chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she just had soreness on her arm; 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 55 year-old female patient received bnt162b2 (BNT162B2) (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), outcome "unknown", described as "she just had soreness on her arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: These all things that I had done in my arm has started making me feel tingle in my left 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 COVID-19 Vaccine - Manufacturer Unknown, (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: PARAESTHESIA (non-serious), outcome "unknown", described as "These all things that I had done in my arm has started making me feel tingle in my left arm".  Additional information: This is to be in the record and the patient saw someone who put the vaccine in' (not clear), The patient tried to find put if this was put in the patient without being authorizing it. So, was there anyway to know that you were given the vaccine, the patient didn't want to had it done, so the patient don't know if they put it without me knowing about it. the patient went to emergency room and they had the patient 'arm' (not clear) check and the patient don't know about this vaccine." (consumer was not sure if consumer got the vaccine and name of vaccine was not clarified further, hence suspect captured as Unspecified Vaccine).  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
Clinical narrative: Mild pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80 year-old male patient received bnt162b2 (BNT162B2) (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 (non-serious), outcome "recovered", described as "Mild pain". Therapeutic measures were not taken as a result of pain. Additional information: The patient reported that he got mild pain for 2 to 3 days and went away on an unspecified date but has returned (reported as reversed) after 13-14 days (as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Feeling of body temperature change, Headache, Illness
Clinical narrative: Hot and cold chills; Hot and cold chills; Nose won't stop running; Keep getting nausea; Headache; the next week started getting sick; Hasn't felt good ever since.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Lot number: EW2161, Expiration Date: 31Jul2021) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHILLS (non-serious), FEELING OF BODY TEMPERATURE CHANGE (non-serious) all with onset 20Apr2021, outcome "unknown" and all described as "Hot and cold chills"; RHINORRHOEA (non-serious) with onset 20Apr2021, outcome "unknown", described as "Nose won't stop running"; NAUSEA (non-serious) with onset 20Apr2021, outcome "unknown", described as "Keep getting nausea"; HEADACHE (non-serious) with onset 20Apr2021, outcome "unknown", described as "Headache"; FEELING ABNORMAL (non-serious) with onset 15Apr2021, outcome "unknown", described as "Hasn't felt good ever since."; ILLNESS (non-serious) with onset 20Apr2021, outcome "unknown", described as "the next week started getting sick".  Additional information: Patient was calling in regard to the Pfizer Covid-19 vaccine. She received the Covid-19 vaccine on 15Apr2021 and hasn't felt good ever since and reported that she is about to go to the emergency room. She reported that she has been experiencing hot and cold chills, her nose won't stop running, she keeps getting nausea, and a headache keeps coming to her head. Patient stated that at 1:00 on 28Apr2021, she was expecting a doctor to call and reported that it was an important call from her grandson who is a psychiatrist. She reported that she was going to the emergency room in a few minutes. She reported that she received the Covid-19 vaccine on 15Apr2021 and the next week started getting sick on Tuesday, 20Apr2021. She declined to provide an email address or alternate phone number. She reported that her physician is at (withheld) she reported that she was unable to provide her physician's zip code, phone number, or email address. She needed to end the phone call because she needed to go to the emergency room. She unable to provide NDC number of Covid-19 vaccine as it was not listed in her vaccination paperwork.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rhinorrhoea
Clinical narrative: Hot and cold chills; Hot and cold chills; Nose won't stop running; Keep getting nausea; Headache; the next week started getting sick; Hasn't felt good ever since.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Lot number: EW2161, Expiration Date: 31Jul2021) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHILLS (non-serious), FEELING OF BODY TEMPERATURE CHANGE (non-serious) all with onset 20Apr2021, outcome "unknown" and all described as "Hot and cold chills"; RHINORRHOEA (non-serious) with onset 20Apr2021, outcome "unknown", described as "Nose won't stop running"; NAUSEA (non-serious) with onset 20Apr2021, outcome "unknown", described as "Keep getting nausea"; HEADACHE (non-serious) with onset 20Apr2021, outcome "unknown", described as "Headache"; FEELING ABNORMAL (non-serious) with onset 15Apr2021, outcome "unknown", described as "Hasn't felt good ever since."; ILLNESS (non-serious) with onset 20Apr2021, outcome "unknown", described as "the next week started getting sick".  Additional information: Patient was calling in regard to the Pfizer Covid-19 vaccine. She received the Covid-19 vaccine on 15Apr2021 and hasn't felt good ever since and reported that she is about to go to the emergency room. She reported that she has been experiencing hot and cold chills, her nose won't stop running, she keeps getting nausea, and a headache keeps coming to her head. Patient stated that at 1:00 on 28Apr2021, she was expecting a doctor to call and reported that it was an important call from her grandson who is a psychiatrist. She reported that she was going to the emergency room in a few minutes. She reported that she received the Covid-19 vaccine on 15Apr2021 and the next week started getting sick on Tuesday, 20Apr2021. She declined to provide an email address or alternate phone number. She reported that her physician is at (withheld) she reported that she was unable to provide her physician's zip code, phone number, or email address. She needed to end the phone call because she needed to go to the emergency room. She unable to provide NDC number of Covid-19 vaccine as it was not listed in her vaccination paperwork.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: It greatly reduced my nasal polyps which I have suffered for years; 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) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "It greatly reduced my nasal polyps which I have suffered for years".  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Mass, Nasal oedema, Nausea
Clinical narrative: The side of her nose was swollen; polyps; Bump on the side of her nose; Nose hurting, tender; Little headache; Little nauseous; Felt a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 14:00 (Lot number: ER8729) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sinus" (unspecified if ongoing), notes: she has had sinus related stuff in the past.; "urinary tract" (unspecified if ongoing), notes: she was having problems with her Urinary tract. Concomitant medication(s) included: PROZAC taken for menopausal symptoms; PROGESTERONE taken for menopausal symptoms; D MANNOSE. The following information was reported: HEADACHE (non-serious) with onset 22Apr2021, outcome "recovered" (22Apr2021), described as "Little headache"; NAUSEA (non-serious) with onset 22Apr2021, outcome "recovered" (22Apr2021), described as "Little nauseous"; RHINALGIA (non-serious) with onset 24Apr2021, outcome "recovering", described as "Nose hurting, tender"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (23Apr2021), described as "Felt a little tired"; NASAL OEDEMA (non-serious), outcome "unknown", described as "The side of her nose was swollen"; POLYP (non-serious), outcome "unknown", described as "polyps"; MASS (non-serious) with onset 24Apr2021, outcome "recovering", described as "Bump on the side of her nose". She says she noticed they were normal side effects, she was fine to eat and drink. She said she noticed her nose bump and pain in the daytime, it seems to have almost gone away, she hasn't looked up inside, just the outside, she feels much better, something slightly there, no big lump there anymore, she had not looked, if she presses it it is tender, it did not hurt, before it was hurting without touching it, it was uncomfortable, kind of like she got smacked in her face, punched in her face. She says it doesn't feel like it is even really there, last night she could feel it slightly, she can't see it, just feel it mainly on the inside. She says her husband looked at her nose and kind of noticed a difference. She says when she felt it she could feel the outside as well as inside, it is swollen she guesses. She says she tried to stick a Q-Tip up there to see if it was tender, she couldn't do it. She laughs and says she was trying to do a self assessment here. She says she was not sure the exact date of headache and nausea, not sure if it was Thursday or Friday, later confirmed as Thursday 22Apr2021. She was feeling puny the next day, but when she woke up Saturday she noticed the bump on nose. She clarified that by feeling puny she means she felt a little tired but she still continued about her day.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Polyp, Rhinalgia
Clinical narrative: The side of her nose was swollen; polyps; Bump on the side of her nose; Nose hurting, tender; Little headache; Little nauseous; Felt a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 14:00 (Lot number: ER8729) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sinus" (unspecified if ongoing), notes: she has had sinus related stuff in the past.; "urinary tract" (unspecified if ongoing), notes: she was having problems with her Urinary tract. Concomitant medication(s) included: PROZAC taken for menopausal symptoms; PROGESTERONE taken for menopausal symptoms; D MANNOSE. The following information was reported: HEADACHE (non-serious) with onset 22Apr2021, outcome "recovered" (22Apr2021), described as "Little headache"; NAUSEA (non-serious) with onset 22Apr2021, outcome "recovered" (22Apr2021), described as "Little nauseous"; RHINALGIA (non-serious) with onset 24Apr2021, outcome "recovering", described as "Nose hurting, tender"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (23Apr2021), described as "Felt a little tired"; NASAL OEDEMA (non-serious), outcome "unknown", described as "The side of her nose was swollen"; POLYP (non-serious), outcome "unknown", described as "polyps"; MASS (non-serious) with onset 24Apr2021, outcome "recovering", described as "Bump on the side of her nose". She says she noticed they were normal side effects, she was fine to eat and drink. She said she noticed her nose bump and pain in the daytime, it seems to have almost gone away, she hasn't looked up inside, just the outside, she feels much better, something slightly there, no big lump there anymore, she had not looked, if she presses it it is tender, it did not hurt, before it was hurting without touching it, it was uncomfortable, kind of like she got smacked in her face, punched in her face. She says it doesn't feel like it is even really there, last night she could feel it slightly, she can't see it, just feel it mainly on the inside. She says her husband looked at her nose and kind of noticed a difference. She says when she felt it she could feel the outside as well as inside, it is swollen she guesses. She says she tried to stick a Q-Tip up there to see if it was tender, she couldn't do it. She laughs and says she was trying to do a self assessment here. She says she was not sure the exact date of headache and nausea, not sure if it was Thursday or Friday, later confirmed as Thursday 22Apr2021. She was feeling puny the next day, but when she woke up Saturday she noticed the bump on nose. She clarified that by feeling puny she means she felt a little tired but she still continued about her day.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired for a day or two; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: EN6207) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "traumatic brain injury" (ongoing), notes: Verbatim: traumatic brain injury; "migraine" (ongoing), notes: Verbatim: migraines., uses compressed O2 for her cluster migraines.; "small concussion", start date: 2016 (unspecified if ongoing), notes: Major events 2003, 2005, 2011, minor one in 2016-small concussion. The patient's concomitant medications were not reported. Past drug history included: Flu vaccine , start date: Nov2020, stop date: Nov2020. The following information was reported: FATIGUE (non-serious) with onset 30Mar2021, outcome "unknown", described as "tired for a day or two".  Additional information: When probing suspect product information, she reports she received both her Covid 19 vaccines in her left arm. She reports with the first dose she hardly noticed any symptoms. She was maybe tired for a day or two with the first dose. She experienced no problems with her arm. Second Covid 19 vaccine given on 20Apr2021 in the left arm, Lot# EW0162, NDC/Expiry not known. When probing medical history she reports she has a history of traumatic brain injury. She's had major events from this in 2003, 2005, and 2011. She had a minor event in 2016, a small concussion. She does report she uses compressed O2 for her cluster migraines. She reports she received the flu vaccine in Nov2020 because she thought if she got the flu vaccine then if she got the Covid 19 virus, the Covid 19 virus wouldn't be so bad. Prior Vaccinations (within 4 weeks) :no. AE(s) following prior vaccinations: no. Relevant Tests: No  No follow-up attempts are possible. No further information was expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm on the left side; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 73-year-old female patient received BNT162B2 (BNT162B2), administered in arm left, administration date 24Apr2021 16:30 (Lot number: EW0165) at the age of 73 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Apr2021, outcome "recovered" (26Apr2021), described as "Sore arm on the left side".  Additional Information: The patient had no prior vaccinations (within 4 weeks) and no adverse effects following prior vaccinations. The patient was calling about the COVID-19 vaccine. The patient had her first vaccine on 24Apr2021, and everything is fine other than a sore arm. The sore arm was on the left side after the patient's injection and her arm did not bother her anymore 26Apr2021 (Monday). The patient had no other side effects, she feels great. The patient's second COVID-19 vaccine is scheduled for 22May2021 and that is 4 weeks instead of 3. The patient was asking if that is still going to be effective.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First Dose: Sore Left Arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 (Lot number: EJ1686, Expiration Date: 31Mar2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Tetanus (maybe July thinks last July). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Mar2021, outcome "recovered" (16Mar2021), described as "First Dose: Sore Left Arm".  Additional Information: Caller states she had the first dose of the vaccine on 13Mar2021 and the second dose on 03Apr2021. There is no other product present. Reporter states at first patient was offered the Moderna and patient changed when they offered the Pfizer, because of the breast issues from the Moderna. Prior Vaccinations (within 4 weeks), patient had received both doses of the Pfizer Covid Vaccine. There was know none family medical history relevant to AE(s).  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dehydration, Fatigue, Muscle spasms, Myalgia
Clinical narrative: Muscle cramps; Muscle pain; fatigue; dehydration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: ER8733) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 2005 (unspecified if ongoing). Concomitant medication(s) included: SHINGRIX, start date: Mar2021.  The following information was reported: MUSCLE SPASMS (non-serious) with onset Apr2021, outcome "unknown", described as "Muscle cramps"; MYALGIA (non-serious) with onset Apr2021, outcome "unknown", described as "Muscle pain"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "fatigue"; DEHYDRATION (non-serious) with onset Apr2021, outcome "unknown", described as "dehydration". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported as first dose was mild, though she did get weird muscle cramps that were a different kind, they were not usual ones like flu, they were more like the kind with dehydration. She says actually she had the muscle cramps both times, even though she was drinking a lot of water, and weird muscle pains and fatigue. Patient had Shingrix vaccination during the four weeks of first dose of the Pfizer COVID-19 vaccine. She says that they had said wait two weeks after she had Shingrix, so she got that 15 days ahead of the first Pfizer COVID-19 vaccine dose. Patient had difficulty remembering when she was diagnosed with hypothyroidism and says something about mental that she does not clarify. Body temperature was 101 Fahrenheit on 24Apr2021, 100.5 Fahrenheit on 26Apr2021 and 100.1 Fahrenheit on 27Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: I smell and taste smell like rotten fish; I smell and taste smell like rotten fish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune thyroiditis" (unspecified if ongoing), notes: Verbatim: Hashimoto's disease. Concomitant medication(s) included: LEXAPRO. The following information was reported: PAROSMIA (non-serious), TASTE DISORDER (non-serious), outcome "unknown" and all described as "I smell and taste smell like rotten fish". Therapeutic measures were not taken as a result of parosmia, taste disorder.  Additional information: The due date of second dose of vaccine consumer stated, 29Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness at site of injection; 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) (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), for Covid-19 immunisation. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Redness at site of injection".  Additional Information: Consumer stated," I am calling about my side effect, I had my 2 dose of Pfizer yesterday at 10:16 that I when to give me for my first dose, when had 24 hours redness at site of injection so calling what to do. "Consumer was informed about the Medical Information Department and provided the number. Consumer stated, "Why do you need this information? I called for Medical advise, I need medical help I don't need information and put my experience frog vaccine. QR Comment: As consumer was unwilling to share further information. Hence further probing could not be done. Limited information available over the call.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Muscle spasms
Clinical narrative: tired; Muscle cramp; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 15:00 (Lot number: EW0153) at the age of 85 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset 09Apr2021, outcome "unknown", described as "Muscle cramp"; FATIGUE (non-serious) with onset 12Apr2021, outcome "not recovered", described as "tired".  Additional information: She noticed the tiredness two days later and has been tired ever since. She called her HCP and they just told her to rest and keep hydrated, to drink fluids. She doesn't want to go get another shot if she was going to start all over again being tired. Adds she also had muscle cramps in her legs almost right after the shot. The muscle cramps in her legs gradually went away about three days ago. Adds they just gradually went down and she did exercises to limber it up. She was in the hospital about two months ago, predating treatment with the Pfizer COVID 19 vaccine. All her tests were done when she was in the hospital two months ago. She has had no tests since she had the first dose of the vaccine. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No Emergency room and Physician office visit, she only called in but did not see the doctor. No Prior Vaccinations (within 4 weeks). No Family History.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: tired; Muscle cramp; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 15:00 (Lot number: EW0153) at the age of 85 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset 09Apr2021, outcome "unknown", described as "Muscle cramp"; FATIGUE (non-serious) with onset 12Apr2021, outcome "not recovered", described as "tired".  Additional information: She noticed the tiredness two days later and has been tired ever since. She called her HCP and they just told her to rest and keep hydrated, to drink fluids. She doesn't want to go get another shot if she was going to start all over again being tired. Adds she also had muscle cramps in her legs almost right after the shot. The muscle cramps in her legs gradually went away about three days ago. Adds they just gradually went down and she did exercises to limber it up. She was in the hospital about two months ago, predating treatment with the Pfizer COVID 19 vaccine. All her tests were done when she was in the hospital two months ago. She has had no tests since she had the first dose of the vaccine. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No Emergency room and Physician office visit, she only called in but did not see the doctor. No Prior Vaccinations (within 4 weeks). No Family History.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Muscle spasms
Clinical narrative: I am still tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 85-year-old patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 85 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Blood cholesterol" (unspecified if ongoing). The patient concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "I am still tired".  Additional information: 3 weeks ago, this Friday patient received the first shot. patient was wondering how long  are supposed to stay tired. patient was still tired."  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 85.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: I am still tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 85-year-old patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 85 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Blood cholesterol" (unspecified if ongoing). The patient concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "I am still tired".  Additional information: 3 weeks ago, this Friday patient received the first shot. patient was wondering how long  are supposed to stay tired. patient was still tired."  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vaccination site oedema
Clinical narrative: local sick suffering; Local site swelling; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 31Dec2020 13:00 (Lot number: EK9231) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabtes", stop date: 2018; "Migraine", start date: 1982 (unspecified if ongoing); "IBD" (unspecified if ongoing); "CLL", start date: 2017 (unspecified if ongoing). Concomitant medication(s) included: AMBIEN; SYNTHROID; OZEMPIC; BYSTOLIC; LOSARTAN HCTZ; DEXILANT. Past drug history included: Tetanus tox for Past Drug Event, reaction(s): "Astma"; Pruritus. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "local sick suffering"; VACCINATION SITE OEDEMA (non-serious), outcome "recovered", described as "Local site swelling".  No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach knotted up so tight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 87 year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 09:00 (Batch/Lot number: unknown) at the age of 87 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hard of hearing" (unspecified if ongoing), notes: Caller states that she is very hard of hearing. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, No events reported), when the patient was 87 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 04Mar2021 20:00, outcome "unknown", described as "Stomach knotted up so tight".  Additional information: Reporter tried to report the results of her Pfizer COVID vaccine shot. Re-porter reports that she got her second shot on 04Mar2021 at about 9AM, and by about 8PM that same night, her stomach knotted up so tight, she almost wanted to go to the ER, but she decided against that because she figured it was just from the shot. Reporter stated that she had that extremely tight feeling in her stomach for 8 hours, and then it just stopped completely. Re-porter stated that she was fine after that until last week, when she had the same reaction happen again. Reporter stated that the second time occurred toward the end of Apr2021 and her second shot was all the way back in early Mar2021. Reporter wondered if this was a known side effect of the product. Reporter would like to talk to someone about it. Reporter stated that she was over-whelmed with her stomach happening again just last week that she did not write down the exact date, but here we are at the end of Apr2021. Reporter stated that she was very hard of hearing and her closed caption phone was not working at this time, so agent will need to speak loudly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old patient received bnt162b2 (BNT162B2), administration date 03Feb2021 (Batch/Lot number: unknown) at the age of 69 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: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "soreness in arm".  Additional information: When probed concern, Patient stated just wanted to report the side effects from Pfizer shot and had no problems with the first shot except from soreness in arm which was when patient got the first shot (03Feb2021) all this patient had soreness in arm, so there was no problem with it there. Patient received second dose on 24Feb2021. When probed for vaccine (first and second shot) LOT# patient stated Pfizer it looks like EL8. As patient was not willing to proceed the call. Product details (LOT#, expiration date, NDC# and UPC#), Pharmacy details and treatment could not be probed over the call. Limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Hyperaesthesia, Insomnia
Clinical narrative: His skin where he got the shot in that left arm and a little around the shoulder skin is really sensitive to touch; The sensitivity has been keeping him awake at night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 15:00 (Lot number: EW0150) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type-2 Diabetes" (unspecified if ongoing), notes: Verbatim: Type 2 diabetes. The patient took concomitant medications. The following information was reported: HYPERAESTHESIA (non-serious), outcome "unknown", described as "His skin where he got the shot in that left arm and a little around the shoulder skin is really sensitive to touch"; INSOMNIA (non-serious), outcome "unknown", described as "The sensitivity has been keeping him awake at night". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hyperaesthesia.  Additional information: The patient did not receive any additional vaccines on same date of the pfizer suspect, did not have prior vaccinations within 4 weeks and not have any family medical history relevant to event. Clinical course: it was reported that patient got the first Pfizer vaccine on 20Apr2021 and about 3 to 4 days later his skin where he got the shot in that left arm and a little around the shoulder skin was really sensitive to touch and there was not a rash or broken out, but he just couldn't stand to touch it or have anybody else touch it. The sensitivity was ongoing and has been remaining the same and he just went and talked to them and got a can of Dermaplast spray to kind of numb it, the sensitivity has been keeping him awake at night quite a bit at this point and he had to do something, and he sleeps on that left side also. Patient HCP saw him on 16Apr2021 before he got the pfizer vaccine and he had lab work, and everything done at that time, and everything was good and his A1C was down at 6.8; states he has a history of type 2 diabetes and his kidney function, and everything was really good, and he was glad to see that. His patient card has a sticker with the information on it and there is not an expiry date or NDC listed for the Pfizer Vaccine, the card also has TLC 18301 written on it. The second dose of the vaccine was scheduled for 11May2021. Patient was no sick or anything at the time of the Pfizer vaccine, he takes a blood pressure medicine that he started taking several years ago but does not know the name or dosage of the blood pressure pill.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Decreased appetite, Fatigue, Flatulence
Clinical narrative: The past 4 days I basically just been in bed; Haven't had the energy to get up and do anything/Real weak; I've gotten up couple of times each day to eat but not very much; Sleep for couple of hour, I wake up for an hour or hour and half and I sleep for couple more hours; Really bad gas problem; Real tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Apr2021 (Lot number: ER8735, Expiration Date: Jul2021) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL 12HOUR. Vaccination history included: Bnt162b2 (First dose,, Lot Number: ER8732, Anatomical location: right arm,, Vaccine Lot Expire Date: Jul2021, Time the Vaccination was Given: About 10:45 am), administration date: 03Apr2021, when the patient was 59 years old, for COVID-19 immunization; Swine flu shot, reaction(s): "diarrhea", "sick", "really bad body aches", "vomiting". The following information was reported: FATIGUE (non-serious) with onset 24Apr2021, outcome "unknown", described as "Real tired"; FLATULENCE (non-serious) with onset 28Apr2021, outcome "recovering", described as "Really bad gas problem"; BEDRIDDEN (non-serious), outcome "unknown", described as "The past 4 days I basically just been in bed"; ASTHENIA (non-serious), outcome "unknown", described as "Haven't had the energy to get up and do anything/Real weak"; DECREASED APPETITE (non-serious), outcome "unknown", described as "I've gotten up couple of times each day to eat but not very much"; SOMNOLENCE (non-serious), outcome "unknown", described as "Sleep for couple of hour, I wake up for an hour or hour and half and I sleep for couple more hours".  Additional Information:No Emergency Room and Physician Office. No Prior Vaccinations within 4 weeks  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: The past 4 days I basically just been in bed; Haven't had the energy to get up and do anything/Real weak; I've gotten up couple of times each day to eat but not very much; Sleep for couple of hour, I wake up for an hour or hour and half and I sleep for couple more hours; Really bad gas problem; Real tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Apr2021 (Lot number: ER8735, Expiration Date: Jul2021) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL 12HOUR. Vaccination history included: Bnt162b2 (First dose,, Lot Number: ER8732, Anatomical location: right arm,, Vaccine Lot Expire Date: Jul2021, Time the Vaccination was Given: About 10:45 am), administration date: 03Apr2021, when the patient was 59 years old, for COVID-19 immunization; Swine flu shot, reaction(s): "diarrhea", "sick", "really bad body aches", "vomiting". The following information was reported: FATIGUE (non-serious) with onset 24Apr2021, outcome "unknown", described as "Real tired"; FLATULENCE (non-serious) with onset 28Apr2021, outcome "recovering", described as "Really bad gas problem"; BEDRIDDEN (non-serious), outcome "unknown", described as "The past 4 days I basically just been in bed"; ASTHENIA (non-serious), outcome "unknown", described as "Haven't had the energy to get up and do anything/Real weak"; DECREASED APPETITE (non-serious), outcome "unknown", described as "I've gotten up couple of times each day to eat but not very much"; SOMNOLENCE (non-serious), outcome "unknown", described as "Sleep for couple of hour, I wake up for an hour or hour and half and I sleep for couple more hours".  Additional Information:No Emergency Room and Physician Office. No Prior Vaccinations within 4 weeks  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: I had tremors on my arms would shake, my back you know I had weird shaking; I had tremors on my arms would shake, my back you know I had weird shaking; 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 female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "I had covid, 17Dec", start date: 17Dec2020 (unspecified if ongoing). Concomitant medication(s) included: TYLENOL. Vaccination history included: Bnt162b2 (Dose number 1, lot number EN6201), administration date: 23Feb2021, for COVID-19 immunization, reaction(s): "lost control of my bladder".  The following information was reported: TREMOR (non-serious), TREMOR (non-serious) all with onset Mar2021, outcome "recovered" and all described as "I had tremors on my arms would shake, my back you know I had weird shaking". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tremor, tremor.  Additional information: When probed for concern the consumer stated, "I had covid, 17Dec, my system started and then about 90 days later I had the Pfizer and then had Pfizer again and its been a while since it is been over two weeks what I had covid. I had lost control of my bladder not completely but enough so that I had to change my pajamas bottoms quite often. When I had first Pfizer shot about day and half I had the same problem. The second Pfizer shot that I had, I took Tylenol before and Tylenol after and then two Tylenol before bedtime. I did have tremors with the second Pfizer shot and I thought I still tell you that because my doctor often said that incontinence is not symptom of covid but it might was. So I tell you that. No it was just after the shot. I had covid symptoms started in December 17th and lasted for about 2 or 3 weeks I guess. I have experience of covid. I am 77 years old. My experience of covid is incontinence not all the time but particularly night and when I have first Pfizer shot about 3 months later after the day and half the covid symptoms came back including the incontinence and then for second shot I had tremors on my arms would shake, my back you know I had weird shaking. I'm all right now, there is no problem right now."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle spasms, Neck pain, Pain in extremity
Clinical narrative: Left Arm Pain; arm is still sore and underneath it is like spasming. States it is so sore, it feels like someone was punching and punching her; Pain going up the back of her neck; Pain going up the back of her neck; Feels like a muscle spasm; 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 58 year-old female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Lot number: ER8735) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID taken for thyroid atrophy. Vaccination history included: Bnt162b2 (Lot number:ER8737, Dose:1, start date:01Apr2021), administration date: 01Apr2021, for COVID-19 Immunization, reaction(s): "Pain in arm"; measels (verbatim: Caller states as a kid, she had the Measles vaccine and then after that she got the Measles. NDC, Lot, and Expiration Unknown. Caller states it happened once before with the flu vaccine too, but she thinks the virus was already in her body. NDC, Lot, Expiration Unknown.). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Apr2021, outcome "not recovered", described as "Left Arm Pain; arm is still sore and underneath it is like spasming. States it is so sore, it feels like someone was punching and punching her"; BACK PAIN (non-serious), NECK PAIN (non-serious) all with onset 25Apr2021, outcome "not recovered" and all described as "Pain going up the back of her neck"; MUSCLE SPASMS (non-serious) with onset 25Apr2021, outcome "not recovered", described as "Feels like a muscle spasm". Therapeutic measures were taken as a result of pain in extremity, back pain, neck pain, muscle spasms.  Additional information: Caller states the vaccine was administered 22Apr2021, her second shot. Caller states she had her first shot in her right arm and it was sore, but it went away after 3 days. Caller states with the second vaccine she got it in her left arm. States the paper said after 10 days it should go away, but her arm is still sore and underneath it is like spasming. States it is so sore, it feels like someone was punching and punching her.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: unbalanced / issues with balance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female 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: BALANCE DISORDER (non-serious), outcome "unknown", described as "unbalanced / issues with balance". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.