chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination site to elbow burning/stinging sensation; burns like a bee sting; Vaccination site to elbow burning/stinging sensation; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Vaccination site to elbow burning/stinging sensation), SKIN BURNING SENSATION (burns like a bee sting) and VACCINATION SITE PAIN (Vaccination site to elbow burning/stinging sensation) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Jan-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 08-Mar-2021, the patient experienced PAIN (Vaccination site to elbow burning/stinging sensation), SKIN BURNING SENSATION (burns like a bee sting) and VACCINATION SITE PAIN (Vaccination site to elbow burning/stinging sensation). At the time of the report, PAIN (Vaccination site to elbow burning/stinging sensation), SKIN BURNING SENSATION (burns like a bee sting) and VACCINATION SITE PAIN (Vaccination site to elbow burning/stinging sensation) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment included  Ibuprofen  Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked.
Patient discharged after a 4-day inpatient stay 11/13-11/17/21 The patient is a 74 y.o. Female who presents with HA, cough, wheezing, body aches, nausea, diarrhea, and poor PO intake. She states her symptoms started on 11/10/21. She currently lives with her daughter and son-in-law, both of whom are COVID+. She states as soon as she started to get sick, she knew it was COVID. She states she has not been able to eat or normally drink for the last few days as her symptoms progressed due to nausea.   On arrival to ED, she was tachypneic and hypoxic to 89% on room air. COVID test was positive. CMP showed mild hyperkalemia, BUN 28, Cr 1.3, Alk Phos 143. CBC showed mild leukocytosis at 11.49 with lymphopenia on the differential. Troponin x1 was 14 (indeterminate). Her lactic acid and BNP were normal. EKG showed paced rhythm, no ST elevation or depression. D-dimer was elevated at 1070. CTA thorax showed no evidence of PE but limited study, no additional signs of cardiopulmonary disease. She was given 500ml IV NS and subsequently admitted to the hospital for acute hypoxic respiratory failure due to Acute COPD exacerbation caused by COVID-19 infection.   Upon arrival to the floor, the patient's blood pressure was still soft, and she was given another 500ml IV NS, to which she responded well. She was started on a 5-day course of remdesivir, a 10-day course of steroids, and a 3-day course of Azithromycin with regular duo-neb treatments. Due to her dehydration and hypotension on admission, we held her Entresto, sotalol, and spironolactone; they remained on hold until discharge for blood pressures in the 110's/70's. She showed steady improvement in wheeze and oxygen requirements, reaching mid 90's saturation on room air by day 3. She completed remdesivir course and was medically and vitally stable for discharge home with a 5-day course of oral steroids.
Currently 7 weeks pregnant, had healthy ultrasound Feb 10, the day prior to vaccination. I have had on and off low grade fever, body aches-unable to get out of bed, numbness of arm where injection was received. Pain in arm where injection occurred, pain has spread to back/underarm/chest. Also have had fogginess and headache as well and pain throughout back. Symptoms have gotten better but I'm on day 3 and still sluggish and have low mobility in my arm.  My husband also experienced a similar reaction to the vaccine. Had similar reaction to 2nd dose- lasted shorter but more intense.
Left arm became very hot, itchy and had a burning sensation. Numerous welts/hives formed on arm. Unknown how long it lasted, placed antibiotic/anti-itch salve on hives. Arm where injection was given was very sore for 4 days.
pt recv vax APR96 & devel a rash on abd & trunk, which looked exactly the same as chicken pox;It was noted that the pt was due for 2nd vax 20MAY96;No further details were provided;
25mg bendryl 8:20 pm for itching tongue 25mg benadryl 8:40 pm itching tongue  patient had "weird" sensation on tongue, breathing and throat were fine, no labored breathing. patient stayed for roughly 20 more min after second dose and then was taken home to father by 2 other friends. Father called and says she has epi pen and allergy medication at home as she has allergy to peanuts. he will monitor and call me back for questions. advised if any concern breathing needs to go to ER immediately.
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 30-JAN-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Initially:  headache, fatigue, muscle aches, tinnitus.  Tinnitus continued for several months.  Headache, fatigue, muscle aches resolved after 24-48 hours.   Tinnitus continued for many months,  eventually improving then returning after 3rd booster vaccine on 12/07/2021.  Vertigo and diplopia developed approx 6  weeks post 04/01/2021 "second" vaccination.  Vertigo resolved after approx 2 weeks and returned after third Pfizer vaccination on 12/07/2021.  Diplopia has not resolved.
Dose administered after 30-day Use By Date; No adverse event; HCP is calling to report that a 65-year-old patient received an expired 6th dose of Moderna COVID-19 vaccine (Lot# & Exp. Date: unknown) on 17JUL2023, beyond 30 days use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP is calling to report that a 65-year-old patient received an expired 6th dose of Moderna COVID-19 vaccine (Lot# & Exp. Date: unknown) on 17JUL2023, beyond 30 days use by date.), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP is calling to report that a 65-year-old patient received an expired 6th dose of Moderna COVID-19 vaccine (Lot# & Exp. Date: unknown) on 17JUL2023, beyond 30 days use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP is calling to report that a 65-year-old patient received an expired 6th dose of Moderna COVID-19 vaccine (Lot# & Exp. Date: unknown) on 17JUL2023, beyond 30 days use by date.), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP is calling to report that a 65-year-old patient received an expired 6th dose of Moderna COVID-19 vaccine (Lot# &amp; Exp. Date: unknown) on 17JUL2023, beyond 30 days use by date.) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine were unknown. Concomitant medication details not reported by the reporter. Dosage text was reported as unknown. Vial was initially stored in the refrigerator on 16-JUN-2023. Size of the vial was reported as 2.5 ml. Vial did not undergo any temperature excursions. Treatment details was not reported by the reporter.
immediate injection site soreness, later lethargy and upper body soreness, and continuing full body sore/aches and lethargy
PT received pfizer vaccines on 03/04/21 and 03/25/21. Pt went to urgent care on 10/28/21 with complaints of sore throat and recent COVID exposure. Pt was found to be COVID positive. Pt then came to the ED due to multiple recent falls. Pt was not hypoxic and did not require supplemental oxygen
pt was given APAP as recommended by MD & had fallen asleep; pt suddenly woke up screaming x 1-1 1/2 hrs; mom called & MD suggested DPH; pt was given & became drowsy & went to sleep;
Muscle Pain; Joint Pain; Arm Pain; Tiredness; This is a spontaneous report from a contactable consumer (reported for himself). A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EWO177/Batch number was not reported) via an unspecified route of administration, administered in left arm on 19May2021 (at the age of 75-year-old) as dose 1, single for COVID-19 immunization at other. Medical history included atrial fibrillation, myocardial infarction, chronic obstructive pulmonary disease, chronic kidney disease from, neuropathy peripheral, coronary artery disease and hypertension. Concomitant medication(s) included warfarin morphine, atorvastatin and amlodipine all the drugs taken for an unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received warfarin. On 20May2021, the patient experienced muscle pain, joint pain, arm pain and tiredness. No treatment was given for the events. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
I did get the shot afterward. But I have had shingles twice since then/ Suspected vaccination failure; Shingles is awful; nerve pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles 6 years ago, it was awful).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I did get the shot afterward. But I have had shingles twice since then/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles is awful) and post herpetic neuralgia (Verbatim: nerve pain).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: Gsk receipt date 18 Sep 2023 This case was reported by a consumer via interactive digital media. The patient stated that shingles was awful, the patient had them and still had nerve pain on the day of reporting. It had been 6 years the patient had shingles and he/she did get shot afterward. The patient had shingles twice since then, but it was not bad as 1st time. The patient advised to get shot if you had chickenpox.   This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not reported.
10cm x 5 1/2cm red area, warm to touch. Pt reports it started on the day after injection and is a little bit achy. Was advised to use heat as she has been applying ice.
Patient presented to PCP and received the following vaccines during the visit by RMA: influenza (lot TM9Z5) IM in patient's left deltoid, MENACTRA (Lot # U6143AA) IM in patient's left deltoid, and GARDASIL (Lot N035957) IM in patient's right deltoid on 11/26. The following day the patient's family contacted the provider and endorsed rash, redness, swelling and warmth of left arm for the past day. Patient was seen by provider on 11/27 for follow up. MD diagnosed " 3-4cm area over lateral aspect of LUE noted to be erythematuous with induration; no tenderness, no drainage".  Patient diagnosed with vaccine induced cellulitis. Patient prescribed cephalexin 500mg PO BID, as well as TYLENOL/MOTRIN as needed.
At first I had a sore throat and cough. The cough would not go away and just go worse over the next 3 days until I was very sick and hardly being able to breathe with chest congestion and 100.5 fever by Thanksgiving day. On Friday, 11/23/2007 I returned to the Physicians Assistant as I was coughing up blood with some mucus. I was given a prescription for Azrithromycin and told to use my rescue inhaler frequently. The antibiotic has had little affect after 4 days. Use of the rescue inhaler has helped some, but I am still sick. HHS has been very negligent in not spreading the word that there was a differnt formulation of flu shot vaccine for people with severe allergies. I am not and have never been allergic to eggs. It is the dam Mercury and preservatives that are the problem.
Symptoms: nausea, scratchy throat  Outcomes: improved with PO Benadryl and extended monitoring
Pt devel cold sx & cough w/wheezing approx 2 wks p/receiving flu vax; also exp confusion & dilation of the pupils; The pt was hospitalized @ this time for a period of 11 days;
Patient was perfectly healthy with no know illness. On 08/27/2019 she got her vaccinations to prepare for kindergarten. On 08/29/2019 less than 48 hours after vaccinations, she had her first grand mal seizure. She was taken by ambulance to the emergency room. She was showing all signs of a hypotonic/hyporesponsive episode but was sent home. After several more grand mal seizures she was ambulanced to Hospital. Blood tests, genetics test, MRI's, CT's, and a spinal fluid tests were done. On October 1st, 2019 patient's CSF results came back positive for Anti-NMDA receptor encephelitis. She was treated with IVIG therapy, steroids, and Rituximab IV. She has also been on seizure meds since her 2nd grand mal seizure. She will continue iv therapy.  Patient went through seizures, psychosis, catatonia: behavioral, muscular, cognitive, mood, and caused cuteness and gait walk. She has slight improvement from treatments but is still suffering.
Administered a 2nd dose of Tdap  3 months after a 1st one was given.
Patient received pediatric 10mcg dose of Pfizer vaccine instead of the 30mcg dose of Pfizer vaccine. Communicated error with patient and her mother and the plan for her 2nd dose of vaccine.
Information has been received from a physician concerning a 14 year old female with no pertinent medical history and no drug reactions/allergies who in approximately August 2010 (as of 06-AUG-2010 and was reported as at last week), was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (LOT# not reported) and right after getting the vaccine she started experiencing "excruciating pain" at the injection site. She even called the office 48 hours later and was still experiencing it. There was no lab diagnostics studies performed. At this time of reporting, the patient's out come was unknown. Follow-up information has been received from the physician who reported that the female student with no illness at the time of vaccination or adverse events following prior vaccination or pre-existing allergies, birth defects, medical conditions who on 04-AUG-2010 at 02:30 PM was vaccinated intramuscularly at left arm with the first dose of GARDASIL (LOT# 666163/0664Z). On that day, the patient experienced severe arm pain and pain in axillary node for one week following vaccine. The patient was still having pain in arm and also painful node, but not severe three weeks later. Additional information has been requested.
a lot of tears in her eyes and couldn't see well; a lot of coughing, an uncontrollable cough; breast starts to hurt a lot; a little pain in the front of the body from the shoulder down; pain in the top / back of the head; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (a lot of tears in her eyes and couldn't see well), COUGH (a lot of coughing, an uncontrollable cough), BREAST PAIN (breast starts to hurt a lot) and CHEST PAIN (a little pain in the front of the body from the shoulder down) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: FLU VACCINE VII (Patient received the flu vaccine one month before Moderna's). Concurrent medical conditions included Allergy to topical drugs, Drug allergy and Drug allergy. Concomitant products included VITAMIN D NOS for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 08-Apr-2021, the patient experienced LACRIMATION INCREASED (a lot of tears in her eyes and couldn't see well). In April 2021, the patient experienced COUGH (a lot of coughing, an uncontrollable cough), BREAST PAIN (breast starts to hurt a lot), CHEST PAIN (a little pain in the front of the body from the shoulder down) and HEADACHE (pain in the top / back of the head). At the time of the report, OROPHARYNGEAL PAIN (sore throat), LACRIMATION INCREASED (a lot of tears in her eyes and couldn't see well), COUGH (a lot of coughing, an uncontrollable cough), BREAST PAIN (breast starts to hurt a lot), CHEST PAIN (a little pain in the front of the body from the shoulder down) and HEADACHE (pain in the top / back of the head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included high blood pressure medication and cholesterol medication.  No treatment information provided.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Vomiting-Medium, Additional Details: Patient was exhibiting symptoms of syncope: sweatiness, hot, dizziness, and also vomited. BP was 111/62 HR 65. We have her water and monitored for an additional 10 minutes. She felt better after throwing up and drinking water. She also received her flu vaccine that day.
Father vax'd for smallpox approx 25 days prior to son developing pustular rash. Report from a 3rd party: "PT visiting another state was seen in a hospital ER on 3/27/03 w/erythematous rash w/some pustules on back, trunk. No fever, chills, pruritus. No lesions in mouth, palms, or soles. Has slight URI. Two MD's examined the son (PT) and dx'd possible generalized vaccinia due to close contact w/his father, who received smallpox vax 25 days prior. PT has history of varicella. Direct smear done on right shoulder vesicle and found to be negative for varicella. Father reports on 3/28/03 that they were going to return home where they would have PCR testing done.
This spontaneous report as received from certified medical assistant (C.M.A) refers to a 4 year old patient of unknown gender. On an unknown date in 2014 (reported as "within last week"), the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot # J013730, exp. date 30-OCT-2015, (dose, route and site of administration were not reported) that was improperly stored. No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
sore arm; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 16Mar2021 17:30 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Gilbert's syndrome" (unspecified if ongoing); "Familial tremor" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination, and he has not been tested for COVID-19 since the vaccination. The patient did not know of any allergies to medications, food, or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
the day following vax pt exp large, red, itchy, swollen area at inject site about size of orange & flu like sx lasting a couple of hours; on 6/22 pt indicated arm better just itchy at site;
tested positive for COVID-19 but she was asymptomatic; tested positive for COVID-19 but she was asymptomatic; This is a spontaneous report from a contactable consumer (patient's husband). A 65 year old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 15Jan2021 at 20:30 (at the age of 64 years old) (Batch/Lot Number: EL3249) as a single dose, and dose 2 via an unspecified route of administration on 05Feb2021 at 13:00 (at the age of 64 years old) (Batch/Lot Number: EL9269) as a single dose, dose 2 for COVID-19 immunisation. Relevant medical history and concomitant medication were not provided. On 23Apr2021, the patient tested positive for COVID-19 but she was asymptomatic.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 23Apr2021. The patient did not receive treatment for the event. The outcome of the event tested positive for COVID-19 but she was asymptomatic was unknown.    ; Sender's Comments: Linked Report(s) : PFIZER INC-2021483900 same drug/reporter/event, different patient
got sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Meningococcal B vaccine.     Additional Information: GSK Receipt Date: 08-Jun-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had the Men B vaccine and still got sick. Additional Supportive Information: The follow-up would not be possible as no contact details were available