chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Rash macular, Vaccination complication
Clinical narrative: horrible reaction; pains; spots on wrist|chest|bend of elbow; rash all over chest|arm|face/long lasting rash for at least a month; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (horrible reaction), PAIN (pains), RASH MACULAR (spots on wrist|chest|bend of elbow) and RASH (rash all over chest|arm|face/long lasting rash for at least a month) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to codeine), Drug allergy (Allergic to Phenergan), Contrast media allergy (Allergic to contrast dye) and Allergy to nuts (Allergic to Peanuts). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, CLOPIDOGREL, CARVEDILOL, ASPIRIN [ACETYLSALICYLIC ACID], TAMOXIFEN, TRAMADOL and PARACETAMOL (TYLENOL ARTHRITIS) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (horrible reaction), PAIN (pains), RASH MACULAR (spots on wrist|chest|bend of elbow) and RASH (rash all over chest|arm|face/long lasting rash for at least a month). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (horrible reaction), PAIN (pains), RASH MACULAR (spots on wrist|chest|bend of elbow) and RASH (rash all over chest|arm|face/long lasting rash for at least a month) had resolved.            After the second dose patient had a horrible reaction, rash, long lasting rash for at least a month, all over chest, arm, face, pains, all kinds of horrible things.Every once and a while out of the clear blue, patient got some spots on her wrist, chest and bend of elbow.  Patient did not experienced tightness or breathing problems.   Patient claimed she was doing fine and never got Covid19 even though her granddaughter got covid19 after having the Pfizer vaccine.  Patient taken aspirin for side effects at the time.   This case was linked to MOD-2022-500341 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Furuncle
Clinical narrative: Boiled in their groin area; Cyst in the armpit; This spontaneous case was reported by a nurse and describes the occurrence of FURUNCLE (Boiled in their groin area) and CYST (Cyst in the armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FURUNCLE (Boiled in their groin area) and CYST (Cyst in the armpit). At the time of the report, FURUNCLE (Boiled in their groin area) and CYST (Cyst in the armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown if the patient had allergies (medications, food, and other products).  It was reported that the nurse could not provide the information regarding the vaccines the patient had took or personal information. It was unknown if patient had acute and chronic illnesses at the time of vaccination.  No concomitant medications were reported. There was no product complaint associated. No treatment medications were reported. It was unknown if patient ever had COVID positive test or diagnosis.   This case was linked to MOD-2022-500611 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered to patient/ it was found out later that the Moderna vaccine had already expired on; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient/ it was found out later that the Moderna vaccine had already expired on) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccination (Dose Number: 1) on 20-Jan-2021 and COVID-19 Vaccination (Dose Number: 2) on 12-Feb-2021. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccination and COVID-19 Vaccination. Concurrent medical conditions included Penicillin allergy (Allergic to Penicillin), Illness (Acute illness) and Illness (Chronic illness).    On 06-Jan-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient/ it was found out later that the Moderna vaccine had already expired on). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient/ it was found out later that the Moderna vaccine had already expired on) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  Patient didn't have COVID-19 positive test.  No treatment medication was provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Cyst
Clinical narrative: cyst near their neck; This spontaneous case was reported by a nurse and describes the occurrence of CYST (cyst near their neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CYST (cyst near their neck). At the time of the report, CYST (cyst near their neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Nurse reported that one person in her job has a has cyst near their neck after vaccination but couldn't provided information regarding the vaccines they took or personal information. Other vaccination given within 1 month prior to Moderna COVID-19 vaccine were unknown.  Treatment information was not provided.   This case was linked to MOD-2022-500447 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Blister, Feeling abnormal, Mechanical urticaria, Pruritus, Scar
Clinical narrative: Severe Urticaria / Hives; Dermatographia; Feels awful; Extremely itchy hives on various body parts that worsen if i scratch them and then spread; Patient back was currently covered with still healing scars from sores that looked like bug bites; Sores that looked like bug bites; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Severe Urticaria / Hives), MECHANICAL URTICARIA (Dermatographia), FEELING ABNORMAL (Feels awful), PRURITUS (Extremely itchy hives on various body parts that worsen if i scratch them and then spread) and SCAR (Patient back was currently covered with still healing scars from sores that looked like bug bites) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced URTICARIA (Severe Urticaria / Hives), MECHANICAL URTICARIA (Dermatographia), FEELING ABNORMAL (Feels awful), PRURITUS (Extremely itchy hives on various body parts that worsen if i scratch them and then spread), SCAR (Patient back was currently covered with still healing scars from sores that looked like bug bites) and BLISTER (Sores that looked like bug bites). At the time of the report, URTICARIA (Severe Urticaria / Hives), MECHANICAL URTICARIA (Dermatographia), FEELING ABNORMAL (Feels awful), PRURITUS (Extremely itchy hives on various body parts that worsen if i scratch them and then spread), SCAR (Patient back was currently covered with still healing scars from sores that looked like bug bites) and BLISTER (Sores that looked like bug bites) had not resolved.            No concomitant medication were reported. Treatment included daily Antihistamines that control itching. Without antihistamines patient get extremely itchy hives on various body parts that worsen if patient scratch them and then spread. Patient has been and was still, honestly, a torturous experience. .
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Severe Urticaria / Hives; Dermatographia; Feels awful; Extremely itchy hives on various body parts that worsen if i scratch them and then spread; Patient back was currently covered with still healing scars from sores that looked like bug bites; Sores that looked like bug bites; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Severe Urticaria / Hives), MECHANICAL URTICARIA (Dermatographia), FEELING ABNORMAL (Feels awful), PRURITUS (Extremely itchy hives on various body parts that worsen if i scratch them and then spread) and SCAR (Patient back was currently covered with still healing scars from sores that looked like bug bites) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced URTICARIA (Severe Urticaria / Hives), MECHANICAL URTICARIA (Dermatographia), FEELING ABNORMAL (Feels awful), PRURITUS (Extremely itchy hives on various body parts that worsen if i scratch them and then spread), SCAR (Patient back was currently covered with still healing scars from sores that looked like bug bites) and BLISTER (Sores that looked like bug bites). At the time of the report, URTICARIA (Severe Urticaria / Hives), MECHANICAL URTICARIA (Dermatographia), FEELING ABNORMAL (Feels awful), PRURITUS (Extremely itchy hives on various body parts that worsen if i scratch them and then spread), SCAR (Patient back was currently covered with still healing scars from sores that looked like bug bites) and BLISTER (Sores that looked like bug bites) had not resolved.            No concomitant medication were reported. Treatment included daily Antihistamines that control itching. Without antihistamines patient get extremely itchy hives on various body parts that worsen if patient scratch them and then spread. Patient has been and was still, honestly, a torturous experience. .
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, SARS-CoV-2 test, Vaccination site rash
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE RASH (rash on the side of her body, one line of rash on the side of the body where she received the injection) and RASH PRURITIC (it´s very itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 026L20A and 026L20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 06-Jan-2022. Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, the patient experienced VACCINATION SITE RASH (rash on the side of her body, one line of rash on the side of the body where she received the injection) and RASH PRURITIC (it´s very itchy). At the time of the report, VACCINATION SITE RASH (rash on the side of her body, one line of rash on the side of the body where she received the injection) outcome was unknown and RASH PRURITIC (it´s very itchy) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2022, SARS-CoV-2 test: positive (Positive) positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Vitamins reported as concomitant. It was reported that the patient did not take any other vaccines within 1 month prior to receiving the Moderna COVID-19 vaccine. Patient had no medical history related to the adverse event and both acute and chronic illnesses at the time of vaccination. Patient height: 5' 6". Patient received three doses of vaccine on non dominant arm. No treatment information was provided. This case was linked to MOD-2022-500858 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, Rash pruritic
Clinical narrative: Red blotches after receiving the booster dose/2 spots at the time/Spots on arms and legs/4-5 little spots in a line/ has on torso back shoulders, besides arms legs; little itchy red spots/4-5 little spots in a line and they itch; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotches after receiving the booster dose/2 spots at the time/Spots on arms and legs/4-5 little spots in a line/ has on torso back shoulders, besides arms legs) and RASH PRURITIC (little itchy red spots/4-5 little spots in a line and they itch) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 014M20A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Penicillin variants), Allergic reaction to analgesics (Tramadol), Food allergy (Garlic), Blood pressure and Arteriosclerosis (plaque on blood). Concomitant products included ATORVASTATIN for Arteriosclerosis, LISINOPRIL for Blood pressure.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced RASH MACULAR (Red blotches after receiving the booster dose/2 spots at the time/Spots on arms and legs/4-5 little spots in a line/ has on torso back shoulders, besides arms legs) and RASH PRURITIC (little itchy red spots/4-5 little spots in a line and they itch). At the time of the report, RASH MACULAR (Red blotches after receiving the booster dose/2 spots at the time/Spots on arms and legs/4-5 little spots in a line/ has on torso back shoulders, besides arms legs) and RASH PRURITIC (little itchy red spots/4-5 little spots in a line and they itch) had not resolved.            Patient does not had tested positive for COVID and does not had similar events in the past.  It was reported that after using steroids, the red spots became large. Two days after receiving the booster dose, patient started to experience the adverse reactions. Patient went to his Doctor first and he referred him to a dermatologist, he's been visiting him since December.  Patient took 2 series of Steroids as treatment. With treatment (steroids), the adverse event has improved but If patient stops taking steroids the blotches comes back.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue
Clinical narrative: I was supposed to go back on 15Feb2022 for the 2nd one; 3-4 days later, I had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (3-4 days later, I had a sore arm) and PRODUCT DOSE OMISSION ISSUE (I was supposed to go back on 15Feb2022 for the 2nd one) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PAIN IN EXTREMITY (3-4 days later, I had a sore arm). On 15-Feb-2022, the patient experienced PRODUCT DOSE OMISSION ISSUE (I was supposed to go back on 15Feb2022 for the 2nd one). At the time of the report, PAIN IN EXTREMITY (3-4 days later, I had a sore arm) had resolved and PRODUCT DOSE OMISSION ISSUE (I was supposed to go back on 15Feb2022 for the 2nd one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information was reported.  Patient started to experience event 3-4 days after vaccination. Patient received full dose of dose 1 and patient did a lot of lifting at work, so guessed it took awhile to come.  No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered greater than 12 hours post puncture/ Vaccine was first punctured on 2Mar2022 at 11:30 a.m. and a syringe loaded; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture/ Vaccine was first punctured on 2Mar2022 at 11:30 a.m. and a syringe loaded) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2022 at 8:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2022 at 8:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture/ Vaccine was first punctured on 2Mar2022 at 11:30 a.m. and a syringe loaded). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture/ Vaccine was first punctured on 2Mar2022 at 11:30 a.m. and a syringe loaded) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was mentioned that the vial was initially stored in the refrigerator on 02-Mar-2022. The vial did not undergo any temperature excursions. Total amount of time the vial exposed to room temperature range (8 degree to 25 degree Celsius = 46 degree to 77 degree Fahrenheit ) for 4 and a half hours.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased, Malaise
Clinical narrative: Elevated heart rate and BP; Elevated heart rate and BP; Felt unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Lot number: EW0158) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Graves' disease" (unspecified if ongoing), notes: Other medical history: Graves' disease, FM/CFM, osteoarthritis, IBS; "FM/CFM" (unspecified if ongoing), notes: Other medical history: Graves' disease, FM/CFM, osteoarthritis, IBS; "osteoarthritis" (unspecified if ongoing), notes: Other medical history: Graves' disease, FM/CFM, osteoarthritis, IBS; "IBS" (unspecified if ongoing), notes: Other medical history: Graves' disease, FM/CFM, osteoarthritis, IBS; "Known allergies: gluten" (unspecified if ongoing), notes: Known allergies: Salicylates, gluten, dairy; "Known allergies: dairy" (unspecified if ongoing), notes: Known allergies: Salicylates, gluten, dairy. Concomitant medication(s) included: TAPAZOLE; CETIRIZINE HCL; VITAMIN B [VITAMIN B NOS]; VIT D [VITAMIN D NOS]. Past drug history included: Salicylates, reaction(s): "Known allergies: Salicylates", notes: Known allergies: Salicylates, gluten, dairy. The following information was reported: HEART RATE INCREASED (non-serious), BLOOD PRESSURE INCREASED (non-serious) all with onset 08Apr2021, outcome "recovered" (2021) and all described as "Elevated heart rate and BP"; MALAISE (non-serious) with onset 08Apr2021, outcome "recovered" (2021), described as "Felt unwell". The events "elevated heart rate and bp", "elevated heart rate and bp" and "felt unwell" 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 not taken as a result of heart rate increased, blood pressure increased, malaise.  Additional information: Patient did not have other vaccine in four weeks. Patient did not had COVID prior vaccination. Patient did not had COVID tested post vaccination.  Follow-Up (24Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Paraesthesia
Clinical narrative: feeling tingling in her hands and feet again; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the parent reporting for a patient (daughter).  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jun2021 (Lot number: EW0177) at the age of 15 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (product= COVID 19, brand= Pfizer, dose number: 1, lot number: EW0173, vaccine location= Left arm), administration date: 02Jun2021, when the patient was 15 years old, for COVID-19 immunization, reaction(s): "foggy brain", "tingling in hands and feet". The following information was reported: PARAESTHESIA (non-serious) with onset 15Jul2021, outcome "not recovered", described as "feeling tingling in her hands and feet again". The event "feeling tingling in her hands and feet again" 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 paraesthesia.  Additional information: Known allergy was None. If other vaccine in four weeks was None. Other medications in two weeks were None. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. It was reported that two weeks after the first dose, the reporter's daughter experienced "foggy" brain and tingling in hands and feet. Her pediatrician examined her and took bloodwork with normal results. The tingling lasted one week and then disappeared. She started feeling tingling in her hands and feet again this week with it being constant starting on the evening of 15Jul2021. The reporter reported it to her pediatrician again and she is to rest and stay cool.  Follow-up attempts are completed. No further information is expected..
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Ache; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 (Lot number: EW0185, Expiration Date: 31Aug2021) at the age of 47 years as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "recovered" (2021), described as "Ache". Therapeutic measures were not taken as a result of pain.  Additional information: Emergency Room? No, Physician Office? No, Prior Vaccinations (within 4 weeks): None. He got the second shot three weeks ago. The first shot nothing happened. Once he got the second shot and about two days later his arms, joints started to feel pain. It has been going on three weeks now.He stated after getting the Pfizer COVID shot when he squeezes his fist it hurts around the elbow. Initially he declined to continue with report. Stated he is meeting someone about a job. However, three weeks is a long time to have this pain. Caller went on to say, he has not done anything to make his arm hurt. He stated maybe the second shot, maybe the nurse when she poked him inside it touched the bone. He does not know if should feel that. The first shot he felt nothing. When he was given the second shot it seemed that it hit the bone. Then two days later at night he was sore. Then the next day the soreness stopped. He never had the flu or fever. However, it progressed to his arm, joints hurting. His arm, joint felt like pain. It started he believes 02Jul2021. The third day it was the worst. He still feels it now, but confirmed outcome currently as the same. He read on line that people may have joint pain a couple days and now he have been having this pain for three weeks now. If he lifts heavy stuff he has pain. If he straightens his muscle it hurts at the elbow. Consumer sated, "I called Friday, I had a vaccine shot, the second one and it has affected my arm and I called Friday already to you guys and she gave me a number, if you want the number, the confirmation number or something and she told me to call this number. So, because when I got first shot, when I got it, it was okay, it just ache for one day and then the next day, it goes away and then when I got the second shot on 30Jun2021 (not clarified) and then the second day in the morning, my elbow and around elbow too, it seems like when I grip my fist together, it hurts there and if I lift something, grips my fist and pull up, it hurts and it has been three weeks that is why (sentence incomplete). I looked online and it says it is for couple of days, it is not couple of days, it is three weeks."  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms".  Additional Information: Verbatim and event description was swap from Pfizer-sponsored program patient had both of the Covid vaccine. Patient mention first shot he had flu like symptoms and after his second shot of the vaccine he had a seizure and wanted to report his experience. Patient refused to speak to medical profession. Urgent sent due to caller having seizure and ending up in the hospital Transferred to program department  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: vomiting; headache; nausea; 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), administration date 17Jul2021 (Lot number: elr8731) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: VOMITING (non-serious) with onset 17Jul2021, outcome "unknown", described as "vomiting"; HEADACHE (non-serious) with onset 17Jul2021, outcome "unknown", described as "headache"; NAUSEA (non-serious) with onset 17Jul2021, outcome "unknown", described as "nausea".  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Three months later, I had the same reaction:  I woke up with one day of sore throat, then chills for three days; chest congestion; sinus congestion; I was so cold; including chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Mar2021 12:00 (Lot number: EN6207) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; VITAMIN D NOS. Vaccination history included: Bnt162b2 (Dose 1, Lot number EN6201, lot unknown False, administration date 01Mar2021, administration time 12:00 PM, vaccine location Right arm), administration date: 01Mar2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 22Mar2021, outcome "recovered" (2021), described as "including chills"; OROPHARYNGEAL PAIN (non-serious) with onset 30Jun2021 08:00, outcome "recovered" (2021), described as "Three months later, I had the same reaction:  I woke up with one day of sore throat, then chills for three days"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 30Jun2021 08:00, outcome "recovered" (2021), described as "chest congestion"; SINUS CONGESTION (non-serious) with onset 30Jun2021 08:00, outcome "recovered" (2021), described as "sinus congestion"; FEELING COLD (non-serious) with onset 30Jun2021 08:00, outcome "recovered" (2021), described as "I was so cold". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, oropharyngeal pain, respiratory tract congestion, sinus congestion, feeling cold.  Additional Information: No other vaccine in four weeks. Took lisinopril 10mg 1xday, vit d 2000 iu, 1xday in two weeks. The patient had a typical reaction to the second injection on 22Mar2021, including chills, but Three months later, had the same reaction. She woke up with one day of sore throat, then chills for three days, followed by chest congestion and sinus congestion. Because the symptoms so closely resembled the side effects of my second Pfizer vaccine injection, she got a Covid PCR test (negative) at pharmacy. The body temperature for three days hovered around 89.7-90.5. I was so cold. It was nothing she have experienced previously in her long life. She self isolated for ten days, and am now back to normal. No covid prior vaccination. Covid test post vaccination {covid test type post vaccination Nasal Swab, covid test name post vaccination pcr, covid test date 03Jul2021, covid test result Negative}. No known allergies.                                 No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus congestion
Clinical narrative: Three months later, I had the same reaction:  I woke up with one day of sore throat, then chills for three days; chest congestion; sinus congestion; I was so cold; including chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Mar2021 12:00 (Lot number: EN6207) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; VITAMIN D NOS. Vaccination history included: Bnt162b2 (Dose 1, Lot number EN6201, lot unknown False, administration date 01Mar2021, administration time 12:00 PM, vaccine location Right arm), administration date: 01Mar2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 22Mar2021, outcome "recovered" (2021), described as "including chills"; OROPHARYNGEAL PAIN (non-serious) with onset 30Jun2021 08:00, outcome "recovered" (2021), described as "Three months later, I had the same reaction:  I woke up with one day of sore throat, then chills for three days"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 30Jun2021 08:00, outcome "recovered" (2021), described as "chest congestion"; SINUS CONGESTION (non-serious) with onset 30Jun2021 08:00, outcome "recovered" (2021), described as "sinus congestion"; FEELING COLD (non-serious) with onset 30Jun2021 08:00, outcome "recovered" (2021), described as "I was so cold". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, oropharyngeal pain, respiratory tract congestion, sinus congestion, feeling cold.  Additional Information: No other vaccine in four weeks. Took lisinopril 10mg 1xday, vit d 2000 iu, 1xday in two weeks. The patient had a typical reaction to the second injection on 22Mar2021, including chills, but Three months later, had the same reaction. She woke up with one day of sore throat, then chills for three days, followed by chest congestion and sinus congestion. Because the symptoms so closely resembled the side effects of my second Pfizer vaccine injection, she got a Covid PCR test (negative) at pharmacy. The body temperature for three days hovered around 89.7-90.5. I was so cold. It was nothing she have experienced previously in her long life. She self isolated for ten days, and am now back to normal. No covid prior vaccination. Covid test post vaccination {covid test type post vaccination Nasal Swab, covid test name post vaccination pcr, covid test date 03Jul2021, covid test result Negative}. No known allergies.                                 No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Feeling abnormal, Pain
Clinical narrative: Feel very badly/Just feel really badly; GI track feels badly; Back hurts; Ache all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feel very badly/Just feel really badly"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "GI track feels badly"; BACK PAIN (non-serious), outcome "unknown", described as "Back hurts"; PAIN (non-serious), outcome "unknown", described as "Ache all over".  Additional information: Consumer stated that he/she thought he/she was having an adverse reaction to second Pfizer vaccine shot (Unspecified vaccine). Adverse reactions: Consumer stated that feel very badly and GI track feels badly and back hurt and ache all over and dont know quite what to do because he/she thought would get through it fine. So he/she was little bit surprised. Consumer was informed about the role of Pfizer Drug Safety. Concern paraphrased: Consumer stated that he/she was not quite sure but it seems they might be connected, I don't know. Requested to probe to file a safety report. LOT: Consumer stated that Okay, he/she don't have card, have a bunch of papers. He/she was not sure this was the smartest thing to do because you were probably more interested in vaccine then you were in me but. Consumer was informed those information are to file a safety report on behalf of the consumer, consumer stated that he/she did not know that he/she was interested in filing a report, just want to get some advice about what to do. Consumer was informed about the role of Pfizer Medical Information and offered the number. Consumer stated that he/she thought to just wait and talk to a nurse for it. Patient just feel really badly don't really want to go through a different, mean who was he/she going to get when they call a different number? Consumer was provided with the number of Pfizer Medical Information and was requested to select option 3, timings as and 8 am to 8 pm Monday to Fridays as per. Further probing could not be done as the consumer was unwilling to share any further information. Hence limited information available over the call.   Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph glands under left arm became swollen and quite painful within several days/ pain spread to lymph glands below collarbone as well and stayed quite sore for roughly one month; Lymph glands under left arm became swollen and quite painful within several days/ pain spread to lymph glands below collarbone as well and stayed quite sore for roughly one month; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Jun2021 13:31 (Batch/Lot number: unknown) at the age of 65 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: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 14Jun2021 08:00, outcome "recovered" (13Jul2021) and all described as "Lymph glands under left arm became swollen and quite painful within several days/ pain spread to lymph glands below collarbone as well and stayed quite sore for roughly one month". Therapeutic measures were not taken as a result of lymph node pain, lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. It was reported that prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. It was reported that the patient had no relevant test. It was reported that lymph glands under left arm became swollen and quite painful within several days of receiving the shot-the pain spread to lymph glands below collarbone as well and stayed quite sore for roughly one month after the shot. Several days following my first Covid-19 shot, the patient began to notice that the lymph glands in her armpit on left side, (received shot in left arm) were beginning to swell and were moderately painful. Over course of next several days, pain and swelling spread to lymph glands in her upper left chest near her collar bone. The pain and swelling lasted just about a month. the patient stated that she wasted until it was gone completely before receiving second shot in other arm. It was reported that the Pfizer have permission to contact the reporter about this event and also have permission to contact patient's healthcare provider about this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Rhinorrhoea
Clinical narrative: runny nose; annoying; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25May2021 (Lot number: EW0187) at the age of 73 years as dose 1, single and administered in arm left, administration date 15Jun2021 (Lot number: EW0181) as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure. The patient's concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "runny nose"; IRRITABILITY (non-serious) with onset 2021, outcome "unknown", described as "annoying". Therapeutic measures were not taken as a result of rhinorrhoea, irritability.  Additional Information: Is report related to a study or programme was reported as yes. she was having runny nose since she got the first and second dose of Pfizer BioNTech COVID-19 vaccine. Patient had runny nose, that was just running down, literally running down her nose, it was very frustrating with that runny nose, patient feel like she had a cold which she dont so that was very annoying. Treatment: Consumer stated, "No, she haven't done anything, its just that she was going to tissues, like tissue are going out of file, she meant its just like you would think she had cold or something, its just she was sitting here right now talking to you and its just running down, literally running down my nose." Other medical conditions: Consumer stated, "I have like a high blood pressure and being treated for seeing a pain management specialist, its comes from age you know."  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Red splotchy rash across arms, chest, and back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Jun2021 (Lot number: EW0181) at the age of 23 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0191, Vaccine location: Left arm), for Covid-19 immunisation. The following information was reported: RASH MACULAR (non-serious) with onset 17Jul2021 11:00, outcome "not recovered", described as "Red splotchy rash across arms, chest, and back". Therapeutic measures were not taken as a result of rash macular.  Additional Information: The patient did not received any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested post the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain in extremity, Paranasal sinus discomfort
Clinical narrative: sinus pressure; nausea; chills; arm soreness; tired; 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), administration date 07Jul2021 10:30 (Lot number: EW0169) at the age of 48 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "N/A" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE; MEDROXYPROGESTERONE ACETATE. The following information was reported: PARANASAL SINUS DISCOMFORT (non-serious) with onset 08Jul2021 08:00, outcome "recovered", described as "sinus pressure"; NAUSEA (non-serious) with onset 08Jul2021 08:00, outcome "recovered", described as "nausea"; CHILLS (non-serious) with onset 08Jul2021 08:00, outcome "recovered", described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 08Jul2021 08:00, outcome "recovered", described as "arm soreness"; FATIGUE (non-serious) with onset 08Jul2021 08:00, outcome "recovered", described as "tired". Therapeutic measures were not taken as a result of nausea, chills, pain in extremity, fatigue.  Additional Information: No other vaccine in four weeks. On 8Jul2021 - sinus pressure/nausea/chills/arm soreness 9Jul2021 - sinus pressure/nausea/chills/arm soreness 10Jul2021 - sinus pressure/arm soreness/tired 11Jul2021 - sinus pressure/arm soreness/tired. No covid prior vaccination. Covid was tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: She stated that after getting the Pfizer Covid 19 vaccine her vaginal or genital herpes  has been diminished.; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 14:00 (Lot number: EN6205) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Coronary artery disease" (ongoing); "Diabetes" (unspecified if ongoing), notes: on medicines about 3-years-ago; "vaginal or genital herpes" (unspecified if ongoing), notes: since she was 19, 50 years she had it; "heart attack", start date: 1997 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Batch/lot number: EL9267, Anatomical Location: left arm), administration date: 23Feb2021, when the patient was 68 years old, for COVID-19 Immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "She stated that after getting the Pfizer Covid 19 vaccine her vaginal or genital herpes  has been diminished."; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm".  Additional Information: She stated that after getting the Pfizer Covid 19 vaccine her vaginal or genital herpes has been diminished. Stated that she has frequent outbreak (10 days out of a total month) and to go 3 months on over 50 yr's without having any is wonderful.    Follow-up attempts are completed. No further information is expected.