chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to the patient after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to the patient after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to the patient after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to the patient after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date). No concomitant medications were reported. No treatment medications were reported. The patient received half dose of Moderna vaccine. The vial had not undergone any temperature excursions. The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.
patient slumped in his chair after immunization and immediately recovered, he waited several minutes and left, he was accompanied by a family member
pt recvd vax & inj site became reddened, hot, stiff & painful; w/in 24 hrs pt exp generalized joint aching, feeling hot & cold, fever, noc sweats; c/o neck stiffness & soreness; sx persisted for 2 to 3 days;
developed fluorescing heaped 2cm  + 1 cm rash to site of injection   consistent with tinea
No adverse event; patient was administered an expired dose of RECOMBIVAX HB on 11/21/2022.; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies details were not reported.  On 21-NOV-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) thimerosal-free, vial (RECOMBIVAX HB) intramuscular injection, lot #T032918, expiration date: 12-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional information was provided. No additional adverse event or product quality complaint was reported.
Right ear was losing hearing sporadically; Pain in surrounding area on face and cranium  on same side; Pain in surrounding area on face and cranium  on same side/Periodic headaches on same side; Feels a bit like swimmer's ear with pain and muffled sounds; Feels a bit like swimmer's ear with pain and muffled sounds; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 14Apr2021 14:15 (at the age of 39-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included irritable bowel syndrome (IBS) from an unknown date. The patient had known allergies with lactose (lactose intolerance). The patient had no covid-19 prior vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), administered in arm left on 24Mar2021 02:45 PM (at the age of 39-years-old) for covid-19 immunisation. Concomitant medications included vitamin d3; zinc; magnesium; calcium; and vitamin b6; all were taken for an unspecified indication, start and stop date were not reported. On 15Apr2021 12:00PM, the right ear was losing hearing sporadically. Pain in surrounding area on face and cranium on same side. Periodic headaches on same side. Feels a bit like swimmer's ear with pain and muffled sounds. It was unknown if the patient did received any treatment for the events. The outcome of the events was not recovered. The patient did not covid-19 tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Chronic headache (Moderate) nothing makes it go away. I have tried all at home and OTC remedies went to see dr on 10/11/21 and got a toroidal shot.  That also didn?t help. I am waiting to get some blood work done and an MRI appointment.  Still have a headache.
pt recv vax 1-2PM 21FEB97;about 10PM had a fever of 103 w/pain @ inj site 230AM; fever 103;given APAP @ 10PM & 230AM;STAT: t102.7;slept until 930AM looks pale & no energy;not usual behavior;referred to MD;
severe headache 1/26/21, mild swelling in upper R arm,  stiff neck, chills, fatigue,  muscle and joint pain started 1/27/21, and 1/28/21 mild swelling  across upper R chest,  now rash/bumps and red blotchy across upper chest  have taken tylenol for headache,  rotated with motrin for chills and muscle/joint pain, and benadryl for rash
Waited for 30 minutes. About five minutes on the way home started getting a headache. That evening had bad stomach pains, bloated constipation, sharp pains in left shin, back pain, spinal muscle pains. On 1/10, did not eat, tried to drink fluids, still had bad gas about halfway up the spine. Both side where ribs were hurting. Today, drank a couple sips of coca cola, nothing to eat.  Took Colace, helped a little.  Dry heaving today, never vomited, still having pain in spine, gas pain comes and goes. Called pcp, had nurse call and told him to take Tylenol.
Sudden onset right sensorineural hearing loss day 5 after vaccine. Bilateral worsened tinnitus and aural fullness starting 2 days after vaccine, mildly for a few days after 1st dose of vaccine, then more intensely after second dose. Transtempanic steroid injection seems to be helping hearing loss but increase bilateral tinnitus continues to be more intense than baseline.
diagnosed with cellulitis; little local reaction but by the morning the arm was red, swollen, hot; little local reaction but by the morning the arm was red, swollen, hot; little local reaction but by the morning the arm was red, swollen, hot; little local reaction but by the morning the arm was red, swollen, hot; little local reaction but by the morning the arm was tender; some local reaction/all the way from shoulder to elbow; Initial information received on 17-Oct-2019 regarding an unsolicited valid serious case received from a physician.  This case involves a 4 years old male patient who experienced diagnosed with cellulitis (cellulitis), while he received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) in the right arm.  On 15-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ269AA via intramuscular route in the left arm.  On 15-Oct-2019, The patient developed a serious diagnosed with cellulitis (cellulitis) along with associated symptoms little local reaction but by the morning the arm was red, swollen, hot, tender (vaccination site inflammation, vaccination site erythema, vaccination site swelling, vaccination site pain, vaccination site warmth), some local reaction/all the way from shoulder to elbow (skin reaction) same day following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. These events were assessed as medically significant.  Patient required visit to physician office on 16-Oct-2019.  Final diagnosis was diagnosed with cellulitis.   The patient was treated with CEFALEXIN SODIUM (CEPHALEXIN [CEFALEXIN SODIUM]) orally.  The patient outcome is reported as Recovering / Resolving for the events; Sender's Comments: Patient was diagnosed with cellulitis same day after vaccination. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
At 1250 pm mom called a nurse over.  It was not the nurse who administered the vaccine as she as busy with another client.  Patient had vomited and was lying on the floor.  Pale.  BP 80/58  At 1254 BP up to 86/58  Pt stated he felt better and color improved in cheeks.  Pulse 92  At 1301 Pt sitting up.  BP 90/70  Pt wanted to go to the playgroud to play and said he felt much better.  Nurse advised mom to cal PCP if anything changed.  Nurse did offer EMT, and mom refused  I talked with mom today and pt. has been completely fine.  Did play outside that day, dank plenty of fluids.  Mom did not need to call PCP.  Pt returned to school Tuesday 1/18/22.
Nausea; Vomiting; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 10Mar2021 at 13:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, arthritis and known allergies to bees. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included paracetamol (TYLENOL), levothyroxine sodium (SYNTHROID), famotidine (PEPCID) and cyclobenzaprine hydrochloride (FLEXERIL), all for an unknown indication from an unknown date and unknown if ongoing. On 10Mar2021 at 16:45, the patient experienced nausea, vomiting and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event nausea, vomiting and dizziness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient had to go to the hospital and reports "cellulitis" caused by the shingles vaccination. Hospital informed her it could have been a contaminated vaccine.
Pt vaccinated with Recombivax HB developed polyarthritis/arthralgias.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with ROTATEQ (Lot #M004544, expiry date: 18-OCT-2017; lot #M005733, expiry date: 01-OCT-2017) (route: oral) following a temperature excursion to 51F for 24 hours. No adverse effects were reported in any patients. The outcome of the events was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacy technician refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # K023863 with expiry date 03-APR-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Day 1, Swelling, redness, heat, pain 3 inch circumfrance innoculation area; day 2 temperature (101 degrees), joint pains, tiredness, no appetite, general malaise, Day 3 temperature and body pain gone; swelling, redness, heat in vaccination area continue, Days 4-5 swelling, redness, heat in vaccination area continues.  At this point in time (Day 6) swelling, redness, heat continues although somewhat reduced.
11 doses administered after being refrigerated for 34 days; 11 doses administered after being refrigerated for 34 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (11 doses administered after being refrigerated for 34 days) and EXPIRED PRODUCT ADMINISTERED (11 doses administered after being refrigerated for 34 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (11 doses administered after being refrigerated for 34 days) and EXPIRED PRODUCT ADMINISTERED (11 doses administered after being refrigerated for 34 days). At the time of the report, PRODUCT STORAGE ERROR (11 doses administered after being refrigerated for 34 days) and EXPIRED PRODUCT ADMINISTERED (11 doses administered after being refrigerated for 34 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL9266), on 04Mar2021 as dose 2, single (Lot number: EN6205) and on 01Dec2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 80 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LISINOPRIL; ASPIRIN 81; ZETIA. The following information was reported: HEADACHE (non-serious), outcome "recovered"; FATIGUE (non-serious), outcome "recovered".  Additional Information: Caller states he had a severe reaction to the fourth vaccine. Caller states he had a headache and fatigue which he had with the first 3 too but this one he was up all night long with dry heaves, dizziness, achiness and just not feeling well at all. Caller states he had Covid before any of the vaccines were available so he knows it is not a good thing to have.  Treatment included Stay in bed a lot. Fourth Dose or Second Booster Dose taken on 11May2022 with Lot FP7557 or FP4554. Prior Vaccinations (within 4 weeks) was None. AE(s) following prior vaccinations was None. Patient's does not have any medical History (including any illness at time of vaccination). And no family Medical History Relevant to AE(s). AE(s) does not required visit to Emergency room or physician room. Generic zetia and statin are reported; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200720046 Same patient, same event, different dose
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 49-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 93T79, expiry date 30th June 2016). Concomitant products included B12 injection. On 7th March 2016, the patient received FLULAVAL QUADRIVALENT .5 ml. On 7th March 2016, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced headache. On 8th March 2016, the patient experienced injection site pain, axillary pain and rash. On an unknown date, the outcome of the injection site pain, axillary pain and rash were recovering/resolving and the outcome of the headache was recovered/resolved. The reporter considered the injection site pain and axillary pain to be probably related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the headache to be related to FLULAVAL QUADRIVALENT. The reporter considered the rash to be possibly related to FLULAVAL QUADRIVALENT. Additional details were received as follows: This case was previously reported to a doctor. On 8th March 2016, 1 day after vaccination, the patient experienced sore left arm and left axillary area, rash 3 inches below the injection site. The reporter stated that the patient's date of birth was not available.
I developed what I believe was a Morbilliform rash over my entire body, including torso, back, neck, arms and legs.  It began the second day after I was vaccinated and took about 5 days to fully resolve.  Benadryl was not effective in treating the rash, but hydrocortizone cream did alleviate the itching.  After my first COVID19 vaccine I had a circular rash at the site of the injection.
Cough, fatigue, low grade fever to 99.8, new abnormal LFTs, continued pain at vaccine site all for 3wks intermittently after vaccination.
pain at the site; redness at the site; swelling at the site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comment: The patient received a vaccine a week ago and  still had pain, redness and swelling at the site.  The patient was wondering if this was a normal reaction after a week. The patient read a lots of information and most say the reactions last 2-3 days and The patient had for a week. The patient was a nurse and patient's physician doctors look at my arm and it was still red ,swollen and warm after a week and the patient did not  know if this was normal or not.
15 min post vaccine, patient passed out, assisted to ground by father, loc for 10-15 seconds. Assisted to gurney via wheelchair, BP 108/62, A&ox4, drank 8ox of water and 6ox of apple juice. Released to father,
This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L027733, expiration date: 13-SEP-2017 and lot M000442, expiration date: 31-MAR-2018, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion of 46.5 Fahrenheit degrees for 20 minutes. A previous excursion of 46.5 Fahrenheit degrees for 20 minutes was reported. Data logger was involved. It was reported a total time out of range of 40 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA001263: US-009507513-1701USA001264: US-009507513-1701USA001265: US-009507513-1701USA001266: US-009507513-1701USA001267: US-009507513-1612USA012399:
Patient's reaction(s) noted during COVID vaccine observation period:  diaphoretic, pale, clammy, nausea occurred 10 minutes after vaccine administration.  Pt states that she has not eaten since breakfast.    1422: 97/67, 66 BPM, O2 94% 1432: 146/93, 91 bpm, O2 96% (states she is feeling better, color in cheeks, not diaphoretic; eating cracker and drinking Sprite) 1445: 130/77, 84 BPM, 96% She states that she does not want to be further evaluated in ED.  She is stable and states she is okay to drive home.   Actions Taken: vitals, comfort, water, graham cracker  Disposition: Patient declined ED visit
while vaccinating pt the plunger rod became loose & vaccine squirted out;pt recv less than recommended dose of vax;pt will be re-vaccinated;pt exp fussiness, vomiting & diarrhea;T103.5;BP 126/77;HGB 30.7;neutrophil 65;diaper rash, URI;
every day I've been lightheaded when I bend over I get real light-headed if I move my head too quick I get light-headed if I look up; 2 days after I had it I had a bad case of vertigo; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "every day I've been lightheaded when I bend over I get real light-headed if I move my head too quick I get light-headed if I look up"; VERTIGO (non-serious), outcome "unknown", described as "2 days after I had it I had a bad case of vertigo". Additional Information: After 2 days of the first dose, she had a bad case of vertigo and had that a couple times in the past but it only lasts for just an hour or so but this day she had it and ever since then every day she have been lightheaded when she bend over, she get real light-headed if she moved her head too quick; she get light-headed if she looked up and she was reading where there's been a lot of people that have vertigo and dizziness since they had their COVID shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
had vax last SEP according to mom; pt broke out w/hives that very same afternoon; pt was taken to MD; mom states pt had hives for approx 2 wks & then they disappeared; mom states MD said hives were poss from HIB shot;
Patient was 16 at time of vaccine and not 18. No adverse reaction at time of shot.
After 4 hours of the vaccine, the patient had chills, hyperemia, fever up to 39 C. Had one syncope episode. The fever resolved in 12 hours.  The vaccine that was given 1 year ago (regular dose) did not cause any adverse reactions. This year high-dose vaccine was administered, which caused this reaction.
Patient presented to ED on 09/09/2021 with fever, covid positive, and shortness of breath with increased cough.  In ED creatinine, BNP, troponin elevated and chest xray showing viral pneumonia.  Patient expired on 9/17/22 due to Sepsis secondary to Covid PNA.