chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm opposite (left arm) to the one where the injection was put was hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 12Mar2021 (Batch/Lot number: unknown) at the age of 48 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL taken for migraine. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Arm opposite (left arm) to the one where the injection was put was hurting". Therapeutic measures were not taken as a result of pain in extremity. Additional information: The arm where the injection was given, it's not that one that hurts, it's the other one, not in any other part of the patient's body, nothing just her arm was hurting really bad on the left side.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm was sore about 2.5 hours the shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 09:30 (Lot number: 9581) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Feb2021 09:45, outcome "recovered", described as "left arm was sore about 2.5 hours the shot". According to the patient "it had felt like a had a Techna shot. The soreness went away 5-6 hours after the shot". Therapeutic measures were not taken as a result of pain in extremity. The patient has no COVID-19 prior vaccination and has not been tested for it post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: headache; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 13Mar2021 09:30 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: May2020 (ongoing), notes: Verbatim: Asthma; "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 14Mar2021 11:00, outcome "not recovered", described as "headache"; CHILLS (non-serious) with onset 14Mar2021 11:00, outcome "recovered" (Mar2021), described as "chills". Therapeutic measures were taken as a result of headache, chills.   Additional information: The patient was taking Tylenol/ibuprofen to treat. She wants to know how long the headache and chills will last. Reporter seriousness for Headache and Chills: Unspecified. No other additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient received no other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. The events did not cause physician office/emergency room. Description of complaint: Calling to report adverse events from the Covid Vaccine. States that patient had been alternating Tylenol and Motrin but she still had a headache. Tylenol: Lot SCAO51 Expiration: 01/24 Motrin: Lot OFE33249A Expiration: 5/22. No UPC, states she doesn't have the box just the bottle.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Potentiating drug interaction
Clinical narrative: She is asking if it is okay that she took the steroid shot; She has problems in her shoulder due to arthritis.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: She has problems in her shoulder due to arthritis. The patient's concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious) with onset Mar2021, outcome "unknown", described as "She has problems in her shoulder due to arthritis."; POTENTIATING DRUG INTERACTION (non-serious) with onset 12Mar2021, outcome "unknown", described as "She is asking if it is okay that she took the steroid shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: She had throbbing pain radiating from the back of her neck to the elbow in the arm that she received the injection; chills; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "not recovered", described as "She had throbbing pain radiating from the back of her neck to the elbow in the arm that she received the injection"; CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". Therapeutic measures were taken as a result of pain. Additional information: It was reported that patient had an adverse reaction. She had throbbing pain radiating from the back of her neck to the elbow in the arm that she received the injection and it was getting worse after 3 days. ES TYLENOL did not help with the pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received BNT162B2 (BNT162B2), administration date 01Mar2021 (Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Arm soreness".  Additional information: The patient reported having arm soreness 1.5 days after the receiving the dose. She was told by her son that the Pfizer vaccine is not safe and is a biological agent. She wants any and all information regarding the safety of getting the vaccine. She read in the news and online that (name) reports that the vaccine is experimental and not approved and that AstraZeneca COVID vaccine causes blood clots. She also read that one mother (38 y/o) in (Name) died and she told her daughter before she died that it was the vaccine that contributed to her illness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 11Mar2021 13:40 (Batch/Lot number: unknown) at the age of 64 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: HEADACHE (non-serious) with onset 11Mar2021, outcome "unknown", described as "headache". The event "headache" was evaluated at the physician office visit. Therapeutic measures were taken as a result of headache.  Additional information: Patient had someone send him a note, and it said, make sure you don't take Aspirin or Ibuprofen before you take the Covid 19 shot and he hadn't taken any that day but he had taken Ibuprofen the day before on 10Mar2021, so about 22 hours had passed. He states the (public agency name) says there is possible lack of efficacy. He had also taken aspirin prior to that. He takes that regular. He thinks aspirin stays in his body longer maybe 10 days. He didn't now if it made a difference if it was in his system. He took Aspirin last night because of a headache. Patient did not have history of any previous immunization with the Pfizer vaccine. Patient did not take any vaccination prior to covid vaccine. Patient questioned if it was ok to take melatonin and an antidepressant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: My shoulder is still sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "not recovered", described as "My shoulder is still sore".  No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: headache; soreness at the injection site on the second day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Lot number: EN5318, Expiration Date: 31May2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Verbatim: the first vaccine was on 09Feb2021, expiration date 30Apr2021, EL1284, she had no problems with it, not even soreness.), administration date: 09Feb2021, for Covid-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Mar2021, outcome "unknown", described as "soreness at the injection site on the second day"; HEADACHE (non-serious), outcome "unknown", described as "headache". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: The patient reported that she had chicken soup and was better after, she rubbed the injection site with alcohol, she had no fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Culture, Dysgeusia, Oropharyngeal pain, SARS-CoV-2 test, Streptococcus test
Clinical narrative: progressed into a sore throat; taste of metal in his mouth; weird taste in my mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 18:30 (Lot number: EN6205) at the age of 26 years as dose 1 , single for covid-19 immunisation. Relevant medical history included: "Myocarditis", start date: Feb2021 (ongoing); "Wolff-Parkinson-White syndrome", start date: Feb2021 (ongoing); "COVID-19", start date: Dec2020 (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for cardiac disorder. The following information was reported: TASTE DISORDER (non-serious) with onset 05Mar2021, outcome "unknown", described as "weird taste in my mouth"; OROPHARYNGEAL PAIN (non-serious) with onset 10Mar2021, outcome "not recovered", described as "progressed into a sore throat"; DYSGEUSIA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "taste of metal in his mouth". The events "weird taste in my mouth", "progressed into a sore throat" and "taste of metal in his mouth" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of taste disorder, oropharyngeal pain, dysgeusia which included Zyrtec for 3 days.Zyrtec, Cetirizine antihistamine 5mg Pseudoephedrine 120mg.  Additional information: He stated that he was experiencing symptoms after his first dose of the Pfizer vaccine. The next day he had this weird taste in his mouth. 10 days it progressed into a sore throat. Then around the week after on 08Mar2021, he started getting a sore throat. It feels like metal in his mouth. Any food he ate he had this strange metal or taste like nothing. When he did have covid he did not have any symptoms regarding taste. The patient would like to know that whether he can take second dose of vaccine. He knows that sometimes symptoms from the Covid 19 virus can persist. He would like to clarify he did not have loss of taste when he had the Covid 19 virus. He did not receive any other vaccines within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: progressed into a sore throat; taste of metal in his mouth; weird taste in my mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 18:30 (Lot number: EN6205) at the age of 26 years as dose 1 , single for covid-19 immunisation. Relevant medical history included: "Myocarditis", start date: Feb2021 (ongoing); "Wolff-Parkinson-White syndrome", start date: Feb2021 (ongoing); "COVID-19", start date: Dec2020 (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for cardiac disorder. The following information was reported: TASTE DISORDER (non-serious) with onset 05Mar2021, outcome "unknown", described as "weird taste in my mouth"; OROPHARYNGEAL PAIN (non-serious) with onset 10Mar2021, outcome "not recovered", described as "progressed into a sore throat"; DYSGEUSIA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "taste of metal in his mouth". The events "weird taste in my mouth", "progressed into a sore throat" and "taste of metal in his mouth" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of taste disorder, oropharyngeal pain, dysgeusia which included Zyrtec for 3 days.Zyrtec, Cetirizine antihistamine 5mg Pseudoephedrine 120mg.  Additional information: He stated that he was experiencing symptoms after his first dose of the Pfizer vaccine. The next day he had this weird taste in his mouth. 10 days it progressed into a sore throat. Then around the week after on 08Mar2021, he started getting a sore throat. It feels like metal in his mouth. Any food he ate he had this strange metal or taste like nothing. When he did have covid he did not have any symptoms regarding taste. The patient would like to know that whether he can take second dose of vaccine. He knows that sometimes symptoms from the Covid 19 virus can persist. He would like to clarify he did not have loss of taste when he had the Covid 19 virus. He did not receive any other vaccines within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: My arm hurt like mad that night; I couldn't even sleep when I went to bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm hurt like mad that night"; INSOMNIA (non-serious), outcome "unknown", described as "I couldn't even sleep when I went to bed".  Additional information: She received her first dose of the Pfizer vaccine on 09Mar2021 at and she took Benadryl allergy relief, gas x and aspirin a day. Today was the first day she took the aspirin. Her next one on the 30Mar2021. She was at the doctor's office that day. She doesn't like taking medications. She has taken some that she was allergic too. Patient stated, "She didn't take anything NSAID. Her arm hurt like mad that night and she couldn't even sleep when she went to bed. She didn't take medication for her pain. Her first dose was on 09Mar2021 a week tomorrow.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Sever Pain in the armpit with swollen lymph node; Sever Pain in the arm pit with swollen lymph node; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 13Mar2021 12:00 (Batch/Lot number: unknown) at the age of 50 years as dose 2,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 (Product=COVID 19, Brand=Pfizer, Lot unknown=false, Administration date=20Feb2021, Administration time=12:00 PM, Administrator route=Intramuscular, Vaccine location=Left arm), administration date: 20Feb2021, when the patient was 50 years old, for covid-19 immunisation.  The following information was reported: AXILLARY PAIN (non-serious) with onset 13Mar2021 16:00, outcome "not recovered", described as "Sever Pain in the armpit with swollen lymph node"; LYMPHADENOPATHY (non-serious) with onset 13Mar2021 16:00, outcome "not recovered", described as "Sever Pain in the arm pit with swollen lymph node". The events "sever pain in the armpit with swollen lymph node" and "sever pain in the arm pit with swollen lymph node" were evaluated at the physician office visit. Therapeutic measures were taken as a result of axillary pain, lymphadenopathy.  Additional information: The patient did not receive other vaccine in four weeks. The patient had no allergies. The patient has not had covid prior vaccination. The patient did not tested covid post vaccination. The patient receive treatment with Advil for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Feb2021 16:50 (Lot number: EL9261) as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased, start date: 11Jan2021 (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Date: 25Jan2021, Time: 12:40 PM, Site of Injection: Upper Left Arm, Route of administration: Intramuscular, Batch/Lot Number: Lot: EL3302, Expiration Date: 31May2021), administration date: 25Jan2021, for covid-19 immunisation, reaction(s): "headache", "dizziness", "nausea", "had no appetite", "felt ill", "vomited", "extremely tired". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "slight headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior Vaccinations within 4 weeks were reported as none  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: panic attacks; This is a spontaneous report received from a contactable reporter Consumer or other non Health professional from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANIC ATTACK (non-serious), outcome "unknown", described as "panic attacks".  Additional information: Reporter stated that . the (pharmacy name ) pharmacist had the same thing and still experiencing it a month later. He told me 2 others experienced panic attacks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: nausea; threw up last night throw up generally unwell; generally unwell; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 13Mar2021 17:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 15Mar2021, outcome "unknown", described as "nausea"; VOMITING (non-serious) with onset 15Mar2021, outcome "unknown", described as "threw up last night throw up generally unwell"; MALAISE (non-serious) with onset 15Mar2021, outcome "unknown", described as "generally unwell".  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Nervousness, Sleep disorder, Weight
Clinical narrative: his mouth was real dry; he was real nervous when he got his COVID vaccine.; he could hardly sleep/ it was only that night except for now when he may wake up during the night and then it is hard to fall back asleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 (Lot number: EN6199) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Taking Metoprolol for this for about 3 to 4 years. Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal (ongoing). The following information was reported: DRY MOUTH (non-serious) with onset 10Mar2021, outcome "recovering", described as "his mouth was real dry"; NERVOUSNESS (non-serious) with onset 10Mar2021, outcome "unknown", described as "he was real nervous when he got his COVID vaccine."; SLEEP DISORDER (non-serious) with onset 10Mar2021, outcome "unknown", described as "he could hardly sleep/ it was only that night except for now when he may wake up during the night and then it is hard to fall back asleep". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Event Details: Shortly after he got home, about half an hour after he got home, his mouth was real dry and then he could hardly sleep. Then the next morning the dry mouth eased up a little bit. When he would drink water, his mouth became dryer than it usually does, you would think it would do the opposite. It is not as dry as it was the first day, it has improved a little. The night of 10Mar2021 is when he could hardly sleep from his dry mouth, it was only that night except for now when he may wake up during the night and then it is hard to fall back asleep.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache; muscle ache; chills; Plus Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 21:45 (Batch/Lot number: unknown) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19,, lot unknown=False,, administration time=12:00 PM,, vaccine location=Left arm,, dose number=1), administration date: 22Feb2021, for covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 15Mar2021 18:30, outcome "recovering", described as "Headache"; MYALGIA (non-serious) with onset 15Mar2021 18:30, outcome "recovering", described as "muscle ache"; CHILLS (non-serious) with onset 15Mar2021 18:30, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 15Mar2021 18:30, outcome "recovering", described as "Plus Tired". Therapeutic measures were not taken as a result of headache, myalgia, chills, fatigue.  Additional Information:There was no other vaccine in four weeks and no other medications in two weeks. The patient had not COVID prior vaccination and also not done COVID tested post vaccination. Patient had no Known allergies. Query reported as a safety unit recently received the attached report submitted by you via URL. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Response reported as The date patient became aware was Monday evening 15March.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness of arm after 1st dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "soreness of arm after 1st dose".  Additional information: Patient experienced soreness of arm after 1st dose (10Mar2021) and now he's asked if he can take Tylenol or Advil after his 2nd dose which was dated on 31Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: My mother who is with me had a reaction to the vaccine; pharmacist said it was bad enough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 87 -old female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) at the age of 87 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION COMPLICATION (non-serious), outcome "unknown", described as "My mother who is with me had a reaction to the vaccine; pharmacist said it was bad enough". Therapeutic measures were not taken as a result of vaccination complication.  Additional information- Reporter was informed about the Pfizer Medical Information department and  was provided with the number of Pfizer Medical Information as (phone number) and was requested to select option 3, timings are 8 AM to 8 PM from Monday to Sunday as per.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A little soreness in the arm; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Mar2021, outcome "unknown", described as "A little soreness in the arm".  Additional information: It was unknown If covid was prior to vaccination or if covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Very mild soreness at the injection site when touched; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). This consumer reported similar events for two patients. This is 1 of two reports.   A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 11Mar2021 (Lot number: En6204, Expiration Date: Jun2021) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose number=1, Lot number=En6201, expiry date: Jun2021, administration time=11:00 AM, vaccine location=Left arm), administration date: 18Feb2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11Mar2021 11:00, outcome "unknown", described as "Very mild soreness at the injection site when touched". Therapeutic measures were not taken as a result of vaccination site pain.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021275482 same reporter, drug and event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Off label use, Product use issue
Clinical narrative: I could get the nausea; Breast feeding my daughter; Breast feeding my daughter; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 11Mar2021 (Lot number: EN6202) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "I could get the nausea "; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 2021, outcome "unknown" and all described as "Breast feeding my daughter".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021291019 baby case
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Inappropriate schedule of product administration, Migraine
Clinical narrative: dizzy/ lightheaded; migraine attacks; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Feb2021 03:30 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product=COVID 19, brand=Pfizer, lot unknown=False, administration date=13Jan2021, administration time=03:30 AM, vaccine location=Left arm, dose number=1), administration date: 13Jan2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 09Feb2021 16:00, outcome "not recovered", described as "dizzy/ lightheaded"; MIGRAINE (non-serious) with onset 09Feb2021 16:00, outcome "not recovered", described as "migraine attacks"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Feb2021 03:30, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The events "dizzy/ lightheaded", "migraine attacks" and "inappropriate schedule of vaccine administered" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of dizziness, migraine, inappropriate schedule of product administration.  Additional information: Patient has not been vaccinated with 4 weeks of COVID-19 vaccination. Patient has not been tested for COVID-19 test. Patient has not been tested for COVID-19 test post-vaccination. No known allergies reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Vaccination site pain, Vaccination site paraesthesia, Vaccination site warmth
Clinical narrative: Felt warm and tingling sensation  underneath where the injection went; Felt warm and tingling sensation  underneath where the injection went; felt like someone punched her in her arm. It hurt for like a day or two; weird sensation, it feels weaker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PARAESTHESIA (non-serious), outcome "unknown" and all described as "Felt warm and tingling sensation underneath where the injection went"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "felt like someone punched her in her arm. It hurt for like a day or two"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "weird sensation, it feels weaker".  Additional information: The caller felt it when the vaccine went in and then when she was waiting the 15 minutes, she felt warm and tingling sensation underneath where the injection went in but it was fine. Then the caller had the normal effect, everyone said they have where it felt like someone punched her in her arm. It hurt for like a day or two. Then that really hurting feeling went away. Now she was left with her left arm just feeling "off." It was not painful, does not wake up at night, no rash or swelling that she can see. However, she still has this weird sensation, it feels weaker, maybe a little warm, but would touch it and it does not actually feel warm. It was almost as if tingling, sensitive sensation, anywhere from a little bit where the injection went in or up to her elbow. Her elbow and fingers do not hurt. Her arm does not feel totally normal yet. She was 2 weeks out and does not know what this was about. The caller has heard that with Moderna there was a rash and hives, with Pfizer she has heard people are a month out and their arms are whatever. The caller doesn't know if she should get the second dose in the same arm. She doesn't want her other arm to feel like this one so she wanted to know what she should do. The caller's arm felt sensitive and warm, she doesn't know how to explain it. Stated if she touches both arms she does not notices any warmth difference to the touch. One side does not feel any warmer to the touch.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm is swelled; pain in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EN6205) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm is swelled"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in the arm".  Additional information: Patient's arm was swelled and really quite a bit in pain. Patient cannot lift it, and cannot really move it and just wanted to know if that is normal and how long it will last.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Somnolence
Clinical narrative: All he wants to do is sleep all day long/ he is sleepy; He is very sick; This is a spontaneous report received from a contactable reporter (consumer).  An 85 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in deltoid left, administration date 12Mar2021 (Lot number: EN6204) at the age of 85 years as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "He fell over a month ago and hurt his back" (unspecified if ongoing). Concomitant medications included: PHENOBARBITAL; PHENYTOIN; ZOCOR taken for blood cholesterol abnormal. The following information was reported: SOMNOLENCE (non-serious) with onset Mar2021, outcome "unknown", described as "All he wants to do is sleep all day long/ he is sleepy"; ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "He is very sick".  Additional information: The reporter was the patient's wife. Vaccination facility type was pharmacy/drugstore. Reporter stated, "He fell over a month ago and hurt his back and that's all." The patient was also taking vitamins. Reporter stated, "He don't want to get the Covid, but when I had Covid, my son had Covid, he never got it." Reporter stated that the event happened "2 or 3 days later." Reporter stated, "A week ago Friday, my husband got the Covid vaccine. All he wants to do is sleep all day long. Now listen to me, he did not get Covid because I had it in December and he never got that. He's been in good health and I got my paper out and there was no side effect that says he wanted to sleep all the time and I am talking about sitting in his chair and he is sleepy. I don't know what to do about it. He is very sick, and I don't understand this. I wouldn't mind reporting it. I don't know if you are getting anything like this. I want to know what to do about it."  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: she got real sick; body pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she got real sick"; PAIN (non-serious), outcome "unknown", described as "body pain".  Additional information: She has not received the second dose and she is already late. She said that she received the first dose last 17Feb. Caller mentioned that she got real sick and she experienced body pain but she said that it is not because of the covid-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Vaccination site pain, Vertigo
Clinical narrative: Woke up with extreme dizziness; everything spinning so rapidly; making her heave; nausea; soreness at injection site; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 15:30 (Lot number: EN-6206) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies" (unspecified if ongoing). Concomitant medication(s) included: LEVALBUTEROL [LEVOSALBUTAMOL]. Vaccination history included: Bnt162b2 (DOSE 1, Lot number: EN6200, Administration time: 04:15 PM. Vaccine location: Left arm), administration date: 19Feb2021, when the patient was 37 years old, for COVID-19 immunisation, reaction(s): "soreness at injection site", "period of inexplicable clumsiness". The following information was reported: DIZZINESS (non-serious) with onset 14Mar2021 08:45, outcome "unknown", described as "Woke up with extreme dizziness"; VERTIGO (non-serious) with onset 14Mar2021 08:45, outcome "unknown", described as "everything spinning so rapidly"; VOMITING (non-serious) with onset 14Mar2021 08:45, outcome "unknown", described as "making her heave"; NAUSEA (non-serious) with onset 14Mar2021 08:45, outcome "unknown", described as "nausea"; VACCINATION SITE PAIN (non-serious) with onset 14Mar2021 08:45, outcome "unknown", described as "soreness at injection site"; FATIGUE (non-serious) with onset 14Mar2021 08:45, outcome "unknown", described as "fatigue". Therapeutic measures were not taken as a result of dizziness, vertigo, vomiting, nausea, vaccination site pain, fatigue.  Additional information: The dizziness was the most intense she has ever experienced with everything spinning so rapidly. The dizziness is now mild when she is laying down, but she is unable to be upright without it returning and making her heave.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Woke up with extreme dizziness; everything spinning so rapidly; making her heave; nausea; soreness at injection site; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 15:30 (Lot number: EN-6206) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies" (unspecified if ongoing). Concomitant medication(s) included: LEVALBUTEROL [LEVOSALBUTAMOL]. Vaccination history included: Bnt162b2 (DOSE 1, Lot number: EN6200, Administration time: 04:15 PM. Vaccine location: Left arm), administration date: 19Feb2021, when the patient was 37 years old, for COVID-19 immunisation, reaction(s): "soreness at injection site", "period of inexplicable clumsiness". The following information was reported: DIZZINESS (non-serious) with onset 14Mar2021 08:45, outcome "unknown", described as "Woke up with extreme dizziness"; VERTIGO (non-serious) with onset 14Mar2021 08:45, outcome "unknown", described as "everything spinning so rapidly"; VOMITING (non-serious) with onset 14Mar2021 08:45, outcome "unknown", described as "making her heave"; NAUSEA (non-serious) with onset 14Mar2021 08:45, outcome "unknown", described as "nausea"; VACCINATION SITE PAIN (non-serious) with onset 14Mar2021 08:45, outcome "unknown", described as "soreness at injection site"; FATIGUE (non-serious) with onset 14Mar2021 08:45, outcome "unknown", described as "fatigue". Therapeutic measures were not taken as a result of dizziness, vertigo, vomiting, nausea, vaccination site pain, fatigue.  Additional information: The dizziness was the most intense she has ever experienced with everything spinning so rapidly. The dizziness is now mild when she is laying down, but she is unable to be upright without it returning and making her heave.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Clumsiness, Vaccination site pain
Clinical narrative: Soreness at injection site; Clumsiness; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A 37-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Feb2021 16:15 (Lot number: EN6200) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: LEVALBUTEROL [LEVOSALBUTAMOL]. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Feb2021, outcome "unknown", described as "Soreness at injection site"; CLUMSINESS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "Clumsiness". Therapeutic measures were not taken as a result of vaccination site pain, clumsiness. The reporter considered "clumsiness" not related to BNT162B2.  Additional Information: The only side effect of first shot the patient noticed was soreness at injection site, though she did note that she had a period of inexplicable clumsiness for about a week but did not think related.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: based on the known safety profile of vaccine and the information available the event CLUMSINESS was considered unrelated to the suspect drug.