt light headed and very tired, that feeling continued and felt very tired and then that same day; 1st dose of Covid 19 Vaccine (03/09/21) within a minute after the Vaccine she felt light headed and very tired, that feeling continued and felt very tired and then that same day; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 09Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had 1st dose of covid 19 vaccine and within a minute after the vaccine she felt lightheaded and very tired, that feeling continued and felt very tired and then that same day, she woke up again and with the same feeling. The outcome of the event was unknown.   Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: The first 5 days of patient's fasting blood sugar rose from an average of 98 to an average of 113.6; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history included pre-diabetic and take blood sugar twice a day and record it in a spreadsheet. The patient concomitant medications were not reported. The patient stated that he/she received Covid-19 vaccine on 04Mar2021, and it appeared to have worked great. No issues of concern Just 1 piece of feedback. The patient stated that he/she was pre-diabetic and took blood sugar twice a day and record it in an spreadsheet. The first 5 days of patient's fasting blood sugar rose from an average of 98 to an average of 113.6. It was back to normal the morning (11Mar2021) when the patient reported was 97. No complaint just some feedback. The patient reported that he/she felt great. Outcome of the event was recovered on 11Mar2021.  Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Breast pain, Nipple pain, Pain in extremity
Clinical narrative: Pain in her arm; Soreness in her breast; pain in her nipple; Lymph node; This is spontaneous report received from a contactable consumer reported for her daughter. A 37-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 06Mar2021 (age at vaccination was 37 years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first Pfizer COVID vaccine on 06Mar2021 and immediately came home with pain in her arm on the side where she got the shot, pain in her nipple on the side that she got the shot and soreness in her breast on the same side as vaccine administration on an unspecified date, but the symptoms resolved. She stated that it went away after couple of days. She took some Tylenol and was fine. She stated that she knew there were lymph nodes in the area, but wanted to know if that was normal and how to treat it. She wanted to know if possible if it could be a lymph node. She wanted to see if there were other cases where not the lymph node but in the actual breast itself. She received the response which stated that lymphadenopathy is a commonly reported AE from the clinical trials but does not specify location of the lymph nodes in question. No information for timing of onset or duration. The patients in the trial were allowed to treat symptoms with acetaminophen or NSAIDs, if medically appropriate. The caller was referred back to HCP for evaluation and treatment. The outcome of the events pain in her arm, soreness in her breast and pain in her nipple was resolved on an unspecified date in 2021. The outcome of the event lymph node was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report from a Pfizer Sponsored Program Covax support via a contactable consumer (patient, self-reported). A Female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 01Mar2021, as a single dose for COVID-19 immunization. The patient's medical history included cancer and osteopetrosis (Prolia shots to prevent osteopetrosis). Concomitant medications were not reported. On an unspecified date, the patient experienced sinus infection. The patient was scheduled to start Prolia shots to pre-vent osteopetrosis and wanted to know if able to get injections prior to her second dose of the vaccine scheduled for 22Mar2021. She had to delay first injection of Prolia due to sinus infection after March 1st. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report received from contactable consumer (patient) via Pfizer sponsored program. A male patient of unspecified age received first dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for injection, Lot Number were not reported) via on an unspecified route on unknown date as DOSE 1, SINGLE for COVID-19 Immunization. On an unspecified date patient had experienced sinus infection. And reported that had first dose already second dose due to get on 16th wanted to know if he can get second dose or should he postpone it. Therapeutic measures were taken for the event sinus infection and included treatment with Zpack. The clinical outcome of the event was unknown.    Information on the lot/batch number has been requested.     Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphagia, Erythema
Clinical narrative: upper midsternal chest pressure; skin with redness to upper chest and neck; worsened with swallowing; This is a spontaneous report from a contactable other healthcare professional. A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3246), intramuscular on 29Jan2021 14:35 (at the age of 19-years-old) as dose 1, single for covid-19 immunisation. It was unknown if the patient was pregnant at the time of vaccination. The vaccine was administered at the public health department. The patient medical history included childhood asthma. The patient does have a history of anaphylaxis with all fish. Concomitant medications included melatonin; and diphenhydramine hydrochloride (BENADRYL) both were taken for an unspecified indication, start and stop date were not reported; epinephrine (EPIPEN); and medroxyprogesterone acetate (DEPOPROVERA) both were taken for anaphylactic reaction, start and stop date were not reported. The patient previously took prednisone, and experienced anaphylaxis. The patient received 1st dose of vaccine approximately at 14:35. At 15:00 approximately 25 minutes post vaccination patient started feeling upper midsternal chest pressure, worsened with swallowing. Patient's skin with redness to upper chest and neck. The patient received liquid oral Benadryl 50 mg. The outcome of the events was recovered.   No follow-up attempts are possible; information about lot/batch number already obtained.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye allergy
Clinical narrative: Allergic reaction to my right eye; This is a spontaneous report from a contactable consumer (patient).A 34-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 at 08:00 (Batch/Lot number was not reported, Expiry date not reported) (at the age of 34-years-old) as dose 2, single for COVID-19 immunization. The patient did not had any medical history and no allergies to medications, food, or other products. Concomitant medications were not reported. 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 has not been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Feb2021 at 09:15 (Batch/Lot number was not reported, Expiry date not reported) as dose 1, single for COVID-19 immunization. On 15Mar2021 at 20:00, the patient experienced allergic reaction to right eye. It was reported that Same thing happened to her sister who got the shot at the same time. No treatment received for the adverse event. The patient had not yet recovered from the event.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289428 same reporter/drug/AE with different patient
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pain
Clinical narrative: I was just aching with the first injection; This is a spontaneous report from a contactable consumer (patient). An 85-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication stated as yes, details were not provided (other products: yes). The patient experienced just aching with the first injection on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included laboratory test: unknown results on 05Feb2021 and stated it was a long result. Patient called after she got the first injection because she had so many questions that weren't answered for her (not clarified if called in Pfizer drug safety, hence case was marked as initial). Height was stated as probably about 5'3". Facility name where the vaccine was administered, consumer stated as continuing care residency, well they were issued by or distributed by (pharmacy name) pharmacy. When asked about concomitant medication, patient stated she take lot of medications, and to hold, to let her get list of meds. Patient stated she had no problem; she was just aching with the first injection. When asked about product details (LOT# and expiration date) for first dose: Consumer stated to have the first date and guessed as 18Jan and said no. Consumer was informed about Pfizer Medical information department. Patient wanted to know was the injection effective even though she had that itching, concern because she has long list of symptoms that Pfizer gave her, the literature that she had and that was not one of them and just wanted to be sure because it was different, and her results of receiving and having a medication effectiveness was not hampered. Clinical outcome of event was unknown.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Stress
Clinical narrative: Headache; head is killing me, it is stressing me out; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6202; Expiration date was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included traumatic Brain Injury, seasonal allergies from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced headache on an unspecified date. Therapeutic measures were taken as a result of headache. Patient had the Covid shot the day before this report (19Mar2021) and got a headache that couldn't get rid of. Patient asked what to do to get rid of the headache (manufacturer not clarified, hence is this a Pfizer product tab left unchecked). Stated to get a bit of a headache then and it does not go away. Consumer was informed about Pfizer Medical Information department. Consumer further stated to transfer as quick as you can do it because patient head was killing patient, it was stressing patient out. Patient stated that between the allergies and the TBI and this Covid shot got a terrible headache patient couldn't get rid of it. And headache was causing patient a lot of stress right then. Consumer stated, got a TBI that was number 1. Got Traumatic Brain Injury (Intent: History) and number 2 was that patient take medications for allergy (Further not clarified over the call hence captured as unspecified medication). So, between the allergies and the TBI and this Covid shot patient got a terrible headache patient couldn't get rid of it. Patient took Tylenol the day before this report. Consumer informed about Pfizer Medical Information Department and about the role of Pfizer Drug safety. When asked about LOT#: Consumer stated, "I can't understand you it's hard to me to understand you because of you accent I am not trying to be rude I just don't understand when you, the second was EN6204." (unclear, so retained as EN6202). Consumer stated that he/she was going to take Ibuprofen or Advil, the headache was killing. Product details (NDC# UPC# and Treatment) and Pharmacy details could not be probed as consumer was unwilling to share further information. Hence further probing could not be done. Limited information available over the call. Clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: in the past I have gotten a lump in my neck, like a swollen gland that eventually goes away; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received flu vaccine on an unspecified date. Caller received first dose 04Mar2021 and second dose scheduled for 25Mar2021. Caller asked if she should get second injection on the same arm and stated: in the past she had gotten a lump in her neck, like a swollen gland that eventually went away. Her Doctor told her to definitely go get the Covid19 vaccination, the lump usually resolves. Caller mentioned they do not know if the lump was caused with another vaccine or with the flu vaccine in the past. The outcome of event was recovered on an unspecified date.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; This is a spontaneous report from a contactable other hcp. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 immunization. The Patient Medical history included, surgeries in January from an unknown date and unknown if ongoing. The patient concomitant medications was not reported. The patient previously took xeljanz xr in the past and it stopped working. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization. The Patient has been off treatment as she had surgeries in January and had both COVID-19 vaccines while off Xeljanz. On Unspecified date, the patient experienced runny nose. She is having anxiety because her son is being deployed in a month. The outcome for the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: strong pain in the vaccinated site six hours after the vaccination; This is a spontaneous report from a non-contactable consumer. An adult patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (reported as 610, CCYYMM) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced strong pain in the vaccinated site six hours after the vaccination with the outcome of unknown. The patient also received the second dose of BNT162B2 on an unspecified date in Jan2021 (Batch/Lot number was not reported) for COVID-19 immunisation.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: she noted of "every" joint & body was aching & after receiving first dose covid 19 vaccine (pfizer); she feels achy; This is a spontaneous report from a Pfizer- sponsored program. A contactable other healthcare professional and a contactable consumer (patient) reported that a 47-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), oral from 21Jan2021 and ongoing, at 11 mg, 1x/day for rheumatoid arthritis. Medical history included thinning of nail, recurring bad acne, rheumatoid arthritis, and depressed. Concomitant medication included benzoyl peroxide (MANUFACTURER UNKNOWN) for acne and methotrexate (MANUFACTURER). The patient reported that after exercising for a few days on an unspecified date, she noted of "every" joint & body was aching & after receiving first dose covid 19 vaccine (Pfizer), she feels "achy" (unknown if this is muscle/joint), resolved after two days. MD was aware. The action taken in response to the events for tofacitinib citrate was unknown. The patient recovered from the events on an unspecified date.    No follow up attempts are needed. Further information of lot/batch number not obtained.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Chronic kidney disease, Ultrasound kidney
Clinical narrative: stage-3 chronic kidney disease; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: UKNOWN) via unspecified route on 08Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) on 15Jan2021 as a single dose for COVID-19 immunization. Two days after the second dose (10Feb2021), the patient went in for routine blood test that he/she has taken every year. Patient never had a problem with kidneys before, it had always been normal, but 2 days after that vaccine, the patient had abnormal reading on kidney that put him/her in a stage-3 chronic kidney disease (10Feb2021). Then doctor sent the patient for an ultrasound (unspecified date). There was nothing wrong with kidney, not even a tiny little cyst. Patient inquired if the vaccine can possibly interfere with blood test specially kidney function. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding, Polymenorrhoea
Clinical narrative: Cycle started on cycle day 25 . It's been extremely heavy extremely hard cramps; Cycle started on cycle day 25 . It's been extremely heavy extremely hard cramps; spotting; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 15:45 (at the age of 37-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromium, colecalciferol, copper, cyanocobalamin, ferrous fumarate, folic acid, magnesium oxide, manganese, nicotinamide, potassium iodide, pyridoxine hydrochloride, riboflavin, selenium, thiamine hydrochloride, tocopheryl acetate, zinc (PRENATAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;S) taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Patient pregnant was unknown and pregnant at the time of vaccination was unknown. The patient previously received first dose of BNT162B2 (Lot number: EN6204) via an unspecified route of administration, administered in Arm Left on 13Mar2021 06:45 PM (at the age of 37-year-old) for COVID-19 immunization. Facility type vaccine was other. The patient did not receive any other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Patient had no known allergies. Reported that started spotting on cycle day 23. Cycle started on cycle day 25. It's been extremely heavy extremely hard cramps (06Apr2021 06:00). I was always on time. Never early or late. My cycles were like click work at 28 days. There was no treatment for the events. The clinical outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Discomfort, Dysgeusia, Dysphagia, Feeling abnormal
Clinical narrative: injection site has mild soreness; a weird taste in my mouth; constricted my throat/a tightness in the back of my throat, as though the glands were swollen; a tightness in the back of my throat, as though the glands were swollen; constricted my throat making it uncomfortable to swallow; discomfort; felt weakness in my whole body; walking felt strange; This is a spontaneous report from a non-contactable consumer (patient) reported herself that a 41-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/ lot number: EN6207), via an unknown route of administration in left arm on 13Apr2021 at 09:45 as single dose (at age of 41-years old) for COVID-19 immunization. The patient's medical history included diabetes mellitus from an unknown date to unknown if ongoing. No known allergies. Concomitant medications were not reported. No other vaccine in four weeks. Other medication in two weeks was multi-vitamins. On 13Apr2021 at 09:45, the patient experienced injection site has mild soreness even 24 hours later. Shortly after injection, during the initial 15 minutes waiting period until 5 or 6 hours later, there was a weird taste in her mouth and a tightness in the back of her throat, as though the glands were swollen and constricted her throat making it uncomfortable to swallow. There was no pain. Between a rating of 1 to 10, the discomfort level was about 5. She also felt weakness in her whole body and walking felt strange and lasted for the entire day. No COVID prior vaccination. No COVID tested post vaccination. No treatment received for events. The outcome of the events was recovered on an unspecified date in Apr2021.  No follow-up attempts are possible. No further information is expected.