chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Started hearing ring in right ear on 26Apr2021 at 4PM PSTIt hasn't stopped since, I noticed it intensified on 13May2021 evening and I think my left ear is experiencing a ring noise too/Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 09Apr2021 10:45 (Lot number: EW0153) as dose 1, single and intramuscular, administered in deltoid right, administration date 01May2021 10:00 (Lot number: EP6955) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Preventative care", start date: 05May2021 (ongoing), notes: Preventative care; "Thoracic puncture wound", start date: 21Apr2018, stop date: 2018, notes: Thoracic puncture wound. Family history included: "Father deceased due to Leukemia" (unspecified if ongoing), notes: Father deceased due to Leukemia. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 26Apr2021 16:00, outcome "not recovered", described as "Started hearing ring in right ear on 26Apr2021 at 4PM PSTIt hasn't stopped since, I noticed it intensified on 13May2021 evening and I think my left ear is experiencing a ring noise too/Tinnitus". The event "started hearing ring in right ear on 26apr2021 at 4pm pstit hasn't stopped since, i noticed it intensified on 13may2021 evening and i think my left ear is experiencing a ring noise too/tinnitus" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus. Additional information: Started hearing ring in right ear on 26Apr2021 at 4PM PST It hasn't stopped since, noticed it intensified on 13May2021 evening and he think his left ear is experiencing a ring noise too although the one coming from the right ear is more overpowering. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First dose- left arm pain two days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 14:30 (Lot number: EW0167) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sinuses - GER" (unspecified if ongoing). Concomitant medication(s) included: SIMETHICONE. Past drug history included: Sulfur, reaction(s): "Allergy:Sulfur"; Codeine, reaction(s): "Allergy:Codeine". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "First dose- left arm pain two days". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient took Anthistamine/NasalDecongesta as other medications in two weeks. Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Confusional state, Electrocardiogram, Feeling abnormal
Clinical narrative: My brain is not working; All I want to do is sleep, it just feel weird; It feels like I am coming out of an anesthesia and I can't get enough sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 10:00 (Lot number: EW0187) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus", start date: 08Aug2009 (ongoing); "High Blood Pressure", start date: 07Jul2000 (ongoing); "Fatty Liver Disease", start date: 10Oct2020 (ongoing); "Inflammation Disease", start date: 15Feb2021 (ongoing); "stroke" (unspecified if ongoing); "Dystonia", start date: 24Oct1988 (ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Batch/Lot number: EW0171, Time: 9:30, Site and route of injection: Left arm), administration date: 22Apr2021, when the patient was 61 years old, for COVID-19 Immunization.  The following information was reported: SOMNOLENCE (hospitalization) with onset May2021, outcome "not recovered", described as "It feels like I am coming out of an anesthesia and I can't get enough sleep"; FEELING ABNORMAL (hospitalization) with onset May2021, outcome "not recovered", described as "All I want to do is sleep, it just feel weird"; CONFUSIONAL STATE (hospitalization) with onset May2021, outcome "not recovered", described as "My brain is not working". The patient was hospitalized for somnolence, feeling abnormal, confusional state (start date: 23May2021, discharge date: 24May2021, hospitalization duration: 1 day(s)). The events "it feels like i am coming out of an anesthesia and i can't get enough sleep", "all i want to do is sleep, it just feel weird" and "my brain is not working" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (23May2021) normal; computerised tomogram: (23May2021) normal; electrocardiogram: (23May2021) normal; urine analysis: (23May2021) normal. Therapeutic measures were taken as a result of somnolence, feeling abnormal, confusional state.  Clinical course: Patient stated that she was having an adverse effect to this vaccine, she didn't know what to do because it feels like she was coming out of an anesthesia and  couldn't get enough sleep. She was asking whether she should go to the hospital because of the events. Patient stated that she was taking like 8 concomitant medications(no further information provided). Also stated, patient had stroke and did lab work done probably in June or 12May that was last time. Vaccination facility type was Pharmacy drug store. No prior vaccinations received. AE outcome was mentioned as recovered and date of recovery was mentioned as still ongoing.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Urine analysis
Clinical narrative: My brain is not working; All I want to do is sleep, it just feel weird; It feels like I am coming out of an anesthesia and I can't get enough sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 10:00 (Lot number: EW0187) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus", start date: 08Aug2009 (ongoing); "High Blood Pressure", start date: 07Jul2000 (ongoing); "Fatty Liver Disease", start date: 10Oct2020 (ongoing); "Inflammation Disease", start date: 15Feb2021 (ongoing); "stroke" (unspecified if ongoing); "Dystonia", start date: 24Oct1988 (ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Batch/Lot number: EW0171, Time: 9:30, Site and route of injection: Left arm), administration date: 22Apr2021, when the patient was 61 years old, for COVID-19 Immunization.  The following information was reported: SOMNOLENCE (hospitalization) with onset May2021, outcome "not recovered", described as "It feels like I am coming out of an anesthesia and I can't get enough sleep"; FEELING ABNORMAL (hospitalization) with onset May2021, outcome "not recovered", described as "All I want to do is sleep, it just feel weird"; CONFUSIONAL STATE (hospitalization) with onset May2021, outcome "not recovered", described as "My brain is not working". The patient was hospitalized for somnolence, feeling abnormal, confusional state (start date: 23May2021, discharge date: 24May2021, hospitalization duration: 1 day(s)). The events "it feels like i am coming out of an anesthesia and i can't get enough sleep", "all i want to do is sleep, it just feel weird" and "my brain is not working" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (23May2021) normal; computerised tomogram: (23May2021) normal; electrocardiogram: (23May2021) normal; urine analysis: (23May2021) normal. Therapeutic measures were taken as a result of somnolence, feeling abnormal, confusional state.  Clinical course: Patient stated that she was having an adverse effect to this vaccine, she didn't know what to do because it feels like she was coming out of an anesthesia and  couldn't get enough sleep. She was asking whether she should go to the hospital because of the events. Patient stated that she was taking like 8 concomitant medications(no further information provided). Also stated, patient had stroke and did lab work done probably in June or 12May that was last time. Vaccination facility type was Pharmacy drug store. No prior vaccinations received. AE outcome was mentioned as recovered and date of recovery was mentioned as still ongoing.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Oral mucosal blistering
Clinical narrative: Blisters in mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19May2021 (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, single), for COVID-19 Immunization. The following information was reported: ORAL MUCOSAL BLISTERING (non-serious), outcome "unknown", described as "Blisters in mouth". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Migraine, Tinnitus
Clinical narrative: Migraines, earache, tinnitus; Migraines, earache, tinnitus; Migraines, earache, tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04May2021 11:00 (Lot number: 6347) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Peri menopause" (unspecified if ongoing), notes: Other medical history: Peri menopause; "Hypothyroidism", start date: 11Nov1999 (ongoing), notes: Other medical history: Hypothyroidism. Concomitant medication(s) included: LIOTHYRONINE; LEVOTHYROXINE; CITALOPRAM; LEVOXYL taken for hypothyroidism, start date: Nov1999 (ongoing); CELEXA [CITALOPRAM HYDROBROMIDE] taken for anxiety, start date: Aug2011 (ongoing). Vaccination history included: Covid-19 vaccine (product=COVID 19, brand=Pfizer ,, lot unknown=True,, lot unknown reason=Unable to locate or read the details,, dose number=1,, vaccine location=Left arm, Time(24hrs):11:00, Anatomical site of injection: Left arm, Route of Administration: Intramuscular, Lot number: 6347), administration date: 06Apr2021, when the patient was 50 years old, for Covid-19 immunisation.  The following information was reported: TINNITUS (non-serious) with onset 05May2021, outcome "recovered" (18Jun2021), MIGRAINE (non-serious) with onset 05May2021, outcome "recovered" (15Jun2021) and all described as "Migraines, earache, tinnitus"; EAR PAIN (non-serious) with onset 05May2021, outcome "recovered" (20Jun2021), described as "Migraines, earache, tinnitus". The event "migraines, earache, tinnitus", "migraines, earache, tinnitus" and "migraines, earache, tinnitus" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus, ear pain. Therapeutic measures were taken as a result of migraine.  Additional Information: The Facility where the most recent COVID-19 vaccine was administered Pharmacy or Drug Store. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient not tested for COVID-19. The Patient took OTC, Pain reliever for migraine.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Constipation, Feeling hot, Nasal discomfort, Oropharyngeal pain
Clinical narrative: Throat burning; Nose and throat burning; Nose and throat burning and sore; Unable to poop but feel like stomach may have diarrhea; Warm no fever; Fingertips were tingly.; Stomach pains; Nose and throat burning and sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24May2021 11:45 (Batch/Lot number: unknown) at the age of 36 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRINTELLIX. The following information was reported: THROAT IRRITATION (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Throat burning"; NASAL DISCOMFORT (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Nose and throat burning"; RHINALGIA (non-serious), OROPHARYNGEAL PAIN (non-serious) all with onset 24May2021 14:30, outcome "not recovered" and all described as "Nose and throat burning and sore"; CONSTIPATION (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Unable to poop but feel like stomach may have diarrhea"; FEELING HOT (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Warm no fever"; PARAESTHESIA (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Fingertips were tingly."; ABDOMINAL PAIN UPPER (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Stomach pains". Therapeutic measures were not taken as a result of throat irritation, nasal discomfort, rhinalgia, constipation, feeling hot, paraesthesia, abdominal pain upper, oropharyngeal pain.  Additional information: On 24May2021 at 14:30, the patient experienced nose and throat burning and sore. Stomach pains. Unable to poop but felt like stomach may have diarrhea, warm no fever. Fingertips were tingly. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rhinalgia, Throat irritation
Clinical narrative: Throat burning; Nose and throat burning; Nose and throat burning and sore; Unable to poop but feel like stomach may have diarrhea; Warm no fever; Fingertips were tingly.; Stomach pains; Nose and throat burning and sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24May2021 11:45 (Batch/Lot number: unknown) at the age of 36 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRINTELLIX. The following information was reported: THROAT IRRITATION (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Throat burning"; NASAL DISCOMFORT (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Nose and throat burning"; RHINALGIA (non-serious), OROPHARYNGEAL PAIN (non-serious) all with onset 24May2021 14:30, outcome "not recovered" and all described as "Nose and throat burning and sore"; CONSTIPATION (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Unable to poop but feel like stomach may have diarrhea"; FEELING HOT (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Warm no fever"; PARAESTHESIA (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Fingertips were tingly."; ABDOMINAL PAIN UPPER (non-serious) with onset 24May2021 14:30, outcome "not recovered", described as "Stomach pains". Therapeutic measures were not taken as a result of throat irritation, nasal discomfort, rhinalgia, constipation, feeling hot, paraesthesia, abdominal pain upper, oropharyngeal pain.  Additional information: On 24May2021 at 14:30, the patient experienced nose and throat burning and sore. Stomach pains. Unable to poop but felt like stomach may have diarrhea, warm no fever. Fingertips were tingly. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Vaccination site pain
Clinical narrative: slight site pain; chills; sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "slight site pain"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Reporter was asking for information on the covid vaccine trials the booster trials". "Patient received both shots from Pfizer. Her 2nd dose (Pfizer covid vaccine) was on 26Jan2021. She knew a booster trial was going on. She thought she would be a good candidate for the trial. She had the normal side effects with the 2nd dose. After the first dose Patient had slight site pain but it was because she slept on that arm. She stated "You have a good product". She want to participate for the booster trials. She also stated that she had received both doses and had the normal standard side effects like chills and a sore arm.  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: Impaired healing
Clinical narrative: Shot spot is still not healed- stillscanned- but cant see if its red or notcause I have a tattoo in that spot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Apr2021 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy to nuts" (unspecified if ongoing), notes: known_allergies: cashews; "Penicillin allergy" (unspecified if ongoing), notes: known_allergies: Penicillin; "Peanut allergy" (unspecified if ongoing), notes: known_allergies: peanuts. Concomitant medication(s) included: ALEVE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, LOT NUMBER: UNKNOWN, ANATOMIC SITE: RIGHT ARM), administration date: 2021, for COVID-19 immunisation. The following information was reported: IMPAIRED HEALING (non-serious) with onset 21Apr2021, outcome "not recovered", described as "Shot spot is still not healed- stillscanned- but cant see if its red or notcause I have a tattoo in that spot". Therapeutic measures were not taken as a result of impaired healing.  Additional information: 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 vaccination. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor/ health care professional clinic visit.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Pulsatile tinnitus in left ear after first dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: ER8733) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "Pulsatile tinnitus in left ear after first dose". The event "pulsatile tinnitus in left ear after first dose" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. Prior to the vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Severe muscle spasms, stiffness and heavy feeling; Severe muscle spasms, stiffness and heavy feeling; Severe muscle spasms, stiffness and heavy feeling; This is a spontaneous report from a contactable nurse, the patient. A non-pregnant 50-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 1111111) via an unspecified route of administration on an unknown date at the age of 50 years as a single dose for COVID-19 immunisation. Medical history included hypertension, eggs allergy and milk allergy. The patient previously took Phenergan and experienced allergy to it. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was not reported that if the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unknown date, the patient experienced severe muscle spasms, stiffness and heavy feeling in episodes lasting 30 seconds to 2 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe muscle spasms, stiffness and heavy feeling was not recovered at the time of this report.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (24May2021): This case is being submitted to notify that the initial information for this case was first received by the Company on [24May2021] and not on [25May2021] as previously reported. And below amendment has been done together: To amend 1, PRD correction. 2, Postal Code added in Patient Tab. 3, Age/ Age at Vaccination added. 4, Suspect product's lot No. removed from the Products Tab but retained in the narrative. 5, AE "Severe muscle spasms, stiffness and heavy feeling" was split and re-coded to "muscle spasms", "muscle stiffness" and "myalgia". 6, Final sentence updated from "No follow-up attempts are needed. No further information is expected." to "This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.". 7, Narrative updated accordingly.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Fatigue
Clinical narrative: depressed; drained; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Apr2021 10:30 (Lot number: ER8761) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Oct2020 (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "injury to shoulder NOS" (unspecified if ongoing); "Post-traumatic stress disorder" (unspecified if ongoing); "intense nausea" (unspecified if ongoing); "terrible pains in my heart and my chest" (unspecified if ongoing); "terrible pains in my heart and my chest" (unspecified if ongoing); "lost some weight" (unspecified if ongoing); "lots of body pain" (unspecified if ongoing); "Pain" (unspecified if ongoing); "STRESS" (unspecified if ongoing). Concomitant medication(s) included: LIDOCAINE taken for pain. The following information was reported: DEPRESSION (non-serious) with onset 05May2021 02:00, outcome "not recovered", described as "depressed"; FATIGUE (non-serious) with onset 05May2021 02:00, outcome "not recovered", described as "drained". Therapeutic measures were not taken as a result of depression, fatigue.  Additional information: Administration time was 10:30Am. Patient not received other vaccine in four weeks. Other medications in two weeks was lidocaine for pain. No treatment received for AE. Covid was prior vaccination. Covid was not tested post vaccination. No any known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Muscular weakness, Off label use, Vision blurred
Clinical narrative: Second shot was late because he could not get it from being sick from his gastroparesis; Second shot was late because he could not get it from being sick from his gastroparesis; legs feel weak/His arms also feel weak; blurred eyes; 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 66 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 21May2021 (Lot number: EW0165) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Raynaud's Disease" (unspecified if ongoing); "Gastroparesis", start date: Jan2010 (unspecified if ongoing); "Cdiff" (unspecified if ongoing); "Hospitalization" (unspecified if ongoing), notes: He had prior hospitalizations on 23 Feb 2021, and 24 Feb 2021; "Helicobacter pylori", start date: Aug2020 (unspecified if ongoing); "Implant (stomach)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown" and all described as "Second shot was late because he could not get it from being sick from his gastroparesis"; MUSCULAR WEAKNESS (non-serious) with onset 24May2021, outcome "unknown", described as "legs feel weak/His arms also feel weak"; VISION BLURRED (non-serious) with onset 22May2021, outcome "unknown", described as "blurred eyes".  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site dermatitis
Clinical narrative: Interface dermatitis style reaction at prior smallpox vaccination marks; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04May2021 (Lot number: ER8735) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Shingles", start date: 27Aug2014, stop date: Sep2014, notes: Illness/AE: Shingles, Onset Date: 27Aug2014, Stop Date: Sep2014, Pertinent Details: Postherpetic Neuralgia in the affected area (Right side of the head) Ongoing; "Impetigo", start date: 06Apr2019, stop date: 20Apr2019, notes: Illness/AE: Impetigo, Onset Date: 06Apr2019, Stop Date: 20Apr2019, Illness/AE: Impetigo, Onset Date: 01Sep2019, Stop Date: 16Sep2019; "Dermatitis/ Cheilitis", start date: Aug2019 (ongoing), notes: Illness/AE: Contact Dermatitis/ Cheilitis, Onset Date: Aug2019, Ongoing. Concomitant medication(s) included: FLUOCINOLONE ACETONIDE taken for dermatitis contact, start date: May2020. The following information was reported: VACCINATION SITE DERMATITIS (non-serious), outcome "not recovered", described as "Interface dermatitis style reaction at prior smallpox vaccination marks".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache
Clinical narrative: chills; stomach aches; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer-sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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 COVID19-immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach aches"; HEADACHE (non-serious), outcome "unknown", described as "headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: The patient got symptoms after the second dose. she started getting chills, stomach aches, and headache about 20 days after the second dose. "Interpreter is no longer on the call" message played while mid-way isi. tried getting another interpreter, but caller hung up. faxed ae. CoVax US Support CEP 159558.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Dizziness
Clinical narrative: On the third day I experienced lightheadedness/then extreme dizziness to the level that I could not get out of bed easily; I could not get out of bed easily; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 14:00 (Lot number: ER8736) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mild heart disease" (unspecified if ongoing). Concomitant medication(s) included: NORVASTATIN. The following information was reported: DIZZINESS (non-serious) with onset 24May2021 08:00, outcome "recovering", described as "On the third day I experienced lightheadedness/then extreme dizziness to the level that I could not get out of bed easily"; BEDRIDDEN (non-serious) with onset 24May2021, outcome "recovering", described as "I could not get out of bed easily". Therapeutic measures were not taken as a result of dizziness, bedridden.  Additional information: No other vaccine in four weeks. No covid prior vaccination. Not Covid tested post vaccination. No known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: she received her 2nd vaccine dose she had "aches and pains and fatigue; she received her 2nd vaccine dose she had "aches and pains and fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program . The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17May2021 10:00 (Lot number: EW0183, Expiration Date: 31Aug2021) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure", start date: 2010 (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose., Time: 10:00 am, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EW0172, Expiry date: Aug2021), administration date: 26Apr2021, for COVID-19 immunisation, reaction(s): "her arm hurt". The following information was reported: FATIGUE (non-serious), PAIN (non-serious) all with onset May2021, outcome "unknown" and all described as "she received her 2nd vaccine dose she had "aches and pains and fatigue".  Additional Information: There were no prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: my arm at the injection site is red and swollen in 3 inches in diameter it spread hot as swollen; my arm at the injection site is red and swollen in 3 inches in diameter it spread hot as swollen; my arm at the injection site is red and swollen in 3 inches in diameter it spread hot as swollen; my lymph nodes are swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old patient received bnt162b2 (BNT162B2), administration date 21May2021 (Lot number: EW0185) at the age of 62 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: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 21May2021, outcome "unknown" and all described as "my arm at the injection site is red and swollen in 3 inches in diameter it spread hot as swollen"; LYMPHADENOPATHY (non-serious) with onset 21May2021, outcome "unknown", described as "my lymph nodes are swollen". The event "my lymph nodes are swollen" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site warmth, lymphadenopathy. Additional information: The patient's arm at the injection site was red and swollen in 3 inches in diameter, it spread hot as swollen. The patient did not know what that would be in centimeter or nanometer but it was 3 inches being measured it they even drew black wine around it like watch it pro. Patient's my lymph nodes were swollen. Patient went to the doctor, they had it checked (Not further clarified). The patient just took Benadryl. No Investigation Assessment was performed.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tendonitis, X-ray
Clinical narrative: After second Pfizer vaccine shot, left arm became sore and remained sore for 2 months and still sore; Diagnosed with Tendonitis which never had before.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 13:00 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Prostate cancer" (unspecified if ongoing), notes: Prostate cancer 5+ years ago treated with cyberknife; "Kidney stones" (unspecified if ongoing), notes: History of kidney stones. Concomitant medication(s) included: ALLOPURINOL; HYDROCHLOROTHIAZIDE; POTASSIUM CITRATE.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Mar2021 13:00, outcome "not recovered", described as "After second Pfizer vaccine shot, left arm became sore and remained sore for 2 months and still sore"; TENDONITIS (non-serious) with onset 24Mar2021 13:00, outcome "not recovered", described as "Diagnosed with Tendonitis which never had before.". The events "after second pfizer vaccine shot, left arm became sore and remained sore for 2 months and still sore" and "diagnosed with tendonitis which never had before." were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: x-ray: diagnosed with tendonitis. Therapeutic measures were taken as a result of pain in extremity, tendonitis.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with Advil, doing exercises and heating pad.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypoaesthesia, Joint swelling, Nasopharyngitis
Clinical narrative: Hand swelling/Feet swelling; Numbness and tingling in fingers/numbness and tingling in toes; Numbness and tingling in fingers/numbness and tingling in toes; Ankle swelling; Cold chills without a fever; Fatigue; Cold chills without a fever; 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 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6200) at the age of 53 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: PERIPHERAL SWELLING (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Hand swelling/Feet swelling"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 15Mar2021, outcome "not recovered" and all described as "Numbness and tingling in fingers/numbness and tingling in toes"; JOINT SWELLING (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Ankle swelling"; NASOPHARYNGITIS (non-serious), CHILLS (non-serious) all with onset 15Mar2021, outcome "not recovered" and all described as "Cold chills without a fever"; FATIGUE (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Fatigue". The events "hand swelling/feet swelling", "numbness and tingling in fingers/numbness and tingling in toes", "numbness and tingling in fingers/numbness and tingling in toes", "ankle swelling", "cold chills without a fever", "fatigue" and "cold chills without a fever" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of peripheral swelling, hypoaesthesia, paraesthesia, joint swelling, nasopharyngitis, fatigue, chills.  Additional information: Caller stated he has a primary care doctor and declined to provide HCP information. Patient stated cold chills without a fever is intermittent where it comes for day or two and then goes away for a day or two. Caller stated it is so bad and he has had fatigue where he is in his bed for 3 or 4 hours when it hits him during the day. Caller stated he has taken over the counter medications like Ibuprofen and Tylenol but he has been trying to stay clean with his eating habits and not drink anything. Patient did not administered any other additional vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Hand swelling/Feet swelling; Numbness and tingling in fingers/numbness and tingling in toes; Numbness and tingling in fingers/numbness and tingling in toes; Ankle swelling; Cold chills without a fever; Fatigue; Cold chills without a fever; 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 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6200) at the age of 53 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: PERIPHERAL SWELLING (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Hand swelling/Feet swelling"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 15Mar2021, outcome "not recovered" and all described as "Numbness and tingling in fingers/numbness and tingling in toes"; JOINT SWELLING (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Ankle swelling"; NASOPHARYNGITIS (non-serious), CHILLS (non-serious) all with onset 15Mar2021, outcome "not recovered" and all described as "Cold chills without a fever"; FATIGUE (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Fatigue". The events "hand swelling/feet swelling", "numbness and tingling in fingers/numbness and tingling in toes", "numbness and tingling in fingers/numbness and tingling in toes", "ankle swelling", "cold chills without a fever", "fatigue" and "cold chills without a fever" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of peripheral swelling, hypoaesthesia, paraesthesia, joint swelling, nasopharyngitis, fatigue, chills.  Additional information: Caller stated he has a primary care doctor and declined to provide HCP information. Patient stated cold chills without a fever is intermittent where it comes for day or two and then goes away for a day or two. Caller stated it is so bad and he has had fatigue where he is in his bed for 3 or 4 hours when it hits him during the day. Caller stated he has taken over the counter medications like Ibuprofen and Tylenol but he has been trying to stay clean with his eating habits and not drink anything. Patient did not administered any other additional vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Skin infection
Clinical narrative: Skin infection; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SKIN INFECTION (non-serious), outcome "unknown", described as "Skin infection". Therapeutic measures were taken as a result of skin infection.  Additional information: Patient (Pt) wants to know if he chooses to postpone his second dose of the Pfizer COVID-19 vaccine due to his skin infection and being on antibiotics how long can he wait to receive the second dose after receiving the first dose beyond the recommend 3 week interval. Pt states that he has a skin infection and that his doctor (HCP) has prescribed antibiotics for him to take. Pt was concerned that currently taking these antibiotics at the same time that he is scheduled to receive his second dose may cause the Pfizer COVID-19 vaccine to be less effective or produce less antibodies. He would like to know if taking an antibiotic would cause any interactions with the vaccine. Pt states that he did not have any side effects after receiving his first dose of the Pfizer COVID-19 vaccine, however, he would like to know if he can take Tylenol in the event that he does have side effects after his second dose. He also states that he heard people should not take Tylenol prior to receiving the vaccine. Pt states that at the location where he received his first dose of the Pfizer COVID-19 vaccine the vaccination providers were administering Pfizer and Johnson and Johnson covid vaccines. He asks if he needs to verify that he receives the Pfizer COVID-19 vaccine for his second dose. Pt when received his first dose of the Pfizer COVID-19 vaccine he noticed that there were different colored caps on the vials and he states that with the new authorization of 12 years old and older being able to receive the Pfizer COVID-19 vaccine he is asking if there is any different in the doses for children versus adults (do the different color caps mean different dose strengths). What was the weight range in the group of 12 to 15 year olds in the Phase 3 study. Pt would like to know if the Pfizer COVID-19 vaccine is just as effective when the second dose is given at 6 weeks versus the recommended 3 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from a contactable pharmacist. A 41-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown),  2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed illness/was ill, with outcome of unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.