chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Both my legs from the top of my thighs to my ankles ache. Mainly when I sleep.; Both my legs from the top of my thighs to my ankles ache. Mainly when I sleep.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 11:00 (Lot number: ER8727) at the age of 60 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 26Mar2021, outcome "not recovered" and all described as "Both my legs from the top of my thighs to my ankles ache. Mainly when I sleep.". Therapeutic measures were not taken as a result of pain in extremity, arthralgia.  Additional information: Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medication within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 since the vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Investigation, Migraine, Pain, Pain in extremity
Clinical narrative: Migraine; Chest pain; Pain in arm; Sometimes it feel like very sharp pain like something is bursting; This is a spontaneous report received from a contactable Consumer or other non HCP. The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date 30Aug2021 (Lot number: FC3182) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "thyroid disease" (unspecified if ongoing), notes: I do see a doctor and I came out of pocket but he is my specialist for my thyroid disease. Concomitant medication(s) included: CYTOMEL; SYNTHROID. The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "Migraine"; CHEST PAIN (non-serious) with onset 2021, outcome "unknown", described as "Chest pain"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Pain in arm"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Sometimes it feel like very sharp pain like something is bursting". The events "migraine", "chest pain", "pain in arm" and "sometimes it feel like very sharp pain like something is bursting" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine, chest pain, pain in extremity, pain.  Additional information: Consumer stated that she is pretty sure she has some kind of reaction to the first COVID Vaccine, the first dose. She had a Pfizer vaccine, ever since she had the vaccine, she has been having migraine and she has been having chest pain and pain in the arm and then sometimes it feel like very sharp pain like something is bursting. It is not that she is having a question. She was told to report it.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: vomiting; fever; chills; pain at injection site; nausea; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 immunization.  The following information was reported: VOMITING (non-serious), outcome "unknown", described as "vomiting"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at injection site"; NAUSEA (non-serious), outcome "unknown", described as "nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Off label use, Pain in extremity, Product use issue, Pyrexia
Clinical narrative: sore arm; headache; felt feverish; Child (2-11 Years); Child (2-11 Years); This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  A child female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 28Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, Route: Intramuscular, No Events reported.), administration date: Sep2021, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Sep2021, outcome "recovering", described as "sore arm"; HEADACHE (non-serious) with onset 28Sep2021, outcome "recovering", described as "headache"; PYREXIA (non-serious) with onset 28Sep2021, outcome "recovering", described as "felt feverish"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 28Sep2021, outcome "unknown" and all described as "Child (2-11 Years)". Therapeutic measures were taken as a result of pain in extremity, headache, pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was neither diagnosed with COVID-19 Prior to vaccination, nor been tested for COVID-19 Since the vaccination. The patient received treatment with Advil, and Tylenol for reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Maternal exposure during pregnancy, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: Her right middle finger is sore; Her right middle finger is sore, red; Her right middle finger is sore, red, swollen; Right middle finger is super sore, turning purple; About 17 weeks pregnant to date; This is a spontaneous report received from contactable reporter(s) (Consumer or other nonhealthcare professional) from medical information team. The reporter is the patient. A 23-year-old female patient (pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 15Sep2021 16:30 (Lot number: 30130BA) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "smoke during this pregnancy" (unspecified if ongoing); "Outcome of Previous Pregnancy: Live Birth" (unspecified if ongoing). Date of last menstrual period: 03Jun2021. The patient was 17 weeks pregnant at the time of exposure to bnt162b2. The patient was 15 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 10Mar2022. The patient took concomitant medications. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 15Sep2021 16:30, outcome "unknown", described as "About 17 weeks pregnant to date", PAIN IN EXTREMITY (non-serious) with onset 29Sep2021 17:00, outcome "not recovered", described as "Her right middle finger is sore", ERYTHEMA (non-serious) with onset 29Sep2021 17:00, outcome "not recovered", described as "Her right middle finger is sore, red", PERIPHERAL SWELLING (non-serious) with onset 29Sep2021 17:00, outcome "not recovered", described as "Her right middle finger is sore, red, swollen", SKIN DISCOLOURATION (non-serious) with onset 29Sep2021 17:00, outcome "not recovered", described as "Right middle finger is super sore, turning purple".  Additional information included: Medicinal product: The patient received the injection in her right arm. She was otherwise healthy at baseline and took a multivitamin (1 Tablet a day) as supplementation. Patient received vaccination Facility in Pharmacy. Prior to vaccination, was the patient did not diagnosed with COVID-19. No family medical history Relevant to AE. AE(s) not required to visit Emergency Room and Physician Office.   Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: My left ear is extremely swollen; My left eye lid is heavy and smiling is becoming hard on the left side due to the numbnes; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 16:45 (Lot number: 054859512640) at the age of 42 years as dose 1,single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADDERALL. The following information was reported: EAR SWELLING (non-serious) with onset 28Sep2021, outcome "not recovered", described as "My left ear is extremely swollen"; HYPOAESTHESIA (non-serious) with onset 28Sep2021, outcome "not recovered", described as "My left eye lid is heavy and smiling is becoming hard on the left side due to the numbnes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of ear swelling, hypoaesthesia.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Jan2021 14:00 (Lot number: EL8982) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure/Elevated blood pressure", start date: 2017 (ongoing); "High cholesterol", start date: 2018 (ongoing); "Allergy" (ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE taken for hypertension, start date: 2015 (ongoing); SIMVASTATIN taken for blood cholesterol increased, start date: 2015 (ongoing); CHLOR taken for hypersensitivity, start date: 2021 (ongoing). The following information was reported: HYPERSENSITIVITY (non-serious) with onset 30Jan2021, outcome "recovering", described as "allergy". The event "allergy" was evaluated at the physician office visit. Therapeutic measures were taken as a result of hypersensitivity.  Additional information: The patient later took second dose of bnt162b2 (BNT162B2 on 18Feb2021 at 16:00 at left arm via intramuscular route (lot number: EN6201). Prior vaccination were none. Treatment was done with antihistamine.  Follow-up attempts are completed. No further information is expected
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Incorrect route of product administration, Swelling
Clinical narrative: I am have some swelling like near my armpit on my left side; it look like a little bit of soreness their too; Anatomical site of injection: Consumer stated, "Left shoulder."; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 30Sep2021 (Lot number: FF2589) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D3; N-ACETYLCYSTEINE. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization.  The following information was reported: SWELLING (non-serious), outcome "unknown", described as "I am have some swelling like near my armpit on my left side"; AXILLARY PAIN (non-serious), outcome "unknown", described as "it look like a little bit of soreness their too"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Anatomical site of injection: Consumer stated, "Left shoulder."". Therapeutic measures were not taken as a result of swelling, axillary pain, incorrect route of product administration.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chills, Off label use, Product use issue, Pyrexia
Clinical narrative: FLU VACCINE - which is administered on the same date as Pfizer vaccine; FLU VACCINE - which is administered on the same date as Pfizer vaccine; Shivers; Mild temperature started; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 55-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Sep2021 12:15 (Lot number: EW0217) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 29Sep2021 (Batch/Lot number: unknown) as dose 1, single. The patient had no relevant medical history. Concomitant medication(s) included: FLOVENT. Vaccination history included: Bnt162b2 (1st dose), when the patient was 55 years old, for Covid-19 immunization; Bnt162b2 (2nd dose), when the patient was 55 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 29Sep2021, outcome "unknown" and all described as "FLU VACCINE - which is administered on the same date as Pfizer vaccine"; CHILLS (non-serious) with onset 29Sep2021, outcome "recovering", described as "Shivers"; PYREXIA (non-serious) with onset 29Sep2021, outcome "recovering", described as "Mild temperature started". Therapeutic measures were not taken as a result of chills, pyrexia.  Additional information: 11-12 hours post booster shot, shivers and mild temperature started. this lasted on and off through next 24 hours. This case assessed as non-serious by the reporter. No hospitalization Prolonged. Facility where the most recent COVID-19 vaccine was administered at Workplace clinic. Flovent received within 2 weeks of vaccination. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pain in extremity
Clinical narrative: left me with blockages in my left leg; left arm has been in severe pain; The initial safety information received was reporting only non-serious adverse drug reaction, Upon receipt of follow-up information on 27Jan2022, this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report received from a contactable consumer. The reporter is the patient.  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: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "left me with blockages in my left leg"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "left arm has been in severe pain".  The patient's left arm has been in severe pain since he got the vaccine. On 27Jan2022, the patient stated, "left me with blockages in my left leg".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Purpura
Clinical narrative: big dark blood spots in arms and legs; feels tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A female 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: PURPURA (non-serious), outcome "unknown", described as "big dark blood spots in arms and legs"; FATIGUE (non-serious), outcome "unknown", described as "feels tired".  Additional information: Patient stated she is having big dark blood spots in arms and legs after taking the COVID vaccine and feels tired and added that, before taking the COVID vaccine, she was getting blood spots as well, but just not as dark and big.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: fever; chills; sore arm; muscle aches; headache behind my eyes; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2021 (Lot number: 30155BA) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "AFib" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Oseltamivir, reaction(s): "Allergies: Oseltamivir". Vaccination history included: Bnt162b2 (1st Dose, Lot: 30155BA, Location: arm Left), for COVID-19 immunization, reaction(s): "Sore arm". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "fever"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm"; MYALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "muscle aches"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache behind my eyes"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain in extremity, myalgia, headache, fatigue.  Additional information: Patient received third dose. The patient received other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered Public Health Clinic/ Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; chills; sore arm; muscle aches; headache behind my eyes; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2021 (Lot number: 30155BA) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "AFib" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Oseltamivir, reaction(s): "Allergies: Oseltamivir". Vaccination history included: Bnt162b2 (1st Dose, Lot: 30155BA, Location: arm Left), for COVID-19 immunization, reaction(s): "Sore arm". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "fever"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm"; MYALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "muscle aches"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache behind my eyes"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain in extremity, myalgia, headache, fatigue.  Additional information: Patient received third dose. The patient received other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered Public Health Clinic/ Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: fever; chills; headache; nausea; dizziness; extreme fatigue; sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: 30155BA) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "AFib" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Allergy: oseltamivir, notes: known allergies Oseltamivir. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. RN copied the same Lot number as shot #1, Location of injection: Arm Left), administration date: 20Jan2021, for Covid-19 immunization, reaction(s): "fever", "chills", "Sore arm", "muscle aches", "headache behind my eyes", "fatigue"; Bnt162b2 (Dose Number: 1, Batch/Lot No: 30155BA, Location of injection: Arm Left), for Covid-19 immunization, reaction(s): "Sore arm". The following information was reported: PYREXIA (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "fever"; CHILLS (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "chills"; HEADACHE (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "headache"; NAUSEA (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "nausea"; DIZZINESS (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "dizziness"; FATIGUE (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "extreme fatigue"; PAIN IN EXTREMITY (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, headache, nausea, dizziness, fatigue, pain in extremity.  Additional information: It was reported that the patient had fever, chills, sore arm, headache, nausea, dizziness, extreme fatigue (7days). Patient received COVID-19 vaccine at Public Health Clinic/ facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other unspecified medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; chills; headache; nausea; dizziness; extreme fatigue; sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: 30155BA) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "AFib" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Allergy: oseltamivir, notes: known allergies Oseltamivir. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. RN copied the same Lot number as shot #1, Location of injection: Arm Left), administration date: 20Jan2021, for Covid-19 immunization, reaction(s): "fever", "chills", "Sore arm", "muscle aches", "headache behind my eyes", "fatigue"; Bnt162b2 (Dose Number: 1, Batch/Lot No: 30155BA, Location of injection: Arm Left), for Covid-19 immunization, reaction(s): "Sore arm". The following information was reported: PYREXIA (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "fever"; CHILLS (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "chills"; HEADACHE (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "headache"; NAUSEA (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "nausea"; DIZZINESS (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "dizziness"; FATIGUE (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "extreme fatigue"; PAIN IN EXTREMITY (non-serious) with onset 06Oct2021, outcome "recovered" (13Oct2021), described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, headache, nausea, dizziness, fatigue, pain in extremity.  Additional information: It was reported that the patient had fever, chills, sore arm, headache, nausea, dizziness, extreme fatigue (7days). Patient received COVID-19 vaccine at Public Health Clinic/ facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other unspecified medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Limb mass, Loss of personal independence in daily activities, Pain, Vaccination site pain
Clinical narrative: injection site soreness; Can't lift my arm without pain/ unable to lift my left arm above my head without pain; It has affected every aspect of my life, incluiding bathing/washing my hair, shaving, working out, even my sex life; There is a lump on my arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Feb2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single and intramuscular, administered in arm left, administration date 23Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "injection site soreness"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Can't lift my arm without pain/ unable to lift my left arm above my head without pain"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "It has affected every aspect of my life, incluiding bathing/washing my hair, shaving, working out, even my sex life"; LIMB MASS (non-serious) with onset 2021, outcome "unknown", described as "There is a lump on my arm". Therapeutic measures were taken as a result of vaccination site pain, pain.  Additional information: There was no relevant tests.Specific relevant test for thromboembolic events with thrombocytopenic was none. Treatment received with Pain patches Ibuprofen for vaccination site pain, pain. It was reported that Your vaccine, given to me over six months, is still causing me injection site soreness and I can't lift my arm without pain.I am unable to lift my left arm above my head without pain. It has affected every a suspect of my life, including bathing/washing my hair, shaving, working out, even my sex life. There is a lump on my arm.  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Rash
Clinical narrative: rash on both feet; Other vaccine same date vaccine date 05Oct2021; Other vaccine same date vaccine date 05Oct2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 18:15 (Lot number: ff2589) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: TRULICITY; METFORMIN; JARDIANCE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: er2613, Location of injection: Arm Left), administration date: 05Apr2021, when the patient was 63 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: en6208, Location of injection: Arm Left), administration date: 18Mar2021, when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: RASH (non-serious) with onset 10Oct2021 07:00, outcome "not recovered", described as "rash on both feet"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 05Oct2021, outcome "unknown" and all described as "Other vaccine same date vaccine date 05Oct2021". Therapeutic measures were not taken as a result of rash.  Additional Information: The patient was administered other vaccine (flu shot) on right arm. The patient reported that he had not received other vaccine in four weeks. The patient had no covid prior vaccination and had not tested post vaccination. The patient reported that he had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Pruritus, Rash
Clinical narrative: Rash and itching on her upper torso, it gets more intense and it's spreading to her parts of her body; Rash and itching on her upper torso, it gets more intense and it's spreading to her parts of her body; Also got the flu shot at the same time.; Also got the flu shot at the same time.; 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 77 year-old female patient received bnt162b2 (BNT162B2), administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 01Oct2021 (Batch/Lot number: unknown). Relevant medical history included: "severe degenerative joint disease" (unspecified if ongoing), notes: severe degenerative joint disease; "muscle aches" (ongoing), notes: 20 years ago and this is ongoing so when she gets any shot and they say muscle aches, joint pain, fatigue, headache; "fatigue" (ongoing), notes: 20 years ago and this is ongoing so when she gets any shot and they say muscle aches, joint pain, fatigue, headache; "headache" (ongoing), notes: 20 years ago and this is ongoing so when she gets any shot and they say muscle aches, joint pain, fatigue, headache; "joint pain" (ongoing), notes: 20 years ago and this is ongoing so when she gets any shot and they say muscle aches, joint pain, fatigue, headache. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:02), administration date: 10Mar2021, when the patient was 77 years old, for COVID-19 immunization; Bnt162b2 (Dose:01), administration date: Feb2021, when the patient was 77 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious), PRURITUS (non-serious) all with onset 09Oct2021, outcome "not recovered" and all described as "Rash and itching on her upper torso, it gets more intense and it's spreading to her parts of her body"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 01Oct2021, outcome "unknown" and all described as "Also got the flu shot at the same time.".  Additional information : Reporter seriousness of the events was reported as unspecified.Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dysgeusia, Pain, Product use issue, Pyrexia
Clinical narrative: Body aches; Fever; 2 asthma attacks; bitter taste; same date same vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular (Lot number: FF2587) as dose 1, single and intramuscular, administered in arm left (Lot number: FF2587) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 12Oct2021 10:00, outcome "recovered" (2021), described as "Body aches"; PYREXIA (non-serious) with onset 12Oct2021 10:00, outcome "recovered" (2021), described as "Fever"; ASTHMA (non-serious) with onset 12Oct2021 10:00, outcome "recovered" (2021), described as "2 asthma attacks"; DYSGEUSIA (non-serious) with onset 12Oct2021 10:00, outcome "recovered" (2021), described as "bitter taste"; PRODUCT USE ISSUE (non-serious) with onset 12Oct2021 10:00, outcome "unknown", described as "same date same vaccine". Therapeutic measures were not taken as a result of pain, pyrexia, asthma, dysgeusia.  Additional information: Facility type Hospital, other vaccine in four weeks No, Other medications in two weeks None .Adverse event: Body aches, Fever and 2 asthma attacks and bitter taste  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Cough, Inflammation, SARS-CoV-2 test
Clinical narrative: Inflammatory response to vaccine caused asthma exacerbation; Inflammatory response to vaccine caused asthma exacerbation; I felt tight; woke up from sleep having coughing; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Oct2021 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: had an attack in years. Concomitant medication(s) included: XYZAL; SINGULAIR. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: 22Feb2021, when the patient was 32 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 08Feb2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: INFLAMMATION (non-serious), ASTHMA (non-serious) all with onset 11Oct2021, outcome "recovering" and all described as "Inflammatory response to vaccine caused asthma exacerbation"; CHEST DISCOMFORT (non-serious) with onset 11Oct2021, outcome "recovering", described as "I felt tight"; COUGH (non-serious) with onset 11Oct2021, outcome "recovered" (11Oct2021), described as "woke up from sleep having coughing". The events "inflammatory response to vaccine caused asthma exacerbation", "inflammatory response to vaccine caused asthma exacerbation", "i felt tight" and "woke up from sleep having coughing" were 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 inflammation, asthma, chest discomfort, cough.  Additional information: AE treatment was breathing treatment, steroids. Inflammatory response to vaccine caused asthma exacerbation, which began day after vaccine. Patient had very mild asthma and had not had an attack in years. The next day he felt tight and woke up from sleep having coughing that lasted 30 minutes. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive other vaccine in four weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Second dose Pfizer Covid Vaccine-headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP6955) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "Cholesterol" (unspecified if ongoing); "Blood clots in legs" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR taken for blood cholesterol (ongoing); ELIQUIS taken for thrombosis (ongoing). Vaccination history included: Bnt162b2 (Dose: 01, Batch/lot number: EL3247 , Dosage text: administered in left upper arm), administration date: 03Mar2021, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 24Mar2021, outcome "recovered" (Mar2021), described as "Second dose Pfizer Covid Vaccine-headache".  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Pregnant in her third trimester; Vial the dose was gave from was reconstituted yesterday; And the vial was stored at room temperature/vial the dose was gave from was reconstituted yesterday; And the vial was stored at room temperature; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 26 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), administration date 26Oct2021 (Batch/Lot number: unknown) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization; Bnt162b2 (Second dose), for COVID-19 immunization. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 26Oct2021, outcome "unknown", described as "Pregnant in her third trimester"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 26Oct2021, outcome "unknown", described as "And the vial was stored at room temperature"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 26Oct2021, outcome "unknown", described as "And the vial was stored at room temperature/vial the dose was gave from was reconstituted yesterday"; PRODUCT STORAGE ERROR (non-serious) with onset 26Oct2021, outcome "unknown", described as "Vial the dose was gave from was reconstituted yesterday".  Additional information: The attached storage information: diluted vaccine was stored in the vial at 2 degree C to 30 degree C for up to a cumulative period of 24 hours (i.e., 6 hours time at 8 degree C to 25 degree C described in the Prescribing Information + additional 18 hours excursion time at 8 degree C to 30 degree C in the VIAL ONLY. Reported called about the Comirnaty booster vaccination because she says she has got someone who was given a booster today and this vial the dose was gave from was reconstituted yesterday. She said when she looked at date on the vial she thought it was the time, she thought they reconstituted today but it was 25Oct. She said she needs to know need to do anything or if they need to give the dose again. She says that she just gave the patient the dose a couple hours ago, and she doesn't have much information to give. Height/weight was unknown, caller says she does know the patient is pregnant and in her third trimester. Report was not related to a study or programmed. Patient was pregnant. Patient was bot a reporter.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Arthritis, Back pain, Feeling hot, Headache, Lymphadenopathy
Clinical narrative: Pain at injection site; Hot to touch; Armpit lymph node swollen; Arthritis pain was worse; Lower back left side very painful; Headaches; General unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Jan2021 (Lot number: EL1284) at the age of 61 years as dose 1, single for covid-19 immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), administered in arm left, administration date 06Jan2021 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Known allergies: Grass" (unspecified if ongoing); "Known allergies: other food allergies - not specific" (unspecified if ongoing); "Known allergies: Tomatoes" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; VIT D [COLECALCIFEROL]; FISH OIL; ARTHROTEC; CALCIUM. Past drug history included: Known allergies: nicine, reaction(s): "Known allergies: Nicine"; Known allergies: statins, reaction(s): "Known allergies: statins"; Known allergies: cholesterol drugs, reaction(s): "Known allergies: Cholesterol Drugs". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Pain at injection site"; FEELING HOT (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Hot to touch"; LYMPHADENOPATHY (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Armpit lymph node swollen"; ARTHRITIS (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Arthritis pain was worse"; BACK PAIN (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Lower back left side very painful"; HEADACHE (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Headaches"; MALAISE (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "General unwell". The events "pain at injection site", "hot to touch", "armpit lymph node swollen", "arthritis pain was worse", "lower back left side very painful", "headaches" and "general unwell" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site pain, feeling hot, lymphadenopathy, arthritis, back pain, headache, malaise.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Pain at injection site; Hot to touch; Armpit lymph node swollen; Arthritis pain was worse; Lower back left side very painful; Headaches; General unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Jan2021 (Lot number: EL1284) at the age of 61 years as dose 1, single for covid-19 immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), administered in arm left, administration date 06Jan2021 (Batch/Lot number: unknown) as dose 1, single. Relevant medical history included: "Known allergies: Grass" (unspecified if ongoing); "Known allergies: other food allergies - not specific" (unspecified if ongoing); "Known allergies: Tomatoes" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; VIT D [COLECALCIFEROL]; FISH OIL; ARTHROTEC; CALCIUM. Past drug history included: Known allergies: nicine, reaction(s): "Known allergies: Nicine"; Known allergies: statins, reaction(s): "Known allergies: statins"; Known allergies: cholesterol drugs, reaction(s): "Known allergies: Cholesterol Drugs". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Pain at injection site"; FEELING HOT (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Hot to touch"; LYMPHADENOPATHY (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Armpit lymph node swollen"; ARTHRITIS (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Arthritis pain was worse"; BACK PAIN (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Lower back left side very painful"; HEADACHE (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "Headaches"; MALAISE (non-serious) with onset 08Jan2021, outcome "recovered with sequelae" (2021), described as "General unwell". The events "pain at injection site", "hot to touch", "armpit lymph node swollen", "arthritis pain was worse", "lower back left side very painful", "headaches" and "general unwell" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site pain, feeling hot, lymphadenopathy, arthritis, back pain, headache, malaise.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.