chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt stated about 15 minutes after receiving the covid vax that she started having a itchy face and scalp.  Pt stated the itching spread all over her entire body.  Also her left arm is sore from her elbow up to shoulder.  She was checked by a doctor at the vaccine location and monitored for an hour.  She was instructed to take Benadryl when she got home which she did but states she is still itchy.  She says the itchiness comes and goes in different spots.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient received a possibly improperly stored dose of ROTATEQ oral liquid, orally, lot# reported as M032636 with an expiration date 06-APR-2018 (dose was not reported). No adverse effects were reported. The reporter stated that the shipping carton containing the vaccine arrived 24 hours late during delivery (time frame 24 hours). No product quality complaint (PQC) was involved. Additional information is not expected as there was no consent to contact the reporter.
Symptoms:  (All typical viral flu symptoms, very intense) - Headache (unusually strong) - Fever (37.5C) - Chills - Tiredness - Muscle pain Treatment:   - Excedrin (worked well for headache) - Ibuprofen (probably reduced other side effects) Time course: - All symptoms lasted 12 hours and then abruptly were gone, not like typical flu. I was windsurfing next day as usual.
This spontaneous report was received from a nurse and refers to a 29-year-old non-pregnant female patient. The patient's drug reactions included allergy to amoxicillin (hives). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in approximately 1990 (reported as at approximately one year of age) and on an unknown date in approximately 1993 (reported as at fours years of age), the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not provided) for routine immunization. On an unknown date in November 2018, the patient had ''negative titers'' for measles (less than 25.00 (units not provided)), rubella (less than 0.90 units not provided)) and mumps (10.50 (units not provided)). On 13-DEC-2018, the patient received one dose of M-M-R II to treat negative titers. The patient sought medical attention via seeing a physician. The outcome of the events and the causality assessment were not provided.
After receiving flu shot (L) arm/(L) shoulder became swollen/tight, red. Progressively worsened over 2 days with redness/swelling/warmth/tightness/pain moving down to area of elbow & nearing (L) shoulder blade MD recommended BENADRYL/MOTRIN/ice for
Fatigue, Diarrhea, Muscle Pain, Headache, Sore Throat, Nausea/Vomiting lasted for three days. Nausea seems to be hanging on longer. Not sure if this is actually related to the vaccine since the symptoms did not start until more than a week after the injection.
Youth received HPV vaccine in right Deltoid and influenza vaccine in left Deltoid. Approximately 3 hours after receiving, the youth started complaining of legs bilat itching, and left upper arm area itching. Red, bumps noted on left bicep/tricep area.
I am uncertain of time vaccination was given, and time of onset of symptoms on 11/18/09.  Symptoms include pruritic rash on chest per pt.  Pt only informed me today 11/25/09.  Pt then did go on to have a miscarriage 11/20/09.  11/30/09 MR received for vaccine administered on 11/16/09.  12/11/09 MR received for DOS 11/20/09, 11/24/09 and 12/01/09. DX: SAB. Pt started having bleeding and clotting. Pt miscarried and was seen in clinic. Pt had no pain, bleeding or cramping.  OB exam was normal.  Pt was to have follow up care after D&E with weekly blood tests.
The vaccines were applied to patients after being refrozen; shipment was thawed, and then it was refrozen again during transport; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (shipment was thawed, and then it was refrozen again during transport) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (shipment was thawed, and then it was refrozen again during transport). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (shipment was thawed, and then it was refrozen again during transport) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow up document included no new information.
On 10/19/23, my 15 month old child was vaccinated with the Covid Spikevax Moderna vaccine at the health department. I was later informed by the County Health and Human Services department that an adult dose of the Moderna vaccine was administered to my 15 month old child.
Intractible seizures, unresponsive to medications. Resulting in developmental delay. The discharge summary states epilepsy.
Pt received vaccine/GARDASIL 1/15/07. One week later, developed hives which lasted one week. Pt treated with BENADRYL for symptoms relief. Follow-up information received - Date of vaccination and Adverese event onset date.
Large fluid filled knot. Burning, redness and hot to touch  approx 6 inches from injection site by day 3, 12 inches by day 4. Taking benadryl and tylenol with no change in symptoms. Per dr, alternating heat and ice for discomfort. Cool showers and tylenol for fever, rest and fluids for joint and muscle aches.
04Jun90 pt vax;  08Jun90 devel left inguinal lymphadenopathy, 1 1/2" x 1 1/2" in diameter, firm & non tender.  Normal CBC.  30Jun90 gland was decreasing in size & pt exp was still being treated.
This spontaneous report as received from a licensed practical nurse refers to an unknown number of patients with unspecified demographics. The reporter stated that the patients had been administered post supported PNEUMOVAX 23 (injection, strength, route, anatomical location, lot # and expiration date not reported). No adverse events had been noted by any patient. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax 8JUN98 & later the same day pt devel a local rxn @ the inj site redness, (9cm x 11cm), warmth to touch, itchiness, soreness & tenderness;pt seen by MD on 9JUN98;pt tx w/motrin & warm compresses to the site;
Patient is fully vaccinated. 63yo M with PMHx of neurosarcoidosis, HLD and vertigo presents with shortness of breath. Reports he tested positive for COVID 2 days ago and since that time has been having cough, worsening shortness of breath and chest discomfort. No history of heart attack, stroke or blood clots. Does not wear oxygen at home. Reports he had a fall a few days ago. No LOC, head trauma or blood thinner use. In the ER, he was placed on oxygen and given steroids and robitussin with significant improvement in his symptoms. CXR was negative for focal infiltrate. DVT prophylaxis with Lovenox. Discharged home.
CHRONIC DIARRHEA; EPISODES OF  HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: bioidentical hormone therapy, pollen allergy, alcohol user, non smoker, and menopause, and other pre-existing medical conditions included: The patient does not have history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211021A, and expiry: 04-11-2022) dose was not reported, administered on 26-NOV-2021 for prophylactic vaccination.  Concomitant medications included testosterone for drug used for unknown indication, estradiol/estriol for menopause, and progesterone for menopause.  On 02-DEC-2021, the patient experienced chronic diarrhea. On 02-DEC-2021, the patient experienced episodes of headache. Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol/salicylamide, bismuth subsalicylate, and acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic diarrhea, and episodes of headache. This report was non-serious.
Weakness; dizziness; This is a spontaneous report from a Contactable Consumer.  A 84-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in Left arm on 28Jan2021 16:00 (at the age of 84-years-old) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Patient had not received other vaccines within 4 weeks. Patient had not received other medications in two weeks. Prior to vaccination, patient was not diagnosed with COVID-19. The patient was not tested for COVID-19. On 28Jan2021, the patient experienced weakness, dizziness. No treatment received for the events. The clinical outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Mom reported a seizure 2 days after vaccination. Called ER and saw Dr next day.
making pt sick w/low grade fever & churning stomach & dizziness;was taking a rat from a trap & it bit him;will probably not cont treatment;
Patient was given Moderna vaccine 0.5cc in the right deltoid and she is only 16 years old. Per CDC guidelines, Moderna is administered to individuals age 18 or older. No adverse events after injection. Patient was monitored for 20 minutes.
Pain on injection, bleeding, swelling, redness within several hours, heat at injection site swelling increased to size of baseball, injection site aching, hot & red, flushed face 11/2-11/4; took anti-inflammatory on 11/3, redness at injection site and heat continues on 11/4.
The vaccine that was administered to the patient came from a vial that had been punctured at 3:42pm the previous day.  The dose was administered within 24 hours of the vaccine being removed from the refrigerator and punctured.
A report was received from a health care professional on 11/05/03, concerning a 25 year old male vaccinee who experienced swelling and pain the same day of receiving Fluvirin in his left deltoid on 11/3/03. On 11/3/03, the vaccinee experienced swelling in the left upper area and pain. the vaccinee had not yet recovered at the time of reporting. There was insufficient information to determin the reporter's causality assessment. Follow up pending.
lower back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced BACK PAIN (lower back pain). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Back pain, at an unspecified dose and frequency. On 16-Mar-2021, BACK PAIN (lower back pain) had resolved. Not applicable          No concomitant medication provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Regulatory Authority form received on 24-MAY-2021 and patient DOB updated. event outcome updated , treatment information added.
Same day as flu shot was administered, the pt present at ER with erythema of face, neck, upper chest, shakiness and fever. Per doc 213904, eyes watering, temp of 103, muscle pain. The discharge summary states febrile illness, reaction to vaccination.
Low kidney function; A spontaneous report was received from a consumer who was also a 79-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced low kidney function.  The patient's medical history reported include rheumatoid arthritis, and infection. Concomitant medications include medications (unspecified) for rheumatoid arthritis, and antibiotics for infection.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L204A) for prophylaxis of COVID-19 infection.   On an undisclosed date in Jan 2021, the patient's kidney function was low. She reported that her doctor said it was nothing to worry about.  Treatment for the event was not reported.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, low kidney function, was unknown.; Reporter's Comments: This case concerns a 79-year-old, female patient with medical history of rheumatoid arthritis and infection, who experienced an unexpected event of Renal impairment. The event occurred at an unspecified duration after the first dose of mRNA-1273 (Lot number: 025L204A). The patient was taking unspecified antibiotics for unspecified infection. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start  of the event, a causal relationship cannot be excluded.
Patient up to date of COVID vaccines who admitted with COVID detected test and complications from COVID.  Provider d/c note:  "54-year-old female with past medical history significant for Mayer Rokitansky syndrome with solitary kidney and restrictive lung disease on 2 L of oxygen at night at home.  She presented to the emergency department on 09/01/2022 with a chief complaint of shortness of breath and cough.  She was diagnosed with COVID on arrival and did require nasal cannula.  She was started on steroids and remdesivir.  The patient continued to improve over the course of her stay and was on room air at time of discharge.  Oxygen walk test was performed before discharge and she maintained at 98%.  She completed her course of remdesivir and will be discharged home with the remainder of her Decadron.  Patient was doing well, wanted to go home, had no further questions and was given strict return precautions to which she verbalized understanding."
After second Booster on 4/2 Episodes of extreme fatigue send me to bed for several hours.  This fatigue has lasted for 10 days!
A patient received PENTACEL instead of QUADRACEL no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via a consumer/non-health care professional via Global Medical Information (GMI) (Reference number- 00864409) and transmitted to Sanofi on 18-Nov-2021  This case involves a 4 year old patient (unknown gender) who was received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] instead of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (wrong product administered).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination instead of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  It was a case of an actual medication error due to Wrong vaccine administered (latency same day).  It was reported "An medical assistant (MA) inadvertently gave a PENTACEL instead of a QUADRACEL to a 4 year old patient. What should they do? She requests that the information be e-mailed to her since she will be out for the rest of the week."  No other adverse event was reported.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Extreme high pitched buzzing in my ears. Went to ENT my hearing is fine and my ear drums are normal. This is extremely annoying and causing me great anxiety.
Congestion, headache across forehead, sinus swelling and blurred vision. CT scan, eye exam and 2 liters normal saline.
patient was supposed to recieve a flu vaccine however a nurse contracted outof our store gave her the covid 19 bivalent vaccine by accident- no adverse reaction reported at this time
This spontaneous report as received from a certified medical assistant refers to an patient of unknown age and gender. On an unknown date in 2014 (also reported as since 24-JUN-2014), was vaccinated with (Oka/Merck) VARIVAX, subcutaneous (lot # J012380 expiration date not reported), does and route not reported which went out of temperature range multiple times. These excursions were supported. No adverse effects were reported. Outcome of the events were not reported. Causality was not reported. This case has been linked to 1408USA009333, 1408USA013367, and 1408USA013368 as same reporter link. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 66 years old female patient with allergy to codeine. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on 12-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient received ZOSTAVAX at another facility and experienced headache and small red blisters that were extremely painful on 30-OCT-2012. There were about 10-15 of the blisters that were on the back and right shoulder that showed up 2 weeks ago (30-OCT-2012) and yesterday (12-NOV-2012) more of the small red blisters that were extremely painful on the elbow. The patient went to the emergency room but was not admitted, No treatment was given for the events and no lab diagnostic test was performed. The outcome of small red blisters that were extremely painful and headache was reported as not recovered. The relatedness for the reported events was not provided for ZOSTAVAX. The reporting nurse considered the events to be disabling due to patient being in a lot of pain. Additional information has been requested.
Engerix pediatric given to an adult; Engerix pediatric given to an adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number F22EZ, expiry date 03-JUN-2023) for prophylaxis.   On 05-APR-2023, the patient received Engerix B pediatric 10 ug. On 05-APR-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Engerix pediatric given to an adult) and adult use of a child product (Verbatim: Engerix pediatric given to an adult). The outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-APR-2023 The Medical Assistant called to inquire. It was reported an Engerix pediatric (10 mcg, Prefilled) dose was inadvertently administered to an adult patient. The reporter mentioned the dose was administered at an alternate facility. The reporter did not consent to follow-up. Engerix-B was inadvertently administered a pediatric dose to an adult patient, which led to accidental underdose and adult use of a child product.
Metallic taste upon injection  Headache  Muscle ache Fatigue Dizziness
pt recv vax 8JUN93 & felt developed HTN as a result of the vax & was seen by MD; No further info was provided;
Patient received these 4 vaccines in a combo. She developed a swelling in her throat and had a hard time breathing.  She developed a persistent cough. We have been treating with homeopathic medication which has decreased the swelling in her throat.  Cough is still there.
Positive test for Covid after being vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive test for Covid after being vaccinated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive test for Covid after being vaccinated). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive test for Covid after being vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.         No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received and contains No New Information.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Patient has experienced numbness/tingling in right arm starting 10/3/17. This numbness/tingling tends to occur throughout the entire right arm upon awakening and then only occurs in the upper right arm sporadically throughout the day (no lower arm numbness/tingling throughout day). Recommended that patient consult a doctor if symptoms do not improve.