chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: have experienced intense muscle pain.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 16:00 (Lot number: EW0183) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). Concomitant medication(s) included: HYZAAR; PREVACID. Vaccination history included: Bnt162b2 (Product=COVID 19, brand=Pfizer, lot number=EW0183,administration date= 25Jun2021, administration time=03:00 PM, Dose Number: 1, vaccine location=Left arm), administration date: 25Jun2021, when the patient was 59 years old, for Covid-19 immunisation, reaction(s): "Facial Spasm". The following information was reported: MYALGIA (non-serious) with onset 24Jul2021 07:00, outcome "recovering", described as "have experienced intense muscle pain.". Therapeutic measures were not taken as a result of myalgia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included stool softner, multiple vitamin.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Limb discomfort
Clinical narrative: feel crappy; her arm hurt pretty 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 (005570). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 (Lot number: EP7533) at the age of 44 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: FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered" (2021), described as "feel crappy"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "recovered" (2021), described as "her arm hurt pretty bad".  Additional information: She did feel crappy after the first vaccine and her arm hurt pretty bad.That was only after the first one. It only lasted like a day. She has recovered completely. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: Dry mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. 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: DRY MOUTH (non-serious), outcome "unknown", described as "Dry mouth".  Additional Information: No underlying medical conditions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Couple of times a week arm just starts hurting for no reason at the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25May2021 08:45 (Lot number: EW0173) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Adhesive tape allergy" (unspecified if ongoing), notes: Known allergies: Bandaid glue; "Connective tissue disorder" (unspecified if ongoing), notes: Connective tissue disease; "Hypoglycemia" (unspecified if ongoing), notes: Hypoglycemic; "Polyarthritis" (unspecified if ongoing); "CREST syndrome" (unspecified if ongoing), notes: CREST; "Hashimoto's disease" (unspecified if ongoing), notes: Hashimotos; "Raynauds" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Nauseous", notes: Known allergies: codeine makes nauseous; Codeine, reaction(s): "drug allergy", notes: Known allergies: codeine makes nauseous. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26May2021, outcome "not recovered", described as "Couple of times a week arm just starts hurting for no reason at the injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The clinical outcome of the event couple of times a week arm just starts hurting for no reason at the injection site was not recovered at the time of this report. Patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 15Jun2021 at 08:45 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified concomitant medications. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Granulocytes abnormal, Lymphocyte count increased, Platelet count decreased
Clinical narrative: lowered blood platelet count; slightly elevated Granulocytes & Lymphocytes; slightly elevated Granulocytes & Lymphocytes; This is a spontaneous report received from contactable reporter consumer or other non HCP. The reporter is the patient.  A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jun2021 (Lot number: EW0217) at the age of 13 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot no was EW0127, vaccine location was left arm, Outcome was lasting a week to two weeks), administration date: 09Jun2021, when the patient was 13 years old, for Covid-19 Immunization, reaction(s): "swollen lymph nodes in neck and base of skull". The following information was reported: PLATELET COUNT DECREASED (non-serious) with onset 29Jul2021, outcome "recovering", described as "lowered blood platelet count"; GRANULOCYTES ABNORMAL (non-serious), LYMPHOCYTE COUNT INCREASED (non-serious) all with onset 29Jul2021, outcome "recovering" and all described as "slightly elevated Granulocytes & Lymphocytes". The events "lowered blood platelet count", "slightly elevated granulocytes & lymphocytes" and "slightly elevated granulocytes & lymphocytes" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of platelet count decreased, granulocytes abnormal, lymphocyte count increased.     Additional information:- The patient had no known allergies.Facility where the most recent COVID-19 vaccine was administered in pharmacy or Drug Store.Reported event that swollen lymph nodes in neck after dose 1 followed by swollen lymph nodes in neck and base of skull lasting a week to two weeks CBC conducted 29Jul2021 at pediatric office showed lowered blood platelet count (113) and slightly elevated Granulocytes & Lymphocytesthe patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient did not received within 2 weeks of vaccination.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, patient had not been tested for COVID-19.There was seriousness criteria.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: she experienced nausea; This is a spontaneous report received from a non-contactable reporter consumer or other non HCP for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "she experienced nausea".  Additional information:-Verbatim and event description that Caller's Concern: Caller (Name withheld) got the 1st dose of covid-19 vaccine 14Jul2021 and she experienced nausea. Caller asking what she can take for her nausea. Caller refused to provide address and phone number. While warm transfer talking to the agent both lines disconnected. Provide PMI number and HOO. Submitted AE form.Customer and/or medical inquiry forwarded or referred to MI.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Hypersomnia, Influenza
Clinical narrative: said it felt like he had drank a fifth of Captain (name); flu; feeling drained/completely wiped out/ exhausted; felt like he was run over by a tractor trailer; He's been sleeping 10-12-14-16 hours a day and feels completely out of it; lightheaded/ dizzy; 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 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Aug2021 (Lot number: FA7485) at the age of 69 years 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 (1st dose, LOT- EW0196, administered on left arm), administration date: 11Jul2021, when the patient was 69 years old, for COVID-19 immunisation. The following information was reported: MALAISE (non-serious) with onset 03Aug2021, outcome "unknown", described as "felt like he was run over by a tractor trailer"; HYPERSOMNIA (non-serious) with onset 03Aug2021, outcome "unknown", described as "He's been sleeping 10-12-14-16 hours a day and feels completely out of it"; DIZZINESS (non-serious) with onset 03Aug2021, outcome "not recovered", described as "lightheaded/ dizzy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "said it felt like he had drank a fifth of Captain (name)"; INFLUENZA (non-serious), outcome "unknown", described as "flu"; FATIGUE (non-serious) with onset 03Aug2021, outcome "not recovered", described as "feeling drained/completely wiped out/ exhausted".  Additional information: Patient does not received any other vaccines on same date of the pfizer vaccine. Patient does not received any other vaccine prior to COVID-19 vaccine within 4 weeks. Relevant Tests and Family Medical History Relevant to AE was None. Patient received his second dose of the Pfizer BioNTech Covid 19 vaccine on Sunday. On Sunday and Monday he felt fine but then on Tuesday he felt like he was run over by a tractor trailer. He's been sleeping 10-12-14-16 hours a day and feels completely out of it. He's felt lightheaded and dizzy.  After he gets off the phone he wants to go back to sleep.  Yesterday he attempted to get gas but he was so lightheaded he said after a few blocks he turned back around and went home.  He said it felt like he had drank a fifth of Captain (name withheld) and didn't feel safe driving. Adverse events does not require patient to visit emergency room or physician office.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: said it felt like he had drank a fifth of Captain (name); flu; feeling drained/completely wiped out/ exhausted; felt like he was run over by a tractor trailer; He's been sleeping 10-12-14-16 hours a day and feels completely out of it; lightheaded/ dizzy; 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 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Aug2021 (Lot number: FA7485) at the age of 69 years 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 (1st dose, LOT- EW0196, administered on left arm), administration date: 11Jul2021, when the patient was 69 years old, for COVID-19 immunisation. The following information was reported: MALAISE (non-serious) with onset 03Aug2021, outcome "unknown", described as "felt like he was run over by a tractor trailer"; HYPERSOMNIA (non-serious) with onset 03Aug2021, outcome "unknown", described as "He's been sleeping 10-12-14-16 hours a day and feels completely out of it"; DIZZINESS (non-serious) with onset 03Aug2021, outcome "not recovered", described as "lightheaded/ dizzy"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "said it felt like he had drank a fifth of Captain (name)"; INFLUENZA (non-serious), outcome "unknown", described as "flu"; FATIGUE (non-serious) with onset 03Aug2021, outcome "not recovered", described as "feeling drained/completely wiped out/ exhausted".  Additional information: Patient does not received any other vaccines on same date of the pfizer vaccine. Patient does not received any other vaccine prior to COVID-19 vaccine within 4 weeks. Relevant Tests and Family Medical History Relevant to AE was None. Patient received his second dose of the Pfizer BioNTech Covid 19 vaccine on Sunday. On Sunday and Monday he felt fine but then on Tuesday he felt like he was run over by a tractor trailer. He's been sleeping 10-12-14-16 hours a day and feels completely out of it. He's felt lightheaded and dizzy.  After he gets off the phone he wants to go back to sleep.  Yesterday he attempted to get gas but he was so lightheaded he said after a few blocks he turned back around and went home.  He said it felt like he had drank a fifth of Captain (name withheld) and didn't feel safe driving. Adverse events does not require patient to visit emergency room or physician office.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Ultrasound scan
Clinical narrative: 2 swollen lymph nodes in left arm pit on day 6; Headache within one hour of shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 13 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 28Jul2021 15:00 (Lot number: EW0196) at the age of 13 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing), notes: Autism; "DMDD" (unspecified if ongoing), notes: DMDD; "ADHD" (unspecified if ongoing), notes: ADHD; "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: GUANFACINE; BUSPAR; LEXAPRO; METFORMIN; ABILIFY. The following information was reported: HEADACHE (non-serious) with onset 28Jul2021 16:00, outcome "unknown", described as "Headache within one hour of shot"; LYMPHADENOPATHY (non-serious) with onset 03Aug2021 02:00, outcome "not recovered", described as "2 swollen lymph nodes in left arm pit on day 6". The events "headache within one hour of shot" and "2 swollen lymph nodes in left arm pit on day 6" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy. No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Insomnia, Limb discomfort, Pain in extremity, Potentiating drug interaction
Clinical narrative: feeling a lot of pain on her legs like a lot of discomfort; pain in her legs; Doxycycline and the vaccine has interaction; Couldn't sleep due to the pain; bitter taste in her mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jul2021 (Lot number: GW0189) at the age of 48 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Lyme's disease" (unspecified if ongoing), notes: Diagnosed 1.5 years ago; "Headache" (unspecified if ongoing). Concomitant medication(s) included: NAPROXEN taken for headache.  The following information was reported: POTENTIATING DRUG INTERACTION (non-serious) with onset 03Aug2021, outcome "unknown", described as "Doxycycline and the vaccine has interaction"; DYSGEUSIA (non-serious) with onset 30Jul2021, outcome "recovered" (30Jul2021), described as "bitter taste in her mouth"; LIMB DISCOMFORT (non-serious) with onset 04Aug2021, outcome "recovering", described as "feeling a lot of pain on her legs like a lot of discomfort"; INSOMNIA (non-serious) with onset Aug2021, outcome "unknown", described as "Couldn't sleep due to the pain"; PAIN IN EXTREMITY (non-serious) with onset 04Aug2021, outcome "recovering", described as "pain in her legs". Therapeutic measures were taken as a result of limb discomfort, insomnia, pain in extremity.  Additional Information: The caller is calling about the Pfizer covid 19 vaccine. On Friday the caller got the covid 19 vaccine. That day the caller didn't have and side effects other than a bitter taste in her mouth, similar to medicine. The caller had a medical appointment because she has Lyme disease. They sent the caller an antibiotic, doxycycline 100 mg. The caller started the antibiotic on Tuesday night. The caller is feeling a lot of pain on her legs like a lot of discomfort. The caller has already started taking the antibiotic.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Nausea, Tremor, Vertigo
Clinical narrative: Sudden eyes watering; nausea; vertigo; violent body shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 14:00 (Lot number: Ew0169) at the age of 22 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: LACRIMATION INCREASED (non-serious) with onset 05Aug2021 15:00, outcome "recovering", described as "Sudden eyes watering"; NAUSEA (non-serious) with onset 05Aug2021 15:00, outcome "recovering", described as "nausea"; VERTIGO (non-serious) with onset 05Aug2021 15:00, outcome "recovering", described as "vertigo"; TREMOR (non-serious) with onset 05Aug2021 15:00, outcome "recovering", described as "violent body shaking". The events "sudden eyes watering", "nausea", "vertigo" and "violent body shaking" were evaluated at the emergency room visit. Therapeutic measures were not taken as a result of lacrimation increased, nausea, vertigo, tremor.   Additional information: The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient had not covid prior vaccination. The patient had not covid tested post vaccination. The patient had not known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Discomfort, Feeling abnormal, Gait disturbance
Clinical narrative: chills; it is like light cold sweats; couldn't keep his legs still/His legs couldn't rest. They wouldn't stop moving.; legs hurt and ached; he curled up in fetal position in bed. He was uncomfortable; He tried to get up, and he was imbalanced; It was almost like a nervous reaction.; His body wasn't normal/His body was hurting; body was hurting; 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 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 10:30 (Lot number: EW0164) at the age of 70 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN; LAMOTRIN. The following information was reported: NERVOUSNESS (non-serious) with onset Aug2021, outcome "unknown", described as "It was almost like a nervous reaction."; CHILLS (non-serious) with onset 04Aug2021, outcome "recovered" (2021), described as "chills"; COLD SWEAT (non-serious) with onset 04Aug2021, outcome "recovered" (2021), described as "it is like light cold sweats"; LIMB DISCOMFORT (non-serious) with onset 04Aug2021, outcome "recovered" (05Aug2021), described as "couldn't keep his legs still/His legs couldn't rest. They wouldn't stop moving."; PAIN IN EXTREMITY (non-serious) with onset 04Aug2021, outcome "recovered" (05Aug2021), described as "legs hurt and ached"; DISCOMFORT (non-serious) with onset 04Aug2021, outcome "recovered" (05Aug2021), described as "he curled up in fetal position in bed. He was uncomfortable"; FEELING ABNORMAL (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "His body wasn't normal/His body was hurting"; PAIN (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "body was hurting"; GAIT DISTURBANCE (non-serious) with onset 04Aug2021, outcome "recovered" (05Aug2021), described as "He tried to get up, and he was imbalanced".  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Nervousness, Pain, Pain in extremity
Clinical narrative: chills; it is like light cold sweats; couldn't keep his legs still/His legs couldn't rest. They wouldn't stop moving.; legs hurt and ached; he curled up in fetal position in bed. He was uncomfortable; He tried to get up, and he was imbalanced; It was almost like a nervous reaction.; His body wasn't normal/His body was hurting; body was hurting; 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 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 10:30 (Lot number: EW0164) at the age of 70 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN; LAMOTRIN. The following information was reported: NERVOUSNESS (non-serious) with onset Aug2021, outcome "unknown", described as "It was almost like a nervous reaction."; CHILLS (non-serious) with onset 04Aug2021, outcome "recovered" (2021), described as "chills"; COLD SWEAT (non-serious) with onset 04Aug2021, outcome "recovered" (2021), described as "it is like light cold sweats"; LIMB DISCOMFORT (non-serious) with onset 04Aug2021, outcome "recovered" (05Aug2021), described as "couldn't keep his legs still/His legs couldn't rest. They wouldn't stop moving."; PAIN IN EXTREMITY (non-serious) with onset 04Aug2021, outcome "recovered" (05Aug2021), described as "legs hurt and ached"; DISCOMFORT (non-serious) with onset 04Aug2021, outcome "recovered" (05Aug2021), described as "he curled up in fetal position in bed. He was uncomfortable"; FEELING ABNORMAL (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "His body wasn't normal/His body was hurting"; PAIN (non-serious) with onset Aug2021, outcome "recovered" (2021), described as "body was hurting"; GAIT DISTURBANCE (non-serious) with onset 04Aug2021, outcome "recovered" (05Aug2021), described as "He tried to get up, and he was imbalanced".  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Loss of personal independence in daily activities, Magnetic resonance imaging, Scan, Tinnitus
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A 47-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# 025A21A),  at the age of 47, intramuscularly, in left arm, on Mar 1, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced tinnitus (since the day she got the vaccine, she has experienced ringing in left ear), onset Mar 1, 2021, with outcome of not recovered; disturbance in attention, loss of personal independence in daily activities (she is not able to concentrate, affecting her quality of life); vomiting and tremor (transported to the hospital because she was throwing up and shaking violently), with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. Therapeutic measures taken as a result of tinnitus, disturbance in attention, loss of personal independence in daily activities, vomiting and tremor. Additional information: The patient experienced possible adverse events after receiving the 1st dose of the vaccine on Mar 1, 2021 in left arm. The lot number for the vaccine is 025A21A; expiration date not provided. Caller stated since the day she got the vaccine, she has experienced  ringing in the ear. She experienced ringing in both ears but more particularly in left ear. Because of this ringing, she was not able to concentrate and affecting her quality of life. She has gotten  multiple tests done (MRI, scans etc.), but all are coming back normal. She has seen multiple doctors (including ENT as well, but no one can figure out what may be going on. Patient  transported to hospital twice via EMS but was not kept overnight. She was transported to the hospital because she was throwing up and shaking violently; not convulsing though. She was released from the hospital the same day. She was prescribed medications to alleviate the symptoms. She is taking low-dose aspirin, diazepam, gingko biloba, hydroxyzine, and OTC  supplements (flavonoid). The medications are not helping. The ringing in ear still ongoing. She also missed her second dose. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A 47-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# 025A21A),  at the age of 47, intramuscularly, in left arm, on Mar 1, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced tinnitus (since the day she got the vaccine, she has experienced ringing in left ear), onset Mar 1, 2021, with outcome of not recovered; disturbance in attention, loss of personal independence in daily activities (she is not able to concentrate, affecting her quality of life); vomiting and tremor (transported to the hospital because she was throwing up and shaking violently), with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. Therapeutic measures taken as a result of tinnitus, disturbance in attention, loss of personal independence in daily activities, vomiting and tremor. Additional information: The patient experienced possible adverse events after receiving the 1st dose of the vaccine on Mar 1, 2021 in left arm. The lot number for the vaccine is 025A21A; expiration date not provided. Caller stated since the day she got the vaccine, she has experienced  ringing in the ear. She experienced ringing in both ears but more particularly in left ear. Because of this ringing, she was not able to concentrate and affecting her quality of life. She has gotten  multiple tests done (MRI, scans etc.), but all are coming back normal. She has seen multiple doctors (including ENT as well, but no one can figure out what may be going on. Patient  transported to hospital twice via EMS but was not kept overnight. She was transported to the hospital because she was throwing up and shaking violently; not convulsing though. She was released from the hospital the same day. She was prescribed medications to alleviate the symptoms. She is taking low-dose aspirin, diazepam, gingko biloba, hydroxyzine, and OTC  supplements (flavonoid). The medications are not helping. The ringing in ear still ongoing. She also missed her second dose. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: I should have gotten my period around the 5th of May and I did not; 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 received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 15:45 (Lot number: Er8736) at the age of 43 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: MENSTRUATION DELAYED (non-serious) with onset 2021, outcome "unknown", described as "I should have gotten my period around the 5th of May and I did not".  Additional Information: Facility where the most recent COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no list of any other medications the patient received within 2 weeks of vaccination. The patient reported that, she received her first dose on 26Apr2021. She had no adverse reactions but she should have gotten her period around the 5th of May and she did not. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The device date was reported as 08Aug2021.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: L Armpit lymph node swelling and tenderness; L Armpit lymph node swelling and tenderness; Left breast pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Aug2021 11:00 (Lot number: 0181) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: EFFEXOR taken for contraception. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 08Aug2021 08:30, outcome "not recovered" and all described as "L Armpit lymph node swelling and tenderness"; BREAST PAIN (non-serious) with onset 08Aug2021 08:30, outcome "not recovered", described as "Left breast pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain, breast pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. Patient had covid tested post vaccination Nasal Swab, which result as Negative on 11Dec2020.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen armpit node in the same arm that was vaccinated; This is a spontaneous report received from a contactable reporter(s) (Other HCP) via a sponsored program. The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Aug2021 10:00 (Lot number: FA 7485) at the age of 42 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: LYMPHADENOPATHY (non-serious) with onset 06Aug2021 21:00, outcome "not recovered", described as "Swollen armpit node in the same arm that was vaccinated". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. No known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 13:30 (Lot number: FA7484) at the age of 61 years as dose 2, single and administered in arm left, administration date 07Jul2021 13:30 (Lot number: EW0185) 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: TINNITUS (non-serious), TINNITUS (non-serious) all with onset 09Jul2021, outcome "not recovered" and all described as "Severe ringing in the ears, tinnitus". Therapeutic measures were not taken as a result of tinnitus, tinnitus. Additional information: The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had two friends got their first dose got sore arm, second dose knocked them down for 4 or 5 days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A patient (no qualifiers provided) 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 "Had two friends got their first dose got sore arm, second dose knocked them down for 4 or 5 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: I have been having localized heat right in my butt area. Every time I move around its like a spot of heat that just kind of moves around; When I get up; when I walk around I can feel the heat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Aug2021 (Lot number: EW0179) at the age of 54 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: FEELING HOT (non-serious) with onset 06Aug2021, outcome "not recovered", described as "I have been having localized heat right in my butt area. Every time I move around its like a spot of heat that just kind of moves around; When I get up; when I walk around I can feel the heat". Therapeutic measures were not taken as a result of feeling hot. Additional information: The patient stated that, she received the Covid vaccine on yesterday, Saturday, Friday, Thursday (not further clarified) and she have been having localized heat right in her butt area. Every time she move around its like a spot of heat that just kind of moves around. The patient thought it was a reaction to shot. When the patient got up she can feel the heat, when she walk around she can feel the heat. It was a kind of sitting there and she did not have this kind of problem before she got this shot. Its like right under her skin. The patient stated that she had no prior vaccination. The patient did not had any treatment and stated that no, nothing she can do. It was just there. It started the day before reporting. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site coldness
Clinical narrative: His arm is cold from his elbow to his shoulder from where he got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left (Lot number: FA6780) 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: VACCINATION SITE COLDNESS (non-serious), outcome "unknown", described as "His arm is cold from his elbow to his shoulder from where he got the shot". Therapeutic measures were not taken as a result of vaccination site coldness. No follow-up attempts are possible. No further information is expected.  Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle disorder, Neck pain, Oropharyngeal discomfort, Pain
Clinical narrative: I am experiencing lot of pain in my neck and my back, Between my shoulder blade.; I am experiencing lot of pain in my neck; lots of pain; drain into my throat; help with the muscles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW0165) at the age of 57 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Verbatim: Diabetes; "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure; "Cancer" (unspecified if ongoing), notes: Verbatim: Cancer; "surgery related to cancer" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; METFORMIN; INSULIN; LASIX [FUROSEMIDE]; CALCIUM. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "I am experiencing lot of pain in my neck and my back, Between my shoulder blade."; NECK PAIN (non-serious), outcome "unknown", described as "I am experiencing lot of pain in my neck"; PAIN (non-serious), outcome "unknown", described as "lots of pain"; OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown", described as "drain into my throat"; MUSCLE DISORDER (non-serious), outcome "unknown", described as "help with the muscles". Therapeutic measures were taken as a result of oropharyngeal discomfort, muscle disorder.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Lab tests were done on Thursday. Treatment included taking Flonase for the drain into my throat and took some ibuprofen to help with the muscles.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: it was over 12 weeks to get the second dose and yesterday she said that they have given again the 1st dose; Diarrhea; Headache; My arm is sore; Tired and weakness; Tired and weakness; 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. Other Case identifier(s): US-PFIZER INC-202101016458.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Aug2021 (Lot number: EW0187) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Lot no. EW0186), administration date: 05May2021, when the patient was 35 years old, reaction(s): "COVID-19 Immunization". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Aug2021, outcome "unknown", described as "it was over 12 weeks to get the second dose and yesterday she said that they have given again the 1st dose"; DIARRHOEA (non-serious) with onset Aug2021, outcome "unknown", described as "Diarrhea"; HEADACHE (non-serious) with onset Aug2021, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "My arm is sore"; FATIGUE (non-serious), ASTHENIA (non-serious) all with onset Aug2021, outcome "unknown" and all described as "Tired and weakness". Therapeutic measures were not taken as a result of diarrhoea, headache, pain in extremity, fatigue, asthenia. Additional information: The patient reported that she already got the first dose of Pfizer Covid-19 Vaccine last 5May2021. However upon having appointment for the second dose on 06Aug2021 the patient received another first dose because it's been about 12 weeks since the first dose, that's why this patient wanted to ask because she was advised that it passed 4 weeks, so they administered another first dose for her. The patient wanted to know if it was ok to do so. The patient abruptly hung up the call. Product details (LOT, expiration date, NDC and UPC) and Pharmacy details could not be probed over the call. Limited information available over the call and appropriate response could not be provided. No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: it was over 12 weeks to get the second dose and yesterday she said that they have given again the 1st dose; Diarrhea; Headache; My arm is sore; Tired and weakness; Tired and weakness; 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. Other Case identifier(s): US-PFIZER INC-202101016458.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Aug2021 (Lot number: EW0187) at the age of 35 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Lot no. EW0186), administration date: 05May2021, when the patient was 35 years old, reaction(s): "COVID-19 Immunization". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Aug2021, outcome "unknown", described as "it was over 12 weeks to get the second dose and yesterday she said that they have given again the 1st dose"; DIARRHOEA (non-serious) with onset Aug2021, outcome "unknown", described as "Diarrhea"; HEADACHE (non-serious) with onset Aug2021, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "My arm is sore"; FATIGUE (non-serious), ASTHENIA (non-serious) all with onset Aug2021, outcome "unknown" and all described as "Tired and weakness". Therapeutic measures were not taken as a result of diarrhoea, headache, pain in extremity, fatigue, asthenia. Additional information: The patient reported that she already got the first dose of Pfizer Covid-19 Vaccine last 5May2021. However upon having appointment for the second dose on 06Aug2021 the patient received another first dose because it's been about 12 weeks since the first dose, that's why this patient wanted to ask because she was advised that it passed 4 weeks, so they administered another first dose for her. The patient wanted to know if it was ok to do so. The patient abruptly hung up the call. Product details (LOT, expiration date, NDC and UPC) and Pharmacy details could not be probed over the call. Limited information available over the call and appropriate response could not be provided. No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Lymphadenopathy
Clinical narrative: lymph node in the same side that is enlarging like really really big underneath his left armpit/it's getting larger and larger; lymph node in the same side that is enlarging like really really big underneath his left armpit/it's getting larger and larger; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 39 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 06Aug2021 08:15 (Lot number: EW0172) at the age of 39 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: LYMPHADENOPATHY (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 07Aug2021, outcome "not recovered" and all described as "lymph node in the same side that is enlarging like really really big underneath his left armpit/it's getting larger and larger". Therapeutic measures were taken as a result of lymphadenopathy, condition aggravated. Additional information- It was reported that Nurse stated, "My husband received a vaccine on 06Aug2021, Friday and he now has a lymph node in the same side that is enlarging like really  big underneath his left armpit and she was assuming the paperwork that could be a potential side effect and also reported that her husband was really healthy. He's in the gym everyday. No pre-existing health conditions and then all of a sudden this pops up right after getting the Vaccine. Patient also administer an anti inflammatory like Ibuprofen. about 45 minutes ago as a treatment.  No follow-up attempts are possible. No further information is expected.