chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site turned purple red; Big blush around injection site; severe headache; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site discoloration (Verbatim: Injection site turned purple red), injection site erythema (Verbatim: Big blush around injection site), headache (Verbatim: severe headache) and fever (Verbatim: Fever).  The outcome of the injection site discoloration, injection site erythema, headache and fever were resolved.   It was unknown if the reporter considered the injection site discoloration, injection site erythema, headache and fever to be related to Shingrix.     It was unknown if the company considered the injection site discoloration, injection site erythema, headache and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-OCT-2023 The patient self-reported this case. The patient stated that she received Shingrix and developed a reaction. The patient had fever, severe headache, injection site turned purple red and also had a big blush at the injection site. The reporter reported that all symptoms went away 4 to 5 days later. The reporter did not consent to follow up.
My son received a COVID 19 booster shot at 6 pm.  When we drove home and tried to eat dinner, he complained of a stomach ache.  He went to bed not feeling well.  He woke up at 6 am with a fever of 102 and vomited and complained of stomach pain.  After several hours, he complained his stomach pain was worse and was unable to stand up.  I gave him PO Zofran and some Tylenol to control his fever and nausea.  He was able to hold down the Tylenol but continued to have a fever, weakness, and stomach pain.  At 12 pm I took him to the ER where he had labs drawn and they gave him 400 cc of saline and said his blood sugar was 57.  AT this point, his fever broke and he felt better 4 hours into his ER Stay.  We took him home.  On Thursday, he woke up with poor energy and appetite so I gave him Zofran again.  An hour later, he complained his feet where feeling strange and then they became itchy and swollen.  The nurse I called thought it was athlete's foot but he also broke out into a rash on his arm where he received his booster shot.  I gave him topical hydrocotisone and that helped for the day.  He then experienced a break out of the rash on his arm and feet daily.  HE complains of bad itching and discomfort at the booster injection site and feet.  We are giving him daily Benadryl and topical hydrocortisone which seem to help briefly but then it flares again.  As of right now, the rash has worsened.
Patient is a 67-year-old male with no PMH who presents to the ED complaining of SOB, fever and cough x8 days.  Patient is vaccinated against COVID. He states that he started having shortness of breath, fever and coughing on 01/21 that progressively worsened. States he tested positive for COVID on 01/21 at Community Clinic, was given azithromycin and prednisone.  On 01/26 he return to community clinic and was given Augmentin, DuoNeb, supplemental oxygen.  Patient's states that he was feeling much better until today having a acute respiratory attack or a had increased shortness of breath.  He states that after having this increased shortness of breath he was concerned and came to our facility.  DISCHARGE: Patient is a 67-year-old male with no PMH who presents to the ED complaining of SOB, fever and cough x8 days.  Patient is vaccinated against COVID. He states that he started having shortness of breath, fever and coughing on 01/21 that progressively worsened. States he tested positive for COVID on 01/21 at Community Clinic, was given azithromycin and prednisone.  On 01/26 he return to community clinic and was given Augmentin, DuoNeb, supplemental oxygen.  Patient's states that he was feeling much better until today having a acute respiratory attack or a had increased shortness of breath.  He states that after having this increased shortness of breath he was concerned and came to our facility.  Patient states he has had a fever with T-max 102.  Chest x-ray on admission showed mild peripheral airspace disease suspicious for COVID pneumonia.  Patient placed on 1.5 liters nasal cannula in the ED in increased up to 2 liters nasal cannula while in hospital.  On the day of his discharge patient was on room air in asymptomatic.  Patient was treated with IV Solu-Medrol stay due to allergy to dexamethasone.  Patient also given remdesivir, albuterol inhaler, ipratropium inhaler.  On the day patient's discharge patient was asymptomatic, stable and doing much better on room air oxygen. Discharge condition: Stable. Pt was advised to follow up with PCP in one week, and to return to the ED for further evaluation if symptoms recur, persist, or worsen. The patient voiced understanding
Chills, extreme weakness, and excruciating  bone and muscle pain, diarrhea lasting 48 hours. Improved with Meloxicam. The keratitis flared up.  Developed keratitis after the first dose on 12/17/2020.  Lot EK5730. The keratitis presented with dry eyes, photophobia and reduced reading ability. I am treated with steroid drops and artificial tears.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On an unknown date in July 2015 the patient was vaccinated with one dose of the GARDASIL series (dose 1, strength and route of administration not reported). Concomitant medications were not reported. On 15-JAN-2016 the patient received a dose of GARDASIL 9 (dose 1, strength and route of administration not reported) (reported as second dose in the series). (Incorrect schedule of drug administered) (wrong drug administered). The patient was present at the office at the time of report. No adverse effects were reported. Causality assessment was not provided. Additional information has been requested.
Leg aches, nausea, headaches, "didn't feel good" for 1 week. Couldn't move arms/legs for 1-1 1/2 days.
Body rash and itching; loratadine; body rash subsided the following day  Extreme pain in arm of injection site; unable to utilize; could not sleep on that side; pain dissipated after two days
lip numbness, sore throat, Brown urine, Body/joint aches, cold sweets, base of rib pain Narrative:
The patient, a healthy 41-year old woman, had a hemorragic stroke five days after receiving the COVID booster shot at the pharmacy. Paralyzed on the right side. No history of hypertension (in fact, history of low blood pressure). Not overweight (5 ft 4 inches, 113 lbs). No diabetes. Doctors have no explanation for why this happened.
patient got the Moderna vaccine half the dose also she got the second dose on the 8th  of December and she was supposed to get the full dose on the 15th of December
Red knot, turned to local red area covering front half of upper arm and moved downward. Heat present but no pain.
Awake all night, screaming and crying; fever 101, began 3-4 hours after getting vaccine; complained of body and head hurting. Said (L) arm hurt more but bot equally red.
Patient reported having a high fever (101F), minor itching, feeling nauseous and having a headache. The patient also had an onset of hives on the right side of her arm from her elbow to her shoulder, with extreme arm pain. Patient reported onset of symptoms several hours after the vaccine was administered and reported these to the pharmacy on 1/5/17 at 1pm, at the time of which she still had arm pain and hives. She went to her doctor on 1/5/17 and received a prescription for prednisone for her hives.
This spontaneous report was received from the consumer's husband and refers to a 64 year old female patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On an unknown date in approximately 2017 (reported as 2 years ago), the patient was vaccinated with zoster vaccine live (manufacture unknown) for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). On 10-APR-2019 (reported as two days ago), the patient developed shingles (Herpes ophthalmic). It was reported that within the last two days, the patient experienced, very hard and difficult headache, running into the top of her left eye. Patient also felt a knot come above her head and it was inflamed red. The patient's physician stated that there was a possibility that patient could lose her vision. The patient sought for medical attention. The outcome of herpes ophthalmic was unknown. At the time of the report, the causality between the aforementioned events and zoster vaccine live (manufacture unknown) was not provided. Upon internal review the event Herpes ophthalmic was determined to be medically significant.
Patient who received the expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient who received the expired dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who received the expired dose). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient who received the expired dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
DRY COUGH; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. 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 (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 06-SEP-2021) dose was not reported, 1 total, administered on 23-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. The patient received non-company suspect vaccine Moderna (Spikevax, elasomeran) (Dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination.  On 21-MAR-2022, the patient had symptoms of headache and dry cough, both symptoms still lingered but did not seem to be getting worse (Dose number in series 2). On 24-MAR-2022, the patient tested negative for Binax rapid test (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from headache, and dry cough. This report was non-serious. This case, involving the same patient is linked to 20220357912. This case, from the same reporter is linked to 20220354365.; Sender's Comments: V0 : Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Arms red rash, face red, states arms itching. Gave 75mg BENADRYL PO. Mom notified.
Patient passed out while driving, the patient called me when they got home.  His wife stated that he felt fine and I advised them to get him checked out as their earliest convince.
I felt very comfortable and stared to sweat cold and felt I could not breath. I lost conscious for some time and my husband was able to hold my before I heat the floor. I felt I needed to use the restroom. Went to the restroom and pooped. I felt better and walk back to the chair and drink a little bit of water. After 5 minutes I started feeling terrible very very sleepy and cold not breath and my hart was going fast. Was loosing conscious again and felt I needed to go to the bathroom. I vomit and had to use the restroom. I still feel very weak and and having difficulty breathing. I'll update if I need too.
pt recv vax 1APR97 & during the noc 2APR97 pt exp h/a, fever & emesis;by 2APR97 or 3APR97 pt recovered;
Mother of child states that pt. has anoxic seizures and is under the care of a neurologist. Has had vaccinations in the past with no triggered seizures. Neurologist has advised that vaccination is still recommended. Mother of child knows actions to take if seizure occurs. Vaccinations given, after vaccination child held breath and experienced a 1.5 minuet seizure. Mother of child stated that the seizure was typical of others in the past. No injury occurred, mother held child throughout the duration of seizure and during recovery. Offered oxygen and to call 911 but mother declined. Child recovered from seizure with no injury but was irritable. Mother consouled child and sat in clinic for 30 minuets to recover. Advised mother to call neurologist and update on the occurance of seizure after vaccination and if any further seizures occur.
On 12/25/2022 I developed fever, chills, sweating, cough, shortness of breath, fatigue, muscle and body aches, headache, sore throat, congestion, and runny nose. I had 2 positive at home COVID-19 tests, one was done on 12/26/2023 and the other one on 12/28/2023. On 01/03/2023 I went to the walk-in clinic and they took my vital signs. There was a referral to a PA. They gave me some medications and advised me to stay at home. The medicine they gave me was LAGEVRIO.
Dec 19th I was awakened early evening with tachycardia with excess of 130 bpm, no chest pain or shortness of breath. Within 45mins of onset of symptoms I went to the ER. They did an EKG, bloodwork, chest x-ray, urine specimen, covid, RSV, and flu. I was placed on a heart monitor and the started an IV of Cardizem. They also tried IV of Lopressor. Heart rate did not go down in ER, I was admitted. It took 24hrs for the drugs work. They thought I had an UTI and gave me antibiotics- after further testing to the culture they determined I did not have an UTI and stopped antibiotic. When I was laying down my hear rate when slow down a bit but if I stood up it went right back up. On 12/21/2021 they took me to get transesophageal to rule out a blood clot, and I received a shock to the heart- Cardio Version - successful returned to sinus rhythm. I was released the 21st. On the 22nd they installed a 14 day heart monitor. I do not have the results yet for that. I am going to follow-up with a provider at a clinic.  In October I seen my regular cardiologist and there was no signs of this event.
tingling on left side of her body, underarm, side and top of breast; muscle pain on left side of her body, underarm, side and top of breast; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included covid-19 (hospitalized with COVID-19 for 11 days back in February 2022).   On 6th May 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced tingling and muscle pain. On an unknown date, the outcome of the tingling and muscle pain were unknown.   It was unknown if the reporter considered the tingling and muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-AUG-2022 Reporter's comment: The case was self reported by the patient. The patient received her dose of Shingrix and experienced tingling and muscle pain on the left side of her body and described the tingling and muscle pain to be on her underarm, side and top of her breast. The reporter consented to follow up.
Patient's father noted worsening arm pain followed by fever (101-102.7). Following morning, erythema and edema noted on right arm (vaccine was administered to right deltoid).
sore throat/raw; swollen arm; Headache; fever; aches all over the body; feeling chills; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (sore throat/raw), PERIPHERAL SWELLING (swollen arm), HEADACHE (Headache), PYREXIA (fever) and MYALGIA (aches all over the body) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced INJECTION SITE SWELLING (sore throat/raw), PERIPHERAL SWELLING (swollen arm), HEADACHE (Headache), PYREXIA (fever), MYALGIA (aches all over the body) and CHILLS (feeling chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE SWELLING (sore throat/raw), PERIPHERAL SWELLING (swollen arm), HEADACHE (Headache), PYREXIA (fever), MYALGIA (aches all over the body) and CHILLS (feeling chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.   This case was linked to MOD21-078803, MOD21-078805 (E2B Linked Report).; Sender's Comments:  MOD21-078803: MOD21-078805:
redness, swelling, itching to injection site, large area of redness (6cmx8cm)
A mother reported that her son received a series of vaccines including Hib-TITER, Acel-Imune, MMR, hep B, varicella and poliomyelitis virus from 5/4/00 through 8/6/01. She began to notice developmental delays at 9 to 12 months of age. A diagnosis of autism was made in September 2002 at 2 years of age. She is currently trying to detoxify him of mercury with "DMSA" without physician support. Her "son's physician feels that the autism is hereditary, not related to the vaccines." The reporter noted that she also has a 4 year old son with no health or developmental issues. These events were considered medically important (OMIC). Info regarding this event have been sent to manufacturers of vaccines. No further info was available at the date of this report.
I have been having menstrual spotting three times since 2021; Floaters in my right eye started after 2nd vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 15Mar2021 at 08:00 as dose 2, single (Lot number: EN6205) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lupus", start date: 1974 (ongoing); "High blood pressure", start date: 1999 (ongoing), notes: High blood pressure. The patient's family history included: "Diabetes", start date: 2018 (ongoing), notes: Diabetes (Aunt/Uncle). Concomitant medication(s) included: VALSARTAN oral taken for hypertension (ongoing); JENTADUETO taken for diabetes mellitus (ongoing); HYDROXYCHLOROQUINE [HYDROXYCHLOROQUINE SULFATE] taken for lupus-like syndrome (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Time: 08:30 AM, Anatomical Site of Injection: Right Arm, Route of administration: Intramuscular, Batch /Lot Number: EM9810), administration date: 21Feb2021, when the patient was 67-year-old, for COVID-19 immunization. The following information was reported: VITREOUS FLOATERS (non-serious) with onset 2021, outcome "unknown", described as "Floaters in my right eye started after 2nd vaccine"; POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 2021, outcome "unknown", described as "I have been having menstrual spotting three times since 2021". The patient underwent the following laboratory tests and procedures: Biopsy uterus: (2021) Negative; Platelet factor 4: (unspecified date) Always ran low, notes: Test: Antibody test to platelet factor IV: Always ran low.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024719 same patient, vaccine, different dose and event;
has a big knot in it; left arm started itching; has redness of a long oval; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (has a big knot in it), VACCINATION SITE PRURITUS (left arm started itching) and VACCINATION SITE ERYTHEMA (has redness of a long oval) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 02113A and 16M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced VACCINATION SITE MASS (has a big knot in it), VACCINATION SITE PRURITUS (left arm started itching) and VACCINATION SITE ERYTHEMA (has redness of a long oval). At the time of the report, VACCINATION SITE MASS (has a big knot in it), VACCINATION SITE PRURITUS (left arm started itching) and VACCINATION SITE ERYTHEMA (has redness of a long oval) outcome was unknown.            She had a hard time making out the1st lot  No concomitant medications were reported  No treatment information was provided
Pain, 3"x 3" redness by injection area, soreness, swelling, fever, headache, muscle aches, shivering, fatigue.
Rise in blood sugar levels; Rise in hemoglobin A1c; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Rise in blood sugar levels) and GLYCOSYLATED HAEMOGLOBIN INCREASED (Rise in hemoglobin A1c) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (Rise in blood sugar levels) and GLYCOSYLATED HAEMOGLOBIN INCREASED (Rise in hemoglobin A1c). At the time of the report, BLOOD GLUCOSE INCREASED (Rise in blood sugar levels) and GLYCOSYLATED HAEMOGLOBIN INCREASED (Rise in hemoglobin A1c) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: increased (High) Rise in blood sugar levels. On an unknown date, Glycosylated haemoglobin: increased (High) Rise in hemoglobin A1c.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also had to change the insulin pump settings after receiving Moderna vaccine. No concomitant medication were provided. No treatment details were provided.   This case was linked to MOD-2021-074042 (Patient Link).
pt. recieved vaccine 12 hours past expiration. MD contacted pt. No adverse event. Pt. declined revaccination.