chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired vaccines inadvertently administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number T93SR, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 27-SEP-2022 Reporter's Comments: The medical assistant reported there were 2 boxes of Fluarix that left over from last year which was expired on June 2022. The three vaccines from it was inadvertently administered to 3 patients. The vaccine administration facility was the same as Primary Reporter No other details were available.  Please note that hcp mentioned that the Fluarix was from last year, the drop down list for suspected vaccine name Fluarix does not show any option for last year hence Fluarix Quadrivalent 2020-2021 season was picked. The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Fluarix Quadrivalent 2020-2021, which led to expired vaccine used. This is 1 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR139387:Same reporter US-GSK-US2022AMR139388:Same reporter
OUT OF SPECIFICATION PRODUCT USE; INCORRECT STORAGE OF PRODUCT/TEMPERATURE EXCURSIONS; This spontaneous report received from a health care professional concerned multiple patients. 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: 042A21A, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced out of specification product use, and incorrect storage of product/temperature excursions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect storage of product/temperature excursions was not reported. This report was non-serious.
pt was exposed to varicella approx 3 wk prior to second dose, who on 1MAR96  recv vax & 3MAR96 pt devel 5 vesicles on chest & shoulders, was nauseous, lethargic & exp a fever of 100.7;no further details were provided
Severe nausea and vomiting. I could not even keep down water and became extremely dehydrated, so I ended up going to the ER. They gave me Zofran which helped me keep down water and I started feeling better.
sudden onset of high fever about 14hr post vax & devel gen sz lasting about 15-20min
Patient was found to have COVID-19 virus infection and was started on dexamethasone Pneumonia due to COVID-19 virus
Information has been received from a physician concerning a 50 year old female with no medical history and no allergies who was vaccinated with MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  The patient developed a disseminated rash 12 days after vaccination with MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  The patient's rash was clearing when the physician examined the patient 13 or 14 days after vaccination.  Subsequently, the patient recovered.  No other information to report.  No product quality complaint was involved.  No further information is available.
A couple hours after the vaccination started pain and tingling in my feet and body felt numb and my stomach felt upset and overall I just felt not right. Called on call nurse for primary care same day as the vaccination and they told me that it should subside in a few days and after a few days I called again and then I was told to go to the ER. Went to the ER 11-23-21 was released after medical tests and then I had to return  to the ER 12-1-2021 I was feeling worse at that point, my muscles was very tight, blurred vision and joints aching really bad. No testing because it was done at the 1st ER visit and they screened for a rare adverse reaction and I was told that I didn't have that and hopefully my symptoms would subside and follow up with my primary and have a neurologist appt scheduled in January.
Covid arm with swelling; Redness; Arm felt hot; Rash; Swollen lymph node under arm; Achy all last week; Tired all last week; This spontaneous case was reported by a non-health professional and describes the occurrence of SWELLING (Covid arm with swelling), ERYTHEMA (Redness), FEELING HOT (Arm felt hot), RASH (Rash) and LYMPHADENOPATHY (Swollen lymph node under arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced SWELLING (Covid arm with swelling), ERYTHEMA (Redness), FEELING HOT (Arm felt hot), RASH (Rash), LYMPHADENOPATHY (Swollen lymph node under arm), MYALGIA (Achy all last week) and FATIGUE (Tired all last week). At the time of the report, SWELLING (Covid arm with swelling) and ERYTHEMA (Redness) had not resolved, FEELING HOT (Arm felt hot), RASH (Rash) and LYMPHADENOPATHY (Swollen lymph node under arm) outcome was unknown and MYALGIA (Achy all last week) and FATIGUE (Tired all last week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and medical history were not provided by the reporter. Treatment medicine were not provided.
Bowel movements are minor, "seems alot less stool and much smaller in size", but still am going everyday.
Three-four hours following injection of Zostavac on July 23rd patient developed symptoms of labyrinthitis. Feelings of instability (not vertigo) and lightheadedness with body or head motions, especially those that slightly "jarred" the body. In addition she heard crackling or clapping noises that were not actually present. Meclizine 25 mg relieved symptoms temporarily. Symptoms have continued to return when the drug is discontinued.
Pt. came in for flu vaccine.  I had several patients waiting for vaccination and even though I confirmed with pt that she was getting the flu shot, I grabbed a Moderna syringe I had there for another patient.  Immediately I realized my error and told patient.  I then gave her the flu shot. The patients daughter contacted her physician who advised watching her closely for 2 days. She then told me the patient had a Pfizer vaccine on 2/2/22 in another country.  The patient was fine at the time of vaccination and waiting time.  I will contact daughter in 2 days to determine if patient suffered any side effects or problems.
bad reaction; really sick; achy; bad nausea; headache; got booster shot while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction), ILLNESS (really sick), MYALGIA (achy), NAUSEA (bad nausea) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 24-Oct-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (got booster shot while pregnant). On 25-Oct-2021, the patient experienced VACCINATION COMPLICATION (bad reaction), ILLNESS (really sick), MYALGIA (achy), NAUSEA (bad nausea) and HEADACHE (headache). On 24-Oct-2021, MATERNAL EXPOSURE DURING PREGNANCY (got booster shot while pregnant) had resolved. At the time of the report, VACCINATION COMPLICATION (bad reaction), ILLNESS (really sick), MYALGIA (achy), NAUSEA (bad nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants and treatment information was reported. It was said that no any of the questions related to AE and consent was not obtained either as denied to contact.  This is a spontaneous case concerning an unknown age, female, pregnant patient with no relevant history reported, who experienced  maternal exposure during pregnancy and the unexpected non-serious events of vaccination complication and illness, and expected non-serious events of headache, nausea and myalgia. The events occurred approximately 2 days after the boost dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable.  The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an unknown age, female, pregnant patient with no relevant history reported, who experienced  maternal exposure during pregnancy and the unexpected non-serious events of vaccination complication and illness, and expected non-serious events of headache, nausea and myalgia. The events occurred approximately 2 days after the boost dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable.  The benefit-risk relationship of Spikevax is not affected by this report.
Information has been received from a pharmacist referring to a 60 year old male patient, who was allergic to penicillin. The patient had no medical history. On 07-DEC-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose and route were unknown, lot# L029484 with expired date 06-NOV-2016). Concomitant therapies included AFLURIA, JUBLIA, diazepam (manufacturer unknown) and PERCOCET. On an unknown date in December 2015 the patient developed blisters on the roof of his mouth. The patient called the pharmacy for medical attention. No treatment was given to him and no lab tests were performed. The outcome of the event was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Malaise, headache, slight elevated temperature, sore arm, diarrhea, dizziness.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions and allergies were reported. On 02-NOV-2015 the patient was vaccinated with improperly stored oral, ROTATEQ suspension 2 (strength, dose, frequency and route were not reported) lot # L001316 with an expiry date of 10-NOV-2016. No concomitant medications were reported. No symptoms were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information has been requested.
At 2 mos old, child received DTP, 2 days later developed a Staccato cough which worsened & progressed to emesis, hospitalized & treated w/erythromycin & cromolyn, no bacterial isolation. At 4 mos old received DTP. See WORM for more Info.
2 days post vax, pt developed fever of 102, severe redness over entire left upper arm. Pt was seen in ER with concern over cellulitis or sepsis. Pt was admitted and placed on IV antibiotics, steroids. Discharged home after 2 days with improvement. Pt is afebrile.
I developed a right-sided Bell's Palsy approximately two weeks following the first injection.   Symptoms began on Monday, April 12, 2021.  I was seen in Hospital ER on April 13, 2021 and started on Prednisone.   I was seen by my PCP on April 20, 2021, who provided referrals for Neurology and Physical Therapy.  The palsy persists as of this reporting.
Patient called into the pharmacy today 10/18/17 stating that she was experiencing a possible adverse reaction to the PREVNAR 13 vaccination that she had received the previous week. Patient complained of itching, swelling the size of a golf/softball, redness, and heat at the injection site. The patient stated that she had first felt itchiness and minor swelling the day before on 10/17/2017. She is not feeling any other symptoms.
Pt described Pain and swelling at L deltoid injection site. Erythema and induration noted, max 5cm x 12cm. low grade fever, body aches, chills and mild head ache. Pt reports mild pain from injection site.
Red, swelling, hardening of the vaccination site starting around 10 days after the vaccine. Thought it was an abscess or infection at first.
From initial information received on 19/Nov/2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 66-year old female patient received a dose of TD ADS Adult, lot number U0844AA, administered intra-muscularly in the right deltoid, and a dose of Pnumococcal vaccine, lot number 08714, manufacturer, administered intra-muscularly in the right deltoid on 12/Oct/2003. 7 days later, the patient developed general fatigue, weakness, and redness and warmth at the injection site. The patient's concomitant medications included Nitroglycerin as necessary. The patient's recovery status is currently unknown.
Sunday night woke up 9:30 vomiting and again at 5:30 am Monday  called in sick Monday am to work due to N & V. Also, had extreme fatigue. attended work Tuesday but developed headache during the day. took Tylenol extra strength X 2 and helped headache. Wednesday woke up redness and hot right arm at injection site with slight  swelling. Left work and took Covid test, neg.
48 hours after receiving MMR she broke into a rash all over body with hives.  She was extremely fussy and miserable for the next 48 hrs No treatment
Narrative: Patient received two doses of the covid vaccine. Patient with PMH of HTN, CAD sp cabg (1990s hospital), COPD. Reported SOB after covid vaccines. About one month after the second dose patient had difficulty breathing and had a medical emergency requiring EMS to arrive, CPR, and hospitalization. Patient required stents in heart. Unclear if any details available about cause of death. Reporting per facility instructions.
Besides the usual and expected muscle pain, injection site soreness, and headache, I experienced a mild allergic reaction. Within 5 to 10 minutes after getting the Moderna COVID-19 vaccine (Lot#, handwritten), I experienced a mild swelling of my face and throat. I noticed the throat swelling when I drank water and also noticed my face tightening up. I have a severe allergic reaction to peaches, so I'm hypersensitive to these types of reactions, and I was a little worried.  My throat and face were swollen for about an hour, but very mild compared to my reaction to peaches,  and it subsided after about 2 hours or so.
no additional AE'S; mproperly Stored; Administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 23-MAR-2021 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date was reported as 02-SEP-2022, but upon internal validation established as 06-SEP-2022; dose and route were not reported) for prophylaxis, the vaccine was temperature excursion (product storage error). No additional AE reported.   The administered dose of the vaccine experienced a temperature excursion of 28.34 Fahrenheit (F) for 1 hour and 2 minutes. There was previous temperature excursion (30.28F for 19 minutes; 34.81F for 35 minutes). The digital data logger was involved. Device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for evaluation (obtain was false).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002505: US-009507513-2104USA002840: US-009507513-2104USA002841: US-009507513-2104USA002848: US-009507513-2104USA002849: US-009507513-2104USA002850: US-009507513-2104USA002851:
Metallic taste in mouth immediately , 30-60 min later face and hand on left side became numb, next day felt heavy on left side and body aches, by sunday symptoms resolved
Patient's eyes rolled back. Eye flutter of eyelids lasted 10 seconds. Slight shaking with chills after vaccination. He never had loss of consciousness. Mom requested EMS. He was evaluated at ED on 03/24/2022, then went home.
During administration pt became shaken, pale and drowsy. Parents indicated reaction to sight of blood/injections. Pt recovered after 1-2 min, but was kept in lobby for 10 min for observation before being released to parents.
Patient on the next day after receiving vaccine experienced hear loss. He is MD and has been seen by specialists since then and he has lost 60% of his hearing in one ear.
Experienced a "rash all over body", but predominately on the ankles & feet; Rash disappeared within 24 hrs & then reappeared the next afternoon? 17SEP90; treated with Benadryl, "Cortisone" cream; Resolved;
Headaches; Sore left arm/ feeling achy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm/ feeling achy), PYREXIA (Fever) and HEADACHE (Headaches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concurrent medical conditions included Hypertension, Abdominal discomfort, Drug allergy and Anxiety. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Abdominal discomfort.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm/ feeling achy) and PYREXIA (Fever). On 09-Apr-2021, the patient experienced HEADACHE (Headaches). At the time of the report, PAIN IN EXTREMITY (Sore left arm/ feeling achy), PYREXIA (Fever) and HEADACHE (Headaches) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Aspirin and Multivitamins.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-072728 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072728:dose 1
Pt vaccinated w/1st dose of vax experienced gastrointestinal cramps; Rec'd 2nd dose of vax 23FEB90 & sx recurred which again;
Maternal exposure during pregnancy; Vomiting; Chills; Fever 101.5 degrees Fahrenheit; This solicited pregnancy report received from a consumer concerned a 30 year old female. The patient was enrolled in a non-company sponsored study  Registryt number: C06669). The patient's weight was 47.62 kilograms, and height was 152 centimeters. No past medical history or concurrent conditions were reported. The patient was gravida 1, para 0. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 05-APR-2021 for covid-19 immunisation. No concomitant medications were reported.  On 05-APR-2021, the patient experienced maternal exposure during pregnancy. On 05-APR-2021, the patient experienced vomiting. On 05-APR-2021, the patient experienced chills. On 05-APR-2021, the patient experienced fever 101.5 degrees fahrenheit. The date of the patient's last menstrual period was 30-JAN-2021. Laboratory data (dates unspecified) included: Fever (NR: not provided) 101.5 degrees Fahrenheit. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, and fever 101.5 degrees fahrenheit on 06-APR-2021, and the outcome of maternal exposure during pregnancy was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and vomiting, chills, and fever 101.5 degrees fahrenheit as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related and company causality between covid-19 vaccine ad26.cov2.s, and vomiting, chills, and fever 101.5 degrees fahrenheit as related. This report was non-serious.
Patient called the next day after recieving her vaccine at around 9am with complaints of left arm pain. The patient stated that she had arm pain going up to her neck and then down her arm as well. When asked if patient had pain radiating to her back, she said yes. Patient stated no relief with ibuprofen and tylenol and icing the arm. I recommended that she see her physician. Of note, I called the patient back a couple hours later at around 11:30am,  to see how she was doing and patient told me that she already has issues in her left arm and neck issues including that she has a fused neck and she is 10% disabled in her left arm. When giving the patient the vaccine, the patient preferred the left arm for the vaccine to be given. The patient went to her physician that same day and recieved a tramadol prescription for the pain. The patient also did mention to the pharmacist that she has had similar pain when recieving other vaccinations in the past. The patient did not need the pneumonia shot unfortunately. The reason I thought she was due for it was because when pulling up her profile, the PPSV23 vaccine with the date of 10/15/2009 stated not valid next to it, Therefore thinking she actually did not recieve the vaccine and that it was an invalid entry.  Patient came into the pharmacy over the weekend and was ok with no complaints of pain.