chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Urticaria, Vaccination site bruising, Vaccination site discolouration
Clinical narrative: noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes; noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes; Large brown circle surround site of shot; bruising surrounding it; some welting. Some tenderness; some welting. Some tenderness; Mild concussion with symptoms. Amnesia at time of loss of consciousness.; Mild concussion with symptoms. Amnesia at time of loss of consciousness.; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:30 (at the age of 71-years-old) (Batch/Lot Number: ER8732) as SINGLE DOSE for covid-19 immunisation. Medical history included, neuropathy peripheral, drug hypersensitivity, diarrhoea, vision blurred blurred/double vision since Feb, hypertension Mild high blood pressure. Drop in blood pressure and increase in blood pressure month after Covid, chills, MGUS, non symptomatic ascending aorta aneurysm, pronounced cough, fever, sore throat, flu symptom. I had the virus on 30Nov after being unknowingly infected with virus by someone unknowingly with virus, some 8 feet away, with no direct interaction. Experienced fever 4 days later. tested. Virus positive. Excessive flu symptom-pronounced cough, fever, sore throat. treated w/antibodies some 8 days later. The patient received first dose of BNT162B2 for COVID-19 immunization on 10Mar2021 ({Product=COVID 19, brand=Pfizer, Lot number=EN6199, Lot unknown=False, Administration date=10Mar2021, Administration time=12:30 PM, Vaccine location=Left arm, Dose number=1}]. Concomitant medication included hydrochlorothiazide, lisinopril (ZESTORETIC); bupropion hydrochloride (WELLBUTRIN); naproxen (NAPROXEN). Large brown circle surround site of shot, with additional bruising surrounding it. Not noticed until 18 days after 2nd shot, some welting. Some tenderness. Don't know when first appeared, does not appear to be fading. No reaction after first shot. (There was sudden unexpected loss of consciousness after sudden slumping. Wednesday eve before noting large bump after hour later a large Boulder size bump on forehead same eve as lost of I remembered loss consciousnes. Mild concussion with symptoms. Amnesia at time of loss of consciousness. Do not know if two are related. Deep brown circle on left arm noted 2 day later. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Nov2020. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: first dose of the vaccine on 02Apr2021 and then tested positive for COVID-19 on 06Apr2021; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old female patient received the first dose bnt162b2 (Pfizer, Lot Number: ER8733) via intramuscular on 02Apr2021 16:00 as single dose in arm right for covid-19 immunisation at the age of 49-year-old. There was no medical history and concomitant medication. No previous immunizations with the Pfizer vaccine considered as suspect and no additional vaccines administered on the same date. The patient got her first dose of the vaccine on 02Apr2021 and then tested positive for COVID-19 on 06Apr2021. The outcome of the event is unknown. The patient underwent sars-cov-2 test: positive on 06Apr2021. The event didn't require visit to Emergency Room and Physician Office. The patient was out of isolation and has no symptoms and to ask was it okay for her to get her second dose of the vaccine on 23Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis, SARS-CoV-2 test
Clinical narrative: peri/myocarditis; peri/myocarditis; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm on 14Apr2021 at 11:30 AM at the age of 18-years-old as single dose for COVID-19 immunization at Public Health Clinic. The patient had no COVID prior vaccination. The patient had no other vaccine in four weeks. The patient's medical history included known allergies to nickel and dust mites. The patient's concomitant medications were not reported. The patient developed severe chest pain between the night of 16Apr2021 to 17Apr2021, and was admitted to the hospital on 17Apr2021, diagnosed with peri/myocarditis. The cardiology team was convinced it was an adverse reaction to the vaccine. He remains hospitalized (number of days of hospitalization was also reported as 2). The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization. The patient was tested for COVID post vaccination which was a nasal swab with negative result on 17Apr2021. Therapeutic measures were taken as a result of peri/myocarditis which included ibuprofen, aspirin, and colchicine. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis, inflammation of the pericardium around the heart; This is a spontaneous report from a contactable consumer who reported for herself, a 52-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EWO151), via an unspecified route of administration, administered in right arm on 01Apr2021 at 18:00 (at the age of 52 years old) as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient had no known allergies. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. There were no medical histories nor concomitant medications. The patient previously received the first dose of BNT162B2 on 10Mar2021 at 06:00 PM (lot number: EN6206), at the age of 52 years old, administered in the right arm for COVID-19 immunization. The patient had no other vaccines in four weeks. The patient experienced pericarditis, inflammation of the pericardium around the heart on 14Apr2021 at 16:30. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if treatment was received for the event. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid19; tested positive for Covid19; This is a spontaneous report from contactable consumer. This consumer reported similar events for two patients (wife and daughter). This is 2nd of 2 reports and refers to reporter's daughter.  A female patient (age not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on unknown date (Lot number not provided) as single dose for COVID-19 immunisation and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in Jan2021 (Lot number not provided) as single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient has recently tested positive for COVID19. It was unknown if the patient received treatments for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021446810 Same reporter/drug/event, different patient
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested Positive for Covid on 8APR2021, after receiving the first dose of the Covid vaccine on 30MAR2021.; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318, Expiration Date: 31May2021), via an unspecified route of administration on 30Mar2021 (at the age of 57 years) as single dose for covid-19 immunisation. The patient had no medical history and concomitant medications. On 08Apr2021, the patient was tested positive for covid-19, after receiving the first dose of the Covid vaccine on 30Mar2021. On 09Apr2021, the patient received infusion for covid antibodies as treatment. The patient was due to get second dose tomorrow and asked if it was okay to still get second dose of the vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Apr2021. The report is not related to a study or program. There was a product complaint. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Grunting, Moaning, Pain in extremity
Clinical narrative: grunts and groans; grunts and groans; Legs hurting; Having difficulty walking; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 95-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) at a single dose for Covid-19 immunisation. Medical history included aortic valve replacement. Concomitant medication was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) at a single dose for Covid-19 immunisation. The patient was on the line for Celebrex. The patient ran out of medication. He was enrolled before a long time ago. He told her that he did not had any Celebrex since end of Feb2021 or end of Mar2021, and he could hardly walk and legs were hurting. He has had both COVID shots. He said he grunted and groaned a lot nowadays. He was having difficulty walking. Having difficulty walking was reported as worsened. He was not blaming Pfizer for anything if this was cause of his problems. He would like to determine if being out of medication was a cause of his legs hurting. It just dawned on him, that maybe it was why he was hurting so was because he was out of Celebrex. He did not remember the date his legs hurt. This always happened in the past when he took the Generic. The outcome of the events grunts and groans and legs hurting was unknown. The outcome of the event having difficulty walking was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: aches; extreme fatigue; a possible fever; This is a spontaneous report from contactable consumer (patient). A female patient of unspecified age received second dose of bnt162b2(Pfizer COVID-19 Vaccine, formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on 15Apr2021 as single dose for COVID-19 immunization. Patient historical vaccine included patient received first dose of bnt162b2 (Pfizer COVID-19 Vaccine, formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported that the following day around 2 PM she began to experience aches, Extreme Fatigue, and a possible fever on unspecified date. patient stated that she left work that day and upon arriving home felt asleep in her vehicle for approximately 3 hours. She continued to experience the symptoms for several days and couldn't return to work until 18Apr2021. Patient stated that she doesn't experience any reaction her initial dose of the vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: incredible headache; This is a spontaneous report from a contactable consumer (reported for himself). A 43-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) via an unknown route of administration on 21Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced headaches. It was reported that the patient experienced headaches a day after receiving the vaccine. The event was described as incredible, really painful and almost blinding pain. The patient was treated with Tylenol and Ibuprofen. The outcome of the event was unknown.   No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Ongoing "flu-like" symptoms; This is an initial spontaneous report from a contactable consumer. This 61-year-old female consumer (patient) reported for herself that she received the first dose of the Pfizer COVID vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) as a single dose for COVID-19 immunization. The past medical history and concomitant medications was not reported. On an unknown date, She had ongoing "flu-like" symptoms since then and wants to know how long they could last. The clinical outcome for the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: early appendicitis; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Apr2021 (at the age of 40 years) at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient began to have severe abdominal pain so he went to the emergency room and was evaluated and then about 8 am it was confirmed that he had early appendicitis. The event was considered serious for hospitalization. Patient would like to know if his appendicitis diagnosis is related to the COVID vaccine or if it is completely irrelevant. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Rash pruritic, Urticaria
Clinical narrative: injection site swelling; pain muscle; joint pain; rashes itching; hives; terrible headache; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program . A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient experienced injection site swelling, pain muscle, joint pain, rashes itching, hives, and a terrible headache. Patient asked if she was still able to get the second dose even after she experienced a reaction after the first dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: injection site swelling; pain muscle; joint pain; rashes itching; hives; terrible headache; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program . A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, patient experienced injection site swelling, pain muscle, joint pain, rashes itching, hives, and a terrible headache. Patient asked if she was still able to get the second dose even after she experienced a reaction after the first dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Muscle fatigue, Myalgia
Clinical narrative: collar bone started hurting; muscle aches; muscle fatigue; This is a spontaneous report from a Pfizer-sponsored program reported from a contactable consumer (patient). A female patient of an unspecified age received second dose of  BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. The patient experienced muscle aches, muscle fatigue and collar bone started hurting on an unspecified date. The outcome of the events was unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021466476 same patient, different dose number and event
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Bone pain, Fatigue, Myalgia
Clinical narrative: collar bone started hurting; muscle aches; muscle fatigue; This is a spontaneous report from a Pfizer-sponsored program reported from a contactable consumer (patient). A female patient of an unspecified age received second dose of  BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 11Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. The patient experienced muscle aches, muscle fatigue and collar bone started hurting on an unspecified date. The outcome of the events was unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021466476 same patient, different dose number and event
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: that her daughter lives with them and so they are all exposed.; This is a spontaneous report from a contactable consumer (Patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 15Apr2021 as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypertension, diabetes mellitus and high cholesterol for a number of years now. The patient's concomitant medications were not reported. Patient reported that she, her 64-year-old husband and her 29-year-old daughter all received their first covid vaccine shot last Wednesday. She reported that afterward, her daughter began to experienced a temperature and a cough that lasted for 3 days. Her daughter went to get tested for Covid and tested positive and now she is asking, how she tested positive if they got their first shot? Patient went on to report that her husband also started having a temperature and asks is that normal, should you get a temperature after having the shot? She denied had any symptoms but reported her plan to get tested for fear she may have the virus as well, explaining that her daughter lives with them and so they are all exposed. She was calling about the Pfizer Vaccine and stated she herself, her husband and her daughter went to take the 1st dose of the Pfizer vaccine and had it not yesterday but the Wednesday before. Stated daughter had coughing and had a temperature and stuff like that and they told her it was maybe from the Pfizer Vaccine and sometimes people get the flu vaccine and get that kind of symptoms. Stated her daughter did the test for it and it was positive for covid and she had the needle for covid and now both her parents which is the caller and her husband are over age 65 and have underlying disease. The clinical outcome of the event was unknown.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got Covid; got Covid; This is a spontaneous report from a non-contactable consumer (patient, self-reported) received from a Pfizer-sponsored program. A male consumer of an unspecified age received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 31Mar2021, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got his 1st dose on 31Mar2021 and he was supposed to go on wednesday at noon but he got COVID and he wanted to know whom to talk to reschedule. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID a week and a half after having received BNT162b2; This is a spontaneous report from a contactable consumer (patient), via the Pfizer sponsored program   A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID a week and a half after having received BNT162b2. No further information was reported.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Fatigue, Pain
Clinical narrative: hair loss; aches; fatigue; joint pain; This is a spontaneous report from a contactable consumer (the patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), dose 2 via an unspecified route of administration on 12Mar2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date for covid-19 immunization. On 14Mar2021, the patient developed aches, joint pain, and fatigue (slept for 4 hours during a nap which was unusual for her). 7-10 days after the vaccine dose, on an unspecified date, she started to have some hair loss. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: headache; chills; nausea; This is a spontaneous report from a non contactable consumer (patient). A 56-year-old female patient  received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration, on an unspecified date (at the age of 56-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got all of the side effects within twelve hours. The patient experienced headache, chills and nausea but refused to list her side effects stating that she reported her side effects to safety. Patient wanted to know what possible reason there could be that she got sick and stated is it an ingredient or all of the ingredients. Patient stated that she has not been this sick since she took the flu vaccine and also stated that some get sick and others do not. Patient went to the ER and got an IV. Patient stated she has been out of work and is not doing this again and will not take the second shot. Patient reported to the company and provided a repotum number and stated the I in the reportum number could be a 1. Outcome of the events was unknown.  No followup attempts are possible;Information on lot/batch number cannot be otained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arms are sore; This is a spontaneous report from a contactable consumer (patient's wife). A 50-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arms are sore on 20Apr2021. It was reported that both patient's wife and 50-year-old patient received their first dose of the Pfizer-BioNTech COVID-19 vaccine yesterday (19Apr2021), at a drive-through . She explained both of their "arms are sore" this morning. She asked if it's true that pain medication cannot be taken post-vaccination. Outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Head discomfort, Renal pain, Urticaria
Clinical narrative: one day it was her stomach; head was affected; one day it was around her kidney area; had a "big welt" on her shoulder; This is a spontaneous report from a contactable consumer or other non hcp. An 82-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown) via an unspecified route of administration on 02Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient states that she received her first dose of the Pfizer BioNTech COVID-19 vaccine on 02Apr2021 and scheduled to receive her second dose tomorrow. However, she would like to know if she should get her second dose based on the side effects. she experienced with her first dose. She stated that since receiving her first dose, she has had one organ in her body affected each for 1 day only. For example, she states that on 03Apr2021 she had a "big welt" on her shoulder, not where the injection was given, that went away the next morning "without a trace." She also gives the example that one day her head was affected, one day it was around her kidney area, and one day it was her stomach. A "big welt" on her shoulder the outcome was reported as recovered, outcome of the other events was reported as an unknown.   DSU: E-transmitting AE as caller disconnected before I could offer warm transfer. Response: Spoke from the attached documents regarding contraindications to receiving a dose of the vaccine and what the signs of a severe allergic reaction can include. Referred caller for further guidance.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: I have blood in my urine; This is an initial spontaneous report from a contactable consumer (patient). A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 21Apr2021 16:00 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. He got the second covid shot yesterday at 4PM and he have blood in urine today. He have no other symptoms.   Follow-up activities has been raised. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain
Clinical narrative: body ache; headaches; chills; didn't feel well; This is a spontaneous report from contactable consumer (patient mother) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiration date was not reported) via an unspecified route of administration on an unspecified date (reported as 3 weeks ago) as a single dose for COVID-19 immunization. No patient identifiers were provided but the reporter has first-hand knowledge of the patient. Medical history and concomitant medications were not reported. On an unspecified date, after first dose patient experienced headaches, body aches, chills and didn't feel well. Reporter stated that the vaccination site was shut down due mishandling of the vaccine and had received letters from the state that they need to begin the vaccination series again. Reporter inquired safety or wisdom of receiving potentially a third dose of the vaccine 3 weeks in a row. The caller wants to know if that was correct and if her daughter should get the vaccine because she had reactions the first time. Outcome for the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Oropharyngeal pain
Clinical narrative: bad taste in his mouth; sore throat; This is a spontaneous report received from a contactable consumer. This consumer (Patient Mom) reported for a 24-year-old male patient (Son) that he received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) dose 2 via an unspecified route of administration on 21Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that on 21Apr2021, her son developed a sore throat that evening and the next day, on 22Apr2021, he started to have a bad taste in his mouth. She wanted to know if this side effect was normal. The reporter stated that she took the Moderna vaccine and felt tired and had chills afterwards. The outcome was unknown for both the events.  No follow-up attempts are needed. No further information is expected. Batch/lot number not obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: very tired / extremely tired; has no energy; This is a spontaneous report from a contactable consumer. A 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL2966), via unspecified route of administration on 28Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 for COVID-19 immunization. It was reported that patient had very tired since the second dose she had no energy and extremely tired, which was not normal for her. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product preparation issue, Vaccination site reaction
Clinical narrative: Inappropriate dilution of medication/vial was diluted with 0.18 ml instead of 1.8 ml; it was not diluted properly - got a high dose; injection site/systemic AEs; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received dose 1 Pfizer COVID-19 vaccine on 02Apr2021, and the vaccine wasn't diluted properly, the patient got a high dose: vial was diluted with 0.18 ml instead of 1.8 ml and 0.3 mL was administered to patient. The patient experienced injection site/systemic AEs in Apr2021. The pharmacist followed up with the patient several days later and the injection site/systemic AEs were resolved in Apr2021. No treatment information was reported. The patient was due to dose 2 and he wanted to know if it was ok to administer it at the recommended interval.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Restlessness
Clinical narrative: feeling antsy/cannot relax even though she was tired; can not relax even though she was tired/tiredness; muscle and joint pain; muscle and joint pain; headache was worse/headache very much so; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 21Apr2021 (at the time of 22-year-old) at single dose for COVID-19 immunization. The patient medical history included chronic migraines. Concomitant medications were not reported. The patient previously took acetylsalicylic acid/caffeine/paracetamol (EXCEDRIN) for chronic migraines. On an unspecified date it was reported that patient had the first dose of the Pfizer covid 19 vaccine yesterday, 21Apr2021. She has underlying health issues. She was feeling antsy which only started today. it was not like her heart was racing or beating really hard, just she cannot relax even though she was tired. She has chronic migraines and took Excedrin earlier. It was also reported that maybe the ingredients of the vaccine do not coincide with the caffeine in the Excedrin. She has muscle and joint pain bad today, but her arm was fine. Tiredness and headache very much so. The headache was worse today. She took fiorinal with codeine for the bad headache because the RPh (registered pharmacist) said it was ok. she read side effects and asked the agent if agent was saying that feeling antsy is not a side effect of the vaccine. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hangover, Headache, Illness
Clinical narrative: feels like a headache; feel as if she was having a bad hangover; feels sick; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular on 10Apr2021 (Lot number, Expiration date: unknown) as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient felt like a headache is coming on but it hasn't yet on an unspecified date, felt as if she was having a bad hangover on an unspecified date, felt sick and felt like herself on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Hypersensitivity
Clinical narrative: who received two cortisone shots in the knee yesterday.; severe allergic reaction; This is a spontaneous report from a contactable consumer (Daughter) via Pfizer sponsored program. A female patient (mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported.  Reporter called in for her mother received two cortisone shots in the knee yesterday. She wants to know if her mother can go ahead and take the second dose of the Pfizer BioNTech COVID-19 vaccine due today 20Apr2021. The first dose was given 01Apr2021. She asked if the vaccine could still be administered as planned. She then said she wanted to verify with Pfizer because her mother's orthopedic doctor stated the vaccine may be less effective. As per response, it was reported that she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of this vaccine from CONS-who should not get the vaccine. It was reported that individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. The outcome of the evets was reported as an unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Feeling abnormal, Hypoaesthesia, Vision blurred
Clinical narrative: felt like the left side of her body was numb; felt bad; blurred vision; dizziness; anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 57-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiry date unknown) via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 19Apr2021, the patient experienced difficult breathing, difficult to swallow, dizziness, headache, tachycardia, low blood pressure, redness in her face, felt shortness of breath and felt bad right after received the vaccination. 30 min after administration, the patient was admitted to the emergency room to manage the condition and was in observation for 3 hours and was diagnosed as anaphylactic reaction to the vaccine. After being released from the emergency room, the patient was experiencing blurred vision, tachycardia, continuous headache, felt like the left side of her body was numb, had nausea and dizziness. The patient was treated with benadryl and ondansetron in emergency room. Outcome of the events were reported as unknown.  Follow-up attempts are needed. Further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Real dizzy; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient's brother). A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 17Apr2021 16:43 in right arm as single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. There was no history of previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer Suspect. There were no prior vaccinations within 4 weeks. It was stated that the patient received the first dose of the Pfizer COVID 19 vaccine last Saturday, 17APR2021 at 16:43 PM in the right arm. That day she got a headache, Saturday night (17Apr2021). Then today she woke up real dizzy (20Apr2021 06:20). She wants to know what kind of medication she can take for dizziness. It was also reported that when the patient stands up it gets worse. On 20Apr2021 06:20 am this morning she woke up and felt a little nausea, but she does not have that anymore. She just wants to take something so she can go to woke. Mentions she took Tylenol. The patient did not visit emergency room or physician Office. The outcome of the event headache was recovered/resolved on 17Apr2021 and nausea on 20Apr2021. The outcome of the event dizziness was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: She had two bad days after the second shot that she should have gone to the emergency room but she did not go; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 08Feb2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 18Jan2021 for COVID-19 immunization and experienced hives. On an unspecified date, the patient experienced she had two bad days after the second shot that she should have gone to the emergency room but she did not go. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperventilation, Muscular weakness, Myalgia, Pain
Clinical narrative: Felt drowsy; Headache; Body ache; Muscle aches; Breathing was to the point where had to take deep breaths; Felt weak in his legs; Soreness in his arms; Missing Second Dose of the Vaccine Today; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A male 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 24Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. After taking the first dose, patient was feeling fine until 10-15 days later, he felt drowsy, headache, body ache, muscle aches, and his breathing was to the point were had to take deep breaths on an unspecified date. Caller stated his next vaccine was scheduled for today and he was still feeling body aches, even just leaving his arm in the air to hold the phone, he felt the body aches. He was really looking forward to getting his second shot but when he woke up today, he still felt weak in his legs, had a headache and soreness in his arms on an unspecified date. The patient missing second dose of the vaccine today. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue, Somnolence
Clinical narrative: Felt drowsy; Headache; Body ache; Muscle aches; Breathing was to the point where had to take deep breaths; Felt weak in his legs; Soreness in his arms; Missing Second Dose of the Vaccine Today; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A male 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 24Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. After taking the first dose, patient was feeling fine until 10-15 days later, he felt drowsy, headache, body ache, muscle aches, and his breathing was to the point were had to take deep breaths on an unspecified date. Caller stated his next vaccine was scheduled for today and he was still feeling body aches, even just leaving his arm in the air to hold the phone, he felt the body aches. He was really looking forward to getting his second shot but when he woke up today, he still felt weak in his legs, had a headache and soreness in his arms on an unspecified date. The patient missing second dose of the vaccine today. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Headache, Herpes zoster, Movement disorder
Clinical narrative: shingles; pain to her back; red spots on left breast; pain left breast; itching on left breast/itching on back; left arm sore; Headache; can barely move; This is a spontaneous report from a contactable consumer (the patient). A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0150, Expiration date: Unknown) via an unspecified route of administration, administered in left arm on 11Apr2021 12:15 (at the age of 46-years-old) as single dose for covid-19 immunization. The patient's medical history was not reported. concomitant medications was none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021-13Apr2021, the patient had a headache at 14:00 and a left sore arm at 16:00. On 14Apr2021 she noticed red spots on her left breast at 12:00 which she thought was the seam of her bra and pain left breast at 12:00 for which she visited physician clinic. On 15Apr2021-16Apr2021 she had itching at 15:00 /pain at 02:00 on her back; for pain back she visited physician clinic and thought it was poison ivy. On 20Apr2021, she went to the doctor for shingles 14:30 at. Stated that the pain is unbearable sometimes and can barely move. Stated that she was told to report it because it may be related to Covid vaccine. Stated that her second shot is 03May and wanted to know if she should get it and she will be fine or should not get the second shot. The patient received treatment with Ibuprofen for headache and pain left breast. Stated that she was given Valcyclovir. At the time of report, it was reported, headache recovered completely from 3-4 days later. Stated that the pain from the shingles comes and goes. Outcome of the event: headache- unknown; left arm sore recovering, red spots on left breast- recovering; itching on left breast/itching on back, can barely move- not recovered and pain left breast, shingles, pain to her back- reported as not recovered (worsened).  No follow-up attempts are needed. No further information is expected.