chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had vaccines on 6/4/18 KINRIX given IM right thigh. Varicella sub Q right flank. Tuesday she had a warm red swollen and painful area. Mom has done ice and TYLENOL, BENADRYL given. No relief to symptoms.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. No information regarding concomitant medication, historical condition or current condition was provided. In 2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose detail, route, batch/lot# and expiration date were unknown) for long-term prevention of shingles and zoster-related conditions by a pharmacist. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider (HCP) for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
First vaccine  no issues except soreness.  Second vaccination, fever, chills, cracked a tooth from chattering so hard.  Third bivariant- Extreme pain, fever, chills, disorientation.
Dizziness/faintness; Cold sweat; Tingling in left arm; Fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old non pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via unspecified route of administration in the left arm on 24Mar2021 at 16:30 (at the age of 51-years-old) as single dose for COVID-19 immunisation. Medical history included eosinophilic esophagitis. The patient did not had allergies to medications, food, or other product. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) of 40 mg and ibuprofen (ADVIL) received on unspecified dates for unknown indications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 24Mar2021 at 16:45, the patient experienced sudden onset of dizziness/faintness and cold sweat approximately 15 min after receiving shot, while waiting in monitoring area, tingling in left arm and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for adverse events. The clinical outcome of dizziness/faintness, cold sweat, tingling in left arm and fatigue were recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
Vaccines (PENTACEL, PREVNAR & ROTATEQ) were given on 7/28/09. Baby developed moderate fever (up to 102 degrees) & intermittent mild rash that evening. Was seen in office the next day & advised to cont with TYLENOL. Fever resolved that evening and rash totally resolved by 7-31-09.
This spontaneous report as received from a nurse refers to a unknown number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with PNEUMOVAX 23. No co-suspect and concomitant therapies were reported. The nurse reported that an unknown number of patients received improperly stored PNEUMOVAX 23 on unknown dates. No adverse symptoms reported. The temperature excursion for PNEUMOVAX 23 was found to be a supported excursion with in-house stability data. This is one of several reports from the same source. Additional information has been requested.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 03/10/2023. I went to a clinic and received a prescription. As of today, I have a productive cough and my taste is off a little bit.
Reaction to the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Reaction to the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Reaction to the shot). At the time of the report, VACCINATION SITE REACTION (Reaction to the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
During 15 min observation, employee reported tingling in her lips. She is allergic to grass and has experienced this feeling when she is having an allergic reaction. Employee taken to gurny, VS taken. No hives noted. Reported her throat feels a little tight. 50 mg of Benadryl given. See attachment for VS record. 1:1 observation by RN. No further s/s. Employee states points to her flowers and says it could be the flowers my mom sent me for vaccination day. Monitored employee until 1950 when she was taken home by a co-worker. Employee states she has improved s/s and is now just drowsy. Informed to discuss reaction with PCP and/or EH. Instructed to call EMS or go to ED if symptoms come back.
Pt experienced a twinge as injection began followed by soreness, edema, lymphadenopathy, pain and numbness. Pt visited her doctor and symptoms improved with range of motion, heat ahd Naproxen, but did not resolve and have worsened as of 12/6/02.
p/vax pt T99.5,101;lt arm swollen about size of baseball;red hot & painful fingers are numb & tingling;given Aleve & cool clothes;instructed to cont w/Aleve & cold compressors;
On 02/15/2023 patient presented for a Well Child Check. Patient was due for Tdap vaccine and the clinic was out. So it was suggested that we could give DTap vaccine in it's place. Order was placed and this was given by MA. No reaction was ever reported to the clinic after the vaccine. The only reason it was brought to our attention was because coding/billing was having trouble charging for it.
On day 8 after the vaccine:  rash, itching at injection site, low grade fever, slight sore throat and warmness/tightness in chest
Narrative: Pt died on 6/1/2021. Pt had janssen one dose covid vaccine on 5/13/2021. No information provided about pt's death provided. Not clear if vaccine was related to pt's death or not. Per most recent provider note (5/24/2021) (endocrine provider) notes pt was a 71yo male with diabetes on insulin & metformin, recent homelessness & sometimes missed meals noted. Also had lost his medications in April 2021 & came to ER to replace them. Most recent med list posted below. Active Outpatient Medications Status 1) ALBUTEROL 90MCG (CFC-F) 200D ORAL INHL INHALE 2 PUFFS ACTIVE BY MOUTH FOUR TIMES A DAY IF NEEDED FOR BREATHING 2) ASPIRIN 81MG EC TAB TAKE ONE TABLET BY MOUTH DAILY ACTIVE 3) ATORVASTATIN CALCIUM 80MG TAB TAKE ONE TABLET BY ACTIVE MOUTH EVERY EVENING FOR CHOLESTEROL 4) BUDESONIDE 80/FORMOTER 4.5MCG 120D INH INHALE 2 BY ACTIVE MOUTH TWICE A DAY SHAKE WELL BEFORE USING, RINSE MOUTH AFTER USE 5) CYANOCOBALAMIN 500MCG TAB TAKE TWO TABLETS BY MOUTH ACTIVE DAILY 6) FERROUS SULFATE 325MG TAB TAKE ONE TABLET BY MOUTH ACTIVE TWICE A DAY WITH MEALS 7) FOLIC ACID 1MG TAB TAKE ONE TABLET BY MOUTH EVERY ACTIVE MORNING 8) INSULIN,DETEMIR 100UNIT/ML FLEXTOUCH 3ML INJECT 18 ACTIVE UNITS UNDER THE SKIN EVERY MORNING AND INJECT 22 UNITS AT BEDTIME 9) LOSARTAN 25MG TAB TAKE ONE TABLET BY MOUTH DAILY FOR ACTIVE BLOOD PRESSURE 10) METFORMIN HCL 1000MG TAB TAKE ONE TABLET BY MOUTH ACTIVE TWICE A DAY WITH MORNING AND EVENING MEAL FOR BLOOD SUGAR 11) NEEDLE,PEN 32G,4MM USE NEEDLE AS DIRECTED FOR INSULIN ACTIVE PEN INJECTIONS 12) SERTRALINE HCL 50MG TAB TAKE THREE TABLETS BY MOUTH ACTIVE EVERY MORNING 13) TIOTROPIUM 2.5MCG/ACTUAT 60D ORAL INHL INHALE 2 PUFFS ACTIVE BY MOUTH DAILY
patient had no adverse events, the 0.3 cc of pediatric vial was administered instead of adult vial
Severe swelling and pain in upper arm.  Lethargy, extreme tiredness, upset stomach, no appetite, throughout evening.
this report of SIDS is being submitted in an expedited time frame as requested by the FDA. Information regarding Prevnar was received from an investigator regarding a 4 month old female participant in a post-marketing safety surveillance trial who died as a result of SIDS. The child received the second dose on 2/3/03. The baby had no medical history. The mother reported her child had been sick recently with diarrhea and vomiting. Indication for Prevnar was immunization. Product was administered on 2/3/03. Dose regimen was 1 dose. Concomitant therapy included Pentacel. On 2/7/03, 4 days post immunization, at approximately 0920 hours, the child was found unresponsive. Emergency services was called and emergency personnel responded and started life saving measures. The child was transported to a hospital and life saving measures were continued. The child was pronounced dead on 2/7/03 at approximately 0945 hours. On 2/10/03, an autopsy was performed and revealed petechiae on the thymus. The autopsy reported the cause of death as SIDS. On 2/10/03, toxicologic test results revealed no common acidic, neutral or basic drugs were detected; no blood ethyl alcohol or other alcohols or acetone were detected; and no analgesics or barbiturates were detected by specific drug assay. The cause of death was reported as provisional SIDS and the autopsy cause of death was sudden infant death syndrome. Both the investigator and the medical monitor assessed the SIDS as remotely possibly related to the study vaccine. No additional information was available at the date of this report. The autopsy report received on 2/26/04 states healing fx of clavicle.
Patient said that she developed shingles, 2 spots, on her body after the vaccine, approximately 1 week after immunization.
After the third dose; After the third dose; pretty sick; lost 4 pounds; didn't eat for 3 days; had a fever of 100.9 for 2 days; couldn't get out of bed; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that an 80-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: SW0175, Expiry date: unknown, at the age of 80 years), dose 3 via an unspecified route of administration on 11Aug2021 as dose 3, single for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia (bone marrow cancer diagnosed about 7 years ago), Congestive heart failure from 2004 to unknown if ongoing (very weak heart, ejection fraction of less than 20). There were no concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 administered on deltoid left upper arm on 12Jan2021 (Batch/Lot Number: EL8982, at the age of 80 years) for covid-19 immunization and experienced little arm pain; and second dose of BNT162B2 on 02Feb2021 (Batch/Lot Number: EN6318, at the age of 80 years) for covid-19 immunization and experienced little arm pain. After the third dose the patient reported that he was pretty sick, lost 4 pounds, didn't eat for 3 days, had a fever of 100.9 for 2 days and couldn't get out of bed. On the 4th day he got better. He has now had 4 antibody tests that both showed less than 50. Caller reports tomorrow, 4 weeks after his third shot, he is going to get another antibody test. He had an antibody test, called spike protein tests, at (Hospital name withheld), about a month ago, then one test about two weeks ago and he is getting another test tomorrow. He got himself tested and is showing low antibodies for the virus. Outcome of events for off label use and extra dose administered was unknown and for the rest of the events it was recovering.
I developed tinnitus in my left ear. It is a  soft ringing that I seem to notice more at night , it has never gone away it started after my  second vaccine, but initially I just thought it would go away on its own, and hadn?t made direct correlation with vaccine. I never had ear ringing before , when it didn?t go away I finally made appointments with doctor. He wasn?t sure of cause ,.
10 days post vaccine, started developing hives (spontaneous urticaria) and dermatagraphia.  Itchy scalp, hands, feet and various other parts of body.  Hyper-sensitive histamine reactions.  Treated with over the counter anti-histamines.  Around 8 weeks later, same symptoms with little relief.  Also, developed and clinically diagnosed with Shingles (roughly 2 months post vaccine and 6 weeks into ongoing urticaria and dermatagrphia.
got the first shingrix vaccine in 2018 and the second vaccine in 1/2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first Shingrix vaccine (0.5 ml) in 2018).   In January 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 mg/ml. In January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 6-JUN-2022 Reporter's Comments: The reporter had limited patient demographics and vaccine information. The reporter did not give consent to follow-up. Additional supportive Information: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule.
After getting home from the vaccine, her arm was sore for a long time, wasn't sure how much time had passed, but was fixing lunch (she did not eat breakfast), had sudden dizziness, pounding heart.  No pain in her chest.  She was wondering if that was the end of her life.  Grabbed her phone, went to the bedroom, laid on the bed and called her neighbor who calmed her and it started to subside in an hour or so.  Exhausted after that.  All symptoms resolved by the end of the day.  Family history of heart disease in the family so was concerned regarding that.
Information has been received from a licensed practical nurse (LPN) concerning a 19-week-old female who on 29-JUN-2007 was vaccinated PO with the first 2.0 mL dose of Rotateq. It was unknown if medical attention was sought. The patient did not experience any difficulties. Additional information has been requested.
Red rash on my wrist/rash is about a half an inch wide and 3 inches long; This case was reported by a consumer and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th April 2020, the patient received the 1st dose of Shingrix (unknown). On 16th May 2020, 21 days after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details: The age group was not reported but it was selected as adult as per the vaccine indication.  The patient received the first dose of Shingrix approximately one month ago and noticed a rash around a wrist where the patient weared a leather or silicone watch a red rash that was been on the patient's wrist for about a week an a half. The patient reported that the rash was red at comes and goes with the patient putting creams or oil (tea tree) or hydrocortisone on it. The rash was about a half an inch wide and 3 inches long. Till teh time of report, the patient had not taken a second dosage. The patient further enquired whether this was one of the side effects after the injection.
After injection, felt mild to modeate pain on the arm. By the next day, I started to feel pain in my shoulder up to the neck area and stiffness. The pain has caused difficulty with my sleep. Used acetaminophen the next day, then changed to ibuprophen since the third day. Used ice on shoulder/neck and massage area with pain ointments since the third day. The symptoms have not yet resolved.
After administration of the COVID vaccine Pfizer for 5 through 11 years of age, RN noted the client was 13 years old. The client also received the Per CDC guidance, RN provided education to the client's family stating that for his second dose, the client would receive the Pfizer vaccine for 12 years and older.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. On 04-APR-2014 the patient was vaccinated with first does of GARDASIL (dose and frequency unspecified). The reporter stated that the patient was in the office on 03-NOV-2014 to receive her second dose of GARDASIL. Concomitant medications were not reported. No adverse symptoms were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Additional information has been requested.
INJECTION SITE BUMP; ADMINISTRATION ERROR; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 07-APR-2021 to deltoid for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported. On 07-APR-2021, the subject experienced injection site bump. On 07-APR-2021, the subject experienced administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error and injection site bump was not reported. This report was non-serious.
Painful swelling in arm pit.; Aches in kidneys; headaches; Painful swelling in arm pit; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Oct2021 at 18:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included gout and arthritis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously took codeine(MANUFACTURER UNKNOWN) and experienced drug allergy. On 07Oct2021 at 07:30, the patient experienced painful swelling in arm pit, aches in kidneys and headaches. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events painful swelling in arm pit, aches in kidneys and headaches were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse event; Administered both Proquad and Varivax; This spontaneous report was received from a medical assistant referring to a 12-month-old patient. The patient's concurrent condition, medical history, drug allergy/reaction and concomitant medications were not reported. On 06-FEB-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, formulation, dose/frequency, route, lot# and expiry date were not reported) and varicella virus vaccine live (oka/merck) (VARIVAX) (strength, formulation, dose/frequency, route, lot# and expiry date were not reported) for prophylaxis (inappropriate schedule of product administration). No additional adverse event was reported. The outcome of the events was unknown.
EXPIRED VACCINE GIVEN. NO TEMPERATURE EXCURSIONS OCCURED.  NO PROBLEMS NOTED. WILL REVACCINATE AS DETERMINED BY POLICY AND PROCEDURE.
Moderate to severe flu-like symptoms. Muscle aches, dizziness, fatigue, fever, headache, insomnia.
This is a spontaneous report from a contactable consumer. A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in arm left on 17Feb2021 at 10:30AM as a single dose for COVID-19 immunization. Medical history included Known allergies: Penicillin. Concomitant medications included plecanatide (TRULANCE) for an unspecified indication. Historical drug included BNT162B2 on 20Jan2021 at10:30 AM. The patient experienced Arm/shoulder pain - diminished mostly after 4 days, "Foggy" thinking. Shoulder pain is worse at night, difficult to sleep, Six days after vaccine, still "foggy." Not just sleepy from lack of sleep on 17Feb2021 at 2:00. Taking oral steroids and it is improving. The patient has said that It worsened for a couple days, then started to get better after about 4 days. Then it started worsening probably on 22Feb2021. Patient went to the doctor 26Feb2021. Seems the inflammation went into my rotator cuff. Taking oral steroids and it is improving. The outcome of event was recovering. Information on the lot/batch number has been requested.
APPROXIMATELY 10-15 MINUTES AFTER RECEIVING THE VACCINE PATIENT WAS UNCONCIOUS FOR ABOUT 30 SECONDS.  WITHIN THAT TIME HE DID SHAKE FOR ABOUT 10 SECONDS.  HE WAS CONCIOUS AND ANSWERING QUESTIONS BY THE TIME THE PARAMEDICS CAME TO TAKE HIM TO THE LOCAL HOSPITAL.
patient described swelling in area of vaccine (diameter approx 5 inches by 2 inches) and numbness in her arm
After receiving injection patient had local pain and later noticed some redness and a lump at the site of injection.  She presented to the health center 3 weeks later complaining that the site was still tender, there was still a lump and occasional redness overlying the site.
NASAL CONGESTION; SORE THROAT; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight was 180 pounds, and height was 69 inches. The patient's concurrent conditions included seasonal allergies, celiac disease, non alcohol user, and mri dye allergy, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, the subject experienced nasal congestion, and sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nasal congestion and sore throat was not reported. This report was non-serious.
Arm was mildly sore the next morning, Friday evening around 8:30 I had a quick onset migraine followed by vomiting and chills all night.  Saturday morning still severe headache, extreme body aches, and very large swollen lympnode in my left arm pit.  The area is still sore on and very swollen Sunday.  It is about the size of a small egg,