chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came into the emergency department due to shortness of breath, she was diagnosed with COVID 19 on November 22nd, started on dexamethasone November 24th, she reported progressively worsening shortness of breath, no pain, some cough and fever as well.  She was admitted for further care.   Hospital Course:  Patient was treated with dexamethasone, seen by infectious disease and started on Remdesivir which has been completed, was also given vitamin-C, zinc, vitamin-D, She was discharged when she no longer was requiring supplemental oxygen, other home medications were continued.
nausea, vomiting, fever, chills, headache area erythema approx 3 cm, warm painful to touch
Vaccine given 8/25/20 - pt began feeling ill on 8/26. Migraine headache, tingling in arms/legs. Has progressively gotten worse. Went to ER 8/31/20.
When I awoke the next day after receiving the shot. I noticed a swollen,reddish upper arm which has spread some around my bicep.
Facial swelling; eye actually swelled up; looked like a black eye; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).  A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm on 17Mar2021 at 09:45 (Age at vaccination was 31 years) as dose 1, single for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. There were no concomitant medications. No other vaccinations within four weeks prior administration date of the suspect vaccine. On 19Mar2021 after the first dose of the COVID 19 vaccine patient experienced some side effects and the most concerning was facial swelling and her eye actually swelled up and looked like she had a black eye and wondering if it would be safe for her to get the 2nd dose. She did not have a doctor. The patient took Benadryl as therapeutic measures. The outcome of events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt.'s mom noticed redness on 7/10/19 @ night. The next morning on 7/11/19 the left thigh with increased redness. Warm to touch. Pt. did not have fever. pt. came into office on 7/12/19. No fever but warm to touch. Redness measured 8.0cm from left to right and 5.5cm down left thigh. Mom applied Benadryl cream and will cont to monitor.
Allergic reaction; This is a spontaneous report from a contactable consumer (Patient is reporter's wife). A female patient of unknown age received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: unknown), dose 1 on unknown date as Dose 1 SINGLE for covid-19 immunization (Age of vaccination was unknown). The patient medical history and concomitant medications were not reported. On an unknown date the patient had Allergic reaction. The reporter clarified that his wife had the Pfizer Covid-19 Vaccine, and she did not have a severe reaction, but she had an allergic reaction to the Pfizer Covid-19 Vaccine. The outcome of the event was unknown. No follow-up attempts are possible information about lot/batch number cannot be obtained. No further information is expected.
Pt. complains of dizziness and weakness.  She has a hx of hypertension and diabetes and advised she had not really eaten before vaccine.  Pt. went home w/ son.  Vitals spO2 99%, BP 167/85, HR 65.
For 36 hrs post vaccine there was some itching with a hard, hot welt. Was gone by 72 hrs post vaccine. 8 days after dose the same symptoms returned on a larger scale. Welt is about 3-4 inches in diameter, itchy, red, and hot. No other symptoms. Using topical anti-itch cream and ibuprofen.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 01-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Severe pain at injection site and symptom of rotator cuff injury, decreased active and passive range of motion; symptoms worsened overnight and following day resulting in inability to drive or use left upper extremity; symptoms now persistent with decreased but moderate pain and severe pain with abduction greater than 30 degrees even one week after vaccine administration; small hematoma at injection site which is near the top of the shoulder.
This spontaneous report was received from a physician via a company representative referring to a "healthy" female patient currently in her 50's. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date (reported as "a couple of years ago"), the patient was vaccinated with ZOSTAVAX 19400 plaque forming units (PFU), and the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), for prophylaxis (dose, route of administration, lot # and expiration date were not reported  for any of those two products). On an unknown date, the patient developed Guillain-Barre syndrome. It was stated that the patient received an unspecified treatment from an unspecified neurologist on an unspecified date. The reporting physician also stated that the patient was having some residual side effects (adverse event) for which the patient was receiving an unspecified treatment. It was unknown by the reporter if any lab diagnostics were performed to the patient. At the time of reporting, the outcome of the events was reported as not recovered.  The causality assessment between the events with ZOSTAVAX and sterile diluent (MERCK STERILE DILUENT) was not provided. Upon internal review, Guillain-Barre syndrome was determined to be a medically significant event.
immed burning, appearance of 3cm welt & swelling that was the size of a small egg;also had mild erythema & pain @ site of swelling;
No adverse effect reported; Patient was too young for administration (15 years old) at time of vaccination according to FDA/manufacturer guidelines.
About 36 hours after the injection I started to feel some fairly profound fatigue, and had aching joints throughout my body for about 36 hours after the onset.  I also had some lingering mild pain in the backs of my thighs for about 12-18 hrs after the aches went away.
public health nurse reviewed patients vaccine record in  EHR. looked at immunizations under "profile tab" which indicated that the last covid vaccine given was 2/2023. phn should have looked in database to verify and confirm in EHR through the "patient record" tab which indicated patient received Comirnaty 23/24 on 10/6/2023
I've had mild tinnitus for several years. Shortly after getting the first Pfizer shot, the tinnitus got much worse. The buzzing is much louder than ever before. It's now a constant buzz that impacts my sleep, concentration and just trying to relax.
Ache/pain in shoulder - still occurring 11/21/2012 - I thought the shot was given higher up on my arm than usual.
12/22- SORENESS AND HEAT AROUND PUNCTURE SITE, FEELS LIKE A BP CUFF ON HER ARM, 12/30- ARM/FINGER TINGLING, WITH HEAT STILL PRESENT.
pt recv vax 3DEC96 & 6DEC96 & pt devel local rxn;arm was hot, swollen, red, indurated, & painful for 1wk;pt was given a cold compress & DPH
localized reaction to MMR-upper part of arm red & swollen then white hive appeared in center of redness; completely disappeared 1/2 hr later; MD put cool water towel on arm & checked on pt periodically for 15 mins;
The patient was administered a Moderna COVID-19 vaccine booster dose that had surpassed the refrigeration expiration date by one day. Per our pharmacy, this Moderna  COVID-19 vaccine (LOT #045L21A) expired on 4/6/2022 at 15:11. The patient received a booster dose on 4/7/2022 at 10:51 AM. No adverse reactions were documented after the patient was administered this vaccine.
swelling and knot the size of a goose egg at the injection site; knot / at the injection site which was very red; knot / at the injection site which was / slightly itchy.; her arm was sore for a couple of weeks; knot the size of a goose egg at the injection site; was not able to move her arm for 2 to 3 days; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number H4H34, expiry date 30th November 2021) for prophylaxis.   Concurrent medical conditions included allergy.   On 23rd July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site itching, mobility decreased, pain in extremity and injection site lump. On an unknown date, the outcome of the injection site swelling and injection site lump were not recovered/not resolved and the outcome of the injection site erythema and injection site itching were unknown and the outcome of the mobility decreased and pain in extremity were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site itching, mobility decreased, pain in extremity and injection site lump to be related to Shingrix.  Additional details were provided as follows: The patient received Singrix and she experienced injection site swelling, injection site knot the size of a goose egg, injection site redness, injection site slightly itchy, unable to move her arm for two to three days and sore arm for a couple of weeks. Till the time of reporting patient had a knot and swelling at injection site. The physician was wait for the swelling to resolve before administering the second dose. The reporter consented to follow up.
Myalgia & NauseaVomiting Narrative:  Missed day of work following second dose due to above symptoms
Patient was a 88 yo M who presented to hospital on 2/19/2021 with acute onset unsteadiness and trouble swallowing. The patient noted that these symptoms began on day of admission and receiving his vaccine 7 days ago in which he noticed he had increased malaise and increasing DOE/SOB. Patient was noted to be hypoxic with SpO2 in 80s increasing to 90s on 2L NC and in atrial fibrillation on admission. Patient tested positive for COVID-19 on admission and was placed on dexamethasone 6 mg daily for 4 days, ceftriaxone 2g qd for 4 days, and doxycycline bid 100mg for 4 days. Patient improved over the 6 day stay until he was stable on room air at rest and upon ambulation at which time he was discharged home on 2/25/2021.
Patient received dose of Moderna vaccine post excursion; Patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received dose of Moderna vaccine post excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received dose of Moderna vaccine post excursion).    No concomitant medications were reported.  No treatment medication were reported.  This case was for 5th patient out of 19 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941, US-MODERNATX, INC.-MOD-2023-706966 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Patient 1 of 19 US-MODERNATX, INC.-MOD-2023-706966:Patient 5 of 19
diarrhea, stiffness in arms fingers. swelling in arm for about 4 days. puffyness in my shoulder. red spots on my skin. started on my legs first. tried all the time . no energy.
patient received an expired dose of ADACEL with no reported adverse event; Initial information received on 12-Apr-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 53 years old male patient who experienced patient received an expired dose of adacel with no reported adverse event while receiving vaccine Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Apr-2022, the patient received first dose 0.5 mL of suspect diphtheria-2/tetanus/5 ac pertussis vaccine expiry date: Nov-2021 (form, strength, lot number, route and administration site: unknown) for Immunization.  On an unknown date the patient developed a non-serious patient received an expired dose of adacel with no reported adverse event (expired product administered) (unknown latency) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  It was reported that the "Patient received an expired dose of ADACEL in the facility on 09APR2022. Pharmacist states that the adacel expired in November of 2021 but lot number and expiration date are not available because the adacel has been discarded. This situation is reported as a medication error due to the adacel being expired when administered. Event Information o Treatment o Dose # if series-This was the patient's second dose. The first dose was given on 23MAY2011".   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   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 in the guidelines. 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.
injection site is red, raised, hot and itchy.  Also mild fever for 12 hours.
She received a Pfizer for her first dose but then was given a Modern bivalent for the second dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (She received a Pfizer for her first dose but then was given a Modern bivalent for the second dose) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (first dose). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (She received a Pfizer for her first dose but then was given a Modern bivalent for the second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (She received a Pfizer for her first dose but then was given a Modern bivalent for the second dose) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (She received a Pfizer for her first dose but then was given a Modern bivalent for the second dose).    The concomitant medication was not reported by reporter. Patient received a Pfizer for her first dose but then was given a Modern bivalent for the second dose and Patient wanted to know where did they went from here with the vaccinations of the patient. The treatment medication was not reported by reporter.
1 day after vaccination, patient states she experienced fever, chills, and body aches. 3 days after vaccination, she reported that she noticed welt on back of neck and under eyelid. Patient understood that fever/bodyaches/chills are possible adverse reaction but was not sure if welts are from vaccine. Patient was advised to see her PCP to make sure welts are not from other causes.
Shoulder to elbow, golf ball sized swelling. Diagnosed with cellulitis. Received IV BENADRYL/antibiotics.
This case was reported by a healthcare professional (Chief Executive Officer of a home healthcare agency) and described the occurrence of shortness of breath in a 84-year-old subject of unspecified gender who was vaccinated with Flulaval (GlaxoSmithKline). Concurrent medications were not specified. On an unspecified date (15 November 2007 or later) the subject received 1st dose of Flulaval (unknown) with expiration date March 2008. In November 2007, at an unspecified time after vaccination with Flulaval, the subject experienced shortness of breath, fever, weakness and vomiting. The reaction was classified as systemic. The healthcare professional considered the events were disabling. The reporter suspected a safety and quality issue with the vaccine. At the time of reporting the outcome of the events was unspecified. It was indicated that these events occurred with multiple subjects. Nine specified at the time of the report. It was noted that 2 or 3 subjects had to be treated in the emergency room for these events. Most of the subjects recovered from the events after 2 to 4 days. Some subjects had not yet recovered at the time of reporting. Specifics on each individual subject were not provided.
This spontaneous report as received from a healthcare worker (office manager) and from medical assistant refers to a patient of unknown age and gender who on 20-MAR-2015 was vaccinated with improperly stored dose of GARDASIL (dose, lot #, expiration date and route were not reported). No symptoms were reported (no adverse event). It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information is not expected because there is not permission for the physician to be contact.
Couple of hours after vaccine, injection site pain, flu like symptoms, hurt all over, fatigued, nauseated.  Symptoms lasted for one night after vaccine.  I don't remember if I took anything for discomfort. In January, I felt nauseated at work, heart racing,  feeling numb (arm, tongue, hands), did not feel well, hands starting cramping. Went to Urgent Care and they called for ambulance.  I feel like I am having panic attacks. The doctor gave me breathing exercises to help me calm down.
been more than 4Yr  since 1st shot, 2nd not yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that it had been more than 4 years since patient had the first Shingrix shot and due to the second shot being unavailable and then forgetting about it. The patient had not received the second shot yet.  The patient wanted to know could he/she got the second shot at this time or did needed to started over again. The follow-up could not be possible as no contact details were available. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
sudden onset of nausea/dizziness, headache, severe chills and shaking, extreme body aches that lasted approximately 10 hours, followed by extreme fatigue that lasted about 10 hours.
04/05 - Mother called to report that baby developed fever of 105 within 2 hours post vax, on 04/04. Also thigh is swollen and had wheezing.  Saw physician 4 hours post vax and fever was 104.1. Thigh was red and swollen. No wheezing at that time.  Was at 101 this morning.