chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got first shingles shot, have a small patch of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 23rd March 2022, the patient received the 1st dose of Shingles vaccine. In April 2022, less than 2 months after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-Apr-2022 Reporter's comments: This case was received from Shingrix GSK chatbot. This case was reported by the patient. On 23rd March the patient received Shingles vaccine and in the reporting week, the patient developed small patch of shingles. The patient asked that should he get 2nd shot now.
My urine is bloody; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (My urine is bloody) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 023M20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN for an unknown indication.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 19-Mar-2021, the patient experienced HAEMATURIA (My urine is bloody). At the time of the report, HAEMATURIA (My urine is bloody) outcome was unknown. Not Provided          No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Case number PHEH2012US019118 is an initial spontaneous report received from a nurse on 21 Sep 2012: This report refers to a 16-year-old female patient. She was given only CYW-135 liquid component of MENVEO (batch number: X11052) intramuscularly on 21 Sep 2012. No other adverse reaction was reported following the administration error.
pt recv vax 3NOV97 230PM & 4NOV97 pt T104 po, sl swelling in nose, eye, chin area per mom;mom stated pt c/o feeling sick, dizzy & sl SOB;mom called MD who instructed mom to give 1/2dose on next immun;12NOV97 temp gone pt recovered;
I got my moderna booster on January 7th. I had high fever muscle aches and vomiting next 2 days. But I knew already as I had same side effects on 2nd dose.  But, after 1 weeks, I woke up in morning, I had very bad itching. After talking with doctor, it was diagnosed as hives. As I am not allergic to anything, and I didn't took anything new in that week. I suspect it is because of vaccination. Now I have hives since last 4 days, and it is all over my body. Face, eye, arms legs, hand palms and feet, everywhere. I am taking antihistamines Cetirizine
12 hours after vaccination eyes discharging and crusted overnight, headache, deep and constant muscle pain, joint pain, intestinal pain and discomfort, fever 101, painful, swollen lymph nodes
On 04/26/21 admitted for eval. of nausea & vomiting; "Nausea and vomiting, likely related to poorly controlled diabetes mellitus.  No signs and symptoms to support clinical infection".  Discharged home on  04/29/21 .
Pain in lower back, hip and leg pain.  Unable to transition from laying to standing or sitting to standing without extreme pain.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot #L044058 and expiration date 02-MAY-2017, lot # M002058 and expiration date 11-JUL-2017, lot # reported as M007962 and expiration date 15-AUG-2017, exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 8.7 Fahrenheit degrees for 15 hours before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Client was waiting in his car post vaccination when he felt dizzy, sweaty and was walking back to the vaccination area when he fainted. Client was assisted by a flow worker and client did not suffer any injuries from fainting.  BP was 139/89, client is able to speak and is oriented X3. 911 was called, Medic 209 arrived and evaluated client. Client's glucose was 92, an EKG was performed. Client declined transport to the hospital and asked his wife to pick him up. Client stated that he was feeling better and that understand to call EMS if symptoms worsen on the way home.
DTaP, HIB, IPV, Prevnar given on 12/3/02 at 12:30. On 12/4/02 09:00, child was standing, was heaving, drooling, stiffened, lips blue, appeared pale for about 1.5 minutes. Ambulance arrived. No resucitation done.
Fast heart beat-awaken from sleep; symptoms lasted X 2 hours; symptoms resolved spontaneously
Information has been received from a medical assistant concerning multiple patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unspecified dates, the patients were vaccinated with ZOSTAVAX (lot #: M015925 with expiration date: 15-JUN-2017 (dose, dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 5°F but less than 14 °F for 48 hours and at temperature greater than 14°F but less than 46°F for 72 hours without any previous temperature excursion. No adverse effects were reported. Data logger was reported as No. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA013789: US-009507513-1702USA000247.
Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint pain, and pain at injection site. Lasting about 12 to 24hours. Antihistamines treated at home.
Within 12 hours of receiving Jansen COVID 19 injection pt began having 7/10 to the right posterior head which progressed to a significant Shingles eruption along the right C2 dermatome. This started as pain/tingling within 12 hours of injection, and progressed to full presentation of pustular rash within 36 hours.   Pt was started on Acyclovir 800mg PO five times daily x 10 days as well as ibuprofen and Tylenol PRN as directed.
complaining of intermittent headache for 1 week which started 2 days after first injection with covid pfizer injection, was covid positive 4 weeks and 2 weeks prior to vaccination. feels better have fluid intakes but headache returns every am. advised follow up with pcp, neurology. ED if worst headache of life, any changes in characteristics of headache. educated regarding sign and symptoms of stroke
N/V, achy, chills, some diarrhea, lump in throat.
pt recv vax & reported red, firm, warm, very tender lt upper arm, redness & swelling migrated to lower 2/3 outer aspect of lt arm;
RUA swelling, redness, hot to touch, painful - unsure if this is reaction to shot or cellulitis.  Placed on cephalexin.
Ear pressure, ringing / wind noise. Hearing is greatly deterred. Went to Dr and they said there was fluid behind the eardrum. Prescribed AMOXICILLIN-CLAV 875-125MG, and FLUTICASONE PROP 50 MCG.
Received second vaccine dose 4 weeks from last missed period (11/8/2021) and miscarried  on 12/20/2021.  This was a first time pregnancy in an otherwise healthy patient with a non-contributory past medical history.  Patient had a history of type 1 diabetes (newly diagnosed 5/2021) but this was controlled w/A1c of 5.4 at the time of conception and vaccine administration.
PATIENT WIFE CALLED INFORMING US THAT PATIENT IS SHAKING UNCONTROLLABLY ASKING WHAT TO DO WE INFORM HER TO GO TO URGENT OR GO TO HOSPITAL INFORM HER THAT WE ARE MAKING A REPORT OF THE SITUATION
Constant coughing, progressing to upper sinus infections, nasal polyps, asthma, swollen neck, coughing so bad I detached my retina in my left eye, detached again one month later. Numerous antibiotics and steriods; hospital ER overnight stay, ER visit - returned home, Eye surgery - still undergoing treatment, Dupixent for the asthma.
Case number PHEH2013US016125, is an initial spontaneous report received from a physician on 25 JUL 2013. This report refers to a 37 years old male patient. His medical history and concomitant medication were not reported. He was vaccinated with expired MENVEO (batch number: A10047 and expiry date: DEC 2012), intramuscularly on 24 JUL 2013. No adverse event was reported following this administration error.
pt recv vax; approx 2 hr p/ vax was playing & laughing on the floor; fell over & started jerking all over, eyes rolled back;lasted 10 mins per mom; to ped; T 104.4 R;had been given apap at 3pm prior to shot;
Fever ranging from 100 to 103 for at least 48 hours after immunization headache, muscle joint ache, earache and ringing and kidney pain also during same 48 hours period.
Fever; Muscle aches; Low back and hip pain; Low back and hip pain; Severe headache; This is a spontaneous report from a contactable consumer reported for himself. A 69-year-old male patient received the first dose of BNT162B2 (lot number: EL 9264), via an unspecified route of administration in the left arm on 02Feb2021 07:00 (at the age of 69-years-old) at single dose for COVID-19 immunization. Medical history included COVID-19 on 23Nov2020, heart bypass, high cholesterol and triglyceride. Concomitant medication included clopidogrel bisulfate (PLAVIX), lisinopril, metoprolol, fenofibrate and atorvastatin calcium (ATORVAST).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 03Feb2021 at 12:00 AM, the patient experienced fever, muscle aches, low back and hip pain and severe headache. He stated that its like he has COVID all over again. The outcome of the events was not recovered. It was unknown if the patient received treatment for the events.
Mother states infant was seen by physician on 7/15/02. Both he and sister had "tiny red bumps." No definite Dx at that time. Within 20 mins of vacc. on 7/22/02, mother noticed what she called "hives." Denies shortness of breath. 7/23/02 physician saw infant and stated he had a rash associated with virus. 7/24/02, mom called stating child had hand, foot and mouth disease, mouth full of blisters.
severe pain in left arm for about 3 month initially,  then no clinical symptoms , then new chest pressure with exercise, on cardiac consult diffuse repolarization changes, LVH, ECHO low EF HF at 15-20%, unclear cause of cardiomyopathy, associated coronary dissection which per specialist does not justify the cardiomyopathy with such low EF; notable same cardiologist visit 2014  - reported normal EKG
Five days after receiving the vaccine, the patient woke up covered in raised bumps coving his arms, back and sides of his torso.
Received a dose past 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose past 30-day use by date) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose past 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose past 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter No treatment medications were provided by the reporter.   This case was linked to MOD-2021-355943, MOD-2021-356165, MOD-2021-355963, MOD-2021-355936, MOD-2021-355901, MOD-2021-355936, MOD-2021-355911, MOD-2021-355963, MOD-2021-356222, MOD-2021-356295 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow-up information included no new information
No symptomatic adverse event were reported; Inbound call from office manager calling to report administration of ROTATEQ that was expired to two patients.; This spontaneous report has been received from an office manager, regarding a 2-years-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 31-MAY-2023, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliters (ml) once as prophylaxis (lot number: U038863, which was determined to be valid, with an expiration date on 27-MAY-2023) (Expired product administered). The vaccine did not have any previous temperature excursion outside recommended range in the past.  No additional adverse event was reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2306USA000729:
This spontaneous report as received from a pharmacist via Company Representative refers to 2 patients of unknown age. On unknown dates the 2 patients were vaccinated with ZOSTAVAX (lot# not reported) (route, dose# and dosage not reported). On unknown dates the 2 patients developed shingles after receiving ZOSTAVAX. The outcome of shingles was unknown. Follow-up information was received from the pharmacist who stated that one patient was recently (date not specified in 2014) vaccinated with ZOSTAVAX and was currently taking shingles medication. The reporter did not have additional information. The outcome of the event was unknown. Causality assessment was not provided. This is one of several reports received from the same source. The other case was captured in MARRS# 1406USA000901. Additional information has been requested.
Mosquito bites seem to be lasting much longer than they did prior to the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 28May2021 (at the age of 47-year-old) as a single dose and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 18Jun2021 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 11Jun2021, the mosquito bites seemed to be lasting much longer than they did prior to the vaccine. The patient could not say if it was the vaccine. They were lasting for days when they used to be healed in hours. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mosquito bites seem to be lasting much longer than they did prior to the vaccine was recovered on an unknown date in 2021.
Pt recv vax on 1/28/99; on same day pt exp left arm & shoulder swollen&painful, malaise
In the morning and night, swollen fingers , I have no bumping or itching, but bruse appears and disappears after few days several times already, I feel like to have bugs or hair crawling on the flesh, my allergies medicine is not working, lots of runny nose &  headaches.
Pt called and stated she had a reaction to the vaccine that was given on 1/7. Pt states it began after hours at 6:30 she felt very itchy and then noticed her arm around the area was swollen like a balloon and red around the edges. Pt states she contacted after hours. Pt took BENADRYL and Cortisone cream and is feeling better but her arm is still swollen. PCP contacted patient today and she  said that itching and swelling has improved since yesterday. Felt a little disoriented yesterday.
As a result of confusion and frequent falling patient was brought to the emergency room for evaluation. She was admitted for further treatment of UTI with encephalopathy, given Rocephin and hydration with improvement. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Nauseous, loose bowels, general malaise, gassy stomach, cramping, tiredness
6:30 Am 2018 - Next day after injection all my joints were not moveable, could hardly stand up. Went to bathroom, back to bed, tried to move arms legs-could do very little. By noon some movement. Felt sick, head hurt nose running-felt very tired, arm very sore.
Pt was seen for her first COVID vaccine today.  Pt is breastfeeding and baby is up at night so poor sleep.   Pt began to feel nauseous after she had the vaccine and then started to feel "faint."  Legs were elevated but pt then had a syncopal episode.  She did not hit her head.  Pt laid on round with legs elevated.   BP 79/49.  Pt arousable and could speak with us.  Pulse 52.  O2 sat 100%.  Pt denied SOB, CP, rash.  Pt was sipping orange juice and crackers.     3:39 BP 114/74  Pulse 80   O2 sat 100%   Pt laying in cot with legs elevated   4:11 BP 110/70 pulse 77  O2 sat 100%   4:25 BP 107/90     5:01 BP 107/73  Pulse 78  O2 sat 100%   5:05 pt taken in a wheelchair to her husbands car who drove her home.   4:45 BG 109
pt exp sz 1 days post vax adm to hosp to control sz;eyes fluttered, hands, legs started to shake;
Initial report received from a healthcare professional on 10 December 2013. A 5-year-old female who had history of sickle cell disease and concomitant medication were not reported, had received a dose of PPSV23 (manufacturer: unknown, lot number, dose number, route and anatomical site of administration were not reported) and also received a dose of Meningococcal vaccine (Manufacturer: unknown, lot number, dose number, route and anatomical site of administration were not reported) both vaccines on an unspecified date. On an unspecified date, 2.5 year before the patient had received a dose of PPSV23 (manufacturer: unknown, lot number, dose number, route and anatomical site of administration were not reported). On an unspecified date after vaccination the patient experienced severe arm swelling with edema. The patient had received analgesics, antiemetics, and antibiotic as corrective treatments. On an unspecified date 24 hours later, the patient had recovered from event. Follow-up information received on 18 December 2013. The patient's immunization history included one dose of PPSV23 two and a half years earlier and a dose of the meningococcal conjugate vaccine 6 months prior to the event. She also had received four doses of 7-valent conjugated pneumococcal vaccine, one dose of the 13-valent conjugated pneumococcal vaccine, the hepatitis B vaccine series, and annual influenza vaccinations. Her mother had previously reported that she usually developed a low grade fever after receiving vaccinations, which she would treat at home with ibuprofen. The patient's past medical history included recurrent otitis media, requiring placement of tympanostomy tubes, and asthma. She also had a history of urticarial response to fire ant bites and skin test confirmed allergies to dust, mold, mildew and cockroaches. The patient was treated with Ibuprofen for fever, ondansetron for nausea and ketorolac for pain. She was also treated with intravenous one dose of Ceftriaxone, but blood culture was subsequently negative. Patient was discharged from the clinic with ibuprofen and morphine for breakthrough pain. The swelling in the right arm resolved at home within 24 h.
Nausea - 10/8/15. 10/7/15 local erythema/edema/discomfort/soreness approximately 7 cm x 3.5 cm where Inactivate Flu vaccine given in left upper arm - deltoid.
Chills and fever the night of the shot which ended by the next morning. Strong headache the following day.
Felt mild sciatica pain Thu morning following 1st vaccine shot that Monday. Through the day (I was just working at home like every other day) Sciatica began to get worse deteriorating to probably the worst pain I've ever experienced. As I mentioned, my Sciatica has been well controlled for 10+ years. I would have occasional mild sciatica pain following hard falls wakeboarding or snowboarding, but haven't done either in weeks nor had any hard falls.
mild shingles rash; This case was reported by a physician via sales rep and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the physician (MD). The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter stated that, the patient experienced mild shingles rash following first dose of shingrix. The reporter stated that did not recall specifics regarding the patient but wanted to share with GlaxoSmithKline(GSK). The physician did not agree to be followed up. This case has been linked with case US2019AMR172644, reported by the same reporter.
This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-Jun-2021. On 16-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. No concomitant medications and treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Internal review on 20 Jul 2021 resulted in the update of event verbatim, outcome and pregnancy information (birth type and fetal outcome). On 27-Apr-2021: Added email address of the reporter. Expected delivery date was provided.
Mother refer that next day of vaccination the left upper arm was red, hard and hot. The patient was vaccinated. The patient came to the clinic and was treated with Benadryl.