chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Illness, Pain
Clinical narrative: The booster by far the worse; I experienced electric-like sharp pains radiating from within (not from injection site.); sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 (Lot number: FG3527) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew02017, Location of injection: Arm Left), administration date: 08Jun2021, when the patient was 63 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ew0816, Location of injection: Arm Left), administration date: 17May2021, when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 09Dec2021, outcome "recovered", described as "The booster by far the worse"; PAIN (non-serious) with onset 09Dec2021, outcome "recovered", described as "I experienced electric-like sharp pains radiating from within (not from injection site.)"; ILLNESS (non-serious) with onset 09Dec2021, outcome "recovered", described as "sick".  Additional Information: Each dose resulted in greater side effects. The booster by far the worse. in addition to all the normal side effects, patient experienced electric-like sharp pains radiating from within (not from injection site.), was miserably sick for four days, and considered going to the hospital. NO MORE SHOTS FOR ME. By far, this is the sickest patient had been in her entire life. Patient was not diagnosed with covid prior vaccination and was not tested for covid post vaccination. Patient did not take any other vaccine in four weeks. Patient did not take any other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Fatigue, Oropharyngeal pain
Clinical narrative: chills; fatigue; sore arm; fever of 99.1; body aches; stomachache; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 09Jan2022 11:00 (Lot number: FJ5683) at the age of 13 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "FPIES" (unspecified if ongoing), notes: FPIES. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for COVID-19 Immunization.  The following information was reported: CHILLS (non-serious) with onset Jan2022, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset Jan2022, outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "sore arm"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "fever of 99.1"; PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "body aches"; ABDOMINAL PAIN UPPER (non-serious) with onset Jan2022, outcome "unknown", described as "stomach ache"; OROPHARYNGEAL PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Male 13 year old patient, experienced chills, fatigue, sore arm, fever of 99.1, and body aches, stomach ache and sore throat after receiving booster Covid 19 vaccine on 09Jan2022.  Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: chills; fatigue; sore arm; fever of 99.1; body aches; stomachache; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 09Jan2022 11:00 (Lot number: FJ5683) at the age of 13 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "FPIES" (unspecified if ongoing), notes: FPIES. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for COVID-19 Immunization.  The following information was reported: CHILLS (non-serious) with onset Jan2022, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset Jan2022, outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "sore arm"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "fever of 99.1"; PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "body aches"; ABDOMINAL PAIN UPPER (non-serious) with onset Jan2022, outcome "unknown", described as "stomach ache"; OROPHARYNGEAL PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Male 13 year old patient, experienced chills, fatigue, sore arm, fever of 99.1, and body aches, stomach ache and sore throat after receiving booster Covid 19 vaccine on 09Jan2022.  Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Investigation, Nausea, Pain in extremity, Psoriatic arthropathy
Clinical narrative: lupus; scleroderma; RA; Sjogrens; PA; Raynauds; arm just a little sore/sore arm; a little puffy; a little sleepy; tired in a restless way; nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 23Aug2021 (Lot number: FA8448) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01, Lot: EN6201), administration date: 25Feb2021, when the patient was 40 years old, for Covid-19 immunization, reaction(s): "Felt very tired", "Couldn't keep eyes open from when I got home mid afternoon yesterday till midmorning today", "Injection arm is sore at injection spot", "Pain in my left shoulder blade", "Mouth, throat, eyes and chest felt slightly dryer than usual", "Mouth, throat, eyes and chest felt slightly dryer than usual", "Mouth, throat, eyes and chest felt slightly dryer than usual", "Mouth, throat, eyes and chest felt slightly dryer than usual", "Feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling", "feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling", "A little nausea", "Light headache"; Bnt162b2 (Dose:02, Lot: EN6208), administration date: 18Mar2021, when the patient was 40 years old, for Covid-19 immunization, reaction(s): "Sore arm", "Legs felt heavy in a painful way", "Legs felt heavy in a painful way", "Nausea", "Massive headache", "Sleepy in a restless way". The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus"; SCLERODERMA (medically significant), outcome "unknown", described as "scleroderma"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "RA"; SJOGREN'S SYNDROME (medically significant), outcome "unknown", described as "Sjogrens"; PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "PA"; RAYNAUD'S PHENOMENON (non-serious), outcome "unknown", described as "Raynauds"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm just a little sore/sore arm"; SWELLING (non-serious), outcome "unknown", described as "a little puffy"; SOMNOLENCE (non-serious), outcome "unknown", described as "a little sleepy"; FATIGUE (non-serious), outcome "unknown", described as "tired in a restless way"; NAUSEA (non-serious), outcome "unknown", described as "nauseated". The patient underwent the following laboratory tests and procedures: investigation: negative, notes: I've tested negative this whole time.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Raynaud's phenomenon, Rheumatoid arthritis, Scleroderma, Sjogren's syndrome, Somnolence
Clinical narrative: lupus; scleroderma; RA; Sjogrens; PA; Raynauds; arm just a little sore/sore arm; a little puffy; a little sleepy; tired in a restless way; nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 23Aug2021 (Lot number: FA8448) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01, Lot: EN6201), administration date: 25Feb2021, when the patient was 40 years old, for Covid-19 immunization, reaction(s): "Felt very tired", "Couldn't keep eyes open from when I got home mid afternoon yesterday till midmorning today", "Injection arm is sore at injection spot", "Pain in my left shoulder blade", "Mouth, throat, eyes and chest felt slightly dryer than usual", "Mouth, throat, eyes and chest felt slightly dryer than usual", "Mouth, throat, eyes and chest felt slightly dryer than usual", "Mouth, throat, eyes and chest felt slightly dryer than usual", "Feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling", "feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling", "A little nausea", "Light headache"; Bnt162b2 (Dose:02, Lot: EN6208), administration date: 18Mar2021, when the patient was 40 years old, for Covid-19 immunization, reaction(s): "Sore arm", "Legs felt heavy in a painful way", "Legs felt heavy in a painful way", "Nausea", "Massive headache", "Sleepy in a restless way". The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus"; SCLERODERMA (medically significant), outcome "unknown", described as "scleroderma"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "RA"; SJOGREN'S SYNDROME (medically significant), outcome "unknown", described as "Sjogrens"; PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "PA"; RAYNAUD'S PHENOMENON (non-serious), outcome "unknown", described as "Raynauds"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm just a little sore/sore arm"; SWELLING (non-serious), outcome "unknown", described as "a little puffy"; SOMNOLENCE (non-serious), outcome "unknown", described as "a little sleepy"; FATIGUE (non-serious), outcome "unknown", described as "tired in a restless way"; NAUSEA (non-serious), outcome "unknown", described as "nauseated". The patient underwent the following laboratory tests and procedures: investigation: negative, notes: I've tested negative this whole time.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Systemic lupus erythematosus
Clinical narrative: lupus; scleroderma; RA; Sjogrens; PA; Raynauds; arm just a little sore/sore arm; a little puffy; a little sleepy; tired in a restless way; nauseated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 23Aug2021 (Lot number: FA8448) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01, Lot: EN6201), administration date: 25Feb2021, when the patient was 40 years old, for Covid-19 immunization, reaction(s): "Felt very tired", "Couldn't keep eyes open from when I got home mid afternoon yesterday till midmorning today", "Injection arm is sore at injection spot", "Pain in my left shoulder blade", "Mouth, throat, eyes and chest felt slightly dryer than usual", "Mouth, throat, eyes and chest felt slightly dryer than usual", "Mouth, throat, eyes and chest felt slightly dryer than usual", "Mouth, throat, eyes and chest felt slightly dryer than usual", "Feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling", "feet sore (tingly, dry, burning- feeling not looking) as well yesterday- not from walking but from that achy bone muscle feeling", "A little nausea", "Light headache"; Bnt162b2 (Dose:02, Lot: EN6208), administration date: 18Mar2021, when the patient was 40 years old, for Covid-19 immunization, reaction(s): "Sore arm", "Legs felt heavy in a painful way", "Legs felt heavy in a painful way", "Nausea", "Massive headache", "Sleepy in a restless way". The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus"; SCLERODERMA (medically significant), outcome "unknown", described as "scleroderma"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "RA"; SJOGREN'S SYNDROME (medically significant), outcome "unknown", described as "Sjogrens"; PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "PA"; RAYNAUD'S PHENOMENON (non-serious), outcome "unknown", described as "Raynauds"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm just a little sore/sore arm"; SWELLING (non-serious), outcome "unknown", described as "a little puffy"; SOMNOLENCE (non-serious), outcome "unknown", described as "a little sleepy"; FATIGUE (non-serious), outcome "unknown", described as "tired in a restless way"; NAUSEA (non-serious), outcome "unknown", described as "nauseated". The patient underwent the following laboratory tests and procedures: investigation: negative, notes: I've tested negative this whole time.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Over 24 hours the site became very red and itched very badly; Over 24 hours the site became very red and itched very badly; tiredness; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Jan2022 13:15 (Lot number: 33130BA) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose 2, Lot No: ER6727, Location of injection: Arm Right, Vaccine Administration Time: 14:00), administration date: 03Apr2021, when the patient was 57 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, Lot No: EP7534, Location of injection: Arm Right, Vaccine Administration Time: 14:30), administration date: 13Mar2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 08Jan2022 13:30, outcome "recovering", described as "tiredness"; CHILLS (non-serious) with onset 08Jan2022 13:30, outcome "recovering", described as "chills"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 09Jan2022, outcome "recovering" and all described as "Over 24 hours the site became very red and itched very badly". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site pruritus.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no fever. I also didn't really have site pain at first. Over 24 hours the site became very red and itched very badly. I called the pharmacy and was told to just take a Benadryl. I did and as soon as it wears off it's back to the itching. I feel ok otherwise. Not sure how long this will last. The patient received treatment with Benadryl. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No known allergies were reported.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Jan2022, outcome "unknown", described as "sore arm". It was unknown if therapeutic measures were taken as a result of pain in extremity.  Additional information: Facility where the most recent COVID-19 vaccine was administered Unknown. the patient receive any other vaccines within 4 weeks prior to the COVID vaccine Unknown .Reported Event sore arm Prior to vaccination, was the patient diagnosed with COVID-19 Unknown .Since the vaccination, has the patient been tested for COVID-19 Unknown  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Overdose, Pain, Pyrexia
Clinical narrative: they told him they gave 6 does (1 full vial) instead of 1 dose; fever; lethargy; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2022 12:30 (Batch/Lot number: unknown) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: OVERDOSE (non-serious) with onset 11Jan2022 12:30, outcome "unknown", described as "they told him they gave 6 does (1 full vial) instead of 1 dose"; PYREXIA (non-serious) with onset 11Jan2022, outcome "recovering", described as "fever"; LETHARGY (non-serious) with onset 11Jan2022, outcome "recovering", described as "lethargy"; PAIN (non-serious) with onset 11Jan2022, outcome "recovering", described as "body aches". It was unknown if therapeutic measures were taken as a result of pyrexia, lethargy, pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The device date  was 12Jan2022.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness, Joint swelling
Clinical narrative: swelling, pain and stiffness in joints in hands and wrist.; swelling, pain and stiffness in joints in hands and wrist.; swelling, pain and stiffness in joints in hands and wrist.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 14:45 (Lot number: 33036BD) at the age of 45 years as dose 3 (booster dose), single for covid-19 immunisation. Relevant medical history included: "Known allergies: MAngo" (unspecified if ongoing). Family history included: "Autoimmune disease" (unspecified if ongoing), notes: Other medical history: Autoimmune disease in family. Concomitant medication(s) included: MULTIVITAMIN [VITAMINS NOS]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0153, Location of injection: Arm Left), administration date: 14Apr2021, when the patient was 44 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 24Mar2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: JOINT SWELLING (non-serious), ARTHRALGIA (non-serious), JOINT STIFFNESS (non-serious) all with onset 11Jan2022 17:00, outcome "not recovered" and all described as "swelling, pain and stiffness in joints in hands and wrist.". Therapeutic measures were not taken as a result of joint swelling, arthralgia, joint stiffness.  Additional information: Patient did not receive any other vaccines within 4 weeks. Other medications in two weeks were daily multivitamin. Patient was not received treatment for AE. Prior to vaccination, the patient was not diagnosed with COVID.  Post vaccination patient was not tested for COVID. Device date was 12Jan2022.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Abdominal pain upper, Chromaturia, Faeces discoloured, Off label use, Product use issue
Clinical narrative: Urine turned red; mild stomach pain; stool turned red; Booster shot and flu shot together; Booster shot and flu shot together; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 19:00 (Lot number: 33036BD) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date 07Jan2022 (Batch/Lot number: unknown) as unk unk, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot No: EW0180), administration date: 26Jun2021, when the patient was 36 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Lot No: EW0217), administration date: 05Jun2021, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 07Jan2022 17:00, outcome "unknown" and all described as "Booster shot and flu shot together"; CHROMATURIA (non-serious) with onset 08Jan2022, outcome "not recovered", described as "Urine turned red"; ABDOMINAL PAIN UPPER (non-serious) with onset 08Jan2022, outcome "not recovered", described as "mild stomach pain"; FAECES DISCOLOURED (non-serious) with onset 08Jan2022, outcome "not recovered", described as "stool turned red". Therapeutic measures were not taken as a result of chromaturia, abdominal pain upper, faeces discoloured.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Paraesthesia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient), for a Pfizer sponsored program (005570). A patient (no qualifiers provided) received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient medical history and concomitant medications not reported. Vaccination history included the 1st dose and the 2nd dose of the COVID-19 vaccine (manufacturer unknown) for COVID-19 immunisation. The following  patient felt abnormal/foggy feeling, headache(s) and paresthesia/tingling in hands, with outcome of unknown. Additional information: Patient have had tingling in hands, headaches, foggy feeling, since taking the booster. It has lasted over a month. Patient had no side effects after the first 2 vaccines. The lot number for BNT162B2 not provided and will be requested during follow-up.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: Fever; general body aches; headache; 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 15 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 12Jan2022 20:00 (Lot number: FJ1614) at the age of 15 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION HCL XL; AMPHETAMINE. Vaccination history included: Cormirnaty (Dose Number: 2, Batch/Lot No: EW0186, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 04Jun2021, for COVID-19 Immunization; Cormirnaty (Dose Number: 1, Batch/Lot No: EW0186, Location of injection: Arm Right, Vaccine Administration Time: 04:30 PM), administration date: 14May2021, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Jan2022 21:00, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 13Jan2022 21:00, outcome "recovering", described as "general body aches"; HEADACHE (non-serious) with onset 13Jan2022 21:00, outcome "recovering", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, headache.  Additional information:Patient had no vaccination within 4 weeks of vaccination. Prior to vaccination patient had not been diagnosed with COVID-19. Patient had not been tested for vaccination since vaccination. There were no known allergies. Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Influenza, Myalgia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 59-year-old female patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# 331208A), at the age of 59, in right arm, on Jan 11, 2022, at 10:00, 0.3mL, single dose, for COVID-19 immunisation. Medical history included pre-diabetic, start date: 2021 (unspecified if ongoing), notes: diagnosed late last year. There were no concomitant medications. Vaccination history included the 1st dose of BNT162B2 (Comirnaty, batch/lot# EN6207, expiration date: unknown), at the age of 58, in left arm, on Mar 17, 2021; and received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# EN0150, expiration date: unknown), at the age of 58, in the left arm, on Apr 7, 2021; both single dose, for COVID-19 immunization. The patient experienced neck pain, and arthralgia/horrible pain in back of neck and top of shoulder blade; onset Jan 11, 2022, at 07:00, with outcome of not recovered. The patient also had influenza (felt like she has the flu), onset Jan 12, 2022, with outcome of not recovered; headache, onset Jan 11, 2022, with outcome of not recovered; chills, onset Jan 12, 2022 09:00, with outcome of not recovered; neuralgia (excruciating nerve pain on right-side, from bottom of foot to top of shoulder blade, where she got the injection), onset Jan 11, 2022, at 10:00, with outcome of not recovered; and myalgia/muscle pain, onset Jan 2022, with outcome of unknown. No follow-up attempts possible. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Neuralgia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 59-year-old female patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# 331208A), at the age of 59, in right arm, on Jan 11, 2022, at 10:00, 0.3mL, single dose, for COVID-19 immunisation. Medical history included pre-diabetic, start date: 2021 (unspecified if ongoing), notes: diagnosed late last year. There were no concomitant medications. Vaccination history included the 1st dose of BNT162B2 (Comirnaty, batch/lot# EN6207, expiration date: unknown), at the age of 58, in left arm, on Mar 17, 2021; and received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# EN0150, expiration date: unknown), at the age of 58, in the left arm, on Apr 7, 2021; both single dose, for COVID-19 immunization. The patient experienced neck pain, and arthralgia/horrible pain in back of neck and top of shoulder blade; onset Jan 11, 2022, at 07:00, with outcome of not recovered. The patient also had influenza (felt like she has the flu), onset Jan 12, 2022, with outcome of not recovered; headache, onset Jan 11, 2022, with outcome of not recovered; chills, onset Jan 12, 2022 09:00, with outcome of not recovered; neuralgia (excruciating nerve pain on right-side, from bottom of foot to top of shoulder blade, where she got the injection), onset Jan 11, 2022, at 10:00, with outcome of not recovered; and myalgia/muscle pain, onset Jan 2022, with outcome of unknown. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Mass, Pain in extremity, Sleep disorder
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), on Jan 10, 2022, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of the COVID-19 vaccine (manufacturer unknown), for COVID-19 immunization. The patient had pain in extremity (axillary pain/woke up with an extreme pain under my arm like in armpit area/something else going on in arm/pain in arm), onset Jan 12, 2022, outcome unknown; sleep disorder/not been able to sleep on left-side, onset Jan 10, 2022, with outcome of unknown; and mass/lump, onset Jan 2022, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Increased upper airway secretion, Lethargy
Clinical narrative: Headache; Mucus in back of throat; Body Aches all over; swollen underarm lymph node on left side (left shoulder vaccine site); Fever of 99.9; Tiredness; lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 11Jan2022 15:00 (Lot number: FJ1614) at the age of 13 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: JORNAY PM; METHYL PHENIDATE [METHYLPHENIDATE]; GUANFACINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173), administration date: 14Jun2021, when the patient was 12 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0173), administration date: 20May2021, when the patient was 12 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "Headache"; INCREASED UPPER AIRWAY SECRETION (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "Mucus in back of throat"; PAIN (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "Body Aches all over"; LYMPHADENOPATHY (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "swollen underarm lymph node on left side (left shoulder vaccine site)"; PYREXIA (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "Fever of 99.9"; FATIGUE (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "Tiredness"; LETHARGY (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "lethargy". The events "headache", "mucus in back of throat", "body aches all over", "swollen underarm lymph node on left side (left shoulder vaccine site)", "fever of 99.9", "tiredness" and "lethargy" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of headache, increased upper airway secretion, pain, lymphadenopathy, pyrexia, fatigue, lethargy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Jornay / methyphenidate 100mg, Guanfacine 4 mg within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Headache; Mucus in back of throat; Body Aches all over; swollen underarm lymph node on left side (left shoulder vaccine site); Fever of 99.9; Tiredness; lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 11Jan2022 15:00 (Lot number: FJ1614) at the age of 13 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: JORNAY PM; METHYL PHENIDATE [METHYLPHENIDATE]; GUANFACINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173), administration date: 14Jun2021, when the patient was 12 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0173), administration date: 20May2021, when the patient was 12 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "Headache"; INCREASED UPPER AIRWAY SECRETION (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "Mucus in back of throat"; PAIN (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "Body Aches all over"; LYMPHADENOPATHY (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "swollen underarm lymph node on left side (left shoulder vaccine site)"; PYREXIA (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "Fever of 99.9"; FATIGUE (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "Tiredness"; LETHARGY (non-serious) with onset 12Jan2022 15:00, outcome "not recovered", described as "lethargy". The events "headache", "mucus in back of throat", "body aches all over", "swollen underarm lymph node on left side (left shoulder vaccine site)", "fever of 99.9", "tiredness" and "lethargy" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of headache, increased upper airway secretion, pain, lymphadenopathy, pyrexia, fatigue, lethargy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Jornay / methyphenidate 100mg, Guanfacine 4 mg within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 12 hours after vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: 33025BD) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FISH OIL. Past drug history included: Keflex, reaction(s): "known allergies: keflex", notes: known allergies: keflex. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: ER9727), administration date: 24Mar2021, when the patient was 41 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Lot No: ER8737), administration date: 14Apr2021, when the patient was 41 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 13Jan2022, outcome "recovered" (Jan2022), described as "Fever 12 hours after vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The patient received other medications within 2 weeks of vaccination are fish oil, mutli vitamin The patient did not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination.  Follow-Up (19Jan2022): Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy; 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 left (Batch/Lot number: unknown) at the age of 50 years as dose 1, single and administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). There were no concomitant medications. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "not recovered", described as "Neuropathy". The event "neuropathy" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of neuropathy peripheral.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: had fever/chills - this continued into the following morning (temperature peaking at 1:30am at 100.3degrees); had fever/chills - this continued into the following morning (temperature peaking at 1:30am at 100.3degrees); experienced muscle aches; feeling very fatigued; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jan2022 10:00 (Lot number: FL3197) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Lichen simplex chronicus" (unspecified if ongoing). Concomitant medication(s) included: JUNEL taken for contraception; LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 14Jan2021, when the patient was 32 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Vaccine Administration Time: 03:00 PM), administration date: 04Feb2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 13Jan2022 21:30, outcome "recovering", described as "feeling very fatigued"; CHILLS (non-serious), PYREXIA (non-serious) all with onset 13Jan2022 22:30, outcome "recovering" and all described as "had fever/chills - this continued into the following morning (temperature peaking at 1:30am at 100.3degrees)"; MYALGIA (non-serious) with onset 13Jan2022 21:30, outcome "recovering", described as "experienced muscle aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, chills, pyrexia, myalgia.  Additional details: Patient did not receive any other vaccine in four weeks. List of other medications received in two weeks include: JUNEL 1/20 for birth control and LEVOTHYROXINE 25mcg. Patient did not have covid prior vaccination. Patient did not test for covid, post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Feeling abnormal, Headache, Illness
Clinical narrative: Illness; subacute thyroiditis; pain in the front of the neck; headaches; fever; general achy-ness; feeling bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Dec2021 10:00 (Lot number: 33B0BA) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Right, Vaccine Administration Time: 05:30 PM), administration date: 25Mar2021, when the patient was 57 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Right, Vaccine Administration Time: 05:30 PM), administration date: 04Mar2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "Illness"; THYROIDITIS SUBACUTE (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "subacute thyroiditis"; NECK PAIN (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "pain in the front of the neck"; HEADACHE (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "headaches"; PYREXIA (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "fever"; PAIN (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "general achy-ness"; FEELING ABNORMAL (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "feeling bad". The events "illness", "subacute thyroiditis", "pain in the front of the neck", "headaches", "fever", "general achy-ness" and "feeling bad" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, thyroiditis subacute, neck pain, headache, pyrexia, pain, feeling abnormal and treated with NSAIDs.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Neck pain, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Illness; subacute thyroiditis; pain in the front of the neck; headaches; fever; general achy-ness; feeling bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Dec2021 10:00 (Lot number: 33B0BA) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Right, Vaccine Administration Time: 05:30 PM), administration date: 25Mar2021, when the patient was 57 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Right, Vaccine Administration Time: 05:30 PM), administration date: 04Mar2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "Illness"; THYROIDITIS SUBACUTE (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "subacute thyroiditis"; NECK PAIN (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "pain in the front of the neck"; HEADACHE (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "headaches"; PYREXIA (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "fever"; PAIN (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "general achy-ness"; FEELING ABNORMAL (non-serious) with onset 18Dec2021 17:00, outcome "not recovered", described as "feeling bad". The events "illness", "subacute thyroiditis", "pain in the front of the neck", "headaches", "fever", "general achy-ness" and "feeling bad" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, thyroiditis subacute, neck pain, headache, pyrexia, pain, feeling abnormal and treated with NSAIDs.  No follow-up attempts are possible. No further information is expected.