chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Have a rash on my left arm at the injection site and it is about the size of a quarter; 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 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EN6198) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Premature ventricular contractions" (unspecified if ongoing); "Migraine" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL; TOPIRAMATE. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Have a rash on my left arm at the injection site and it is about the size of a quarter". Additional information: Patient reported this event as the patient was thinking that this was an adverse event from the injection (Covid Vaccine). It was reported that that's the only place on the patient's body that the patient noticed it and patient just noticed today almost nine days after injection. The patient was querying if it was safe to get the second dose. The patient will have the second dose on 29Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Burn oesophageal, Pain
Clinical narrative: I feel burn on my esophagus.; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 (Lot number: EN6207) at the age of 34 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gastric issues" (unspecified if ongoing), notes: Gastric issues. Concomitant medication(s) included: AMITRIPTYLINE; VITAMIN D; PANTOPRAZOLE; PHAZYME. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , Lot number: EL6203 Anatomical site- Arm Right Age at vaccination:34 years, Severe Gastric Issues - I had the issue for a year in a mild format. After first dose I got really bad but I tried to manage that and I thought that is related to the old issue), administration date: 26Feb2021, when the patient was 34 years old, for COVID-19 immunisation, reaction(s): "Gastric disorder". The following information was reported: BURN OESOPHAGEAL (non-serious) with onset 20Mar2021 03:00, outcome "not recovered", described as "I feel burn on my esophagus."; PAIN (non-serious) with onset 20Mar2021 03:00, outcome "not recovered", described as "pain". Therapeutic measures were not taken as a result of burn oesophageal, pain.  Additional Information: A 34-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the right arm on 19Mar2021 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included gastric issues for 1 year in a mild format. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), amitriptyline (MANUFACTURER UNKNOWN), simethicone and calcium carbonate (PHAZYME), and vitamin D (MANUFACTURER UNKNOWN) for unknown indication. The patient had previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL6203), via an unspecified route of administration in the right arm on 26Feb2021 at 19:00 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 20Mar2021 at 03:00, it was reported that the patient had severe gastric issues for a year in a mild format. After the first dose the patient had experienced really bad and tried to manage. On 19Mar2021, the patient got the second dose and she was having pain and had felt burn in her oesophagus on 20Mar2021 at 03:00. The patient did not receive any treatment for the adverse events. The clinical outcome of the events pain and burn in oesophagus were not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Feeling abnormal, Pain
Clinical narrative: Right arm with the bursitis; I had the pain; My arm is killing me; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) from medical information team. The reporter is the patient. A 59-year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient relevant medical history was not reported. Concomitant medication(s) included: TYLENOL taken for inflammation, musculoskeletal stiffness. Vaccination history included: Shingles shot, reaction(s): "shingles shot was a horrible". The following information was reported: BURSITIS (non-serious), outcome "unknown", described as "right arm with the bursitis", PAIN (non-serious), outcome "unknown", described as "I had the pain"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "My arm is killing me". Therapeutic measures were taken as a result of pain.  Additional Information: Caller stated received her first Pfizer shot on Thursday at 11am. Caller stated, Wednesday I was alright but when I woke up Thursday my right arm was stiff. Patient had inflammation. Patient putting on ice packs and she was taking Tylenol (this happened before my covid shot). It was her right arm with the bursitis. It was a different arm than when she got the shot. she got the covid vaccine in my left arm. she went and got it because she did not want to miss it. she had the pain before the appointment. Patient had no problems with the Pfizer vaccine. Bursitis on my arm happens time to time. Can she get a cortisone shot? Patient arm is killing her. The inflammation was not related to the vaccine. The Pfizer vaccine was in my left did not have her arm sore and stiff, thank God for that. The shingles shot was a horrible, first dose in October her arm was very stiff then she got the 2nd dose in January and she was dizzy as a bat and dizzy like that for 2 days. she was scared to walk. From time to time she feel dizzy in the head. Never had this problem. Even the nurse said the shingles shot is a rough shot to take.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Chills, Dysstasia, Gait disturbance, Neuralgia
Clinical narrative: nerve pain; chills; he is unable to even stand or walk; he is unable to even stand or walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 56 year-old male patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Nov2020 (unspecified if ongoing); "diabetes causing high blood sugars" (unspecified if ongoing); "nerve damage" (unspecified if ongoing); "nerve pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NEURALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "nerve pain"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; DYSSTASIA (non-serious), GAIT DISTURBANCE (non-serious) all with onset Mar2021, outcome "unknown" and all described as "he is unable to even stand or walk". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated her son received the first dose of the Pfizer COVID vaccine yesterday. Caller stated her son had COVID-19 in Nov2020 and it accelerated his diabetes causing high blood sugars and caused nerve damage. Caller stated today her son had been experiencing nerve pain that he describes as the worst nerve pain he has ever had. Caller stated her son had nerve pain in the past, but he had been able to stand in the past but today the pain had been so excruciating that he was unable to even stand or walk. Caller stated he had also had chills. Caller would like to know if the vaccine could have aroused him immune system and caused him to have severe nerve 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: Fatigue, Pain in extremity, Somnolence
Clinical narrative: sore in the arm; a lot of fatigue; felt sleepy; 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 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High risk heart condition" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore in the arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "a lot of fatigue"; SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "felt sleepy".  Additional information: Patient was waiting a long time to speak with Medical Information and was supposed to have 2nd dose of the Pfizer vaccine unfortunately, vaccination center closed. The Pfizer vaccine was through a federal program. Monday they are doing the state program which was Monderna. Patient got the normal side effects after the first dose of the Pfizer vaccine; it was nothing. it was good. Patient's parents got it in another country the Pfizer one and had the same side effects (not very big sore arm, light sore arm).  No follow-up attempts are possible. Information about lot/batch number cannot be requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: slight upset stomach; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 18:30 (Lot number: En6202) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADDERALL; ESCITALOPRAM; VITAMIN D NOS. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "slight upset stomach". Therapeutic measures were not taken as a result of abdominal discomfort.  Additional information: A 40-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration in the left arm on 25Feb2021 at 18:30 (at the age of 40-years-old) as single dose for COVID-19 immunisation. The patient experienced slight upset stomach on an unknown date in 2021.The clinical outcome of upset stomach was unknown. Patient had not been tested positive to COVID-19 prior to vaccination. Since the vaccination, the patient had not undergone test for COVID-19. It was not known if patient had other vaccine in four weeks and other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Arm completely cramped up immediately; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2020 06:30 (Lot number: EL0140) at the age of 37 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "allergies: Sulfur drugs" (unspecified if ongoing), notes: allergies: Sulfur drugs, Only thing that I'm allergic to is Sulfur and I turn red with that.; "red" (unspecified if ongoing), notes: allergies: Sulfur drugs, Only thing that I'm allergic to is Sulfur and I turn red with that.; "Arthritis in hips" (unspecified if ongoing), notes: Arthritis in hips. The patient's concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset 30Dec2020 07:00, outcome "recovered" (30Dec2020), described as "Arm completely cramped up immediately".  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. After the 1st dose patients arm completely cramped up immediately for a half hour and slowly went away after an hour.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in both legs wrapping from shin to calf; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 07:30 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LITHIUM. The following information was reported: PARAESTHESIA (non-serious) with onset Mar2021, outcome "recovered", described as "Tingling in both legs wrapping from shin to calf". Additional information: Tingling persisted for nearly three days. Upper legs, feet, and ankles did not have any issue. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Concomitant medication also included "hydrozidine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Vaccination site pain
Clinical narrative: Pain at Injection Site; Chills; Temperature: 99.6; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 18:15 (Batch/Lot number: unknown) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "Lower back pain" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose number=1, product=COVID 19, brand=Pfizer-Biontech, administration date=26Feb2021, administration time=06:30 PM, vaccine location=Left arm), administration date: 26Feb2021, when the patient was 66 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 20Mar2021 19:00, outcome "recovered", described as "Pain at Injection Site"; CHILLS (non-serious) with onset 20Mar2021 19:00, outcome "recovered", described as "Chills"; BODY TEMPERATURE INCREASED (non-serious) with onset 20Mar2021 19:00, outcome "recovered", described as "Temperature: 99.6". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, chills, body temperature increased.  Additional Information: This consumer reported for a 66-years-old male patient. Facility type vaccine: Pharmacy or Drug StoreIf. Other vaccine in four weeks: No. Other medications in two weeks: Yes. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. Other medical history: Hypertension; Hypercholesterolemia; Sleep Apnea; Lower back pain. If treatment ae: No  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
Clinical narrative: pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunisation.The following information was reported: PAIN (non-serious), outcome "unknown", described as "pain". Therapeutic measures were taken as a result of pain.  Additional information: Question: Call transferred from agent (name). The caller refused to provide demographic information. The caller stated she has been taking Tylenol for pain. She is has been taking 800mg of Motrin for that pain and she has not taken it because when she got the second Pfizer shot the nurse told her not to take any of anti-inflammatory medication. She asked if she can take it now. After providing verbal response, the caller still wanted to know if I could tell her if she could take the medication. - unable to offer warm transfer because the caller disconnected the call# e-transmitting AE details (unable to get additional details about the AE because the caller disconnected)  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Oropharyngeal pain
Clinical narrative: dizzy; tired; sore throat; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 13Mar2021 (Lot number: EN6202) at the age of 57 years as unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 18Mar2021, outcome "unknown", described as "dizzy"; FATIGUE (non-serious) with onset 18Mar2021, outcome "unknown", described as "tired"; OROPHARYNGEAL PAIN (non-serious) with onset 18Mar2021, outcome "unknown", described as "sore throat". Therapeutic measures were taken as a result of oropharyngeal pain which included ibuprofen. Additional information: Patient got the vaccine Saturday the 13th and she started feeling dizzy, tired, and sore throat but not until Wednesday.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Muscle spasms
Clinical narrative: lot of cramping; IBS to flare up; 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 54 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "anaphylaxis" (unspecified if ongoing); "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "lot of cramping"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "IBS to flare up".  Additional information: It was reported that patient received first dose of vaccine 3 weeks ago. After getting vaccine caller reports that she experienced above event, she thought it was due to her IBS. Caller later realized that the vaccine has polyethylene glycol in it. Caller reports that she knows that polyethylene glycol causes her IBS to flare up. Caller reports Miralax has polyethylene glycol in it, therefore she does not take it. Caller denies any form of anaphylactic shock to vaccine. Caller mentions she has a history of anaphylaxis to tow other medications. Caller would like to know what contraindications we have for her in regard to getting second dose. Caller would also like to know the amount of polyethylene glycol in the vaccine. Caller would like to know if polyethylene glycol in vaccine is the same as the ingested polyethylene glycol in the medication Miralax.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Body temperature increased, Pain
Clinical narrative: everything hurts; temperature of 102.6; 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 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid", start date: Jul2020 (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN (non-serious) with onset 21Mar2021, outcome "unknown", described as "everything hurts"; BODY TEMPERATURE INCREASED (non-serious) with onset 21Mar2021, outcome "unknown", described as "temperature of 102.6". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This (Age: 47; Unit: Unknown) female consumer (patient). Caller reports that she received first dose of vaccine on 20Mar2021. Caller reports 21Mar2021 she feels as if she has covid. Caller reports having covid in Jul. Caller reports everything hurts. And she has a temperature of 102.6. Caller would like to know if she can give covid to her family from getting vaccine. Caller would like to know if she can take Excedrin for her pain.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Body temperature, Body temperature increased, Feeling abnormal, Headache
Clinical narrative: everything hurts; temperature of 102.6; 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 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid", start date: Jul2020 (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN (non-serious) with onset 21Mar2021, outcome "unknown", described as "everything hurts"; BODY TEMPERATURE INCREASED (non-serious) with onset 21Mar2021, outcome "unknown", described as "temperature of 102.6". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This (Age: 47; Unit: Unknown) female consumer (patient). Caller reports that she received first dose of vaccine on 20Mar2021. Caller reports 21Mar2021 she feels as if she has covid. Caller reports having covid in Jul. Caller reports everything hurts. And she has a temperature of 102.6. Caller would like to know if she can give covid to her family from getting vaccine. Caller would like to know if she can take Excedrin for her pain.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: everything hurts; temperature of 102.6; 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 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid", start date: Jul2020 (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN (non-serious) with onset 21Mar2021, outcome "unknown", described as "everything hurts"; BODY TEMPERATURE INCREASED (non-serious) with onset 21Mar2021, outcome "unknown", described as "temperature of 102.6". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This (Age: 47; Unit: Unknown) female consumer (patient). Caller reports that she received first dose of vaccine on 20Mar2021. Caller reports 21Mar2021 she feels as if she has covid. Caller reports having covid in Jul. Caller reports everything hurts. And she has a temperature of 102.6. Caller would like to know if she can give covid to her family from getting vaccine. Caller would like to know if she can take Excedrin for her pain.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Body temperature increased, Pain
Clinical narrative: I feel horrible; Headache; Took my temperature about half an hour ago and I have 102.6; I knew that my arm was going to be little bit sore but all my fingers, my toes, my legs and my back; I knew that my arm was going to be little bit sore but all my fingers, my toes, my legs and my back; 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 20Mar2021 (Lot number: ER8727) as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Excedrin for headache, notes: I was having like a huge headache, so I was taking Excedrin, it is for the migraine.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 20Mar2021, outcome "unknown", described as "I feel horrible"; HEADACHE (non-serious) with onset 20Mar2021, outcome "unknown", described as "Headache"; BODY TEMPERATURE INCREASED (non-serious) with onset 20Mar2021, outcome "unknown", described as "Took my temperature about half an hour ago and I have 102.6"; BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 20Mar2021, outcome "unknown" and all described as "I knew that my arm was going to be little bit sore but all my fingers, my toes, my legs and my back". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: When paraphrased the concern, consumer stated, "The thing was, got Covid back in Jul and know because patient got sick and feeling almost about the same (further clarification unknown) and at that time temperature was going up to 104.7. Patient was having like a huge headache, so patient was taking Excedrin, it was for the migraine and that seems to help because and the temperature was coming down as well and patient would slept a lot to fell a little better. So patient was just wondering with the vaccine, was it okay if do it again" (not captured as event as consumer had Covid before the vaccine was administered). Consumer stated, "got the Pfizer vaccine (Covid Vaccine) yesterday, the first dose. But today, patient feel horrible. Yesterday, patient knew that arm was going to be little bit sore but all fingers, toes, legs and back. Patient have a headache and took temperature about half an hour ago and have 102.6. Patient do not know, was there any medication do you recommend for the symptoms."  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Back pain, Body temperature, Body temperature increased, Feeling abnormal, Headache
Clinical narrative: I feel horrible; Headache; Took my temperature about half an hour ago and I have 102.6; I knew that my arm was going to be little bit sore but all my fingers, my toes, my legs and my back; I knew that my arm was going to be little bit sore but all my fingers, my toes, my legs and my back; 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 20Mar2021 (Lot number: ER8727) as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Excedrin for headache, notes: I was having like a huge headache, so I was taking Excedrin, it is for the migraine.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 20Mar2021, outcome "unknown", described as "I feel horrible"; HEADACHE (non-serious) with onset 20Mar2021, outcome "unknown", described as "Headache"; BODY TEMPERATURE INCREASED (non-serious) with onset 20Mar2021, outcome "unknown", described as "Took my temperature about half an hour ago and I have 102.6"; BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 20Mar2021, outcome "unknown" and all described as "I knew that my arm was going to be little bit sore but all my fingers, my toes, my legs and my back". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: When paraphrased the concern, consumer stated, "The thing was, got Covid back in Jul and know because patient got sick and feeling almost about the same (further clarification unknown) and at that time temperature was going up to 104.7. Patient was having like a huge headache, so patient was taking Excedrin, it was for the migraine and that seems to help because and the temperature was coming down as well and patient would slept a lot to fell a little better. So patient was just wondering with the vaccine, was it okay if do it again" (not captured as event as consumer had Covid before the vaccine was administered). Consumer stated, "got the Pfizer vaccine (Covid Vaccine) yesterday, the first dose. But today, patient feel horrible. Yesterday, patient knew that arm was going to be little bit sore but all fingers, toes, legs and back. Patient have a headache and took temperature about half an hour ago and have 102.6. Patient do not know, was there any medication do you recommend for the symptoms."  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: I feel horrible; Headache; Took my temperature about half an hour ago and I have 102.6; I knew that my arm was going to be little bit sore but all my fingers, my toes, my legs and my back; I knew that my arm was going to be little bit sore but all my fingers, my toes, my legs and my back; 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 20Mar2021 (Lot number: ER8727) as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Excedrin for headache, notes: I was having like a huge headache, so I was taking Excedrin, it is for the migraine.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 20Mar2021, outcome "unknown", described as "I feel horrible"; HEADACHE (non-serious) with onset 20Mar2021, outcome "unknown", described as "Headache"; BODY TEMPERATURE INCREASED (non-serious) with onset 20Mar2021, outcome "unknown", described as "Took my temperature about half an hour ago and I have 102.6"; BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 20Mar2021, outcome "unknown" and all described as "I knew that my arm was going to be little bit sore but all my fingers, my toes, my legs and my back". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: When paraphrased the concern, consumer stated, "The thing was, got Covid back in Jul and know because patient got sick and feeling almost about the same (further clarification unknown) and at that time temperature was going up to 104.7. Patient was having like a huge headache, so patient was taking Excedrin, it was for the migraine and that seems to help because and the temperature was coming down as well and patient would slept a lot to fell a little better. So patient was just wondering with the vaccine, was it okay if do it again" (not captured as event as consumer had Covid before the vaccine was administered). Consumer stated, "got the Pfizer vaccine (Covid Vaccine) yesterday, the first dose. But today, patient feel horrible. Yesterday, patient knew that arm was going to be little bit sore but all fingers, toes, legs and back. Patient have a headache and took temperature about half an hour ago and have 102.6. Patient do not know, was there any medication do you recommend for the symptoms."  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, SARS-CoV-2 antibody test negative
Clinical narrative: Nausea; Chills; body ache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 10:00 (Lot number: EN9266) at the age of 54 years as dose 2, single for COVID-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Lot number: EN6202, Administration date: 26Feb2021, Administration time: 11:00 AM, Vaccine location: Left arm, Dose number: 1), administration date: 26Feb2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 20Mar2021 05:00, outcome "recovering", described as "Nausea"; CHILLS (non-serious) with onset 20Mar2021 05:00, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 20Mar2021 05:00, outcome "recovering", described as "body ache"; FATIGUE (non-serious) with onset 20Mar2021 05:00, outcome "recovering", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as result of nausea, chills, pain, fatigue.  Additional information: Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and nor received any other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19; Nasal Swab, Rapid PCR and resulted as negative.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: constant runny nose; a bad head cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 25Feb2021 15:45 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroidectomy" (unspecified if ongoing), notes: Hypothyroidism due to total thyroidectomy; "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism due to total thyroidectomy. Concomitant medication(s) included: ARMOUR THYROID.  The following information was reported: RHINORRHOEA (non-serious) with onset 26Feb2021 14:00, outcome "recovered with sequelae" (2021), described as "constant runny nose"; NASOPHARYNGITIS (non-serious) with onset 26Feb2021 14:00, outcome "recovered with sequelae" (2021), described as "a bad head cold". Therapeutic measures were not taken as a result of rhinorrhoea, nasopharyngitis.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Feb2021 at 14:00, the patient experienced constant runny nose similar to a bad head cold for two days. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of runny nose and head cold was recovering with sequalae at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oral mucosal blistering
Clinical narrative: Blisters in mouth; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 05Mar2021 22:45 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ORAL MUCOSAL BLISTERING (non-serious) with onset 19Mar2021 09:30, outcome "not recovered", described as "Blisters in mouth"; HEADACHE (non-serious) with onset 19Mar2021 09:30, outcome "unknown", described as "headache". Therapeutic measures were taken as a result of oral mucosal blistering. Therapeutic measures were not taken as a result of headache. Additional information: The patient was wondering if the mouth blisters could be a side effect. She never had it before. Treatment received for mouth blisters included Tylenol. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Pain
Clinical narrative: body aches; increased temp; fatigue; 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), administration date 20Mar2021 (Batch/Lot number: unknown) 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 of covid-19 vaccine), administration date: 26Feb2021, for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 21Mar2021, outcome "unknown", described as "body aches"; BODY TEMPERATURE INCREASED (non-serious) with onset 21Mar2021, outcome "unknown", described as "increased temp"; FATIGUE (non-serious) with onset 21Mar2021, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This is a report from a Pfizer-sponsored program and other program. Patient received Pfizer Covid-19 vaccine first dose on 26Feb2021 and 2nd dose was 20Mar2021 and after receiving the 2nd dose experienced side effects (body aches, increased temp & fatigue).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 11:45 (Lot number: EP6955) at the age of 45 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Cardiomyopathy" (unspecified if ongoing). Concomitant medication(s) included: COREG. Vaccination history included: Bnt162b2, administration date: 26Feb2021, for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 18Mar2021 13:15, outcome "recovered" (Mar2021), described as "felt sick to her stomach twice"; PAIN (non-serious) with onset 18Mar2021 13:15, outcome "recovered" (Mar2021), described as "achy"; FATIGUE (non-serious) with onset 18Mar2021 13:15, outcome "recovered" (Mar2021), described as "tired". Therapeutic measures were not taken as a result of nausea, pain, and fatigue. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient also received unspecified vitamins and birth control and Entresto (as reported) within 2 weeks of vaccination. No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Malaise
Clinical narrative: feeling off balance; not feeling good overall; Light-headed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Mar2021 14:30 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing); "anxiety" (ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension (ongoing); BUSPAR taken for anxiety (ongoing). The following information was reported: BALANCE DISORDER (non-serious) with onset 17Mar2021, outcome "not recovered", described as "feeling off balance"; DIZZINESS (non-serious) with onset Mar2021, outcome "not recovered", described as "Light-headed"; MALAISE (non-serious) with onset 15Mar2021, outcome "not recovered", described as "not feeling good overall".  Additional information: The report was not related to a study or programme. NDC number and expiry date were unknown. No investigation assessment. Consumer called because she was not feeling good. States she had the vaccine on Monday afternoon, and she had been feeling off balance; light headed; and not feeling good overall. She called for some advice and asked what she should do. Advised caller to follow up with her HCP for medical advice but that Pfizer can provide product specific information. Clarified she received the first dose of the Pfizer COVID 19 vaccine on 15Mar2021 at 14:30 in the right arm. She noticed feeling off balance yesterday, but she had not been feeling well since Monday evening. Adds she was going to call her HCP next as she was not feeling well. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect was reported as none. AE(s) does not require a visit to physician or ER. No prior Vaccinations (within 4 weeks). No family history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity
Clinical narrative: nausea; fatigue; arm sore; This is a spontaneous report from a non-contactable non-healthcare professional, the patient. A 30-year-old female patient received the first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: er2613) via an unspecified route of administration in the left arm on 17Mar2021 at 04:30 P.M. (at the age of 30-year-old) as dose 1, single for covid-19 immunization. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and vitamins (MANUFACTURER UNKNOWN) all for unknown indications from unknown dates and unknown if ongoing. On 17Mar2021, patient experienced nausea, fatigue and arm sore. Therapeutic measures were not taken as a result of events nausea, fatigue and arm sore. The clinical outcome of the events was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Report (patient) information, patient tab, product tab, concomitant medication information and narrative were amended.  No follow-up attempts are needed. No further information is expected.