chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number AVXA68AA, expiry date 31st October 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st November 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 1st November 2021, unknown after receiving Bexsero and Bexsero 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 details were reported as follows: Medical Assistant reported that a patient received an expired dose of Bexsero. Which led to expired vaccine used. The reporter did not consent to follow-up.
soreness at site x 24-48 hours--no treatment slight twitching of left eye x 1 week--no treatment
The employee received the Moderna vaccine on 12/28 with no obvious post vaccine symptoms until this morning 1/4/2021 at 6:30AM.    cc: L upper arm and shoulder pain  HPI: c/o L arm and axillary pain after waking up. Pain also felt with touch. Pain with lifting of arm. Patient received Moderna vaccine on 12/28 (7 days ago). Denies fever or chills.   PMH: none  PSH: Partial Hysterectomy  2008  Meds: MVI  Allergies: seafood - rash                    Peanuts - rash  O: L upper arm/deltoid area - + TTP, +swelling approx. 2" x 3.75" in diameter, +warmth to palpation; stiff with ROM  A: LUE edema s/p covid 19 vaccination  P/I: Cold compress applied at 8:45 AM with instructions to apply 15 minutes x 4x/day.  Ibuprofen 600mg po given at 11:00AM  and q6hrs with food for pain prn.  Will monitor
Nearly two weeks after injection, I now have a 4 inch diameter circle of redness with slight swelling and itchy.  I noticed it after showering two days ago.  It almost looks like a localized allergic reaction but it did not appear until 2 weeks after the shot.  It is slightly warmer to touch than the rest of the area but it is not painful at all.  I had similar markings plus moderate pain around the injection site1-2 days after the shot but they quickly dissipated.  I am not sure if this should be reportable or not but I was a little concerned considering the amount of time that has passed since the shot and considering I am due for my second shot in a couple of weeks.
palpitations, chest heaviness, numbness in fingers and toes, fatigue, nausea lasting 1+ week
Conceived child on or around 3/12/2021  Side Effects include: Fluctuating fever from 101-103 degrees. Chills, nausea.
2nd dose administered on day after the manufacturer expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered on day after the manufacturer expiration date) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered on day after the manufacturer expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose administered on day after the manufacturer expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant drugs were reported.  No Treatment information  were reported.
Inability to walk for a week; limping for 30-days; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Inability to walk for a week) and GAIT DISTURBANCE (limping for 30-days) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced GAIT INABILITY (Inability to walk for a week) and GAIT DISTURBANCE (limping for 30-days). On 26-Mar-2021, GAIT DISTURBANCE (limping for 30-days) had resolved. At the time of the report, GAIT INABILITY (Inability to walk for a week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-031733 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-031733:Reporter's case
I received my first Moderna vaccine 3/20/21 (Lot Number 047A21A) was given in my left arm. On 4/1/21 I discovered a quarter size lesion red in color on my shoulder near vaccination site.  After my second vaccination on 4/17/21 (Lot number  036B21A) in my right arm, the lesion started to spread.  At this point I have lesions on both arms, my chest, back and now my legs.  I have made an appointment with a dermatologist but not until 6/29/21.  I am placing a call to a GP tomorrow.
Pharmacist on duty filled syringe with adult Pfizer vaccination instead of Pediatric Pfizer vaccination. Patient was given 0.2ml of Adult Pfizer.
Patient reports she has a history of "weird allergic reactions" in which her face becomes puffy and itchy, particularly around her eyes. She has never had to use an epi pen. She has never had swelling of the lips or mouth, no angioedema. This occurs 1-2x/year and usually results in patient needing to receive a hydrocortisone injection to alleviate the swelling of the eyelids.  Her doctors are not sure what is causing the allergic reactions but they think it is environmental.   Patient recieved Pfizer in health unit and was watched for 30 minutes as an extra precaution and did fine. Approx 4 hours after recieving the vaccine she began to develop eyelid swelling and intense itching. She describes as identical to prior allergic reactions that have occured. She began to take her Benadryl. She returned to the health clinic on 8/9. During this visit, bilat upper and lower eyelids remained swollen. There is no rash, but patient complains of the area around the eyes feeling intensely itchy.  Patient was administered Triamcinolone IM in clinic and given 7 day supply of loratidine. As of 8/11, she reports her symptoms are slowly improving, but the eyelid swelling is still present. There was no lip or mouth swelling.
pt given DT instead of Apilsol intradermally on forearm;arm red & indurated;
Mom noticed that pt began to break out in "whelps all over" approx 1 hr p/receiving vax; Was taken to ER; Had begun "to swell"; tx EPI;
Pt was vaxed w/Hep B vax in JUL91; w/in 1 to 2 hrs following the vax, devel a tightness in throat & devel hives on the next day tx DPH & sx resolved in approx 1 day;
Pt recv vax on 2/22/99; on 2/23/99 pt exp fever (100.9), emesis x 1, upper ears swollen &red, red areas on neck& upper trunk, whelps under arms &groin area w/ itching
Headache. Chills, Fever as high as 100.7, severe fatigue( I slept on and off for 24 hours.), Pain at the injection site(ongoing still current)  slight rash at injection sight. NO appetite and slight change in taste.
Admitted to the ER after numbness in the left side of the body.  4mm Brain Stroke detected from the  brain MRI after 8 days of vaccine.
Two days following vaccination with PPSV23 into left deltoid (also received influenza, injection right deltoid) now presents with left mid bicep to mid forearm soft swelling, redness - no loss of strength or sensation.
pt recv vax 1030AM on 13MAR97 & APAP given;t105.7 in afternoon & persisted thru 16MAR97 on 15MAR97 t105.9 during noc;pt had vomiting & lethargic;PMD notified;
Information has been received from a physician concerning a 15 year old male patient who on an unspecified date was vaccinated IM with a dose of GARDASIL (lot number unknown). It was reported that the patient was taking GARDASIL and went to school and reported to the school nurse due to difficulty breathing and a flush face. At the time of reporting, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Reactive lymph node on right side by collar bone. Monitoring. Slowly decreasing in size.
Information has been received from a nurse concerning a 16 or 17 year old female who in March 2008, was vaccinated IM with a 1st dose of Gardasil (lot# not reported).  In March 2008, the patient fainted after receiving her vaccination.  Subsequently, the patient recovered from fainted and was fine before leaving the office.
took 2 shots, took the third one; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 90-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (Took 2 shingles shots 4 years ago).   On 22nd June 2022, the patient received the 3rd dose of Shingles vaccine. On 22nd June 2022, unknown after receiving Shingles vaccine, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comments: This case was reported by a consumer. The reporter stated that he/she had inadvertently took a third shingles shot. The reporter stated that he/she forgot that he/she had taken the second one 4 years ago (from the day of reporting) and the third one 15 minutes ago. The reporter enquired the further course of action and the duration does the shingles last. Additional Supportive Information: The patient received the third dose of Shingles vaccine, which led to extra dose administered.
Fever; Headache; Fatigue; Arm very sore; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, headache, fatigue and pain in arm. On an unknown date, the outcome of the fever, headache, fatigue and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fever, headache, fatigue and pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient experienced fever, headache, fatigue and arm was very sore. The patient wanted to know how long did these side effects would last as patient was concerned since Covid was rampant in his/her location and symptoms were very similar.
Day of vaccine I experienced brain fog for about 3 hours. Typical soreness in arm for a few days and bruising at injection site. Arm remained tender but not bad and no concern until day 8, which was yesterday. That is when I experienced itching around injection site and swelling. Day 9 (today) the area below injection site is red, swollen (hard), tender, and the left shoulder joint aches. No other symptoms to report and this seems fairly normal. I'm going to watch closely and take action if there are adverse changes. As of now, this seems like a typical reaction.
I suffer from Chronic Fatigue. I was first diagnosed one or two years ago. I need to pace myself or else I crash, It will get bad enough that I cannot move, and my brain does not function. This particular appoint is just a regular appoint I have with a therapist. I do also have an immune issue and with that cervical pain and neck issues.
TWO WEEKS AFTER VACCINATION PATIENT MAY HAVE COME DOWN WITH A SLIGHT CASE OF SHINGLES.  A RASH/SORES APPEARED ON ARM, THROAT, AND INNER CHEEK.  HAD FEVER SORES BREAK OUT ON LIP (NEVER BEFORE).  SEEMED LOCALIZED ON LEFT SIDE. PATIENT DOING BETTER NOW.
my husband and my friends it was no big deal, just a little sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my husband and my friends it was no big deal, just a little sore arm".  Additional information: She also reports that "my husband and my friends it was no big deal, just a little sore arm"   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Went to sleep at 7:30pm Friday after vaccination, feeling tired, feverish and achy all over.  I did not wake up until Sunday morning about 8:30am.  My husband checked to confirm I was still breathing and let me continue to sleep. I lost over 36 hrs without waking up.I will not obtain a booster due to the freightening event after my second shot.  I contracted Covid on 01/16/2021 and continued to have my antibodies checked in prior to my vaccination- I always tested with maxium antibodies.
Welts to both inner thighs, still present today but faded and smaller welts to lower buttocks on left side, slightly warm to touch, no treatment done.
headache; fever; body aches; chills; nausea; This case was reported by a physician via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Hepatitis A vaccine, Typhoid vaccine and JAPANESE ENCEPHALITIS VACCINE.   On 25th October 2019, the patient received the 2nd dose of Shingrix. On 25th October 2019, less than a day after receiving Shingrix, the patient experienced headache, low grade fever, general body pain, chills and nausea. On an unknown date, the outcome of the headache and low grade fever were recovering/resolving and the outcome of the general body pain, chills and nausea were recovered/resolved.   It was unknown if the reporter considered the headache, low grade fever, general body pain, chills and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that within 12 to 24 hours after the 2nd dose of Shingrix patient developed headache, low grade fever, body aches, chills and nausea. The reporter stated that the symptoms have improved in some ways, but the patient continues to have headache and low grade fever intermittently. The reporter stated that the 15 days prior to receiving Shingrix the patient received Japanese encephalitis, the first dose of Hepatitis A and Typhoid vaccine.
One week AFTER injection, my arm is sore, itchy, hot, and painful at the injection site.  It hurts to touch and move.  The itching is horrible.
Pain in entire arm of injection site, swollen lymph node in arm of injection sight that radiates to breast, total body muscle aches and pain, head ache,  muscle weakness, slept 24 hours, swelling in hands, dizziness, loss of appetite, skin sensitivity, lethargy internal organ pain, low back pain all lasting 24 hours. Arm and lymph node pain still hurting 36 hours later  Tylenol helped with the body pains and headache
Patient had a morning appointment on 7/7/2023, LPN does not recall the details of the visit at this time. On 7/14/2023, there were 2 doses extra left over in the same lot number, when there should have been 0 per internal inventory, Since it is not possible to pinpoint which doses caused the overage, it appears 1 or more doses given between 6/9/2023 and 7/7/2023 may have been expired- 12 hours after opening and reused, therefore all doses given during that period are considered to potentially be expired.
Patient was administered a prefilled Covid-19 vaccine injection in L deltoid. Patient was monitored for 15 minutes following vaccine administration. Post injection the clinic soon realized the injection was empty without the vaccine present. The "prefilled' Johnson and Johnson vaccine was pulled back to 0.5 ml and individually packed and appeared to be a single use vaccine. The patient was called and notified via phone call of the situation and that the patient unintentionally did not receive COVID-19 immunization. Advised patient to FU for any questions or concerns. Health department was notified. Patient was understanding and denied acute concerns.
Narrative:  Patient diagnosed with COVID ON 8/12/21 after receiving COVID vaccines on 1/28/21 and 2/25/21.
Received immunization on 7/31/18 and discovered a red rash in the evening on 8/1/18. Patient stated the rash was located under the right breast, under the right arm, and across the back almost to waist. Patient stated the rash was not itchy and does not hurt. It was bright red during/after hot shower, but it now pink and is not bumpy.
This spontaneous report as received from a licensed vocational nurse refers to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. On unknown dates since 23-JAN-2015, the patients were vaccinated with doses of LIQUID PEDVAXHIB (route, lot # and expiration dates were not provided). Concomitant medication information was not provided. On unknown dates since 23-JAN-2015, the patients had been administered LIQUID PEDVAXHIB which underwent supported temperature excursions. No adverse effects were reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
7/23/22 (15 days after injection) persistent hives observed. They are itchy and change location on the body every few hours. They mostly appear on hands, arms, chest, neck and knees. Sometimes they are raised bumps, sometimes red patches, sometimes long red lines.  Tried, Benadryl, Tagamet and Zyrtec but they didn't do anything.   7/29/22 - Consulted Teladoc who prescribed a short course of Prednasone. Hives stopped in 2 days but came back a few days after Rx was complete. 8/31/22 - GP tested my blood for an immune system problem but all results were normal 9/8/22 - Dermatologist advised me to take Claritin every day for 30 days, which seemed to stop the hives. 9/23/22 - Hives stopped
tired; fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (in right side).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced fever and tiredness. On an unknown date, the outcome of the fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by the patient's husband. The reporter couldn't recall which arm she received the vaccine in, however, the patient had a history of breast cancer in her right side, so he believed she received the Shingrix in the left arm.   The patient experienced a slight fever and tiredness after receiving the first dose of Shingrix. The patient felt fine the first day and the next day her symptoms hit. It was reported that within 24 hours the fever resolved.  The reporter did not consent to follow-up. For tolerance to next dose, refer case US2019GSK080269.
Soreness after four hours, chills after twelve hours, passed out after19 hours, nausea after nineteen hours, fatigue, nosebleed while throwing up, diarrhea during fainting
Inability to fall asleep at regular bedtime and through the night.  Restlessness.   2 other friends reported same issue after Moderna Dose 2
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 12-MAY-2021 or 13-MAY-2021, the patient had contact with COVID-19 and was tested positive on 18-MAY-2021 (suspected clinical vaccination failure and suspected covid-19 infection). The patient never had fever. The patient had few chills, runny nose and body aches. It was reported that COVID-19 had never affected the patient's lungs. The patient had oxygen at home and used as needed and monitored her levels on a daily basis. The patient had stayed hydrated, took Tylenol (paracetamol) daily, double doses of Vitamin D (ergocalciferol), Vitamin C (ascorbic acid,), Elderberry (sambucus nigra) and zinc. The patient had not visited hospital. On 27-MAY-2021, the patient tested negative for COVID-19. The patient was still working to get strength back.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000182683. The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210628624- covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient received first Shingrix injection on Friday, 10/9/20 and developed fever, chills, and shingles-like lesions on Saturday, 10/10/20.  The patient reported several lesions developed on her scalp and forehead, one lesion on each breast, 2-3 lesions on abdomen, and left palm was itchy.  The patient called her doctor Monday morning, 10/12/20, who advised her to notify the pharmacy.  The patient received no treatment for the lesions.  As of Monday, 10/12/20, the lesions were reportedly fading.