chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an 18 year old female who on 21-Sep-2007 was vaccinated with a first dose of Gardasil (lot #658563/1063U) injection.  Concomitant therapy included Advair, Proventil and "clindesse" (therapy unspecified).  On 24-Sep-2007 the patient called the office and on an unspecified date the patient developed swelling at reaction site and pain.  Medical attention was sought.  The patient had a fever of 101 for 2 days and took acetaminophen (Tylenol) for the fever.  The physician also reported that the patient visited the office on 17-Nov-2007 to receive a second dose and reported that the swelling was the size of a golf ball.  The vaccine was not given and it is not known whether the series will be completed.  On an unspecified date that patient had recovered.  Additional information has been requested. Follow-up information was received from the physician. It was also reported that the patient had a large lump where the patient's shot was given. The patient also had redness at the injection site. Additional information is not expected.
Case number PHEH2014US025100, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 64 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 24 Oct 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
1 week after the first dose, i had a headache for 2 weeks straight, day and night) 4 days prior to second date, it stopped.   1 week after second dose, I had a headache that was so bad I went to the ER. Blood pressure was 240 they did a CT, and gave me intravenous medication to bring down my BP, sent me home.  Next day, I was fine until Noon, then it hit again. Went back to ER and BP 240 again Another CT, multiple medications and an overnight stay later, i am sent home now on multiple blood pressure medications.
20 minutes post vax, the pt developed a rash and swelling of left eye and face. No rash or swelling at injection sites.
Pain; Thickening of tongue; Extreme fatigue; Headaches; Joint aches; This is a spontaneous report received from Novo Nordisk. This other company reported on behalf of non-contactable reporter/consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose number unknown, single for Covid-19 immunization. The patients medical history was not reported. The patients concomitant medications included semaglutide (OZEMPIC) and insulin degludec (TRESIBA). On an unspecified date, the patient, who was receiving therapy with Ozempic, Tresiba, and the Pfizer COVID vaccine, reported experiencing pain, extreme fatigue, headaches, joint aches, and thickening of the tongue as side effects. The patient took rest. The clinical outcome of events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Right upper arm swollen size of small orange redness starts at very top of shoulder joint and goes down to just past elbow redness reaches about 3/4 of the way around the upper arm.  Arm is slightly warm to touch.  Patient is moving arm fine complains of mild itching.
Very sore arm. Extremely sore teeth similar to sinus infection. Didn't see that symptom listed and thought I should report it. Very painful.
I had  a delayed reaction of a rash no pimples or anything splotchy and raised. Doctor said to use cold compresses and took Benadryl.
Patient  was to received first dose of primary series monovalent Pfizer;however patient received bivalent instead. No adverse reaction reported.
My Left arm at the top where the shot was given has been very painful ever since i received the flu shot. When I raise my left arm a certain way there is sharp pains in my shoulder where the shot was given.When I raise my left arm to put on deodorant there is sharp pains in my shoulder where the shot was given.When I try turning over in bed I have alot of sharp pain in my shoulder. When I try cleaning out the bathtub i cannot use any pressure in my left arm because of the pain. There is a constant aching in my shoulder all the time & there is also a burning feeling.
Aches and pains Redness pain at injection site Tired/fatigued Nausea Headache
allergic to the first dose; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter was asking if there was any desensitization protocol for a second dose for someone allergic to the first dose. The outcome of the event was unknown.   Information about Lot/Batch has been requested.
Rash, excessive urination, malaise, soreness, mild nausea, chills. Ht: Prednisone 60 mg once daily for 5 days.
The patient came in for her second dose and it was brought to our attention that she is not yet 18. I questioned the patient about any adverse events she may have experienced and she stated that there were none.
This spontaneous report as received from a nurse refers to the patients of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with improperly stored PROQUAD (lot # R013575, expiry date: 10-NOV-2019) (dose, frequency and route were not reported) for prophylaxis. The vaccines were stored in temperature of 47 degree Fahrenheit (F) to 77 F for 1 hour. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.
Patient was given her 2nd dose on 02/04/2022 and the first dose was on 02/02/2022.
was diagnosed with asthma in 12/2022 and again in 01/2023. never had asthma before. was put o long term asthma meds
Approx 5 minutes after admin of vaccine pt stood and then lost consciousness, Dad was near and caught him. Patient was placed on exam table with legs elevated. Pt regained consciousness had 4oz of apple juice, pt requested to use the restroom and upon standing pt said his stomach hurt and turned pale. Pt was placed on exam table again. BP was checked several times and cool compress placed on his forehead. Approx 20 min after admin of vaccine pt states he's ready to stand. Pt went to the restroom accompanied by Dad, no further problems. Pt D/C'd home. Parents advised to call the clinic if further problems.
arm pink, arm warm to touch, arm painful to touch, arm swollen from elbow to shoulder
Patient came into the office for a follow up with provider- APRN. Patient requested influenza vaccine to provider- I was order to administer vaccine. I confirmed allergies before administration, patient denied any allergies.  When I went to chart the vaccine in the state vaccine registry the vaccine had already been charted and administered for 2021 by a different provider.  Duplicate doses administered.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020) and (batch number FJ573 ?, expiry date 30th January 2020). On 22nd January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. The patient was treated with steroids and muscle relaxants. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. The reporter considered the pain in arm to be probably related to SHINGRIX. Additional details were provided as follows: On 22nd January 2018 at 11:25 hours, the patient received SHINGRIX in left deltoid. The patient came into the pharmacy on the day of reporting and stated that her left arm was severely sore. The patient went to her physician and received steroids and a muscle relaxant but neither medication provided any relief. The reported lot number (batch number FJ573 ?) does not match any GSK lot number and clarification has been raised for the same.
Pt became symptomatic with Bell's Palsy two weeks after receiving her flu vaccine. Pt will be treated with steroids over several weeks and comfort measures to be provided to assist with symptoms.
possible administration of invalid dose to patient; Product storage error/temperature excursion/never reached an acceptable range and was always warm by at least 2 degrees C; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product storage error/temperature excursion/never reached an acceptable range and was always warm by at least 2 degrees C) and POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product storage error/temperature excursion/never reached an acceptable range and was always warm by at least 2 degrees C). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product storage error/temperature excursion/never reached an acceptable range and was always warm by at least 2 degrees C) and POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there are 4 days temperature data(between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there is no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided (057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A).  Some vials may have been moved to a refrigerator at some point. There was no temperature data for that storage unit.  No treatment medications were reported.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No Adverse Event) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 012H21B, 004C21A and 018B21A) for COVID-19 prophylaxis. Concurrent medical conditions included Drug allergy (Ultran) and Drug allergy (Flagyl). On 15-Apr-2021 at 11:11 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-May-2021 at 3:17 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Nov-2021 at 9:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 9:15 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 9:15 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022). It was reported that, the error in the documentation, and administered an expired vaccine to more than 40 patients. They thought that Moderna had an extension like Pfizer, and though it would expire on 13-Jul-2022 but it was expired on the 13-May-2022, they realize this on the 8-Jun-2022. The event did not cause the patient to seek medical care. The used vial was placed in the refrigerator on the same day of administration (26 May 2022). The vial did not undergo any temperature excursions. No treatment medications were reported.
child patient was given an expired Pentacel/ No AE; Initial information was received on 27-Jul-2020 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves a two months old female patient who was vaccinated with 0.5 mL dose of expired  vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ084AAA and expiry date 24-Jul-2020) via intramuscular route in the left thigh for prophylactic vaccination on 27-Jul-2020 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  Case details: Reporter stated that female child was given an expired vaccine during a well-baby visit.   It was an actual medication error case due to expired vaccine used.  At a time of reporting no adverse event 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 in Directive and Module VI of the Practices. 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.
2nd day after vaccination patient experienced pain, rash and itching approximately 2 inches around vaccination site and appears to be spreading. Treated w/Ibuprofen but symptoms persisted.
Per doctor's office visit note by physician: 57-year-old patient with palpitations, which have since resolved entirely.  These may have been attributable to her vaccine, or may have been incidental.  She is otherwise feeling at her baseline.  If her symptoms recur or become more bothersome to her, we could consider obtaining baseline labs and/or placing a Holter monitor.  Her rhythm is normal and her physical exam is reassuring, so I do not feel any further work-up is necessary at this time.
pt recv vax 27JAN95 & 6NOV97 pt devel shingles @ rt scapula & interior chest region;
Vaccine was administered on 8/6/08 & patient had no reaction until 8/8/08.  Reaction was a 6in red, raised area around injection site which was warm & patient itched.
dizzy; sinus infection; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number and expiry date unknown, via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first round of the vaccine and was dizzy on unspecified date. The patient informed that it was not like vertigo but similar. The patient informed that he did not know if it has something to do with what was going on or if it was a sinus infection. The patient informed that he went to bed dizzy. The patient informed that he was dizzy right now but not all the time. The outcome of the events was unknown.  Follow-up activities are possible, information on the batch number has been requested.
This is a continuation of worsening symptoms since last report. I have experienced chronic headaches, cognitive dysfunction and peripheral neuropathy.
Severe headache, Fever 100.9F, Dizzy, Nausea, Heart Palpitations, Head congestion, severe fatigue. All lasting approximately 12 hours.
blood sugar has still be all over the place all this time; HgB A1C was reported to be 9.5% while normally it stays around 8%; Was not feeling great after first shot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Was not feeling great after first shot), GLYCOSYLATED HAEMOGLOBIN INCREASED (HgB A1C was reported to be 9.5% while normally it stays around 8%) and BLOOD GLUCOSE INCREASED (blood sugar has still be all over the place all this time) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced MALAISE (Was not feeling great after first shot). On 12-Mar-2021, the patient experienced GLYCOSYLATED HAEMOGLOBIN INCREASED (HgB A1C was reported to be 9.5% while normally it stays around 8%). On 19-Apr-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar has still be all over the place all this time). At the time of the report, MALAISE (Was not feeling great after first shot), GLYCOSYLATED HAEMOGLOBIN INCREASED (HgB A1C was reported to be 9.5% while normally it stays around 8%) and BLOOD GLUCOSE INCREASED (blood sugar has still be all over the place all this time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment medication was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-081237 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: The Telephone Contact Report form received on 17-MAY-2021.No new information is added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081237:2nd dose of vaccine
Patient is a 80 y.o. female with PMH of CKDIII, COPD (3LNC at home), Afib RVR, HFpEF, CAD (s/p CABG 2005), HTN, HLD osteoarthritis.  She was recently admitted 11/15 to 11/20 for exacerbation of bronchiectasis.  She was treated with Ceftriaxone/doxycycline that admission and went home on her usual 3L of oxygen.   However, over the last few days her dyspnea has gradually worsened.  She called EMS and was found to have oxygen sat of 85% on her usual 3L oxygen. In the ED, her temp was over 101. She was placed on nonrebreather mask.  She tested positive for COVID-19 on 11/15 and 11/24.
On 2/28/21 a used vial of Pfizer vaccine was reconstituted again with sodium chloride, they were reconstituted in error and patient received diluent only immunization. The immunization administered that day was not effective in providing protection against COVID.  Patient reported having pain in her leg and has not returned to be revaccinated.
no additional adverse events reported; dose of improperly stored GARDASIL 9 was administered to a patient; This spontaneous report has been received from a vaccine coordinator referring to a 14-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 11-AUG-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliters (ml) once (route of administration, vaccine scheme and anatomical site of vaccination were not reported; lot number T030749 has been verified to be valid, expiration date reported and established as 16-MAR-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of 35.3 degrees Fahrenheit (F) during a time frame of 195 hours and 38 minutes (product storage error). There was no previous temperature excursion, and no additional adverse events were reported (no adverse event).
Pressure in left side of chest  lasted about 15 seconds  every four to five minutes for about 1 hour. No taquicardia. No heart pain.
She didn't feel so great; Sick with a stomach situation; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She didn't feel so great) and ABDOMINAL DISCOMFORT (Sick with a stomach situation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (She didn't feel so great) and ABDOMINAL DISCOMFORT (Sick with a stomach situation). At the time of the report, FEELING ABNORMAL (She didn't feel so great) and ABDOMINAL DISCOMFORT (Sick with a stomach situation) outcome was unknown.            No concomitant medications were reported by reporter  Treatment information was not provided    Reporter did not allow further contact