chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Sleep disorder
Clinical narrative: I'm breastfeeding and my son who is 10mths old; 10mths old could not sleep/nap for 48 hours following my shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient was exposed to bnt162b2 (BNT162B2), transmammary administered in arm left, administration date 11Aug2021 (Lot number: FA7485) as dose number unknown, single for covid-19 immunisation. The mother of the patient was 34 year-old. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE VIA BREAST MILK (non-serious) with onset Aug2021, outcome "unknown", described as "I'm breastfeeding and my son who is 10mths old"; SLEEP DISORDER (non-serious) with onset Aug2021, outcome "unknown", described as "10mths old could not sleep/nap for 48 hours following my shot.".  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. No treatments received for adverse event.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: Pain in injection site; swollen lymph node in arm pit; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Aug2021 10:30 (Lot number: EW0217) at the age of 50 years as dose 2, single for covid-19 immunization. Relevant medical history included: "known allergies: PCN" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, product: COVID 19, brand: pfizer,, lot number: fag720,, administration time: 01:00 PM,, vaccine location: Right arm), administration date: 22Jul2021, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 19Aug2021 18:00, outcome "unknown", described as "Pain in injection site "; LYMPHADENOPATHY (non-serious) with onset 19Aug2021 18:00, outcome "unknown", described as " swollen lymph node in arm pit". Therapeutic measures were not taken as a result of vaccination site pain, lymphadenopathy. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient did not diagnosed with COVID-19. Since the vaccination the patient did not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Agent reports caller said she has tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Agent reports caller said she has tinnitus".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Experiencing pain under her armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adult female patient received bnt162b2 (BNT162B2) (Lot number: EW0164) as dose number unknown, 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: AXILLARY PAIN (non-serious), outcome "unknown", described as "Experiencing pain under her armpit". Therapeutic measures were taken as a result of axillary pain.   Additional information: She did not have prior vaccination (within 4 weeks). The patient received a Pfizer shot on Thursday and experiencing pain under her armpit. She took Tylenol, 20 minutes ago. The patient's mother was concerned that if she should take her to the emergency room.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Condition aggravated, Muscle spasms, Myalgia, Pain
Clinical narrative: Abdominal muscles and tissues pain on my digestive system; Muscles and tendons tied up cause cramping and pain; Muscles and tendons tied up cause cramping and pain; Problem flared up; Extreme pain for five days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Jun2021 17:00 (Lot number: G000196) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: ABDOMINAL PAIN (non-serious), outcome "unknown", described as "Abdominal muscles and tissues pain on my digestive system"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Extreme pain for five days"; MYALGIA (non-serious), MUSCLE SPASMS (non-serious), outcome "unknown" and all described as "Muscles and tendons tied up cause cramping and pain"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Problem flared up".  Additional information: The first dose, dose one. You want me to explain? So, I have had an ongoing problem with my abdominal muscles and tissues pain it's on my digestive system, I have had extensive testing on the digestive system and it's okay so it's just the muscles and tendons that tied up and cause cramping and pain and this is been going on for about a year and a half and so after the first dose and so this problem had really lessened and almost seem to be gone and then when I had the COVID vaccine within in a day this problem flared up again so, it was like a relapse of the problem and I was in extreme pain for five days. I take vitamins, lots of vitamins like Vitamin C and D. I take something called GI restore so it's mainly supplement, vitamin supplements.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur
Clinical narrative: Heart murmur; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 16:00 (Lot number: EW0172) at the age of 14 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: CARDIAC MURMUR (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Heart murmur". The event "heart murmur" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of cardiac murmur.  Additional information: Patient did not take other vaccine in four weeks. Patient did not take any other medications in two weeks. There was no covid prior vaccination. Patient was not tested for covid post vaccination. There were no known allergies. Patient was a perfectly athletic healthy fit teenager. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Paraesthesia
Clinical narrative: so I have to start taking a beetroot supplement (treatment) to get the blood flow back to normal; I noticed a reaction; I felt the tingling again; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "brain cancer" (unspecified if ongoing), notes: brain cancer survivor (history); "mild neuropathy" (unspecified if ongoing), notes: it 'affect' that in my hand and feet with neuropathy; "chemotherapy", start date: 2008, stop date: 2008, notes: had 'forms' the chemotherapy in 2008 along with the radiations to my brain; "radiations", start date: 2008, stop date: 2008, notes: had 'forms' the chemotherapy in 2008 along with the radiations to my brain. The patient's concomitant medications were not reported. The following information was reported: CARDIOVASCULAR DISORDER (non-serious), outcome "recovered", described as "so I have to start taking a beetroot supplement (treatment) to get the blood flow back to normal"; PARAESTHESIA (non-serious), outcome "unknown", described as "I noticed a reaction; I felt the tingling again". Therapeutic measures were taken as a result of cardiovascular disorder, paraesthesia.  Additional information: It was reported that the patient had chemotherapy and radiations to brain and it affected in the hand and feet with neuropathy, and it was been there since, it repaired some but still the hands and feet remained cold because the blood flow in the extremities was rather weak. The patient hesitated about getting the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jul2021 18:45 (Lot number: FA7484) at the age of 12 years as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TDAP, administration date 12Jul2021. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Aug2021 20:00, outcome "recovering", described as "1st dose sore left arm and sore right arm per patient"; MYALGIA (non-serious) with onset 21Aug2021 20:00, outcome "recovering", described as "muscle aches". Therapeutic measures were not taken as a result of pain in extremity, myalgia. Additional information: Other medications in two weeks was None. No Covid prior vaccination. No Covid tested post vaccination. No Known allergies. No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling
Clinical narrative: Armpit swelling; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 15:00 (Lot number: EWO173) at the age of 52 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: SWELLING (non-serious) with onset 20Aug2021 15:00, outcome "unknown", described as "Armpit swelling". The event "armpit swelling" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling.  Additional information: Patient had no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: unilateral axillary lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Aug2021 (Lot number: EW0202) at the age of 32 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 21Aug2021, outcome "not recovered", described as "unilateral axillary lymphadenopathy". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient reported vaccine was injected in L arm. 24 hours later, she began experiencing unilateral axillary lymphadenopathy. The axilla was tender. They persisted 48 hours post-vaccine. No other vaccine was given in four weeks. The patient was not diagnoses with COVID prior vaccination and not tested post vaccination  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neuralgia, SARS-CoV-2 test
Clinical narrative: Swollen Lymph nodes; Nerve pain comes and goes throughout the body.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Aug2021 11:00 (Lot number: FA6780, Expiration Date: 30Sep2021) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gluten" (unspecified if ongoing); "Dairy" (unspecified if ongoing); "Egg yolks" (unspecified if ongoing); "Sulfonamides" (unspecified if ongoing). There were no concomitant medications. The following information was reported: NEURALGIA (non-serious) with onset 08Aug2021, outcome "recovering", described as "Nerve pain comes and goes throughout the body."; LYMPHADENOPATHY (non-serious) with onset 09Aug2021, outcome "unknown", described as "Swollen Lymph nodes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of neuralgia.  Additional information: No other vaccine was given in four weeks.No other medications were given in two weeks: No. The patient did not had covid prior vaccination. The patient did not tested for covid post vaccination. the patient was queried: The Pfizer Drug safety unit recently received the attached report submitted by you via [Website Name] Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. The patient responded the patient first became aware of nerve pain symptoms on 09Aug2021.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Irritability, Tinnitus
Clinical narrative: Ringing in my ears; It's not horrible but it's irritating; 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 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 15:15 (Lot number: FC3183) at the age of 40 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: TINNITUS (non-serious) with onset 18Aug2021 15:30, outcome "not recovered", described as "Ringing in my ears"; IRRITABILITY (non-serious) with onset 18Aug2021, outcome "unknown", described as "It's not horrible but it's irritating". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Patient got first dose on Wednesday last week and 4 hours later I had ringing in my ears. Patient thought it would go away the next day and it didn't. It was not gone away. It's like shooting a gun without ear protection. It's not horrible but it's irritating. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any treatment for the events.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: her right ear started throbbing and it is constant.; 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 female patient received bnt162b2 (BNT162B2), administration date 17Aug2021 (Lot number: EW0217, Expiration Date: 30Sep2021) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Leukemia" (unspecified if ongoing), notes: Verbatim: Leukemia; "Chronic kidney disease" (unspecified if ongoing), notes: Verbatim: Chronic kidney disease; "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: SPRYCEL taken for leukaemia; LEVOTHYROXINE; AMLODIPINE; ROSUVASTIN; CLOPIDOGREL; VIT C; VIT D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (She got the first dose on 27Jul2021 and after that her left ear was hurting), administration date: 27Jul2021, when the patient was 69 years old, for Covid-19 Immunisation, reaction(s): "Ear pain", "burping"; Tetanus shot (Heart rate dropped and the caller passed out Onset Age: 63 Vaccine/Brand Name: , Tetanus Shot; unknown brand Vaccination Date: 6 years ago), when the patient was 63 years old, reaction(s): "Heart rate dropped". The following information was reported: EAR DISCOMFORT (non-serious) with onset 21Aug2021, outcome "not recovered", described as "her right ear started throbbing and it is constant.".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Illness, Tinnitus
Clinical narrative: dizzy; tinnitus; illness; suffers from tinnitus and the said illness has elevated or worsened; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus"; ILLNESS (non-serious), outcome "unknown", described as "illness"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "suffers from tinnitus and the said illness has elevated or worsened".  Additional information: The reporter suffers from tinnitus like the sound of ringing in her ears. She mentioned that she does not want what happened to a friend of hers that also suffers from tinnitus and the said illness has elevated or worsened. Her friend (male) also got dizzy after he took the Pfizer Covid-19 vaccine. She also mentioned that she has anaphylaxis on certain things. She wants to know if it is true that Pfizer is not liable for health injuries.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: I have experienced a hypersensitive sense of smell since receiving the vaccine and constantly smell cigarette smoke when there is no one smoking.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 17:30 (Lot number: Fc3182) at the age of 42 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: PAROSMIA (non-serious) with onset 17Aug2021 18:00, outcome "not recovered", described as "I have experienced a hypersensitive sense of smell since receiving the vaccine and constantly smell cigarette smoke when there is no one smoking.". Therapeutic measures were not taken as a result of parosmia.  Additional information: The smell comes in waves with the odor being strong and more nauseating at times than others. Patient not currently positive for COVID-19 nad not tested positive in the past.   Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Foot swollen after 1st; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15May2021 14:00 (Lot number: EW0181) at the age of 83 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PENICILIN" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL taken for blood pressure measurement. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "Foot swollen after 1st". The event "foot swollen after 1st" was evaluated at the physician office visit. Therapeutic measures were taken as a result of peripheral swelling.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events result in doctor or other healthcare professional office/clinic visit and treatment received for the adverse event was Water pill. The patient received Verapamil medications within 2 weeks of vaccination for Blood Pressure.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Leg and ankle swollen after 2nd dose; Leg and ankle swollen after 2nd dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jun2021 14:00 (Lot number: EW0191) at the age of 83 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies : PENICILIN" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL taken for blood pressure measurement. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0181, Administration time: 02:00 PM), administration date: 15May2021, when the patient was 83 years old, for COVID-19 immunization, reaction(s): "Foot swollen after 1st". The following information was reported: PERIPHERAL SWELLING (non-serious), JOINT SWELLING (non-serious) all with onset 14Jul2021 08:00, outcome "not recovered" and all described as "Leg and ankle swollen after 2nd dose". The event "leg and ankle swollen after 2nd dose" and "leg and ankle swollen after 2nd dose" was evaluated at the physician office visit. Therapeutic measures were taken as a result of peripheral swelling, joint swelling. Additional information: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. AE treatment was water pill.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Somnolence
Clinical narrative: Tired; Took a lot of naps; With her first dose she was fine all she had was a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jul2021 10:30 (Lot number: FAC780) at the age of 72 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jul2021, outcome "recovered" (2021), described as "With her first dose she was fine all she had was a sore arm"; FATIGUE (non-serious) with onset 31Jul2021, outcome "unknown", described as "Tired"; SOMNOLENCE (non-serious) with onset 31Jul2021, outcome "unknown", described as "Took a lot of naps".  Additional Information: She did not have to go the doctor or ER. No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Muscle Cramps; Arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Jul2021 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunization. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MUSCLE SPASMS (non-serious) with onset 2021, outcome "recovering", described as "Muscle Cramps"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovering", described as "Arm pain". Therapeutic measures were not taken as a result of muscle spasms, pain in extremity.  Additional information: Pharmacy or Drug Store Facility used for COVID-19 vaccine administered. The patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Blood Pressure Meds within 2 weeks of vaccination. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. No known allergies:   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Vaccination site pain
Clinical narrative: Mild pain around injection site; tiredness; sore eyes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Aug2021 15:15 (Batch/Lot number: unknown) at the age of 32 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 (Product name: Pfizer covid-19 vaccine , Batch/lot number: EW0173, Anatomical Location: Arm Right , Dose Number: 1), administration date: 31Jul2021, when the patient was 32 years old, for Covid-19 immunization, reaction(s): "Pain around injection site". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Aug2021 15:15, outcome "recovered" (Aug2021), described as "Mild pain around injection site"; FATIGUE (non-serious) with onset 22Aug2021 15:15, outcome "recovered" (Aug2021), described as "tiredness"; EYE PAIN (non-serious) with onset 22Aug2021 15:15, outcome "recovered" (Aug2021), described as "sore eyes". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, eye pain.  Additional information: Lot was unknown reason unable to locate or read the details. Patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not received treatment. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Dec2020 (Lot number: EL0142) as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Therapeutic measures were taken as a result of pain in extremity. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: slight chills; muscle pain; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 41-years-old female patient received bnt162b2 (BNT162B2), administration date 11Jan2021 (Lot number: EL0142) as DOSE 2, SINGLE for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, LOT: EL0142), administration date: 23Dec2020, when the patient was 41 years old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "slight chills"; MYALGIA (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "muscle pain"; FATIGUE (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "fatigue".  Additional Information: Caller said she was a healthcare provider, clarified to being a physical therapist who works with COVID patients. She said she received her third dose booster shot, clarified to being PFIZER COVID-19 vaccine, on Friday and was still home today and is still pretty sick. She said it was important for PFIZER to hear what was happening and she got the third dose booster because her son was immunocompromised. She said after her second dose for the first 24-36 hours, she had slight chills, muscle pain, and fatigue. She said she feels like it was important, since those working in health care environment are shorthanded and health care providers getting the vaccines should be recommended to be staggered. She says that she doesn't need attention, she just wanted to recommend staggering it, because she doesn't want people to hear about negative side effects for a bunch of people and not get it, she would like Pfizer to be ahead of it and not behind it, to better encourage people to get the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain around injection site happened after 1st dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jul2021 (Lot number: EW0173) at the age of 32 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: VACCINATION SITE PAIN (non-serious) with onset 22Aug2021, outcome "recovered" (2021), described as "pain around injection site happened after 1st dose". Therapeutic measures were not taken as a result of vaccination site pain.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: his brother received the Pfizer Covid-19 vaccine and got sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "his brother received the Pfizer Covid-19 vaccine and got sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, SARS-CoV-2 test, Ventricular extrasystoles
Clinical narrative: elevated heart rate; PVC's which lasted for three weeks.; 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 01Jul2021 12:30 (Lot number: EW0100) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "tree nut allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Note: Product=COVID 19, Brand=Pfizer,, Lot number=EW0100,, Lot unknown=False,, Administration date=10Jun2021,, Administration time=01:45 PM,, Dose number=1,, Vaccine location=Left arm), administration date: 10Jun2021, when the patient was 48 years old, for covid-19 Immunisation. The following information was reported: HEART RATE INCREASED (non-serious) with onset 03Jul2021 08:00, outcome "recovered" (2021), described as "elevated heart rate"; VENTRICULAR EXTRASYSTOLES (non-serious) with onset 03Jul2021 08:00, outcome "recovered" (2021), described as "PVC's which lasted for three weeks.". The events "elevated heart rate" and "pvc's which lasted for three weeks." were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heart rate increased, ventricular extrasystoles.  Additional information:The patient AE treatment includes: Blood tests, EKG, Heart monitor.Patient had other vaccine in four weeks: No.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache, Magnetic resonance imaging, Migraine
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (parent). A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed a headache/he had a very severe headache/migraine, with outcome of not recovered. The events evaluated at an emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient received the Pfizer vaccine and since then he experienced a very severe headache/severe migraine. It's 24/7. It doesn't go away. He had CT scan and MRI; but still no improvement. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: my arm swelled; red, and tenderness at injection site.; red, and tenderness at injection site.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Aug2021 14:00 (Lot number: FD8448) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergy: sulfa" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; OMEPRAZOLE. Past drug history included: Iodine, reaction(s): "Known allergy". The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 23Aug2021, outcome "recovering", described as "my arm swelled"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 23Aug2021, outcome "recovering" and all described as "red, and tenderness at injection site.". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema, vaccination site pain. No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt bad; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 18Aug2021 (Batch/Lot number: unknown) at the age of 72 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset Aug2021, outcome "unknown", described as "felt bad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: burning in her face, legs and feet; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (ongoing), notes: Patients concurrent condition.; "Vitamin D deficieincy" (ongoing), notes: Patients concurrent condition. The patient's concomitant medications were not reported. The following information was reported: BURNING SENSATION (non-serious), outcome "not recovered", described as "burning in her face, legs and feet".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 87.0
Sex: U
Vaccine: COVID19
Symptoms: Body height, Dizziness, Eating disorder, Fatigue, Lethargy
Clinical narrative: it start to get sore; sore arm; I have been very dizzy; Feeling lethargic, tired; Feeling lethargic, tired; nauseous to the point this morning I had hardly even eat my breakfast; nauseous to the point this morning I had hardly even eat my breakfast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 87 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 (Lot number: EW0196) at the age of 87 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing), notes: I do have vertigo but I really don't have a problem with it because unless I lay on my back, you know. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Aug2021, outcome "unknown", described as "it start to get sore; sore arm"; DIZZINESS (non-serious) with onset 20Aug2021, outcome "unknown", described as "I have been very dizzy"; LETHARGY (non-serious), FATIGUE (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "Feeling lethargic, tired"; NAUSEA (non-serious), EATING DISORDER (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "nauseous to the point this morning I had hardly even eat my breakfast". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, dizziness, lethargy, fatigue, nausea, eating disorder. Additional information-Consumer stated, Patient had the vaccine on Wednesday 18th and that was Wednesday probably Thursday, patient was sorry. Patient was feeling okay and patients arm kept working on patient arm to keep it from getting sore and when it start to get sore patient exercises more so that was not a problem for patient. Problem was the sore arm. But the next day on Friday and ever since patient had been very dizzy and nauseous and nauseous to the point this morning patient had hardly even eat breakfast. So patient did not know what was going on in here. Consumer stated, Yes, had first shot, this Wednesday. Consumer stated, No. had not talked to anyone about it until talk to us. No vaccination prior 4 weeks. Prior vaccination (4 Weeks prior): Consumer stated, "No. Consumer stated, "On 07Sep2021 that was when supposed to take second shot. No follow-up attempts are possible. No further information is expected.
Age: 87.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Weight
Clinical narrative: it start to get sore; sore arm; I have been very dizzy; Feeling lethargic, tired; Feeling lethargic, tired; nauseous to the point this morning I had hardly even eat my breakfast; nauseous to the point this morning I had hardly even eat my breakfast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 87 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 (Lot number: EW0196) at the age of 87 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing), notes: I do have vertigo but I really don't have a problem with it because unless I lay on my back, you know. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Aug2021, outcome "unknown", described as "it start to get sore; sore arm"; DIZZINESS (non-serious) with onset 20Aug2021, outcome "unknown", described as "I have been very dizzy"; LETHARGY (non-serious), FATIGUE (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "Feeling lethargic, tired"; NAUSEA (non-serious), EATING DISORDER (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "nauseous to the point this morning I had hardly even eat my breakfast". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, dizziness, lethargy, fatigue, nausea, eating disorder. Additional information-Consumer stated, Patient had the vaccine on Wednesday 18th and that was Wednesday probably Thursday, patient was sorry. Patient was feeling okay and patients arm kept working on patient arm to keep it from getting sore and when it start to get sore patient exercises more so that was not a problem for patient. Problem was the sore arm. But the next day on Friday and ever since patient had been very dizzy and nauseous and nauseous to the point this morning patient had hardly even eat breakfast. So patient did not know what was going on in here. Consumer stated, Yes, had first shot, this Wednesday. Consumer stated, No. had not talked to anyone about it until talk to us. No vaccination prior 4 weeks. Prior vaccination (4 Weeks prior): Consumer stated, "No. Consumer stated, "On 07Sep2021 that was when supposed to take second shot. No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in her ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Lot number: EL9269) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2, Lot: EN6201), administration date: 03Mar2021, when the patient was 57 years old, for covid-19 immunisation, reaction(s): "mental health issues", "tinnitus". The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ringing in her ears". The event "ringing in her ears" was evaluated at the physician office visit. No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mental disorder, Tinnitus
Clinical narrative: ringing in her ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 10Feb2021 (Lot number: EL9269) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2, Lot: EN6201), administration date: 03Mar2021, when the patient was 57 years old, for covid-19 immunisation, reaction(s): "mental health issues", "tinnitus". The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ringing in her ears". The event "ringing in her ears" was evaluated at the physician office visit. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: When I got the first shot my arm was just a little stiff; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (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: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "When I got the first shot my arm was just a little stiff".  Additional information: It was reported that, when patient got the first shot arm was just a little stiff, didn't had have any kind of symptoms or anything.  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-202101090747 similar report from same reporter