chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got the vaccine and it wasn't too long after that she noticed significant ringing in the ears, thinking she needed to clean them which she did and it has not gone away.  It has gotten  more pronounced and can hear it all the time, especially when she's in a quiet area and concentrating.  It's pretty much more noticeable at night.  She did not go to the doctor for it, she had a wellness check with her PCP after that and she did tell her about it and she didn't seem too concerned.
Masses or swollen lumps near the side of the neck and on the side of the shoulder.
Case number PHEH2013US012265, is an initial spontaneous report received from a physician on 30 May 2013 with the follow-up received from physician on 30 May 2013. This report refers to a 1-year-old male patient. Past medical history and concomitant medication were not provided. He was vaccinated with MENVEO (batch number: A12118 and expiry date: Aug 2014) intramuscularly on 30 May 2013. No adverse event was reported following this administration error. Follow-up received from physician on 30 May 2013: Updated vaccine expiry date.
Vesicular and morbilliform extensive rash involving face, extremities but milder on trunk. On set 4 days, after vaccine, marked worsening d#7-8.
Information has been received from a registered nurse concerning a 68 year old female patient who in 2000 was vaccinated with the first dose of PNEUMOVAX 23 (662100/0742X). In October 2009, the patient was vaccinated with the second dose of PNEUMOVAX 23 (662100/0742X). 2 and 1/2 hours after the second vaccination, the patient had pain in the arm and could not move her arm. The patient contacted the nurse. The patient had an X-ray conducted at the time and was treated with unspecified antibiotics. The patient also had a magnetic resonance imaging (MRI) conducted and the evaluation physician stated the vaccine might have been given in the bursa. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from a registered nurse concerning the female patient with no illness at the time of vaccination and no pre-existing allergies who on 22-OCT-2009 at approximately 15:00 was vaccinated with the second dose of PNEUMOVAX 23 (662100/0742X) IM into the right deltoid. Concomitant therapy included PLAVIX, SYNTHROID and LIPITOR. On 26-OCT-2009, the patient called and reported that on 22-OCT-2009 at approximately 17:30 she experienced "excruciating pain" in her right shoulder. She stated that she must hold her arm over her chest. The patient had vomited for 24 hours after vaccination. There was no redness, swelling or warmth. The patient took TYLENOL for pain and used ice for the first 12 hours and heat each night. On 28-OCT-2009 (also reported as 29-OCT-2009), the patient saw a physician. An X-ray was performed that showed no problems and "blood work" was also performed that showed infection. The patient was prescribed KEFLEX for right shoulder infection. The patient also had fever and right shoulder swelling. In November 2009, the patient had repeat "blood work" (results not reported) and a magnetic resonance imaging (MRI) (results not reported) performed. At the time of the report, the patient's status was unknown. It was noted that there was no adverse event following prior vaccination. Additional information has been requested.
2nd dose was received in January 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   In JAN-2023, the patient received the 2nd dose of Shingrix. In JAN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose was received in January 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 16-JUN-2023 The reporter on behalf of patient. Further information was not known. The consent to follow up was not asked. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Diarrhea, NauseaVomiting, red tingling face, stomach pain, lightheaded, soreness with localized reaction to injection site, left axilla lymph node enlargement Narrative:
Patient states that one week out she is feeling a "tingling sensation" mostly on the left side of the body (@ injection site and left foot, a little tingling on the right side) but is not describing any loss of sensation or pain.
Unexpected menstrual spotting 48 hours after second dose; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FL9266) via an unspecified route of administration in the left arm on 04May2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and allergy to sulfa drugs. Concomitant medications included unspecified oral birth control (MANUFACTURER UNKNOWN) and levothyroxine sodium (SYNTHROID); both started on an unknown date for unspecified indication. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: eR8729) via an unspecified route of administration in the left arm on 13Apr2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 06May2021, the patient experienced unexpected menstrual spotting 48 hours after the second dose. The clinical outcome of the event unexpected menstrual spotting was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
first Pfizer vaccination on 9 March , second on 30 March. One week after he received his first dose of vaccine he began to 'get thisbad ammonia-type smell'' which seemed to permeate his whole house, clothing, and sheets. separate sensation, of a metallic taste on his tongue. He states both these symptoms worsened after dose 2; at their worst, the ammonia smell was occurring reliably whenever he spent 20-30 minutes in an area and the metallic taste was near constant. His symptoms began to spontaneously improve by the latter part of July, currently experiences the ammonia smell about 3-4x a day (still after remaining stationary for prolonged periods of time) and the metallic taste 1-2x a day.  never had issues with reduced sense of smell or taste. He has never tested positive for COVID, nor has he had symptoms concerning for COVID infection.   Symptoms: UNSPEC DISTURBNCES,SMELL&TASTE
Vaccine administered 7/31/08, pt presented to local ER 8/1/08 with dizziness, nausea, weakness after physical activity; mother phone MERCK to be advised of side effects; physicians office notified on 9/29/08 if immunization services should be continued
HEADACHE; This spontaneous report received from a consumer 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
some dripped down his arm. It was 2 big drops.; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (some dripped down his arm. It was 2 big drops.) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to UNK dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced UNDERDOSE (some dripped down his arm. It was 2 big drops.). On 17-May-2021, UNDERDOSE (some dripped down his arm. It was 2 big drops.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Moderna vaccine dose 1 given to 16 year old by provider at a clinic for indications of 18 and over MD was notified, no reports of side effects or adverse reaction noted by provider
HIGH BLOOD PRESSURE; VERY DEPRESSED; FATIGUED; BAD HEADACHES; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced high blood pressure, very depressed, fatigued, and bad headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigued, high blood pressure, very depressed, and bad headaches. This report was non-serious.
Incorrect product storage; No additional adverse effect reported for all patients; Information has been received from a medical assistant, concerning a patient (gender and age were not provided). The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 29-JUL-2020, the patient received a dose of Hepatitis A Vaccine, Inactivated (VAQTA), (Lot # S032358, expiration date on 11-JAN-2021), intramuscularly, that was inappropriately stored. The vaccine underwent multiple excursions below 36 grades Centigrade for 75 hours. No previous temperature excursion was reported. The information was obtained because of a data logger.   No additional adverse effect was reported.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032358; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA003648: US-009507513-2007USA003649: US-009507513-2007USA002536: US-009507513-2007USA003647: US-009507513-2007USA003651: US-009507513-2007USA003645: US-009507513-2007USA003646: US-009507513-2007USA003005: US-009507513-2007USA002514:
Between Aug90 + Nov90 pt vax w/ hepta B which was expired material.  No adverse experience.
Immediately after delivering dose, patients arm became swollen and red, about 1" circumference around the injection site. There were no systemic signs of allergic reaction/anaphylaxis, no disorientation or difficulty breathing, or swelling  any other areas of the body that were noticeable to me. I asked her to stay in the store for 15 minutes, and swelling went down slightly, she then left with her mother to run an errand down the street, then cam back about 30 minutes later for me to check on her; again swelling was reduced to about 1/2" circumference and redness was minimal. I called again the morning of 9/27/2017- she states she is feeling slightly under the weather but that the swelling in her arm is less than it was last night.
This case was reported by a consumer via call center representative and described the occurrence of decreased appetite in a 78-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 5th September 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On 6th September 2018, 1 days after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced decreased appetite, sleepiness and upset stomach. On an unknown date, the outcome of the decreased appetite, sleepiness and upset stomach were recovered/resolved. The reporter considered the decreased appetite, sleepiness and upset stomach to be related to SHINGRIX. It was unknown if the reporter considered the decreased appetite, sleepiness and upset stomach to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The patient reported that the next morning after receiving SHINGRIX she did not want to eat anything, her stomach was upset and she slept all day. The symptoms just lasted one full day. The reporter said that she received the flu vaccine the same day of the SHINGRIX vaccine on 5th September 2018. The reporter was relating all events to the SHINGRIX. This case has been linked with case US2018180206 reported by the same reporter.
Date of Admission:  2/4/2022   Chief Complaint:  Shortness of breath   Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 86y.o. female with a past medical history significant for asthma, biventricular ICD Saint Jude, chronic heart failure with preserved ejection fraction, cardiomyopathy nonischemic, hypertension.  She presented to hospital on 2/4/2022 for evaluation of subjective shortness of breath and new onset cough.  She states that the shortness of breath is worse with exertion.  She denies any orthopnea.  She states that her cough is productive of green-colored sputum.  She states that the symptoms have been worsening over the last 2 to 3 days.  She also notes intermittent nausea that she gets with dizziness.  She states that over the same timeframe that when she goes to walk she has become unsteady and at times is felt like she is going to fall.  She denies any falling, loss of consciousness.  She describes a sensation as the room spinning as opposed to lightheadedness.  She states that she is vaccinated for Covid with a Johnson & Johnson one-time dose.  She denies any new onset fevers.   Discussed case with emergency department, patient was set for discharge however during ambulation test patient was very unsteady and required assistance.  She lives in a community living facility where she does not have significant help.  Admission for PT OT evaluation and close O2 monitoring with regards to new Covid diagnosis.
On the same day of vax, the pt developed an injection site reaction in the right arm characterized by swelling which extended over the upper arm and pain. The pt also developed ecchymotic areas in the upper arm and forearm. The pt recovered.
Information has been received from a medical assistant concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported.  On an unknown dates, the patients were administered improperly stored doses of LIQUID PEDVAXHIB lot # M027884, expiration date 19-APR-2019, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported.  The doses of LIQUID PEDVAXHIB were exposed to a temperature >46°F but <77°F and were out of range for 112 hours. A data logger was not used to track the temperature and there was a prior excursions of 34.20 F for 15 hours. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA003705: US-009507513-1701USA003706:
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. The patient's drug allergies and pertinent medical history was unspecified. On 25-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (Dose/Frequency: 0.5 ml, Subcutaneously, lot # K004281 and expiry date: 22-MAR-2015). Concomitant medications were unspecified. On 25-OCT-2014, the patient experienced swelling, hardening, warmth, redness and soreness around injection site after receiving PNEUMOVAX 23. The patient sought medical attention (spoke to pharmacist) and no treatment was provided for the events. Lab studies performed were unspecified. The outcome of swelling, hardening, warmth, redness and soreness around injection site was reported as not recovered/not resolved. The causality of the events was not reported. No product complaint was reported for PNEUMOVAX 23. Additional information is not expected as the reporter did not wish to contact.
Suspected vaccination failure/ Had the vaccine on December 18, 2020 / breaking out with Shingles around April 1, 2021; Breaking out with Shingles around April 1, 2021; The outbreak was severe with pain; Permanent scars on my nose and face from the shingles; Damage to my face and body; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2020, the patient received Shingrix. On 1st April 2021, 104 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, scar and injury. On an unknown date, the outcome of the vaccination failure, shingles, pain, scar and injury were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, scar and injury to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient had the Shingrix vaccine on the recommendation of the physician and started breaking out with Shingles around 1st April 2021. The outbreak was severe with pain. The patient has permanent scars on the nose and face from the shingles. The patient stated that he/she could send the pictures of the scars and damage to the face and body for review. The patient stated he/she would prefer to deal directly with GlaxoSmithKline on a settlement, instead of dealing with outside counsel with thousands of clients and being just a number. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule and laboratory confirmation for shingles were unknown.
Soreness at the injection site; Administered a 2 mL dose of Flucelvax Quadrivalent in a patient's arm; This spontaneous case was received on 18-Sep-2020 from physician via agency (reference number: SEQW20-01987) and concerned an adult male patient in his 30s.  The patient's medical history and concomitant medications were not reported.   On 18-Sep-2020, in the morning, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 2 ml, route of administration and anatomical location: not reported) (explicitly coded as 'Overdose') for protection against seasonal influenza. The batch number reported was 283847 and expiry date was 30-Jun-2021.   On the same day, five or six hours after vaccination, the patient experienced soreness at the injection site. No treatment was used.  On an unspecified date in Sep-2020, the patient recovered from soreness at the injection site.  The reporter assessed the case as non-serious.  Company comment: The event of 'vaccination site pain' is considered as related, while the event of 'overdose' is considered as not related to Flucelvax QIV.; Sender's Comments: The event of 'vaccination site pain' is considered as related, while the event of 'overdose' is considered as not related to Flucelvax QIV.
Anaphylaxis started 12 hours after injection on dose 2 in April. Anaphylaxis happened again 12 hours after the booster shot on Nov 30, more severe. Went to ER.
Person given expired  vaccine. Vaccine expired 5/25/21, administered 5/27/21
I had 4-5 hours of dizziness and tachycardia. I have brief dizzy spells. Having more intense and frequent migraines.
Diagnosed with covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with covid) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013C20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced COVID-19 (Diagnosed with covid). At the time of the report, COVID-19 (Diagnosed with covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Chest only (rash). "Small bumps" raised and red. NO advise response to HBV #1 and #2. Noticed rash at 10pm, post 3rd HBV.
On 3-17-12 pt developed fever 103.5, cough, wheezing. She tested positive for RSV and flu. She was treated at hospital. She was on ventilator for weeks. She was in hospital for 18 days. Dx her RUL pneumonia. Severe respiratory distress.
Noticed swelling left upper arm radiation to left trapezes aching treatment was Motrin. @cm red area.
DVT L leg, possible PE; DVT L leg, possible PE; This is a spontaneous report from a contactable physician. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 09Mar2021 (at the age of 76 years old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took NSAIDS. The patient experienced DVT L leg, possible PE on 12Mar2021. Treatment given included Eliquis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was recovering.  Information on the batch/lot number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events deep vein thrombosis and possible pulmonary embolism occurred in a plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.