chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: started convulsing; passed out; throat felt funny; condition was worsening; hard to swallow; breathing was becoming more difficult; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 16:45 (Lot number: FD8448) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. No Known allergies. There were no concomitant medications. No other Vaccine in four weeks. No Other medications in two weeks. The following information was reported: SEIZURE (medically significant, life threatening) with onset 23Aug2021 16:45, outcome "recovered", described as "started convulsing"; LOSS OF CONSCIOUSNESS (medically significant, life threatening) with onset 23Aug2021 16:45, outcome "recovered", described as "passed out"; OROPHARYNGEAL DISCOMFORT (life threatening) with onset 23Aug2021 16:45, outcome "recovered", described as "throat felt funny"; CONDITION AGGRAVATED (life threatening) with onset 23Aug2021 16:45, outcome "recovered", described as "condition was worsening"; DYSPHAGIA (life threatening) with onset 23Aug2021 16:45, outcome "recovered", described as "hard to swallow"; DYSPNOEA (life threatening) with onset 23Aug2021 16:45, outcome "recovered", described as "breathing was becoming more difficult". The events "started convulsing", "passed out", "throat felt funny", "condition was worsening", "hard to swallow" and "breathing was becoming more difficult" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of seizure, loss of consciousness, oropharyngeal discomfort, condition aggravated, dysphagia, dyspnea. Clinical course: Immediately after receiving the shot the patient started convulsing and then passed out. The patient CMA to and waited until the color was back in his face and was able to stand. After 15 minutes we were told we could leave. The patient returned to his home, which is 2 miles from the pharmacy. The patient then alerted his mother that his throat felt funny. His mother called the pharmacy and they instructed him to watch for increased heartrate and labored breathing and go to the ER if this happens. The patient stated the condition was worsening and it was hard to swallow and breathing was becoming more difficult. # was called and the the patient then went to a neighbor's house who is a nurse and has epinephrine. He was administered an injection and immediately able to breathe. The ambulance arrived, took his vitals and then transported him to Hospital in (City and state name). AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event. Treatment included Patient was taken to ER at Hospital. No covid prior vaccination. No covid tested post vaccination.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: runny nose; Red raised rash at injection site/redness remained for 3-4 days; at 6hrs post shot fever began; chills; sweating; Headache; Joint pain; Itching at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 04Aug2021 08:45 (Lot number: EW0164) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. Past drug history included: Pcn, reaction(s): "Allergy", notes: PCN. The following information was reported: RHINORRHOEA (non-serious) with onset 04Aug2021 15:00, outcome "recovered" (2021), described as "runny nose"; VACCINATION SITE ERYTHEMA (non-serious) with onset 04Aug2021 15:00, outcome "recovered" (2021), described as "Red raised rash at injection site/redness remained for 3-4 days"; PYREXIA (non-serious) with onset 04Aug2021 15:00, outcome "recovered" (2021), described as "at 6hrs post shot fever began"; CHILLS (non-serious) with onset 04Aug2021 15:00, outcome "recovered" (2021), described as "chills"; HYPERHIDROSIS (non-serious) with onset 04Aug2021 15:00, outcome "recovered" (2021), described as "sweating"; HEADACHE (non-serious) with onset 04Aug2021 15:00, outcome "recovered" (2021), described as "Headache"; ARTHRALGIA (non-serious) with onset 04Aug2021 15:00, outcome "recovered" (2021), described as "Joint pain"; VACCINATION SITE PRURITUS (non-serious) with onset 04Aug2021 15:00, outcome "recovered" (2021), described as "Itching at injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The most recent COVID-19 vaccine was administered at doctor's office/urgent care. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient had not seen in the emergency department.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: runny nose; Red raised rash at injection site/redness remained for 3-4 days; at 6hrs post shot fever began; chills; sweating; Headache; Joint pain; Itching at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 04Aug2021 08:45 (Lot number: EW0164) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: was the patient diagnosed with COVID-19?:Yes. The patient's concomitant medications were not reported. Past drug history included: Pcn, reaction(s): "Allergy", notes: PCN. The following information was reported: RHINORRHOEA (non-serious) with onset 04Aug2021 15:00, outcome "recovered" (2021), described as "runny nose"; VACCINATION SITE ERYTHEMA (non-serious) with onset 04Aug2021 15:00, outcome "recovered" (2021), described as "Red raised rash at injection site/redness remained for 3-4 days"; PYREXIA (non-serious) with onset 04Aug2021 15:00, outcome "recovered" (2021), described as "at 6hrs post shot fever began"; CHILLS (non-serious) with onset 04Aug2021 15:00, outcome "recovered" (2021), described as "chills"; HYPERHIDROSIS (non-serious) with onset 04Aug2021 15:00, outcome "recovered" (2021), described as "sweating"; HEADACHE (non-serious) with onset 04Aug2021 15:00, outcome "recovered" (2021), described as "Headache"; ARTHRALGIA (non-serious) with onset 04Aug2021 15:00, outcome "recovered" (2021), described as "Joint pain"; VACCINATION SITE PRURITUS (non-serious) with onset 04Aug2021 15:00, outcome "recovered" (2021), described as "Itching at injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The most recent COVID-19 vaccine was administered at doctor's office/urgent care. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient had not seen in the emergency department.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: sore arm; fever; extremely tired for several days; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 70 year-old patient received bnt162b2 (BNT162B2), intramuscular, adminis-tered in arm left, administration date 15Mar2021 09:45 (Lot number: EN6204) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PMR", start date: 2020 (ongoing), notes: I was diagnosed with polymyalgia rheumatica in 2020; "Reflux", start date: 1990 (ongoing), notes: I was diagnosed with reflux at the age of 40 years old; "IC", start date: 1990 (ongoing), notes: I was diagnosed with Interstitial cystitis around the age of 40; "Chronic rhinitis" (ongoing), notes: I was diagnosed with chronic rhinitis years ago, cannot remember the exact date. Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing); AMLODIPINE taken for essential hypertension (ongoing); PREDNISONE taken for polymyalgia rheumatica, start date: Oct2020, stop date: 22Mar2021; CENTRUM SILVER +50 taken for vitamin a (ongoing). Vaccination histo-ry included: Bnt162b2 (dose 1, single, Lot: EM9809, Location: Left arm, Route: Intramuscular, Time: 09:25 AM), administration date: 22Feb2021, when the patient was 70 years old, for Covid-19 immunization, reaction: "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Mar2021 19:00, outcome "unknown", described as "sore arm"; PYREXIA (non-serious) with onset 15Mar2021 19:00, outcome "unknown", described as "fever"; FATIGUE (non-serious) with onset 15Mar2021 19:00, outcome "unknown", described as "extremely tired for several days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Swelling face
Clinical narrative: 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 26Aug2021 17:00 (Lot number: FC3184) at the age of 22 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "If Covid prior vaccination: Yes" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: SWELLING FACE (non-serious) with onset 28Aug2021 05:00, outcome "recovering", described as "slightly swollen face"; FACIAL PAIN (non-serious) with onset 28Aug2021 05:00, outcome "recovering", described as "face that hurt to touch or even blink". Therapeutic measures were not taken as a result of swelling face, facial pain. Additional information: Patient had no other vaccine in four weeks. Patient had no other medications in two weeks. I woke up today on 28Aug2021 with a slightly swollen face that hurt to touch or even blink. I put a cold compress on it which helped the swelling, but it still was very uncomfortable to touch or blink. Patient did not Covid-19 tested post vaccination. known allergies: Not that I know of. No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: Laid on the couch with 102 Degrees fever; resting heartbeat with 130 beats per minutes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 10:00 (Lot number: FD8448) at the age of 44 years as dose 1, single and administered in arm right, administration date 20Sep2021 10:00 (Lot number: FE3592) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid virus", start date: 01Jul2021, stop date: 15Jul2021. Family history included: "Multiple sclerosis", start date: 10Oct2018 (ongoing), notes: Verbatim: Multiple sclerosis; "Exercise Induced asthma" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AUBAGIO. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Laid on the couch with 102 Degrees fever"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "resting heartbeat with 130 beats per minutes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, heart rate increased.  Additional information: Patient recently got her second shot yesterday through Pfizer and she laid on the couch right now with 102 Degrees fever and her resting heartbeat on the couch right now is 130 beats per minutes and pretty much that happen with the first dose. Don't know she need a medical help or not last time the same thing happened, so reporter want to make sure these could be normal side effects she received from her second (dose) vaccine yesterday. She is experiencing the same thing as from the first dose, so reporter guess her side effects 102 Degrees fever and lying on couch heartbeat is 130 beats per minute. Treatment for the event received with Motrin and Tylenol. No Any prior vaccination within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Heart rate, Heart rate increased, Palpitations
Clinical narrative: she reports having heart palpitations; feeling of pressure in the chest area; it feels like a fast heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Aug2021 17:45 (Lot number: FN7435) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vegetarian" (unspecified if ongoing); "Gluten free diet" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PALPITATIONS (non-serious) with onset 28Aug2021, outcome "recovering", described as "she reports having heart palpitations"; CHEST DISCOMFORT (non-serious) with onset 28Aug2021, outcome "recovering", described as "feeling of pressure in the chest area"; HEART RATE INCREASED (non-serious) with onset 28Aug2021, outcome "recovering", described as "it feels like a fast heart rate". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that patient received fist dose of the Pfizer Vaccine on 28Aug2021, Saturday. Since the night of having her vaccine, she reports having above event. The above event are during a "resting state." The patient was really fit and doesn't take any medicine. It was reported that the first couple of hours Saturday night, within 2 hours of getting the vaccine, the caller had above events. This was most uncomfortable Saturday night. The caller notices it most when she is in a resting state like when she stops, it feels like a fast heart rate. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patients did not visit Emergency Room or Physician Office for events. No prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. No family Medical History Relevant to AE(s).  No follow-up attempts are possible. No further information is expected.  Follow-up (13Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: severe headache / headache get so severe that it feels like it is going to explode; severe headache / headache get so severe that it feels like it is going to explode; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 16:45 (Lot number: EP7533) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D NOS; POTASSIUM CITRATE; TRAMADOL; AMBIEN. Vaccination history included: Bnt162b2 (Dose Number: 1, Previous dose details: , Previous dose product=COVID 19, Previous dose brand=Pfizer, Previous dose brand unknown=False, Previous dose lot number=EN6204, Previous dose lot unknown=False, Previous dose administration date=03Mar2021, Previous dose administration time=04:45PM, ), administration date: 03Mar2021, when the patient was 64 years old, for COVID-19 immunization, reaction(s): "Covid test result=Positive", "Covid test result=Positive". The following information was reported: HEADACHE (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 25Mar2021, outcome "not recovered" and all described as "severe headache / headache get so severe that it feels like it is going to explode". The event "severe headache / headache get so severe that it feels like it is going to explode" and "severe headache / headache get so severe that it feels like it is going to explode" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, condition aggravated.  Patient did not receive any other vaccine in four weeks. Patient is under treatment at (clinic name). Patient did not have covid prior to vaccination, but patient tested positive post vaccination. Patient has severe headache since 25Mar2021.Visited neurologist for headcahes, got MRI and still going to clinic. No pain relief yet, headache get so severe that it feels like it was going to explode.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Headache, Magnetic resonance imaging
Clinical narrative: severe headache / headache get so severe that it feels like it is going to explode; severe headache / headache get so severe that it feels like it is going to explode; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 16:45 (Lot number: EP7533) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D NOS; POTASSIUM CITRATE; TRAMADOL; AMBIEN. Vaccination history included: Bnt162b2 (Dose Number: 1, Previous dose details: , Previous dose product=COVID 19, Previous dose brand=Pfizer, Previous dose brand unknown=False, Previous dose lot number=EN6204, Previous dose lot unknown=False, Previous dose administration date=03Mar2021, Previous dose administration time=04:45PM, ), administration date: 03Mar2021, when the patient was 64 years old, for COVID-19 immunization, reaction(s): "Covid test result=Positive", "Covid test result=Positive". The following information was reported: HEADACHE (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 25Mar2021, outcome "not recovered" and all described as "severe headache / headache get so severe that it feels like it is going to explode". The event "severe headache / headache get so severe that it feels like it is going to explode" and "severe headache / headache get so severe that it feels like it is going to explode" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, condition aggravated.  Patient did not receive any other vaccine in four weeks. Patient is under treatment at (clinic name). Patient did not have covid prior to vaccination, but patient tested positive post vaccination. Patient has severe headache since 25Mar2021.Visited neurologist for headcahes, got MRI and still going to clinic. No pain relief yet, headache get so severe that it feels like it was going to explode.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: medium headache/ severe headache; ringing in the ears (tinnitus); This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 05Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 06Feb2021, outcome "recovered" (13Mar2021), described as "medium headache/ severe headache "; TINNITUS (non-serious) with onset 06Feb2021, outcome "not recovered", described as "ringing in the ears (tinnitus)".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021334526 similar report from same reporter
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and Itching on my Arms, Feet and Legs; Hives and Itching on my Arms, Feet and Legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 17:30 (Lot number: FC3180) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "If covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: PRURITUS (non-serious), URTICARIA (non-serious) all with onset 25Aug2021 07:00, outcome "recovering" and all described as "Hives and Itching on my Arms, Feet and Legs". Therapeutic measures were not taken as a result of pruritus, urticaria.  Additional information: Patient did not receive any other vaccine in four weeks. Patient did not receive Other medications in two weeks. AE resulted in None of the above. Patient did not test COVID post vaccination..  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Lip swelling
Clinical narrative: When I wake up  like 07:00 AM, I saw that, My lip was swollen.; Upper left part of my lips was swollen and numb; Right side of my face became numb like partially numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 12:45 (Lot number: FF2588) at the age of 24 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: HYPOAESTHESIA (non-serious) with onset 09Sep2021 12:47, outcome "unknown", described as "Right side of my face became numb like partially numb"; LIP SWELLING (non-serious) with onset 10Sep2021 07:00, outcome "unknown", described as "When I wake up  like 07:00 AM, I saw that, My lip was swollen."; HYPOAESTHESIA ORAL (non-serious) with onset 10Sep2021 07:00, outcome "unknown", described as "Upper left part of my lips was swollen and numb".  Additional information: Patient got her first Pfizer shot yesterday and she was having some bad side effects. So, right after almost immediately after getting the shot, May be two minutes after the shot, she started right side of her face, became numb like partially numb so, she did not think it is a big deal so, she went home and when she was waking, when she wake up like 07 am, she saw that her lip was swollen. The upper left part of her lips was swollen and numb."   Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Headache, Heart rate increased
Clinical narrative: Rapid heart rate; Tight feeling around left side of chest; muscle twitching in my left eyebrow along with both leg calfs; sweats; headaches; chills; fever; fatigue; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Sep2021 10:30 (Lot number: FE3592) at the age of 22 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: HEART RATE INCREASED (non-serious) with onset 05Sep2021 20:00, outcome "not recovered", described as "Rapid heart rate"; CHEST DISCOMFORT (non-serious) with onset 05Sep2021 20:00, outcome "not recovered", described as "Tight feeling around left side of chest"; MUSCLE TWITCHING (non-serious) with onset 05Sep2021 20:00, outcome "not recovered", described as "muscle twitching in my left eyebrow along with both leg calfs"; HYPERHIDROSIS (non-serious) with onset 05Sep2021 20:00, outcome "not recovered", described as "sweats"; HEADACHE (non-serious) with onset 05Sep2021 20:00, outcome "not recovered", described as "headaches"; CHILLS (non-serious) with onset 05Sep2021 20:00, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 05Sep2021 20:00, outcome "not recovered", described as "fever"; FATIGUE (non-serious) with onset 05Sep2021 20:00, outcome "not recovered", described as "fatigue". The events "rapid heart rate", "tight feeling around left side of chest", "muscle twitching in my left eyebrow along with both leg calfs", "sweats", "headaches", "chills" and "fever" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, chest discomfort, muscle twitching, hyperhidrosis, headache, chills, pyrexia, fatigue.  Additional information: Patient did not receive other vaccine in four weeks and Other medications in two weeks. Rapid heart rate, Tight feeling around left side of chest, muscle twitching in my left eyebrow along with both leg calfs. Along with sweats, headaches, chills, fever, & fatigue. The side effects are still happening a week later although the fatigue & fever has lessenend. Patient did not receive treatment ae. If covid prior vaccination: No, Known allergies: No  Follow-Up (15Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Muscle twitching, Pyrexia, SARS-CoV-2 antibody test negative
Clinical narrative: Rapid heart rate; Tight feeling around left side of chest; muscle twitching in my left eyebrow along with both leg calfs; sweats; headaches; chills; fever; fatigue; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Sep2021 10:30 (Lot number: FE3592) at the age of 22 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: HEART RATE INCREASED (non-serious) with onset 05Sep2021 20:00, outcome "not recovered", described as "Rapid heart rate"; CHEST DISCOMFORT (non-serious) with onset 05Sep2021 20:00, outcome "not recovered", described as "Tight feeling around left side of chest"; MUSCLE TWITCHING (non-serious) with onset 05Sep2021 20:00, outcome "not recovered", described as "muscle twitching in my left eyebrow along with both leg calfs"; HYPERHIDROSIS (non-serious) with onset 05Sep2021 20:00, outcome "not recovered", described as "sweats"; HEADACHE (non-serious) with onset 05Sep2021 20:00, outcome "not recovered", described as "headaches"; CHILLS (non-serious) with onset 05Sep2021 20:00, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 05Sep2021 20:00, outcome "not recovered", described as "fever"; FATIGUE (non-serious) with onset 05Sep2021 20:00, outcome "not recovered", described as "fatigue". The events "rapid heart rate", "tight feeling around left side of chest", "muscle twitching in my left eyebrow along with both leg calfs", "sweats", "headaches", "chills" and "fever" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, chest discomfort, muscle twitching, hyperhidrosis, headache, chills, pyrexia, fatigue.  Additional information: Patient did not receive other vaccine in four weeks and Other medications in two weeks. Rapid heart rate, Tight feeling around left side of chest, muscle twitching in my left eyebrow along with both leg calfs. Along with sweats, headaches, chills, fever, & fatigue. The side effects are still happening a week later although the fatigue & fever has lessenend. Patient did not receive treatment ae. If covid prior vaccination: No, Known allergies: No  Follow-Up (15Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Genital pain, Pruritus, Sensitive skin, Sexually transmitted disease test
Clinical narrative: Very sensitive and somewhat itchy and painful skin on genitalia; Very sensitive and somewhat itchy and painful skin on genitalia; Very sensitive and somewhat itchy and painful skin on genitalia; Sensitive skin on knuckle of right hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jun2021 (Lot number: EW0196) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Nov2020 (unspecified if ongoing). There were no concomitant medications. The following information was reported: SENSITIVE SKIN (non-serious), GENITAL PAIN (non-serious) all with onset Jun2021, outcome "not recovered" and all described as "Very sensitive and somewhat itchy and painful skin on genitalia"; PRURITUS (non-serious) with onset Jun2021, outcome "recovering", described as "Very sensitive and somewhat itchy and painful skin on genitalia"; SENSITIVE SKIN (non-serious) with onset Jun2021, outcome "not recovered", described as "Sensitive skin on knuckle of right hand". The events "very sensitive and somewhat itchy and painful skin on genitalia", "very sensitive and somewhat itchy and painful skin on genitalia" and "very sensitive and somewhat itchy and painful skin on genitalia" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section included Full STD Screening: Negative (2021). Therapeutic measures were taken as a result of sensitive skin, genital pain, pruritus, sensitive skin included topical lotions and anti-itch cream.   Additional Information: The patient wanted to report long term side effects that he had been experiencing for the last three months. The patient had very sensitive and somewhat itchy and painful skin on genitalia. Sensitive in a bad way per the patient. Painful itch pretty much everyday. Stated it started after his first dose of the vaccine which was on 22Jun2021. It might have started around June 30th or sooner. Stated it might be a little better than it was, but it was persisting. Sensitive skin on knuckle of right hand. The patient stated this started at the same time as his very sensitive and somewhat itchy and painful skin on his genitalia. This was also persisting. The patient stated that he had a full STD screening and it was negative. There were no visible signs of anything being wrong. His doctor had just been managing his symptoms with topical lotions and anti-itch cream. The patient stated it was not just itchy though, it was also painful. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks).   No follow-up attempts are possible. Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Eye irritation, Taste disorder
Clinical narrative: Acrid taste to mouth/ tongue; Burning eyes; Tight chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 26Aug2021 12:00 (Lot number: FA748S) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "note: I do smoke cigarettes" (unspecified if ongoing), notes: otherwise great health good. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: TASTE DISORDER (non-serious) with onset 27Aug2021 18:00, outcome "not recovered", described as "Acrid taste to mouth/ tongue"; EYE IRRITATION (non-serious) with onset 27Aug2021 18:00, outcome "not recovered", described as "Burning eyes"; CHEST DISCOMFORT (non-serious) with onset 27Aug2021 18:00, outcome "not recovered", described as "Tight chest". Therapeutic measures were not taken as a result of taste disorder, eye irritation, chest discomfort.  Additional Information: If other vaccine in four weeks was No. Patient experienced Acrid taste to mouth tongue-noticed approximately 24 hours following injection - to current date. Burning eyes. Tight chest. No apparent fever or major adverse event. If covid prior vaccination was No and If covid tested post vaccination was No. No Known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysgeusia, Joint range of motion decreased, Tinnitus, Vaccination site pain
Clinical narrative: Decreased range of motion in left shoulder joint; Pain/left shoulder joint; Tinnitus; Vaccination site pain; Metallic taste in mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 13:30 (Lot number: FC3182) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroidectomy" (unspecified if ongoing); "Allergies: eggs" (unspecified if ongoing); "Allergies: Sulfa drugs" (unspecified if ongoing); "Allergies: onions" (unspecified if ongoing); "allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Doxycycline, reaction(s): "Known allergies to doxycycline". The following information was reported: TINNITUS (non-serious) with onset 26Aug2021 15:00, outcome "recovered" (Aug2021), described as "Tinnitus"; DYSGEUSIA (non-serious) with onset 26Aug2021 13:30, outcome "recovered" (Aug2021), described as "Metallic taste in mouth"; VACCINATION SITE PAIN (non-serious) with onset 26Aug2021 15:00, outcome "recovered" (Aug2021), described as "Vaccination site pain"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Decreased range of motion in left shoulder joint"; ARTHRALGIA (non-serious) with onset 27Aug2021, outcome "not recovered", described as "Pain/left shoulder joint". Therapeutic measures were not taken as a result of tinnitus, dysgeusia, vaccination site pain, joint range of motion decreased, arthralgia.  Additional information: Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated
Clinical narrative: 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 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Aug2021 14:00 (Lot number: EW0186) at the age of 69 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Broke finger" (unspecified if ongoing), notes: He had the broke finger and surgeries before he got the shot; "Surgeries" (unspecified if ongoing), notes: He had the broke finger and surgeries before he got the shot; "Diagnosed allergies" (unspecified if ongoing); "Compromised immune status" (unspecified if ongoing); "Respiratory illness" (unspecified if ongoing); "Genetic/chromosomal abnormalities" (unspecified if ongoing); "Endocrine abnormalities (including diabetes)" (unspecified if ongoing); "Endocrine abnormalities (including diabetes)" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergic to Codeine", notes: Illness/AE: Allergic to Codeine, Morphine and those type of things., Onset Date: It has been 20 years ago or longer.; Morphine, reaction(s): "Allergic to Morphine", notes: Illness/AE: Allergic to Codeine, Morphine and those type of things., Onset Date: It has been 20 years ago or longer. The following information was reported: ARTHRALGIA (non-serious) with onset 09Aug2021 14:30, outcome "not recovered", described as "joint pains"; ARTHRALGIA (non-serious) with onset 09Aug2021 14:30, outcome "not recovered", described as "joint pain in neck and back of shoulders"; CONDITION AGGRAVATED (non-serious) with onset 09Aug2021, outcome "unknown", described as "joint pains/Joint pain was reported as worsened". Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling, Pyrexia
Clinical narrative: my lip was swollen; my upper lip was swollen; running a fever; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 74 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Sep2021 (Lot number: FC3184) at the age of 74 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: LIP SWELLING (non-serious) with onset Sep2021, outcome "unknown", described as "my lip was swollen; my upper lip was swollen"; PYREXIA (non-serious) with onset Sep2021, outcome "unknown", described as "running a fever".  Additional information: Concern: Consumer stated, I woke up this morning I had the vaccine shot (Clarified as Pfizer COVID 19 vaccine) and I woke up this morning and my lip was swollen that is all. Height and Weight: Consumer stated, My height is 5'3 I mean 5'6 and my weight I think might be 160(pounds). Site of injection: Consumer stated, It's my upper lip. My right arm. Treatment taken: Consumer stated, (Not appropriately clarified if taken any treatment). If taken any vaccination before first shot of COVID: Consumer stated, No. Anything else to help with: Consumer stated, No I just woke up this morning and my upper lip was swollen. I try to see if it go down and I running a fever and it's just a swelling that's all. I am just wondering if why it made it swelled up if vaccine made it.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: felt minor chest pains/the 2nd week he felt like a heavy strong chest pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 (Lot number: EW0179) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "cholesterol is a little high", start date: 2021 (unspecified if ongoing), notes: did bloodwork back in Jun2021 or Jul2021 and was told his cholesterol was a little high; "Covid", start date: Mar2021 (unspecified if ongoing), notes: had Covid in Mar2021. There were no concomitant medications. Vaccination history included: Tb shot (got the TB shot and it left a mark). The following information was reported: CHEST PAIN (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "felt minor chest pains/the 2nd week he felt like a heavy strong chest pain". Additional information: HCP occupation/specialty was pediatrician. Caller states that the 2nd or 3rd day after the shot he felt minor chest pains and the 2nd week he felt like a heavy strong chest pain that he did not go to the ER or doctor for. Caller relays that it went away after 2-3 minutes, that it seemed longer to him but it was probably like 2-3 minutes. No investigation assessment. States that after that 1st week on the 2nd or 3rd day it went away and did not happen again until the middle of the 2nd week it happened again and went away and he hopes it does not come again. Caller states he had Covid in Mar2021 and did not get that strong chest pain then. Time the vaccination was given around 12-1pm. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the pfizer suspect. No prior vaccinations (within 4 weeks). Caller was asking should he take the 2nd shot.   No follow-up attempts are possible. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Retinal artery occlusion
Clinical narrative: Central retinal artery occlusion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. Other Case identifier(s): US-PFIZER INC-202200165097 (Pfizer).  A male patient received bnt162b2 (BNT162B2), administration date 24Aug2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RETINAL ARTERY OCCLUSION (medically significant) with onset 15Sep2021, outcome "unknown", described as "Central retinal artery occlusion".  Clinical Course: Reporter stated that patient has not had a history of stroke or blood clot and after the occurrence of this a battery of stroke intervention tests were run and no other clots were found. Could the booster have contributed to the blood clot causing this permanent loss of vision in his right eye?  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Arthritis, Gait disturbance, Hypokinesia, Inflammation
Clinical narrative: barely able to walk; inflammation in my legs; can barely move my arms due to inflammation in my shoulders; can barely move my arms due to inflammation in my shoulders; barely able to get into and out of the bed; Anemia; can barely move my arms due to inflammation in my shoulders; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), when the patient was 71 years old, for Covid-19 Immunization, reaction(s): "joint pain", "joint pain inflammation", "aching muscles and joints after the first shot for a week continued aching muscle and joint pain inflammation". The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "barely able to walk"; INFLAMMATION (non-serious), outcome "unknown", described as "inflammation in my legs"; LIMB DISCOMFORT (non-serious), ARTHRITIS (non-serious), HYPOKINESIA (non-serious), outcome "unknown" and all described as "can barely move my arms due to inflammation in my shoulders"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "barely able to get into and out of the bed"; ANAEMIA (non-serious), outcome "unknown", described as "Anemia".  Additional information: It was reported that the patient had aching muscles and joints after the first shot for a week continued aching muscle and joint pain inflammation as separate of eighty and anemia. The patient was barely able to walk due to inflammation in legs, can barely move arms due to inflammation in shoulders, was barely able to get into and out of the bed.The patient had aching muscles and joints after the first shot for a week, continued aching muscle and joint pain, inflammation at sed rate of eighty and anemia after the 2nd vaccine it had been 10 weeks and patient was barely able to walk.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.