chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a non-pregnant female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, anatomical location, lot # and expiration date were not reported) (3 dose series vaccine). On an unknown date, after receiving GARDASIL (dose number was unspecified), the patient experienced dysautonomia syndrome. The patient was not given a treatment for the adverse event. The patient sought unspecified medical attention. The outcome of dysautonomia syndrome was unknown. The relatedness between the event and the vaccination with GARDASIL was not provided. Additional information has been requested.
swelling in his left calf; swelling in his left ankle; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in his left calf) and JOINT SWELLING (swelling in his left ankle) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical History Information was reported.     On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling in his left calf) and JOINT SWELLING (swelling in his left ankle). At the time of the report, PERIPHERAL SWELLING (swelling in his left calf) and JOINT SWELLING (swelling in his left ankle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 16-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in his left calf) and JOINT SWELLING (swelling in his left ankle) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical History Information was reported.     On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling in his left calf) and JOINT SWELLING (swelling in his left ankle). At the time of the report, PERIPHERAL SWELLING (swelling in his left calf) and JOINT SWELLING (swelling in his left ankle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant medications were reported.   No Treatment information for the event was provided.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
I received shot in left arm - 45 min later I felt dizzy and faint. I ate lunch, waited another hour and 45 min - still really dizzy and started seeing white spots. Went to nurse at 2:00 pm.
March 23, 2021: Moderna vaccine taken at 12:20 pm soon after soreness in right arm about 30 min after the shot. Soreness in arm progressed each day thereafter. March 26: arm very sore with muscle pain, cannot lift arm above my head, and cannot lift anything heavy at all,  compared to my left arm which I do not have any problems lifting heavy objects . April 2, 2021 called doctor and report side effects of aching arm and not being able to lift arm above head. They said they would call back by next business day which should be no later than Monday, April 5. Have not received a call bac as of today April 4, 2021. Also, on April 2, 2021 (day 10 after the Modena vaccine) notice new symptoms i.e. hands itching, middle fingers developed itching bumps
I had a heavy cold that lasted three weeks, thick phlegm, nausea, vomiting, diarrhea, I was fighting dehydration as I was unable to keep anything in my body. I called and made an appointment with my primary care physician, he did not run any tests RSV was prevalent in the area and we had a young child staying with us at the time. I was told to hydrate and that there was nothing they could give me to get over the RSV.
FAST HEART BEAT; BODY ACHE; ITCHY RASH (PUFFY); RASH (THEY SEEM LIKE WARTS); HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported.  The patient's concurrent conditions included penicillin allergy, inflammatory bowel disease, nonsmoker, and abstains from alcohol, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 14:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced body ache. On 26-MAR-2021, the subject experienced itchy rash (puffy). On 26-MAR-2021, the subject experienced rash (they seem like warts). On 27-MAR-2021, the subject experienced fast heart beat. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from body ache, and had not recovered from rash (they seem like warts), headache, fast heart beat, and itchy rash (puffy). This report was non-serious.
4/25 Rash on arms and legs, fever, ecchymosis at injection site. 4/29 Fever to 103.5, joint pain, limp. Urticarial rash symptoms continued through 5/3 when she was treated with oral steroids for presumed serum sickness with rapid resolution of symptoms. 4/20: MMR, Varicella, DTaP, Polio. 4/22: Hive-like maculopapular rash develops on extremities (including hands). Vaccination site looks particularly bad - large red/dark patch. 4/23: Rash starts itching. 4/24: Fever of 102.5, rash is itchy. 4/25: Seen by Dr. who suggests there is one reaction at the vaccination site and the rest is a viral rash. 4/25-4/28: Rash continues and keeps itching. Does not respond to BENADRYL. Spreads to face. 4/29: Preschool director calls to say that patient is having right knee pain, possibly due to stumbling. She won't put weight on it and limps (although she can put weight on it). Won't let us go near it or ice it. 4/30: Wakes up screaming at dawn with 103 fever and extreme knee pain. Seen by Dr. who orders blood work. Blood work shows elevated Sed rate (28) and CRP, but otherwise normal. Joint pain spreads to arms and legs. 5/1: Fever continues, spikes to 104.9 at night. Joint pain is severe, rash is back - both seem to come and go with fever. 5/2: Fever breaks in the morning and then rises through the day. Starts complaining of non-specific abdominal pain (has barely eaten since Friday but is taking in some liquids). Joint pain and rash come and go with the fever. Fever spikes again in the evening at 104.9. Sees Drs. for follow up. Has enlarged lymph nodes. 5/3: Dr. - after consulting with colleagues - suggest serum sickness after vaccines. Fever is gone during the day (along with rash for the most part and joint pain) but then spikes again in the afternoon. First dose of prednisone at 6:00pm as treatment if serum sickness theory is correct. Still waiting on parvovirus and Lyme results. 5/4: (After starting prednisone the evening of 5/3) - rash is back without the fever and is very itchy again for the first time since 4/28. Joint pain is gone although in the middle of the night she was complaining of leg pain (but pointing to her quads not her joints). 5/6: No fever, no joint pain, itchy rash is gone. Returns to school. Develops rash that looks (perhaps) like varicella, but it resolves within a day.
rash appeared on legs, arms, thighs, & stomach in the evening of the day Hep B was given (light red dots); appeared to have spread by next AM; seen by MD; DPH & Dexamthosone;
This case was reported by a physician via call center representative and described the occurrence of overdose in a 1-year-old male patient who received HAV (Havrix adult) (batch number U95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included HAV (Havrix adult) (batch number U95H7, expiry date unknown) for prophylaxis.   Previously administered products included Havrix (1st dose received on an unknown date).   On 9th December 2021, the patient received the 3rd dose of Havrix adult. On an unknown date, the patient received the 2nd dose of Havrix adult. On 9th December 2021, unknown after receiving Havrix adult and not applicable after receiving Havrix adult, the patient experienced extra dose administered, adult product administered to child and overdose. On an unknown date, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose, adult product administered to child, extra dose administered, adult product administered to child and overdose were unknown.  Additional details were provided as follows: The age at vaccination was not reported. Physician reported that the patient received adult dose of the Havrix vaccine inadvertently for his second and third dose of the series, which led to overdose, adult product administered to child and extra dose administered. No further information reported. The reporter consented to follow-up. This case has been linked with cases US2021254949 and US2021254932 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021254932:Same reporter. US-GLAXOSMITHKLINE-US2021254949:Same reporter.
SLEEPY; ACHY; CHILLS; LIGHT HEADEDNESS; TIRED; DIZZY WHEN STANDING; COLD; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage at the time of reporting. The patient experienced drug allergy when treated with fluconazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 09:53 on right arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced light headedness. On 12-MAR-2021, the subject experienced tired. On 12-MAR-2021, the subject experienced dizzy when standing. On 12-MAR-2021, the subject experienced cold. On 12-MAR-2021, the subject experienced chills. On an unspecified date, the subject experienced sleepy, and achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy when standing, had not recovered from light headedness, tired, chills, and cold, and the outcome of sleepy and achy was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
01/11/22 presents to ED for "weakness and near syncope". PMHx of "anemia and GI bleed"
Immediate wheal and flare at all 3 injection sites coinciding with perioral erythema.
Patient reported a sore arm after receiving a FLUZONE injection 1 month ago. Dr has diagnosed tendonitis.
Pt. had vaccines on 6-5-09, and on 6-14-09 child began to have a rash that looked like clots on back, no drainage or raised areas. It is now everywhere
HAD A ROUGH NIGHT; BURNING UP; GASTRO UPSET; CHILLS; VOMITING; NAUSEA; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced had a rough night, burning up, gastro upset, chills, vomiting, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had a rough night, chills, burning up, nausea, vomiting, gastro upset and headache was not reported. This report was non-serious.
States she was not stable, that arm was sore, that she had difficulty walking, felt dizzy, had lost control of muscles, nauseated.  Did not indicate she had these sx until 6/26/19, did not wish to go to ER at that time.  Came in for outpatient visit on 7/3 for provider eval.
injection area was swollen to the size of her fist; arm where received the injection was tender; arm where received the injection was tender; redness at injection site; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE SWELLING (injection area was swollen to the size of her fist), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (arm where received the injection was tender) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included METFORMIN, LISINOPRIL, ATENOLOL and ATORVASTATIN for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 08-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site). On 09-Mar-2021, the patient experienced VACCINATION SITE SWELLING (injection area was swollen to the size of her fist) and VACCINATION SITE PAIN (arm where received the injection was tender). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Itching, at an unspecified dose and frequency and CLOBETASOL for Itching, at an unspecified dose and frequency. On 01-Mar-2021, PAIN IN EXTREMITY (sore arm) outcome was unknown. At the time of the report, VACCINATION SITE SWELLING (injection area was swollen to the size of her fist), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (arm where received the injection was tender) outcome was unknown.            This case was linked to MOD-2021-124213 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: outcome of events, dosage information and  treatment medications were updated.
fever of 102 on the second day for a couple hours.  Painful bruising and discoloration in leg.
Fever of 102.8-oral/vomiting/loss of appetite/swelling & redness at injection site; 4-5 inches in diameter by the evening of 8/14/2015. Fever lasted until 08/16/2015 evening. Redness & swelling lasted until 8/17/2015. Vomiting subsided when temperature was stable.
Varicella like rash seen by doctor (Dermatology) for scraping/biopsy, rash on trunk and arms and face. Acyclovir admin.
The 16 year old patient received the "booster" which is only approved for 18 years of age and older.   Patient had no adverse reaction but did receive the booster shot at age 16 instead of 18.
This spontaneous report as received from a nurse refers to a 6 months 5 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Itching immediately after vaccine given on 3-13-19. Noted redness and induration on 3-14-19. Itching continues. Injection site warm to touch.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On multiple unspecified dates, the patients were administered improperly stored M-M-R II (dose and route unknown, lot # L047133, expiration date: 24-NOV-2017). The vaccines were exposed to temperature excursions in 3 different refrigerators, but not exposed to multiple excursions. The three refrigerators were described as "A: temperature: max 48 Fahrenheit degree for 15 hours, B: temperature: max 49.3 Fahrenheit degree for 15 hours, and C: temperature max 51.4 Fahrenheit degree for 15 hours. No previous excursions. There was no data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT HAD PFIZER COVID VACCINE Dose 1 date: 01/5/2021,  Dose 2 date:01/26/2021, AND TESTED POSITIVE TO COVID.
Patient was given a bivalent vaccine instead of the monovalent vaccine for the initial dose of primary series
My son began to have crossed eyes for no apparent reason. No vomiting, no headaches, no gait issues. The eyes would cross and uncross.  We saw the pediatrician where the vaccines were done and they advised us to see ophthalmologist if "it kept reoccurring in a few weeks". I did not feel like this was right as my son's eyes were continued to be crossed. I made an appt at the ophthalmologist the next day (Friday 6/21).  During exam he noticed increased pressure on the optic nerve. He advised us to go to hospital.   At hospital, after MRI & MRIV the determined it necessary to do an LP where they determined opening pressure was 34.5mm Hg. They drained off the excess spinal fluid. His eyes were better after that. Diagnosis was pseudotumor cerebri. We were given Diamox to be taken twice a day for a month with reg followups with the ophthalmologist.
+ hx of sz disorder which had somewhat worsened a/20AUG96 but was exacerbated by that vax; 3 partial complex & 2 grand mal sz on the following 24hr;did well w/second vax w/APAP;
Throat hurts; Arm hurts; Head hurts; Feel very tired; Not hungry; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of throat pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 05-APR-2023, the patient received the 2nd dose of Shingles vaccine. On 05-APR-2023, less than a day after receiving Shingles vaccine, the patient experienced throat pain (Verbatim: Throat hurts), pain in arm (Verbatim: Arm hurts), headache (Verbatim: Head hurts), tiredness (Verbatim: Feel very tired) and appetite absent (Verbatim: Not hungry). The outcome of the throat pain, pain in arm, headache, tiredness and appetite absent were unknown.   It was unknown if the reporter considered the throat pain, pain in arm, headache, tiredness and appetite absent to be related to Shingles vaccine.     It was unknown if the company considered the throat pain, pain in arm, headache, tiredness and appetite absent to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and stated that it was strong and his or her throat, arm and head was hurts.  Patient was felt very tired and not hungry but it was better to receive the vaccine than to suffer for many months. Follow-up would not possible as no contact details were available.
Dose 1 / Dose 2 Moderna; Dose 1 / Dose 2 Moderna; Booster; sleepy (slept from 11:30 pm on 16th to 2:00 pm on 17th; body is so achy, like not just arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 22 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 09Feb2021, when the patient was 21 years old, for Covid-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 12Jan2021, when the patient was 21 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 16Nov2021, outcome "unknown" and all described as "Dose 1 / Dose 2 Moderna"; IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "Booster"; SOMNOLENCE (non-serious) with onset 16Nov2021, outcome "recovering", described as "sleepy (slept from 11:30 pm on 16th to 2:00 pm on 17th"; PAIN (non-serious) with onset 16Nov2021, outcome "recovering", described as "body is so achy, like not just arms". Therapeutic measures were not taken as a result of somnolence, pain.  Additional Information: Patient was sleepy (slept from 11:30 pm on 16th to 2:00 pm on 17th body was so achy, like not just arms). Prior to vaccination, patient was not diagnosed with COVID-19. The patient was not COVID tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I had arm pain. I had headache and nausea. I had eye infection. I been sick with vomiting for about 3 days. I was hospitalized for 3 days. I have lost 18 lbs. of weight. I have joint pain in my hip and wrist. I went to a physical therapy for. I completely lost of my appetite. I also have swollen lymph nodes. I have an extra heartbeat.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included blood pressure high. Concomitant products included Lisinopril/Hydrochlorothiazide. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm and approximately 20 hours after receiving SHINGRIX, the patient experienced shivering, cold, fever, influenza-like symptoms, upset stomach, tiredness and muscle pain. On an unknown date, the outcome of the pain in arm, shivering, cold, fever, influenza-like symptoms, upset stomach, tiredness and muscle pain were recovered/resolved. The reporter considered the pain in arm, shivering, cold, fever, influenza-like symptoms, upset stomach, tiredness and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left arm. The patient stated that 24 hours later after receiving the vaccine she had a sore arm. Approximately 20 hours later she experienced shivering, cold, fever, flu-like symptoms, upset stomach, tired, and muscle aches throughout entire body from neck to shoulder to lower muscles of the body. The patient slept for 9-10 hours as she was tired, and next day when she woke up she was normal and all her symptoms were resolved. The patient had denied permission to contact their physician. No further details were provided by the caller.
Mother reported child broke out in hives after receiving vaccines.  Stated she gave benadryl and they went away.