chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: has a schedule for Cortisone injection for her knee; 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 female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (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: ARTHROPATHY (non-serious), outcome "unknown", described as "has a schedule for Cortisone injection for her knee". Therapeutic measures were taken as a result of arthropathy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pain
Clinical narrative: headache; tiredness; dizziness; nausea; body hurts; 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 female patient received bnt162b2 (BNT162B2), administration date 13Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "tiredness"; DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "dizziness"; NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "nausea"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "body hurts".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased
Clinical narrative: temperature dropped to 93, 93 then 98; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (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: BODY TEMPERATURE DECREASED (non-serious) with onset 11Mar2021, outcome "unknown", described as "temperature dropped to 93, 93 then 98". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Medical Information:  There were no unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: fogginess feeling; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "fogginess feeling".  Additional information: Patient experienced fogginess feeling for several hours after vaccine administration. No significant medical history. Patient experienced this shortly after administration. Symptoms resolved after resting in bed for several hours. Event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Jan2021 (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 22Jan2021, outcome "not recovered", described as "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: some injection site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "some injection site pain".   Additional information: Patient too experienced some injection site pain, but resolved after 2 to 3 days. Patient was wondering if you have seen prolonged pain in the clinical trials and if there was any advice with respect to the second dose (e.g., use the other arm).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: The injection site is sore; Overall body aches; Headache; tired; 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "The injection site is sore"; PAIN (non-serious), outcome "unknown", described as "Overall body aches"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "tired".  Additional Information: Description of event, second covid shot. The injection site is sore. Overall body aches. Headache and tired, the day after.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: Caller wants to know if she can get a shot in her eye while waiting to take her second covid vaccine. Clarified that this eye appointment was made after the first dose of the covid vaccine.; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE DISORDER (non-serious), outcome "unknown", described as "Caller wants to know if she can get a shot in her eye while waiting to take her second covid vaccine. Clarified that this eye appointment was made after the first dose of the covid vaccine."  Additional Information: Reported as, eye appointment was made after the first dose of the covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Pain in extremity, Platelet count
Clinical narrative: arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (086396). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 80 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "thyroid medicine" (unspecified if ongoing). The patient took concomitant medications.The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was sore". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site discomfort
Clinical narrative: extremely tired; Discomfort to Injection Site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 79 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27Feb2021 14:00 (Lot number: EN6202) at the age of 79 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis", start date: 2010 (ongoing), notes: None; "High BP", start date: 2001 (ongoing), notes: Controlled by medication. Family history included: "Hx of cancer" (unspecified if ongoing), notes: Hx of cancer + high BP. Concomitant medication(s) included: LISINOPRIL taken for hypertension, start date: 2001 (ongoing); LISINOPRIL/HCTZ taken for hypertension, start date: 2001 (ongoing). Vaccination history included: Bnt162b2 (Date: 06Feb2021, Time: 13:00, Anatomical Location: Right Fore Arm, Lot. No. EL324), administration date: 06Feb2021, for COVID-19 immunisation, reaction(s): "discomfort to injection site". The following information was reported: FATIGUE (non-serious) with onset 27Feb2021 18:00, outcome "unknown", described as "extremely tired"; VACCINATION SITE DISCOMFORT (non-serious) with onset 27Feb2021 18:00, outcome "unknown", described as "Discomfort to Injection Site".  Additional information: The patient provided information to regarding the reported adverse event(s) with the use of the product: Yes, Self. The reporter consider the Pfizer product had a casual effect to the adverse event.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Headache, Hyperhidrosis, SARS-CoV-2 test
Clinical narrative: Excessive sweating especially at nighttime; blurry vision; headaches; increased depression and anxiety; increased depression and anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 11:00 (Lot number: EN6208) at the age of 51 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "GERD" (unspecified if ongoing); "PTSD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine, reaction(s): "allergy". The following information was reported: HYPERHIDROSIS (non-serious) with onset 16Mar2021 13:00, outcome "not recovered", described as "Excessive sweating especially at nighttime"; VISION BLURRED (non-serious) with onset 16Mar2021 13:00, outcome "not recovered", described as "blurry vision"; HEADACHE (non-serious) with onset 16Mar2021 13:00, outcome "not recovered", described as "headaches"; DEPRESSION (non-serious), ANXIETY (non-serious) all with onset 16Mar2021 13:00, outcome "not recovered" and all described as "increased depression and anxiety". The events "excessive sweating especially at nighttime", "blurry vision", "headaches", "increased depression and anxiety" and "increased depression and anxiety" 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 hyperhidrosis, vision blurred, headache, depression, anxiety. Additional information: Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. Patient had administered in arm right, administration date 06Apr2021 13:00 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. Patient underwent treatment as Medication and instruction. 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 and Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, patient had covid test post vaccination via nasal swab and result as Negative. No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Excessive sweating especially at nighttime; blurry vision; headaches; increased depression and anxiety; increased depression and anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 11:00 (Lot number: EN6208) at the age of 51 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "GERD" (unspecified if ongoing); "PTSD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine, reaction(s): "allergy". The following information was reported: HYPERHIDROSIS (non-serious) with onset 16Mar2021 13:00, outcome "not recovered", described as "Excessive sweating especially at nighttime"; VISION BLURRED (non-serious) with onset 16Mar2021 13:00, outcome "not recovered", described as "blurry vision"; HEADACHE (non-serious) with onset 16Mar2021 13:00, outcome "not recovered", described as "headaches"; DEPRESSION (non-serious), ANXIETY (non-serious) all with onset 16Mar2021 13:00, outcome "not recovered" and all described as "increased depression and anxiety". The events "excessive sweating especially at nighttime", "blurry vision", "headaches", "increased depression and anxiety" and "increased depression and anxiety" 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 hyperhidrosis, vision blurred, headache, depression, anxiety. Additional information: Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. Patient had administered in arm right, administration date 06Apr2021 13:00 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. Patient underwent treatment as Medication and instruction. 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 and Since the vaccination, the patient had been tested for COVID-19. On 12Apr2021, patient had covid test post vaccination via nasal swab and result as Negative. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Nausea
Clinical narrative: I am having still after effects of, not feeling well; I am still feeling nauseous prior; some amount of light headedness like dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 14May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0172), administration date: 23Apr2021, for COVID-19 immunization, reaction(s): "I am still feeling nauseous prior", "some amount of light headedness like dizziness". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I am having still after effects of, not feeling well"; NAUSEA (non-serious), outcome "unknown", described as "I am still feeling nauseous prior"; DIZZINESS (non-serious), outcome "unknown", described as "some amount of light headedness like dizziness ".  Additional information: The patient got the Pfizer shot on Friday having the second shot on Friday and the patient was having still after effects of not feeling well. The patient was still feeling nauseous prior and some amount of light headedness like dizziness and didn't know if it was normal to have this a while.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Immunisation, Pyrexia, Rash
Clinical narrative: 102 degree fever; rash under arms and in groin area; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received BNT162b2 (BNT162B2), administered in arm right, administration date 30Dec2021 15:00 (Lot number: Er8737) at the age of 32 years as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing); "some GI issues" (unspecified if ongoing). Concomitant medication(s) included: LEVAQUIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0170, Vaccine Administration Time: 04:30 PM), administration date: 30Apr2021, when the patient was 31 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Fj1611, Location of injection: Arm Right, Vaccine Administration Time: 03:30 PM), administration date: 09Apr2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021 15:00, outcome "unknown", described as "Booster"; PYREXIA (non-serious) with onset 01Jan2022 18:00, outcome "not recovered", described as "102 degree fever"; RASH (non-serious) with onset 01Jan2022 18:00, outcome "not recovered", described as "rash under arms and in groin area". The events "102 degree fever" and "rash under arms and in groin area" 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 pyrexia, rash.  Additional Information: The patient did not have other vaccine in four weeks. The patient did not have covid prior to vaccination. The patient did not test post vaccination. The patient did not have known food allergies that have resulted in a rash. It was also mentioned that the patient had 102 degree fever for 12 hours the 1st day after vaccine, and experience rash under arms and in groin area 2nd and 3rd day after vaccine. The patient used Antihistamine as treatment for AE .  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Immunisation, Insomnia, Pain
Clinical narrative: whole body aches; joint paint; headache; insomnia; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in arm right, administration date 31Dec2021 13:00 (Lot number: FL3198) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: RESTASIS. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 23Feb2021, when the patient was 50 years old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 16Mar2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "mild body ache", "joint pain", "fatigue". The following information was reported: IMMUNISATION (non-serious) with onset 31Dec2021 13:00, outcome "unknown", described as "booster"; PAIN (non-serious) with onset 01Jan2022 02:00, outcome "recovering", described as "whole body aches"; ARTHRALGIA (non-serious) with onset 01Jan2022 02:00, outcome "recovering", described as "joint paint"; HEADACHE (non-serious) with onset 01Jan2022 02:00, outcome "recovering", described as "headache"; INSOMNIA (non-serious) with onset 01Jan2022 02:00, outcome "recovering", described as "insomnia". Therapeutic measures were not taken as a result of pain, arthralgia, headache, insomnia.  Additional Information: The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has not been tested for Covid-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Myalgia
Clinical narrative: Low grade fever; chills; muscle aches; soreness in arm of injection site; fatigue; headache; Dose number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 31Dec2021 09:00 (Lot number: 33130BA) at the age of 28 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 01May2021, when the patient was 27 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0151, Location of injection: Arm Right), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 31Dec2021 09:00, outcome "unknown", described as "Dose number: 3"; PYREXIA (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "Low grade fever"; CHILLS (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "chills"; MYALGIA (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "muscle aches"; VACCINATION SITE PAIN (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "soreness in arm of injection site"; FATIGUE (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "fatigue"; HEADACHE (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "headache". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia, vaccination site pain, fatigue, headache. Additional information The patient was diagnosed with COVID-19 prior to vaccination.  The patient had not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Low grade fever; chills; muscle aches; soreness in arm of injection site; fatigue; headache; Dose number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 31Dec2021 09:00 (Lot number: 33130BA) at the age of 28 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 01May2021, when the patient was 27 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0151, Location of injection: Arm Right), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 31Dec2021 09:00, outcome "unknown", described as "Dose number: 3"; PYREXIA (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "Low grade fever"; CHILLS (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "chills"; MYALGIA (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "muscle aches"; VACCINATION SITE PAIN (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "soreness in arm of injection site"; FATIGUE (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "fatigue"; HEADACHE (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "headache". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia, vaccination site pain, fatigue, headache. Additional information The patient was diagnosed with COVID-19 prior to vaccination.  The patient had not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Malaise, Peripheral swelling, Pruritus
Clinical narrative: I got the Covid Booster I had all kinds of side effects/my arm is still very red, swollen and itches like crazy; Fever; Not quite feeling well; I got the Covid Booster I had all kinds of side effects/my arm is still very red, swollen and itches like crazy; itches like crazy; booster; A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 29Dec2021 (Lot number: FJ8762) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 immunization, reaction(s): "didn't have any side effects from first 2 doses"; Covid-19 vaccine (Dose: 2, Manufacturer unknown), for COVID-19 immunization, reaction(s): "didn't have any side effects from first 2 doses". The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "booster"; ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious), outcome "not recovered" and all described as "I got the Covid Booster I had all kinds of side effects/my arm is still very red, swollen and itches like crazy"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; MALAISE (non-serious), outcome "unknown", described as "Not quite feeling well"; PRURITUS (non-serious), outcome "not recovered", described as "itches like crazy". Additional information When probed for the concern, consumer stated, "I got the Covid Booster from my Doctor on Wednesday and my arm is still very swollen. I had all kinds of side effects (from Covid Booster) which I didn't had with the first 2 shots (first and second dose) and I can't call my Doctor right now because it's Sunday but right now most of the side effects have gone away that fever, that not quite feeling well and all but my arm is still very red, slight swollen, it itches like crazy. It's all basically all the bad side effects are in my arm right now and my question to you. I have read that all of these are possible side effects, basically I don't have a lot of these. I don't have the nausea or vomiting or any of that, I don't have any heart problems or breathing problems or anything like that but I am wondering is there anything I can do about the itching."
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I got the Covid Booster I had all kinds of side effects/my arm is still very red, swollen and itches like crazy; Fever; Not quite feeling well; I got the Covid Booster I had all kinds of side effects/my arm is still very red, swollen and itches like crazy; itches like crazy; booster; A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 29Dec2021 (Lot number: FJ8762) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 immunization, reaction(s): "didn't have any side effects from first 2 doses"; Covid-19 vaccine (Dose: 2, Manufacturer unknown), for COVID-19 immunization, reaction(s): "didn't have any side effects from first 2 doses". The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "booster"; ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious), outcome "not recovered" and all described as "I got the Covid Booster I had all kinds of side effects/my arm is still very red, swollen and itches like crazy"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; MALAISE (non-serious), outcome "unknown", described as "Not quite feeling well"; PRURITUS (non-serious), outcome "not recovered", described as "itches like crazy". Additional information When probed for the concern, consumer stated, "I got the Covid Booster from my Doctor on Wednesday and my arm is still very swollen. I had all kinds of side effects (from Covid Booster) which I didn't had with the first 2 shots (first and second dose) and I can't call my Doctor right now because it's Sunday but right now most of the side effects have gone away that fever, that not quite feeling well and all but my arm is still very red, slight swollen, it itches like crazy. It's all basically all the bad side effects are in my arm right now and my question to you. I have read that all of these are possible side effects, basically I don't have a lot of these. I don't have the nausea or vomiting or any of that, I don't have any heart problems or breathing problems or anything like that but I am wondering is there anything I can do about the itching."
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Immunisation, Mobility decreased, Pyrexia
Clinical narrative: Headache; I can't get up; Coughing; booster; Giving the fever like for 3 holidays, after I got the booster I can''t get up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Dec2021 (Lot number: 33130BA) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine ("The first one is on the 22Apr (Clarified as 22Apr2021) this year., dose 1 , MANUFACTURER UNKNOWN), administration date: 22Apr2021, when the patient was 28 years old, for COVID-19 Immunization; Covid-19 vaccine (Second one is on the May 17May (Clarified as 17May2021) this year.", dose 2 , MANUFACTURER UNKNOWN), administration date: 17May2021, when the patient was 28 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "booster"; PYREXIA (non-serious) with onset Dec2021, outcome "not recovered", described as "Giving the fever like for 3 holidays, after I got the booster I can't get up"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; DYSKINESIA (non-serious), outcome "unknown", described as "I can't get up"; COUGH (non-serious), outcome "unknown", described as "Coughing". Therapeutic measures were taken as a result of pyrexia. Therapeutic measures were not taken as a result of headache, dyskinesia, cough.  Additional information Consumer stated, "I have some question, I on the Sunday of this Dec I got the  booster Pfizer and after got that being, giving the fever like for 3 holidays, I don't know what to do with that, like before I get the booster I was everything was fine but after I got the booster I can't get up and I have a headache, I have fever, I have coughing and I don't know what is going on here, I don't know." Start of adverse event: Consumer stated, "Like after I take the booster on that night I was on the 'service' like at around  6 O'clock that was on 'light' I started to get fever, my fever continues on today I still having fever and it was such dull and 'light'."  Treatment: Consumer stated, "I don't took any medications, in general it doesn't seems right." When again probed for the treatment, Consumer stated, "I take Advil to lower my fever because I have been keeping having fever for three days and it still continues on, I don't know what to do with that, I feel so helpless. That's why I call you." When probed if the, Consumer stated, "The Advil helps me just temporarily like I take it I feel  little better and few hours later and then it comes back."
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Developed severe itching the hands; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. Other Case identifier: NUS2021US198285 (Novartis).  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: PRURITUS (non-serious), outcome "unknown", described as "Developed severe itching the hands".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: under his armpit it is like very swollen lymph node; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose number unknown , Manufacturer- Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "under his armpit it is like very swollen lymph node".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Product use issue, Temporomandibular joint syndrome
Clinical narrative: Severe jaw pain like lock jaw and ear pain. Dr called it TMJ; dose received 3; influenza vaccine on 20Dec2021; influenza vaccine on 20Dec2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 16:45 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm right, administration date 20Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for influenza. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "Sulpha" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; METOPROLOL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0162, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 12Apr2021, when the patient was 47 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 22Mar2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 16:45, outcome "unknown", described as "dose received 3"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 20Dec2021, outcome "unknown" and all described as "influenza vaccine on 20Dec2021"; TEMPOROMANDIBULAR JOINT SYNDROME (non-serious) with onset 22Dec2021 07:00, outcome "recovering", described as "Severe jaw pain like lock jaw and ear pain. Dr called it TMJ". The event "severe jaw pain like lock jaw and ear pain. dr called it tmj" was evaluated at the physician office visit. Therapeutic measures were taken as a result of temporomandibular joint syndrome. Additional information Adverse event: Severe jaw pain like lock jaw and ear pain. Dr called it TMJ The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Ae treatment: Muscle relaxers-Flexarall The patient was not diagnosed with COVID-19 prior to vaccination.  The patient had not been tested for COVID-19 since the vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Immunisation, Irritable bowel syndrome, Myalgia
Clinical narrative: Severe flare up of my IBS and my Rheumatoid Arthritis; Severe flare up of my IBS and my Rheumatoid Arthritis; Severe stomach aches; Nauseous; Severe joint and muscle pain; Severe joint and muscle pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 21Dec2021 09:00 (Lot number: FF8839) at the age of 48 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "IBS" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE. Vaccination history included: BNT162B2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 23Mar2021, when the patient was 48 years old, for COVID-19 immunization; BNT162B2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 02Mar2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 21Dec2021 09:00, outcome "unknown", described as "Booster"; RHEUMATOID ARTHRITIS (medically significant), IRRITABLE BOWEL SYNDROME (non-serious), outcome "not recovered" and all described as "Severe flare up of my IBS and my Rheumatoid Arthritis"; ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "Severe stomach aches"; NAUSEA (non-serious), outcome "not recovered", described as "Nauseous"; ARTHRALGIA (non-serious), MYALGIA (non-serious), outcome "not recovered" and all described as "Severe joint and muscle pain". Therapeutic measures were not taken as a result of rheumatoid arthritis, irritable bowel syndrome, abdominal pain upper, nausea, arthralgia, myalgia.  Additional information: it was reported that the patient had a severe flare up of IBS and Rheumatoid Arthritis. She also had severe stomach aches, severe joint and muscle pain.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rheumatoid arthritis
Clinical narrative: Severe flare up of my IBS and my Rheumatoid Arthritis; Severe flare up of my IBS and my Rheumatoid Arthritis; Severe stomach aches; Nauseous; Severe joint and muscle pain; Severe joint and muscle pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 48-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 21Dec2021 09:00 (Lot number: FF8839) at the age of 48 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "IBS" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE. Vaccination history included: BNT162B2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 23Mar2021, when the patient was 48 years old, for COVID-19 immunization; BNT162B2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 02Mar2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 21Dec2021 09:00, outcome "unknown", described as "Booster"; RHEUMATOID ARTHRITIS (medically significant), IRRITABLE BOWEL SYNDROME (non-serious), outcome "not recovered" and all described as "Severe flare up of my IBS and my Rheumatoid Arthritis"; ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "Severe stomach aches"; NAUSEA (non-serious), outcome "not recovered", described as "Nauseous"; ARTHRALGIA (non-serious), MYALGIA (non-serious), outcome "not recovered" and all described as "Severe joint and muscle pain". Therapeutic measures were not taken as a result of rheumatoid arthritis, irritable bowel syndrome, abdominal pain upper, nausea, arthralgia, myalgia.  Additional information: it was reported that the patient had a severe flare up of IBS and Rheumatoid Arthritis. She also had severe stomach aches, severe joint and muscle pain.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Pulmonary sarcoidosis
Clinical narrative: Pulmonary Sarcoidosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date May2021 (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 (first dose), administration date: Apr2021, for Covid-19 immunisation. The following information was reported: PULMONARY SARCOIDOSIS (medically significant) with onset Sep2021, outcome "unknown", described as "Pulmonary Sarcoidosis". Patient had the Pfizer 2 dose Covid-19 vaccine in Apr/May2021. By Sep Patient noticed trouble swallowing, talking, and breathing. After several CT scans, doctors have determined that Patient have Pulmonary Sarcoidosis. It's Patient's belief that this diagnosis is directly related to the vaccine. The event "pulmonary sarcoidosis" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (Sep2021) pulmonary sarcoidosis, notes: After several CT scans, doctors have determined that I have Pulmonary Sarcoidosis.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Blood pressure measurement, COVID-19, Drug ineffective, Hypertension
Clinical narrative: she tested positive for Covid-19 on 27Dec2021; she tested positive for Covid-19 on 27Dec2021; reports a very high blood pressure incident reaching 190/95; Caller reports losing her voice; This is a spontaneous report received from a contactable reporter(Consumer) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic to most medications" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Flu shot for Immunization, reaction(s): "Allergies: allergic to flu shot". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "she tested positive for Covid-19 on 27Dec2021"; HYPERTENSION (medically significant) with onset 2021, outcome "unknown", described as "reports a very high blood pressure incident reaching 190/95"; APHONIA (non-serious) with onset 2021, outcome "unknown", described as "Caller reports losing her voice". The event "reports a very high blood pressure incident reaching 190/95" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) 190/95; sars-cov-2 test: (27Dec2021) positive. Therapeutic measures were taken as a result of covid-19, hypertension, aphonia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: she tested positive for Covid-19 on 27Dec2021; she tested positive for Covid-19 on 27Dec2021; reports a very high blood pressure incident reaching 190/95; Caller reports losing her voice; This is a spontaneous report received from a contactable reporter(Consumer) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic to most medications" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Flu shot for Immunization, reaction(s): "Allergies: allergic to flu shot". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "she tested positive for Covid-19 on 27Dec2021"; HYPERTENSION (medically significant) with onset 2021, outcome "unknown", described as "reports a very high blood pressure incident reaching 190/95"; APHONIA (non-serious) with onset 2021, outcome "unknown", described as "Caller reports losing her voice". The event "reports a very high blood pressure incident reaching 190/95" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) 190/95; sars-cov-2 test: (27Dec2021) positive. Therapeutic measures were taken as a result of covid-19, hypertension, aphonia.  The lot number for bnt162b2 was not provided and will be requested during follow up.