chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 19:00 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MELOXICAM. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "Sore arm"; VACCINATION SITE PAIN (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "tenseness at injection site"; DIZZINESS (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "waves of faintness"; FATIGUE (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "tiredness"; OROPHARYNGEAL PAIN (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "red sore throat"; RHINORRHOEA (non-serious) with onset 23Jul2021 23:00, outcome "recovering", described as "runny/stuffy nose". Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain, dizziness, fatigue, oropharyngeal pain, rhinorrhoea. Additional information: Other medications in two weeks: multivitamin, meloxicam. No other vaccine was administered in four weeks. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin disorder
Clinical narrative: Had skin things on and off and said something is going on; Barely sore; 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 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jun2021 (Lot number: EW0180) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bell's palsy" (ongoing); "Underlying autoimmune disorder" (ongoing), notes: Verbatim: underlying autoimmune disorder; "Morton's neuroma" (ongoing); "Nerve surgery", start date: 2015 (unspecified if ongoing), notes: Verbatim: nerve surgery on her feet back in 2015; "Allergy: Latex" (unspecified if ongoing), notes: States she had an extreme nearly life threatening reaction to latex and adhesives also. There were no concomitant medications. The following information was reported: SKIN DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Had skin things on and off and said something is going on"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Barely sore".  Additional information: The patient reported that when she went in for her first shot of the Pfizer COVID Vaccine she had photos of the type of severe allergy she had on her feet from the adhesive and had bells palsy in the last two years and had skin things on and off and said something was going on. The patient reported that she did not know what was going on but has had this since she was a little kid and the pharmacy said she will be fine and took time to look up information and said for her not to be nervous and she was safe. The patient reported that the first dose of the Pfizer vaccine was great and easy and no problem and was barely sore and like nothing ever happened. The patient did not receive any other vaccinations within four weeks prior to COVID vaccine. The patient family medical history relevant to adverse events were none. Relevant tests were none. The patient had received both doses of the Pfizer COVID-19 vaccine. She received the second dose on 12Jul2021.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD21-122727 (Moderna). A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "Her roommate's arm was black and blue after he received his Pfizer shot". Additional information: After reporting her brothers adverse events as well as her own, the caller states that her roommate's arm was black and blue after he received his Pfizer shot. She states she and her room mate were not sick after receiving their injections. Both the caller and the room mate received the Pfizer vaccine. There is no concomitant list. 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: Pain, SARS-CoV-2 test
Clinical narrative: Had a little bit of pain with the first vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jun2021 (Lot number: EW0178) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Celiacs", start date: 2018 (ongoing), notes: Verbatim: Celiacs diagnosed 2018, she doesn't take medication for it, she just avoids gluten; "COVID-19" (unspecified if ongoing), notes: She had COVID a year ago. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Had a little bit of pain with the first vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm/mild; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Mar2021 (Lot number: EN6204) at the age of 56 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: PAIN IN EXTREMITY (non-serious) with onset 10Mar2021, outcome "recovered" (12Mar2021), described as "sore arm/mild". The event "sore arm/mild" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of pain in extremity.  Additional information: The first shot she had a sore arm. Treatment was received: applied ice took Advil. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none reported. She called her physician and they advised her to go to the ER. Prior Vaccinations (within 4 weeks) was none reported. Family medical history relevant to adverse event was none reported. Relevant Tests was none reported. Adverse event following prior vaccinations was none, she used to go for allergy shots and never had a reaction. Vaccine was administered at upper right arm. Investigation assessment was not reported.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling in my thumb and in my pinkie; It was kind of numbness; My left thumb kind of never really, the numbness is still a bit left; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date May2021 (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 (DOSE 1), for Covid-19 immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "recovered", described as "Tingling in my thumb and in my pinkie"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "It was kind of numbness; My left thumb kind of never really, the numbness is still a bit left".  Additional information: Patient wanted to ask about their second vaccine, that they had it in early May and stated, when had the vaccine, patient got some tingling in the thumb and in pinkie, so then it kind of went away in few days. It was kind of numbness and patient was trying to stretch it out but the patient's left thumb kind of never really, the numbness was still a bit left and patient wanted to know if that was something, patient was hoping it was not permanently damaged, nerve damage. Patient wanted to know was that temporary or does that go away in a few months, it had been three months now. It was minor but it was still there, patient did not know what to do, exercises or patient had been trying to stretch it and stuff and so.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: neurological reaction; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 01971214 (Merck).  A female patient received bnt162b2 (BNT162B2), administration date Jan2021 (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: NEUROLOGICAL SYMPTOM (non-serious) with onset 2021, outcome "unknown", described as "neurological reaction".  Additional information: Reporter stated that, patient received the Pfizer COVID vaccine, only one dose, back in Jan2021, and had a neurological reaction to it. Patient stated she could not take any more mRna vaccines anymore because of this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Ear discomfort, Fatigue, Tinnitus, Vaccination site 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 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Jul2021 17:15 (Lot number: EW0198) at the age of 34 years as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "Neurocardiogenic Syncope" (unspecified if ongoing), notes: Verbatim: Neurocardiogenic Syncope. Concomitant medication(s) included: Pristiq; Adderall; Fludrocortisone; Meloxicam. The following information was reported: FATIGUE (non-serious) with onset 18Jul2021 21:00, outcome "not recovered", described as "Fatigue extreme"; ASTHENIA (non-serious) with onset 18Jul2021 21:00, outcome "not recovered", described as "lack of energy since injection"; TINNITUS (non-serious) with onset 18Jul2021 21:00, outcome "not recovered", described as "tinnitus left ear"; EAR DISCOMFORT (non-serious) with onset 18Jul2021 21:00, outcome "not recovered", described as "fluttering sound in ear"; VACCINATION SITE PAIN (non-serious) with onset 18Jul2021 21:00, outcome "not recovered", described as "sore arm/muscle injection site". Therapeutic measures were not taken as a result of fatigue, asthenia, tinnitus, ear discomfort, vaccination site pain. Additional Information: Facility type for vaccine reported as pharmacy or drug store. No other vaccine in four weeks. Patient had no Covid-19 prior vaccination. Patient was not tested Covid-19 post vaccination. No known allergies reported. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tooth disorder
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on May 7, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced pain in extremity/sore arm, and tooth disorder/teeth problems, onset 2021, with outcome of unknown. Additional information: There is no concomitant list. The patient stated she did fine after her vaccine. Her arm was sore. She has been having teeth problems, but she didn't have any side effects. She believed she received the vaccinations in April and May 7, 2021. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Experienced slight headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 26Jul2021 (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: HEADACHE (non-serious), outcome "unknown", described as "Experienced slight headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: She is feeling like she is getting a cold; Feel like I am getting a cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "She is feeling like she is getting a cold; Feel like I am getting a cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site pain
Clinical narrative: throbbing pain in her left arm that is hurting where she got the shot; hard to lift up her left arm, it hurts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Apr2021 (Lot number: ER8732, Expiration Date: 31Jul2021) at the age of 79 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Alzheimer's" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Date: 03Apr2021, lot: ER8732, Location: left arm, expiration: 30Jul2021), administration date: 03Apr2021, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "throbbing pain in her left arm that is hurting where she got the shot"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "hard to lift up her left arm, it hurts". Therapeutic measures were taken as a result of vaccination site pain, limb discomfort.  Additional information: It was reported that throbbing pain in the patient's left arm started a week after the second vaccine. The patient has Alzheimer's.  So, the caller did not know if it was improved, persisted, or worsened. The patient stated it was hard to lift up her left arm, it hurts. They tried topical Tylenol ointment, extra strength Tylenol Pills, and ice. She tried tylenol and it has been over 5 months and they have tried everything. Nothing was relieved it. Caller wants to know if this is expected with the vaccine and was there anything they could do. Treatment medication: extra strength acetaminophen, UPC: unknown, Lot: 0JV1501, Expiration: Jun2022. Investigation Assessment: No  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Hypopnoea, Tremor
Clinical narrative: Light-headed; Dizzy; Not able to take deep breath, she can only take shallow breathing; Had an anxiety reaction; Body was shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administration date 23Jul2021 (Lot number: FA6780) at the age of 16 years as dose number 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 23Jul2021, outcome "not recovered", described as "Light-headed"; DIZZINESS (non-serious) with onset 23Jul2021, outcome "unknown", described as "Dizzy"; HYPOPNOEA (non-serious) with onset 23Jul2021, outcome "not recovered", described as "Not able to take deep breath, she can only take shallow breathing"; ANXIETY (non-serious) with onset 23Jul2021, outcome "unknown", described as "Had an anxiety reaction"; TREMOR (non-serious) with onset 23Jul2021, outcome "unknown", described as "Body was shaking". The events "light-headed", "dizzy", "not able to take deep breath, she can only take shallow breathing", "had an anxiety reaction" and "body was shaking" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of dizziness, dizziness, hypopnoea, anxiety, tremor.  Additional information: Reporter Reported that Reporter  daughter experienced after having COVID vaccine. After she had the vaccine, starting about 15 minutes later, she was feeling light-headed and dizzy and that lasted for about six hours, when reporter finally found, she was also not able to take deep breath, she could only take shallow breathing and Reporter end up taking her to emergency room and doctor there, they said, she had an anxiety reaction and they had to gave her medication to get her body, to stop, her body was shaking. So, they gave her medication (treatment) to make her body stop shaking and help her calm, get her breathing. They said that was something they didn't hear of very often. There were no any prior vaccination. They gave her she believed Benadryl and Valium for the treatment. Reporter didn't have Dose of treatment medications.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: They shot me with a shot and that made my period come; This is a spontaneous report received from a non-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 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: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "They shot me with a shot and that made my period come".  Additional information- The patient was walking and talking fine not had fever and did everything on own.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine
Clinical narrative: felt off in the middle of the night; migraine; 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 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 (Lot number: EW0181) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "essential tremors" (unspecified if ongoing); "deep brain stimulator" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2, for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "felt off in the middle of the night"; MIGRAINE (non-serious) with onset 23Jul2021, outcome "recovered" (24Jul2021), described as "migraine".  Additional Information:  Caller stated she developed a migraine and felt off in the middle of the night and she was bouncing off the wall to get to the bathroom, lying down helped this. The off feeling lasted all day Saturday and her family wanted her to go to the ER but she called an after hours surgeon who comforted her. On Sunday she reports she still wasn't steady, but today is back to normal. Caller is stressed and seeking information if she should receieve her second dose of the vaccination series.  Clinical course: The caller called into her newer surgeon. The caller states she has a condition similar to Parkinson's, but it is called essential tremors. The caller has a DBS, deep brain stimulator in her brain and batteries in the caller's chest. The caller was hesitant to receive the first dose Pfizer Covid 19 Vaccine due to having these pre-existing conditions. The caller had the instruction sheet from Rite Aid and saw that the migraine can happen. The caller is currently 71 years old, turned 71 on Sunday, 25Jul2021. Everything was on and was okay with the battery. The feeling off only seemed to last maybe 24 hours. The caller's weight is probably right now what it was when the caller was pregnant 47 years ago. The caller is about 190lbs. The caller clarifies the surgeries referenced occurred prior to receiving the first dose Pfizer Covid 19 Vaccine, like 2 years ago. The caller states in the past she has had the shingles and the flu vaccines. AE(s) did not require a visit to Emergency Room or Physician Office. Everybody in caller's family was worried and need to go to ER and caller didn't want to go to the emergency room, the patient called the newer surgeon, even though she knew they weren't in, given an emergency number. Prior Vaccinations (within 4 weeks) no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Even after new shingle vaccine, had two of them, no reaction. The caller states these vaccines occurred when the caller did not have her deep brain stimulator.  Follow-up (11Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Fatigue
Clinical narrative: tired/Felt tired and weak and he did not receive his second dose; weak/Felt tired and weak and he did not receive his second dose; Really bad back pain like I could not move my back as my back hurt so bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 30Apr2021 (Lot number: EW0176) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Hydrocephalus" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT. The following information was reported: FATIGUE (non-serious) with onset 30Apr2021, outcome "unknown", described as "tired/Felt tired and weak and he did not receive his second dose"; ASTHENIA (non-serious) with onset 30Apr2021, outcome "unknown", described as "weak/Felt tired and weak and he did not receive his second dose"; BACK PAIN (non-serious) with onset 30Apr2021, outcome "unknown", described as "Really bad back pain like I could not move my back as my back hurt so bad". Therapeutic measures were taken as a result of fatigue, asthenia, back pain.  Additional information: It is a consumer who received their first dose (clarified as: Pfizer-BioNTech COVID-19 Vaccine) on 30Apr of this year and afterwards he felt tired and weak and he did not receive his second dose and he still has not received his second dose as of today. So, that would be greater than 42 days if he decides to get the second dose. And he is 41 years old. So, he was calling because he got his first dose on 03Apr and he felt tired and weak. So, he did not get the second dose. So, he wanted to know if he can still have the second dose. It started getting worst that night. started experiencing a little bit of tired that day. And then when it really hit me the most was the next day. I had like really bad back pain like I could not move my back as my back hurt so bad." Treatment received Patient took like Advil and stuff."  No follow-up attempts are possible. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: her arm was a little sore; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  AA 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Apr2021 10:30 (Lot number: EW0161) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Lot Number: ER8734, 1st dose, Time: 10:30 am, Route of administration: Intramuscular), administration date: 02Apr2021, when the patient was 66 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered" (2021), described as "her arm was a little sore"; HEADACHE (non-serious), outcome "recovering", described as "Headache". Therapeutic measures were taken as a result of headache. Additional information: The patient states for the 2nd dose her arm was a little sore that day and that was it and she was going to check not serious on the letter and then 4 hours later after the vaccine is when the event occurred and her appointment was at 10:30am in the afternoon sometime.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Malaise, Pain
Clinical narrative: feeling weak; sore all over; she is not feeling well/ feeling bad; headache; 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 48 year-old male patient received bnt162b2 (BNT162B2), administration date 23Jul2021 (Batch/Lot number: unknown) at the age of 48 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: HEADACHE (non-serious) with onset 23Jul2021, outcome "not recovered", described as "headache"; ASTHENIA (non-serious) with onset 24Jul2021, outcome "not recovered", described as "feeling weak"; PAIN (non-serious) with onset 24Jul2021, outcome "not recovered", described as "sore all over"; MALAISE (non-serious) with onset 24Jul2021, outcome "not recovered", described as "she is not feeling well/ feeling bad".  Additional information:Patient was is a 48-year-old consumer who got his first dose of the Pfizer BioNTech Covid-19 vaccine on Friday 23Jul2021. He reported that he had a headache the first day, but didn't feel bad. On the second day, he reported feeling weak and sore all over. Adds it seems like he feels better for a while and then get to feeling bad again. He is asking if that is normal and how long it lasts.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Frustration tolerance decreased, Headache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 10:00 (Lot number: FA7484) at the age of 55 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "ME/CFS" (unspecified if ongoing); "ME/CFS" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Vitamin D Deficiency" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "allergy: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 23Jul2021, outcome "recovering" and all described as "arm soreness & swelling"; HEADACHE (non-serious) with onset 23Jul2021, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 23Jul2021, outcome "recovering", described as "fatigue"; MALAISE (non-serious) with onset 24Jul2021, outcome "recovering", described as "malaise"; PAIN (non-serious) with onset 24Jul2021, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 24Jul2021, outcome "recovering", described as "chills"; DECREASED APPETITE (non-serious) with onset 24Jul2021, outcome "recovering", described as "loss of appetite"; SOMNOLENCE (non-serious) with onset 25Jul2021, outcome "recovering", described as "sleepiness/I have slept approximately 55# hours plus since Friday"; FRUSTRATION TOLERANCE DECREASED (non-serious) with onset 26Jul2021, outcome "recovering", described as "frustration"; WEIGHT DECREASED (non-serious) with onset Jul2021, outcome "unknown", described as "losing 4 lbs.". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pain in extremity, peripheral swelling, headache, fatigue, malaise, pain, chills, decreased appetite, somnolence, frustration tolerance decreased, weight decreased. Additional Information: facility type vaccine was Pharmacy or Drug Store. if other vaccine in four weeks was no. Day 1 - arm soreness & swelling; headache & fatigue. Day 2 - malaise; arm soreness & swelling, in addition to, body aches & chills, loss of appetite. Day 3 - continued fatigue & sleepiness; loss of appetite; Day 4- continued fatigue & sleepiness; loss of appetite & frustration; Day 5 - continued fatigue & sleepiness; frustrated. I have slept approximately 55# hours plus since Friday, 23Jul2021, in addition to losing 4 lbs., since my first vaccination. if Covid-19 prior vaccination and If Covid-19 tested post vaccination was no. Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pain in extremity, Peripheral swelling, Somnolence
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 10:00 (Lot number: FA7484) at the age of 55 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "ME/CFS" (unspecified if ongoing); "ME/CFS" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Vitamin D Deficiency" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "allergy: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 23Jul2021, outcome "recovering" and all described as "arm soreness & swelling"; HEADACHE (non-serious) with onset 23Jul2021, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 23Jul2021, outcome "recovering", described as "fatigue"; MALAISE (non-serious) with onset 24Jul2021, outcome "recovering", described as "malaise"; PAIN (non-serious) with onset 24Jul2021, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 24Jul2021, outcome "recovering", described as "chills"; DECREASED APPETITE (non-serious) with onset 24Jul2021, outcome "recovering", described as "loss of appetite"; SOMNOLENCE (non-serious) with onset 25Jul2021, outcome "recovering", described as "sleepiness/I have slept approximately 55# hours plus since Friday"; FRUSTRATION TOLERANCE DECREASED (non-serious) with onset 26Jul2021, outcome "recovering", described as "frustration"; WEIGHT DECREASED (non-serious) with onset Jul2021, outcome "unknown", described as "losing 4 lbs.". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pain in extremity, peripheral swelling, headache, fatigue, malaise, pain, chills, decreased appetite, somnolence, frustration tolerance decreased, weight decreased. Additional Information: facility type vaccine was Pharmacy or Drug Store. if other vaccine in four weeks was no. Day 1 - arm soreness & swelling; headache & fatigue. Day 2 - malaise; arm soreness & swelling, in addition to, body aches & chills, loss of appetite. Day 3 - continued fatigue & sleepiness; loss of appetite; Day 4- continued fatigue & sleepiness; loss of appetite & frustration; Day 5 - continued fatigue & sleepiness; frustrated. I have slept approximately 55# hours plus since Friday, 23Jul2021, in addition to losing 4 lbs., since my first vaccination. if Covid-19 prior vaccination and If Covid-19 tested post vaccination was no. Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 10:00 (Lot number: FA7484) at the age of 55 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "ME/CFS" (unspecified if ongoing); "ME/CFS" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Vitamin D Deficiency" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "allergy: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 23Jul2021, outcome "recovering" and all described as "arm soreness & swelling"; HEADACHE (non-serious) with onset 23Jul2021, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 23Jul2021, outcome "recovering", described as "fatigue"; MALAISE (non-serious) with onset 24Jul2021, outcome "recovering", described as "malaise"; PAIN (non-serious) with onset 24Jul2021, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 24Jul2021, outcome "recovering", described as "chills"; DECREASED APPETITE (non-serious) with onset 24Jul2021, outcome "recovering", described as "loss of appetite"; SOMNOLENCE (non-serious) with onset 25Jul2021, outcome "recovering", described as "sleepiness/I have slept approximately 55# hours plus since Friday"; FRUSTRATION TOLERANCE DECREASED (non-serious) with onset 26Jul2021, outcome "recovering", described as "frustration"; WEIGHT DECREASED (non-serious) with onset Jul2021, outcome "unknown", described as "losing 4 lbs.". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of pain in extremity, peripheral swelling, headache, fatigue, malaise, pain, chills, decreased appetite, somnolence, frustration tolerance decreased, weight decreased. Additional Information: facility type vaccine was Pharmacy or Drug Store. if other vaccine in four weeks was no. Day 1 - arm soreness & swelling; headache & fatigue. Day 2 - malaise; arm soreness & swelling, in addition to, body aches & chills, loss of appetite. Day 3 - continued fatigue & sleepiness; loss of appetite; Day 4- continued fatigue & sleepiness; loss of appetite & frustration; Day 5 - continued fatigue & sleepiness; frustrated. I have slept approximately 55# hours plus since Friday, 23Jul2021, in addition to losing 4 lbs., since my first vaccination. if Covid-19 prior vaccination and If Covid-19 tested post vaccination was no. Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: sick; my body goes crazy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 43 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: ILLNESS (non-serious), outcome "unknown", described as "sick"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "my body goes crazy".  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: Lymphadenopathy, Pain, SARS-CoV-2 test
Clinical narrative: painful lymphadenopathy on the ispilateral side; painful lymphadenopathy on the ispilateral side; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administration date 08Jan2021 (Lot number: EL1284) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1 administration on 17Dec2020., Name: Pfizer Sars-coc-2 Vaccination, Manufacturer: Pfizer, Inc, Location: (place name)), administration date: 17Dec2020, when the patient was 30 years old, for COVID-19 IMMUNISATION. The following information was reported: PAIN (non-serious), LYMPHADENOPATHY (non-serious), outcome "recovered" and all described as "painful lymphadenopathy on the ispilateral side". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Just had little you know like not dizzy but its normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 (Lot number: FW0171) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "root canal for my tooth" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Just had little you know like not dizzy but its normal".  Additional information: Reaction/event as reported by primary source: He was supposed to be getting the second dose on the 17May but he said he did not take it. Reaction: Missed dose. Reaction/event: Product dose omission issue. He is calling because he got the first dose of the Pfizer COVID-19 Vaccine on the 26Apr2021 and he was supposed to be getting the second dose on the 17May2021 but he said he did not take it. So, he wants to know if it is still safe for him to take the second dose. I already provide the 's pharmacy hone number. Yes, is it safe for me if take it like 3 months later?. No, I did the first shot. I was okay no side effects. Just had little you know like not dizzy but its normal. No, just a root canal for my tooth. That is all, didn't take any blood test. Time for first vaccine dose: it was like 12 o'clock afternoon.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Weight
Clinical narrative: she and her husband received the first Pfizer Covid 19 Vaccine on 12April2021. They both felt tired after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 (Lot number: EW0151) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). There were no concomitant medications. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "she and her husband received the first Pfizer Covid 19 Vaccine on 12April2021. They both felt tired after the vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller reports that she and her husband received the first Pfizer Covid 19 Vaccine on 12April2021. They both felt tired after the vaccine  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Muscle twitching
Clinical narrative: metal taste in my mouth; Right eye started twitching; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 61 years 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: DYSGEUSIA (non-serious), outcome "not recovered", described as "metal taste in my mouth"; MUSCLE TWITCHING (non-serious), outcome "not recovered", described as "Right eye started twitching".  Additional information: About five minutes after the injection patient had a metal taste in the mouth and that lasted mmm for probably about five hours mmm then sometime in the afternoon maybe two hours after she vaccinated her right eye started twitching and it is still twitching today and patient did not known how long this will last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: 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. Other Case identifier(s): US-PFIZER INC-202100969793 (Pfizer). A 80 year-old male patient received bnt162b2 (BNT162B2), administration date 22Jul2021 (Lot number: EW0198) at the age of 80 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: VISION BLURRED (non-serious) with onset 24Jul2021, outcome "recovered" (24Jul2021), described as "Blurry vision right eye". Additional information: Caller was a male consumer who states that he had his first dose of the Pfizer COVID 19 vaccine on 22Jul2021 and then two days later on 24Jul2021 he experienced some blurry vision (he had blurred vison in his right eye for most of the day and then it went away). This had since subsided. He stated he had no other side effects, not even a sore arm. He relayed that his daughter and her husband also had the Pfizer COVID-19 vaccine and they only had mild symptoms. He would like to know if this had been reported and if it could happen again when he had his second dose on 12Aug2021. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: I stopped getting my period; then bled for apporiximately one day after the second shot; and then stopped getting my period for approximately three months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Lot number: EW0175) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0186, Vaccine location: Right Arm), for Covid-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 22May2021 18:00, outcome "recovered with sequelae", described as "I stopped getting my period; then bled for apporiximately one day after the second shot; and then stopped getting my period for approximately three months". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Patient was not COVID prior vaccination and did not test for COVID post vaccination. Patient had no Known allergies.   No follow-up attempts are possible. No further information is expected.