chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Diarrhoea, Inappropriate schedule of product administration, Stool analysis
Clinical narrative: she had Pfizer Covid vaccine on 05Aug2022 and 30Sep2022; Stomach issues: diarrhea/gets really mucousy and it's very consistent; This is a spontaneous report received from a Consumer or other non HCP.  A 4-year-old female patient received BNT162b2 (BNT162B2), on 30Sep2022 (between 2pm-3:30pm early afternoon) as dose 2 (maroon cap), single (Lot number: FT9142) at the age of 4 years, in arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: pfizer/biontech COVID-19 vaccine (DOSE 1 (MAROON CAP), SINGLE , Lot Number: FT9142, Time: between 2pm-3:30pm early afternoon, Anatomical Site of injection: arm), administration date: 05Aug2022, when the patient was 4-year-old, for COVID-19 immunisation, reaction(s): "Stomach issues: diarrhea/gets really mucousy and it's very consistent". The following information was reported: DIARRHOEA (non-serious) with onset 2022, outcome "recovered" (Oct2022), described as "Stomach issues: diarrhea/gets really mucousy and it's very consistent"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Sep2022, outcome "unknown", described as "she had Pfizer Covid vaccine on 05Aug2022 and 30Sep2022". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea.  Additional information: The patient was taking a probiotic multivitamin (started taking about 3 years ago - ongoing). The reporter stated 2 years ago when the Covid vaccine was first available to kids under 6 her daughter received it and started having stomach issues a week after. They didn't think it was related to the Covid vaccine and she had stool samples done and those were perfectly fine. They didn't know why she was having diarrhea.  She got Covid last year and didn't get the vaccine.  2 weeks ago, she got the Covid vaccine and the same exact symptoms she was having she is having again. Her doctor said it might be possible she is having a side effect and to call and report. It's too much of a coincidence of it happening a couple of days after.  Stated the doctor is doing another stool sample since this is similar and she didn't get it last year. Stated she had the flu shot last year and this year and nothing happened. All 4 kids got it, and she was the only one that had this. The reporter clarified she had Pfizer Covid vaccine on 05Aug2022 and 30Sep2022. Lot for both is FT9142. Does not have NDC or expiry to provide. The reporter stated that the diarrhea got really mucousy and it was very consistent. It started after the 05Aug2022 dose and lasted almost 2 months. They even changed her diet thinking it was lactose, and it was nothing related to nothing like that. The reporter stated the diarrhea stopped mid Oct2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400291214 same patient, different dose/events;
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: cancer; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer". The reporter's wife got the vaccine at Pfizer and the reporter wants to go there and get it. He said his wife was getting chemo now so he can't ask her. Therapeutic measures were taken as a result of neoplasm malignant. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Pain
Clinical narrative: continual joint pain (both knees, hips and wrists); overall body soreness; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19Oct2024 at 08:00 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 19Oct2024 as dose number unknown, single), in right arm for immunisation. The patient's relevant medical history included: "Type II Diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; METFORMIN HCL; ROSUVASTATIN. The following information was reported: ARTHRALGIA (non-serious) with onset 19Oct2024 at 16:00, outcome "not recovered", described as "continual joint pain (both knees, hips and wrists)"; PAIN (non-serious) with onset 19Oct2024 at 16:00, outcome "not recovered", described as "overall body soreness". Therapeutic measures were not taken as a result of arthralgia, pain.  Additional information: The vaccine was administered in the Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the vaccines which are being reported. The patient has no known allergies.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; This is a spontaneous report received from a consumer from a sales representative.  A 20-year-old female patient received BNT162b2 omicron (KP.2) (COMIRNATY (2024-2025 FORMULA)), on 29Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 20 years for COVID-19 immunisation. The patient's relevant medical history included: "Drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; COVID-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; COVID-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 30Oct2024, outcome "recovered" (2024), described as "Tired". Therapeutic measures were not taken as a result of fatigue.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Rsv shots (Had all the other Covid shots, RSV shots, is all up to date with those, just does not have the latest booster.), for Immunization; Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Reporter was enrolled for Paxlovid medication and was inquiring about Pfizer's latest vaccine. Patient did not had latest booster shot, inquiring about financial assistance for Covid shot. Trying to see how he can get it because, currently, he had Covid. Understands, while he has Covid, he should not take it. Was trying to get booster before Covid came and he contracted this. Insurance not covering it. Had all the other Covid shots, RSV shots, is all up to date with those, just does not have the latest booster.  Batch/lot number is not provided, and it cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Vaccination site rash
Clinical narrative: Rash at the injection site; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Oct2024 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 30Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 31Oct2024, outcome "not recovered", described as "Rash at the injection site". Therapeutic measures were not taken as a result of vaccination site rash.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Body temperature, Chills, Eye irritation, Headache, Pain
Clinical narrative: Chills; 100.5 fever; body aches; headache; burning eyes; This is a spontaneous report received from a Consumer or other non HCP.  A 47-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Nov2024 at 18:45 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 01Nov2024), in left arm. The patient's relevant medical history included: "Various food items allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, manufacture unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, manufacture unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, manufacture unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4, manufacture unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 5, manufacture unknown), for Covid-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset 02Nov2024 at 07:00, outcome "recovering", described as "100.5 fever"; CHILLS (non-serious) with onset 02Nov2024 at 07:00, outcome "recovering"; PAIN (non-serious) with onset 02Nov2024 at 07:00, outcome "recovering", described as "body aches"; EYE IRRITATION (non-serious) with onset 02Nov2024 at 07:00, outcome "recovering", described as "burning eyes"; HEADACHE (non-serious) with onset 02Nov2024 at 07:00, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, pain, headache, eye irritation. Additional information: There were no other vaccines received in four weeks prior to the vaccines. There were no other medications in two weeks.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pyrexia
Clinical narrative: Chills; 100.5 fever; body aches; headache; burning eyes; This is a spontaneous report received from a Consumer or other non HCP.  A 47-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Nov2024 at 18:45 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; influenza vaccine inact split 3v (FLUARIX), on 01Nov2024), in left arm. The patient's relevant medical history included: "Various food items allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, manufacture unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, manufacture unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, manufacture unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4, manufacture unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 5, manufacture unknown), for Covid-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset 02Nov2024 at 07:00, outcome "recovering", described as "100.5 fever"; CHILLS (non-serious) with onset 02Nov2024 at 07:00, outcome "recovering"; PAIN (non-serious) with onset 02Nov2024 at 07:00, outcome "recovering", described as "body aches"; EYE IRRITATION (non-serious) with onset 02Nov2024 at 07:00, outcome "recovering", described as "burning eyes"; HEADACHE (non-serious) with onset 02Nov2024 at 07:00, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia, pain, headache, eye irritation. Additional information: There were no other vaccines received in four weeks prior to the vaccines. There were no other medications in two weeks.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Had new vaccine 4 weeks ago Tested positive for Covid; Had new vaccine 4 weeks ago Tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "Had new vaccine 4 weeks ago Tested positive for Covid". Clinical course: The patient received Paxlovid.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Thrombosis, Ultrasound scan
Clinical narrative: Pain in leg and swelling; Pain in leg and swelling; possible blood clot; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 23Oct2024 as dose 1, single (Lot number: LN0589) for covid-19 immunisation, Device Lot Number: LN0589. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset Oct2024, outcome "unknown", described as "possible blood clot"; PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 24Oct2024, outcome "not recovered" and all described as "Pain in leg and swelling". The patient underwent the following laboratory tests and procedures: Ultrasound scan: (Oct2024) Unknown results, notes: to check for a possible blood clot.
Age: 26.0
Sex: M
Vaccine: UNK
Symptoms: Lip swelling
Clinical narrative: His lips began to swell; Delayed allergic reaction.; This spontaneous case, initially received on 10-Oct-2024 (with additional information received on 17-Oct-2024), was reported by a health professional and concerns an adult male patient.  Prescriptions, over-the-counter medications, dietary supplements, or Street address: herbal remedies being taken at the time of vaccination; Allergies; Other illnesses at the time of vaccination and up to one month prior; Chronic or long-standing health conditions, Medical tests and laboratory results: N/A  Administration of company suspect drug: On 17-Sep-2024, the patient received Flucelvax (TIV) for Indication not reported, dose: not reported; Route of administration: Intramuscular; anatomical location: in Arm, Lot number: AW3225B. batch number reported as AW3225B. CSL Seqirus Batch number unable to be matched.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 19-Sep-2024, the patient experienced His lips began to swell (outcome: Not Reported), Delayed allergic reaction. (outcome: Not Reported).  Patient stated he had no symptoms initially. however, as he was talking with his professor on 19-Sep-2024 his lips began to swell. his professor sent him to urgent care where they told him he was having a delayed allergic reaction.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide the seriousness and causality.; Reporter's Comments: Causality was related to the administration of Flucelvax (TIV)
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Chills; Injection site red; Injection site hard; Injection site warm; Injection site painful; This spontaneous case, initially received on 10-Oct-2024, was reported by a health professional  (with additional information received on 17-Oct-2024), and concerns an adult female patient.   Administration of company suspect drug: On 17-Sep-2024, the patient received Flucelvax (TIV) for Indication not reported., Dose regimen : not reported, route of administration: Intramuscular in Left arm, Lot number: AW3225B, CSL Seqirus Batch number unable to be matched.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 18-Sep-2024, the patient experienced Chills (outcome: Unknown), Injection site red (outcome: Unknown), Injection site hard (outcome: Unknown), Injection site warm (outcome: Unknown), Injection site painful (outcome: Unknown).  On 17-Sep-2024, patient stated she felt fine. she woke up the following morning with chills, and noticed that the injection site was swollen, red, hard, warm and painful to the touch. patient had her teacher mark the redness on the morning of 19-sep-2024, and by noon the redness had extended beyond the market area.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide the seriousness and causality for the events.; Reporter's Comments: All events are related.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Syncope
Clinical narrative: Patient had a very dizzy spell and fainted on bench outside pharmacy. We had the patient lay down for about 10 minutes.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Patient had a red rash and swelling show up at site.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Gave standard dose flu vaccine to 93 year old. I understand it isn't mandatory but wanted to report just encase.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Laboratory test, Pain, Pain in extremity
Clinical narrative: Flu symptoms 4 days then leg pain more severe in right leg.  Before vax walked my black lab 2+miles most days.  Now I cannot walk without pain afterward.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Myalgia, Ultrasound scan normal
Clinical narrative: Muscle/shoulder pain and decreased muscle strength ongoing since vaccine administration.  Ultrasound completed to determine if cyst was present from injection and none found.  Provider requested VAERS report
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: pain at injection site that has lasted since administration.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Patient received 2nd dose 7 days after dose 1 when it should have been 30 days after.
Age: 19.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Inflammation, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain
Clinical narrative: Pt states area of injection (right arm) is painfull, swollen red and hard and area of inflammation extends into neck
Age: 19.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Injection site swelling
Clinical narrative: Pt states area of injection (right arm) is painfull, swollen red and hard and area of inflammation extends into neck
Age: 17.0
Sex: F
Vaccine: FLU3, HPV9, MNQ
Symptoms: Fall, Skin laceration
Clinical narrative: Verified with patient if she wanted all three vaccines HPV, Menquadfi and flu. Patient verbally stated she wanted all three vaccines. Went in patient room and patient was sitting on patient table. Notified patient that I was gonna give flu and Menquadfi in the left arm and the HPV in the right arm. Gave immunizations and went to throw away the needles at the sharp container and that's when I heard a thump. Patient had fell into the floor. Patient had a large laceration to forehead area. Patient was awake and remained lying down until ambulance came. Patient O2 sats where check here at clinic 99% RA. EMT arrived and got patient on stretcher and was taken to the ER for further evaluation. Patient vomited once prior to being taken from the clinic.
Age: 76.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red skin at and below injection site accompanied by swelling, warmth and tenderness
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient called the clinic today and states she has redness and warm at the injection site of the Shingles vaccine on her right arm. She denies any fever or problems breathing.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: Patient develop rash after getting vaccine  ( reported about 1 month later)
Age: 27.0
Sex: M
Vaccine: TYP
Symptoms: Extra dose administered
Clinical narrative: Patient was given another dose of typhoid vaccine on 06NOV2024 instead of the Hepatitis A #2 which he needed. Pt already had the typhoid vaccine on 22AUG2024. Pt Was ca
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: After giving patient her influenza shot (FLUZONE), she walked around the store with her mom for about 5-10 minutes (according to her mom).  She then told her mom that she felt lightheaded and passed out in the store. An ambulance was called and they took her to the hospital. The patient was seen at the hospital and then discharged with instructions to keep the patient hydrated.  The mom is following up with their PCP tomorrow.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Capillary fragility, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: patient's mother reports that symptoms began 11-1-2024. symptoms reported: her arm swollen twice the normal size, redness, warmth around the injection site itchy, bumpy texture appeared to have broken capillaries a burning sensation at the injection site
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Skin texture abnormal
Clinical narrative: patient's mother reports that symptoms began 11-1-2024. symptoms reported: her arm swollen twice the normal size, redness, warmth around the injection site itchy, bumpy texture appeared to have broken capillaries a burning sensation at the injection site
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: PATIENT NOTICED TWO DAYS LATER SWELLING OF LYMPH NODE ON THE LEFT SIDE OF SHINGRIX VACCINE RECEIVING SIDE.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Head injury, Headache, Loss of consciousness, Presyncope
Clinical narrative: After giving vaccination patient experienced vasovagal episode and fell from standard height chair, hitting R side of head on the floor. Patient experienced brief tremors before regaining consciousness almost immediately, episode lasted less than 10seconds. Per pt and father he has had this happen before after needlestick but has been years since he last actually passed out. Since patient hit head patient father was recommended to keep a very close eye on patient for signs of concussion such as worsening headache, visual changes, nausea, vomiting or confusions and take patient to emergency room immediately. Pt neuro exam and vitals stable upon leaving office, patient reported headache but states he felt fine otherwise.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: After giving vaccination patient experienced vasovagal episode and fell from standard height chair, hitting R side of head on the floor. Patient experienced brief tremors before regaining consciousness almost immediately, episode lasted less than 10seconds. Per pt and father he has had this happen before after needlestick but has been years since he last actually passed out. Since patient hit head patient father was recommended to keep a very close eye on patient for signs of concussion such as worsening headache, visual changes, nausea, vomiting or confusions and take patient to emergency room immediately. Pt neuro exam and vitals stable upon leaving office, patient reported headache but states he felt fine otherwise.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Abdominal pain upper, Chest discomfort, Diarrhoea, Headache, Hyperhidrosis
Clinical narrative: Within 30 to 40 minutes of receiving the vaccine, I experienced severe stomach cramping that was on and off throughout the day. While sleeping the pain was so bad it woke me up the next day. I experienced a headache, nausea heaviness on my chest. The next day I had diarrhea all day, along with severe stomach cramping, and headache and sweats
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Nausea, Sleep disorder
Clinical narrative: Within 30 to 40 minutes of receiving the vaccine, I experienced severe stomach cramping that was on and off throughout the day. While sleeping the pain was so bad it woke me up the next day. I experienced a headache, nausea heaviness on my chest. The next day I had diarrhea all day, along with severe stomach cramping, and headache and sweats
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Not known-related to vaccinations.
Age: 40.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Nasopharyngitis, Peripheral swelling, Thrombosis
Clinical narrative: Got a blood clot in arm that caused arm to swell
Age: 33.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site reaction, Pain in extremity
Clinical narrative: I was injected in the right arm in my deltoid muscle. 24 hours after the injection around 0630 AM my middle finger felt numb, and my arm was in a lot of pain. A couple of hours later my index finger was numb. Now today 11/6 at the injection site feels tight and numb and pain at the site.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Skin tightness
Clinical narrative: I was injected in the right arm in my deltoid muscle. 24 hours after the injection around 0630 AM my middle finger felt numb, and my arm was in a lot of pain. A couple of hours later my index finger was numb. Now today 11/6 at the injection site feels tight and numb and pain at the site.
Age: 33.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: I was injected in the right arm in my deltoid muscle. 24 hours after the injection around 0630 AM my middle finger felt numb, and my arm was in a lot of pain. A couple of hours later my index finger was numb. Now today 11/6 at the injection site feels tight and numb and pain at the site.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: This patient received two 2024-2025 flu vaccines
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Unevaluable event
Clinical narrative: The patient made an appointment for his flu shot on 9/23. He came in and got the shot
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: TWO DAYS AFTER RECEIVING THE SPIKEVAX VACCINE, THE PATIENT EXPERIENCED ARM SWELLING BELLOW THE SITE OF INJECTION.  THE AREA WAS PAINFUL TO THE TOUCH, RED AND HOT.  IT SEEMS ISOLATED TO THE AREA JUST BELOW DELTOID.   PATIENT ADVISED TO SELF MONITOR AND REPORT TO DOCTOR IF SYMPTOMS WORSEN.
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Erythema, Mobility decreased, Swelling
Clinical narrative: Patient presented with shoulder pain and was unable to lift her arm.  The area was red and swollen.  This was 12 days after the incident.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash
Clinical narrative: Child developed a pinpoint rash similar in appearance to a typical viral rash on torso, upper arms, and lower face
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Reddened, hot, swollen and very painful injection site and surrounding area around 2 inches in diameter. Still swollen after 3 days, the day of reporting this effect, but it has subsided a little bit but is now getting itchy. Less painful. Seems to be recovering. Pharmacist notified and advised me to report this effdct.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Burning sensation, Chills, Fatigue, Headache
Clinical narrative: Vaccine given Sunday afternoon but by the evening I had chills, joint pain and muscle aches that extended into Monday . By Tuesday (10/22) to Frida (10/25) I had throat irritation, general malaise, fatigue, achy joints . Headache started Friday (10/25) that became worse Saturday with nausea and fatigue. Joint pain continued Sat 10/26 to present. Left toe pain started Tuesday 10/29 with swelling that subsided after Tylenol. Joint pain continued all week. Thursday and Friday,  I experienced burning to lower legs and paresthesia to lower limbs.  Until now , I get intermittent joint pain, tingling and achy muscles (especially in the morning).
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Myalgia, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: Vaccine given Sunday afternoon but by the evening I had chills, joint pain and muscle aches that extended into Monday . By Tuesday (10/22) to Frida (10/25) I had throat irritation, general malaise, fatigue, achy joints . Headache started Friday (10/25) that became worse Saturday with nausea and fatigue. Joint pain continued Sat 10/26 to present. Left toe pain started Tuesday 10/29 with swelling that subsided after Tylenol. Joint pain continued all week. Thursday and Friday,  I experienced burning to lower legs and paresthesia to lower limbs.  Until now , I get intermittent joint pain, tingling and achy muscles (especially in the morning).
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Throat irritation
Clinical narrative: Vaccine given Sunday afternoon but by the evening I had chills, joint pain and muscle aches that extended into Monday . By Tuesday (10/22) to Frida (10/25) I had throat irritation, general malaise, fatigue, achy joints . Headache started Friday (10/25) that became worse Saturday with nausea and fatigue. Joint pain continued Sat 10/26 to present. Left toe pain started Tuesday 10/29 with swelling that subsided after Tylenol. Joint pain continued all week. Thursday and Friday,  I experienced burning to lower legs and paresthesia to lower limbs.  Until now , I get intermittent joint pain, tingling and achy muscles (especially in the morning).
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Dizziness postural, Fatigue, Flatulence
Clinical narrative: Upon leaving doctor's office, patient limped and complained injection leg felt funny and made it difficult to walk. At or around 10pm she has severe nausea and began vomiting. The vomiting continued in bouts until about 2am. The child had a mild fever. She woke in the morning with a 101F fever, chills, fatigue, stomach ache, headache and gas. Her stomach aches at times were strong. When she stood up she complained of feeling dizzy. Tylenol helped the fever but it came back two times and each subsequent time Tylenol was given. The parents contacted the doctors office and were told it may or may not be related to the vaccine. They asked if there was anything different about this vaccine as their daughter has had other flu vaccines without these symptoms.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Headache, Limb discomfort, Nausea, Pyrexia
Clinical narrative: Upon leaving doctor's office, patient limped and complained injection leg felt funny and made it difficult to walk. At or around 10pm she has severe nausea and began vomiting. The vomiting continued in bouts until about 2am. The child had a mild fever. She woke in the morning with a 101F fever, chills, fatigue, stomach ache, headache and gas. Her stomach aches at times were strong. When she stood up she complained of feeling dizzy. Tylenol helped the fever but it came back two times and each subsequent time Tylenol was given. The parents contacted the doctors office and were told it may or may not be related to the vaccine. They asked if there was anything different about this vaccine as their daughter has had other flu vaccines without these symptoms.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Upon leaving doctor's office, patient limped and complained injection leg felt funny and made it difficult to walk. At or around 10pm she has severe nausea and began vomiting. The vomiting continued in bouts until about 2am. The child had a mild fever. She woke in the morning with a 101F fever, chills, fatigue, stomach ache, headache and gas. Her stomach aches at times were strong. When she stood up she complained of feeling dizzy. Tylenol helped the fever but it came back two times and each subsequent time Tylenol was given. The parents contacted the doctors office and were told it may or may not be related to the vaccine. They asked if there was anything different about this vaccine as their daughter has had other flu vaccines without these symptoms.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on arm, back and breast
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 8cm area of itching and blanching erythema  near injection site
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Injection site cellulitis
Clinical narrative: Patient reported to the pharmacist that her upper left arm has cellulitis infection one day after receiving the RSV vaccine. Patient visited Dr. and picked up the Doxycycline prescription on 11/5/24 (today).
Age: 28.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Contraindication to vaccination, Exposure during pregnancy, Wrong product administered
Clinical narrative: I was 35 weeks pregnant at the time (now 36 weeks) with my second child (due date December 2, 2024) and went in for a TDap vaccine to Obstetrics & Gynecology at 1pm on 10/30/24. I confirmed with the nurse prior to getting it that I was only getting a TDap vaccine today, she said "yes", and then gave me a shot at around 1:20pm.   Two hours after arriving home, the hospital staff called me to inform me they had accidentally given me an HPV vaccine (GARDASIL 9). This is not recommended for pregnant women. They told me I'd be fine and should come back in for a TDap vaccine, and also that someone would call me the next day for a wellness check. Nobody called me in a week, and nobody apologized. I decided to go to the Health Department instead to get the Tdap vaccine yesterday (11/6/24). The nurse there told me they had no records in the Immunization Database that I was given an HPV vaccine. After going back to doctor office for a record of the HPV vaccine they entered it into the database as given on 11/6/24 (and not 10/30/24). They have since corrected this to the right date.   After speaking with the makers of the HPV vaccine, Merck (per my sister-in-law's recommendation, not the hospital), they informed me that 27.4% of their test group of pregnant women had miscarriages and 2.1% had live birth defects. I've asked the hospital group to cover the cost of a non-stress test (NST) and an ultrasound to give me peace of mind. They won't, even though their nurse gave me the wrong vaccine.
Age: 28.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: I was 35 weeks pregnant at the time (now 36 weeks) with my second child (due date December 2, 2024) and went in for a TDap vaccine to Obstetrics & Gynecology at 1pm on 10/30/24. I confirmed with the nurse prior to getting it that I was only getting a TDap vaccine today, she said "yes", and then gave me a shot at around 1:20pm.   Two hours after arriving home, the hospital staff called me to inform me they had accidentally given me an HPV vaccine (GARDASIL 9). This is not recommended for pregnant women. They told me I'd be fine and should come back in for a TDap vaccine, and also that someone would call me the next day for a wellness check. Nobody called me in a week, and nobody apologized. I decided to go to the Health Department instead to get the Tdap vaccine yesterday (11/6/24). The nurse there told me they had no records in the Immunization Database that I was given an HPV vaccine. After going back to doctor office for a record of the HPV vaccine they entered it into the database as given on 11/6/24 (and not 10/30/24). They have since corrected this to the right date.   After speaking with the makers of the HPV vaccine, Merck (per my sister-in-law's recommendation, not the hospital), they informed me that 27.4% of their test group of pregnant women had miscarriages and 2.1% had live birth defects. I've asked the hospital group to cover the cost of a non-stress test (NST) and an ultrasound to give me peace of mind. They won't, even though their nurse gave me the wrong vaccine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Drug hypersensitivity
Clinical narrative: Drug allergy; This spontaneous report was received from a consumer via other company, and refers to a 66-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, frequency, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced Drug allergy. At the time of reporting, the outcome of the event Drug allergy was not known.    Causality assessment between Drug allergy and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was considered as related.  Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; HCP reported that an adult patient was inadvertently administered PROQUAD; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown gender. Patient's concomitant therapies included sterile diluent (MERCK STERILE DILUENT). Patient's concurrent conditions and pertinent medical history were not provided.   On 29-OCT-2024, the patient was inadvertently vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (strength, frequency, lot #, expiry date, route of administration, and anatomical location were not provided) (Inappropriate age at vaccine administration).  No adverse event.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Musculoskeletal stiffness, Myalgia, Nervous system disorder
Clinical narrative: Muscle aches and stiffness in 24-48 hours post vaccine. Nerve sensitivity in big toes 5-days post vaccine
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The 3yr over vaccine (Afluria) was administered to this patient who was 2yr 11months old at time of vaccination.  No adverse symptoms at time of vaccination.
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Bexsero was exposed to 48.8 F for 78 hrs, 35 min  It was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Bexsero was exposed to 48.8 F for 78 hrs, 35 min  It was administered to a patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-OCT-2024 The reporter reported that the Bexsero was exposed to 48.8 Fahrenheit for 78 hours and 35 minutes and it was administered to a patient, which led to incorrect storage of drug. The Vaccine Administration Facility was the same as Primary Reporter. This was 1 of the 15 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024123936:Same reporter/Different patient US-GSK-US2024123932:Same reporter/Different patient US-GSK-US2024123934:Same reporter/Different patient US-GSK-US2024123922:Same reporter/Different patient US-GSK-US2024123919:Same reporter/Different patient US-GSK-US2024123912:Same reporter/Different patient US-GSK-US2024123909:Same reporter/Different patient US-GSK-US2024123905:Same reporter/Different patient US-GSK-US2024123915:Same reporter/Different patient US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123924:Same reporter/Different patient US-GSK-US2024123911:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient US-GSK-US2024123897:Same reporter/Different patient US-GSK-US2024123899:Same reporter/Different patient
Sex: M
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Bexsero was exposed to 48.8 F for 78 hrs, 35 min. It was administered to a patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adolescent male patient who received Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Bexsero was exposed to 48.8 F for 78 hrs, 35 min. It was administered to a patient.). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-OCT-2024 The reporter stated that Bexsero was exposed to 48.8 F for 78 hours, 35 min and it was administered to a patient, which led to incorrect storage of vaccine. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via email.; Sender's Comments:  US-GSK-US2024123899: US-GSK-US2024123897:Same reporter/Different patient US-GSK-US2024123928:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient US-GSK-US2024123932:Same reporter/Different patient US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123936:Same reporter/Different patient US-GSK-US2024123911:Same reporter/Different patient US-GSK-US2024123915:Same reporter/Different patient US-GSK-US2024123924:Same reporter/Different patient US-GSK-US2024123912:Same reporter/Different patient
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she was pretty much ill for about at least 12-24 hours.; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (she was pretty much ill for about at least 12-24 hours.) in a 69-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (she was pretty much ill for about at least 12-24 hours.). At the time of the report, ILLNESS (she was pretty much ill for about at least 12-24 hours.) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient reported that that every time she had the vaccine, she was pretty much ill for about at least 12-24 hours.   Treatment information was not reported.   This case was linked to MOD-2024-776497 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2024: Live follow-up received is non-significant. Reference numbers were added.
Age: 22.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site was swollen; Injection site was red; This spontaneous case, initially received on 10-Oct-2024 (with additional information received on 17-Oct-2024), was reported by a health professional by a health professional and concerns an adult male patient.  Administration of company suspect drug On 17-Sep-2024 14:00, the patient received Flucelvax (TIV) for not reported, Dose regimen: not reported, route of administration: Intramuscular, Anatomical location: left arm. Lot number: AW3225B. CSL Seqirus Batch number unable to be matched.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 18-Sep-2024, the patient experienced Injection site was swollen (outcome: Not Reported), Injection site was red (outcome: Not Reported).  Patient advised he had no symptoms, but checked his arm the night of 18-Sep-2024 due to his classmates reporting issues and that was when he noticed the injection site was swollen and red. He stated that, other than the swelling and redness, he had no other symptoms. As an outcome of adverse event patient received a doctor or other health care professional office/clinic visit.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide a serious or causality opinion.; Reporter's Comments: All events were considered related
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix was exposed to 48.8 F for 78 hrs, 35 min. It was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a infant male patient who received HAV (Havrix 720) (batch number 423NL, expiry date 16-NOV-2025) for prophylaxis.   On an unknown date, the patient received Havrix 720. On an unknown date, an unknown time after receiving Havrix 720, the patient experienced incorrect storage of drug (Verbatim: Havrix was exposed to 48.8 F for 78 hrs, 35 min. It was administered to a patient). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-OCT-2024 The reporter stated that Havrix was exposed to 48.8 F for 78 hours, 35 min and it was administered to a patient, which led to incorrect storage of vaccine. The reporter consented to follow up via email. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments:  US-GSK-US2024123912:Same reporter/Different patient US-GSK-US2024123936:Same reporter/Different patient US-GSK-US2024123934:Same reporter/Different patient US-GSK-US2024123932:Same reporter/Different patient US-GSK-US2024123928:Same reporter/Different patient US-GSK-US2024123926:Same reporter/Different patient US-GSK-US2024123924:Same reporter/Different patient US-GSK-US2024123922:Same reporter/Different patient US-GSK-US2024123920:Same reporter/Different patient US-GSK-US2024123919:Same reporter/Different patient US-GSK-US2024123915:Same reporter/Different patient US-GSK-US2024123911:Same reporter/Different patient US-GSK-US2024123909:Same reporter/Different patient US-GSK-US2024123905:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient US-GSK-US2024123901:Same reporter/Different patient US-GSK-US2024123899:Same reporter/Different patient US-GSK-US2024123897:Same reporter/Different patient US-GSK-US2024123903:Same reporter/Different patient