chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hearing loss in left ear; Dizziness; Tinnitus; This literature-study case was reported in a literature article and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in left ear) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: Otologic manifestations after COVID-19 vaccination: ear clinic experience. 2021;42(9):e1213-8     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 DEAFNESS UNILATERAL (Hearing loss in left ear) (seriousness criterion medically significant), DIZZINESS (Dizziness) and TINNITUS (Tinnitus). At the time of the report, DEAFNESS UNILATERAL (Hearing loss in left ear), DIZZINESS (Dizziness) and TINNITUS (Tinnitus) outcome was unknown. Possible      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEAFNESS UNILATERAL (Hearing loss in left ear), DIZZINESS (Dizziness) and TINNITUS (Tinnitus) to be possibly related.    No concomitant information were reported. This study includes identifying 30 patients with post-vaccination otologic symptoms. In this case, patient had no prior hearing loss associated issues. The adverse effect was seen in left ear. The days to onset of symptoms was set as between 7 days. Lab test included were the mean pure tone average (PTA) was 52.2 ± 30.6 dB HL for the affected ear, and 21.2 ± 12.5 dB HL for the unaffected ear. The word recognition score (WRS) was 60.6 ± 38% for the affected ear, and 90 ± 23.0% for the unaffected ear. Most of the patients were still undergoing treatment, which may include oral, IT steroids, and/or antivirals. In all cases magnetic resonance imaging of the internal auditory canals was also ordered. The extent of hearing recovery and/or symptom resolution is currently unknown.  Company Comment: This case concerns a 67 year old male with no relevant medical history who experienced serious unexpected event of unilateral deafness on unknown after the second dose of the Moderna Covid 19 vaccine on unknown date.  Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.   This case was linked to MOD-2021-337903, MOD-2021-337994, MOD-2021-337995, MOD-2021-337996, MOD-2021-337997, MOD-2021-337998, MOD-2021-337999, MOD-2021-338000, MOD-2021-338001, MOD-2021-338002, MOD-2021-338004, MOD-2021-338005, MOD-2021-338006, MOD-2021-338007, MOD-2021-338008, MOD-2021-338009, MOD-2021-338010 (Patient Link).; Sender's Comments: This case concerns a 67 year old male with no relevant medical history who experienced serious unexpected event of unilateral deafness on unknown after the second dose of the Moderna Covid 19 vaccine on unknown date.  Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.
woke up during noc c/o severe itching, pt noted large welts (white center, red, surrounding area aprox 2cm diameter); welts began on arms then trunk & finally legs; welts cont to appear esp on arms & under breasts;
Medical assistant administered HepA vaccine as ordered by provider.  While documenting vaccine information she was flagged that the lot was expired on 1/16/23.  Provider was notified as patient had left the clinic.  Attempt to contact parent was unsuccessful.  Voice message was left for return call regarding immunization.  Nursing Manager was notified with adverse event documentation.
My arm as so sore I couldn't lift it.; My arm as so sore I couldn't lift it.; Felt like I had rotator cuff issues; I sneezed about 200 times; Couldn't sleep for two nights; This is a spontaneous report from a contactable consumer (patient). A 69-years-old non-pregnant female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EH6201 and Expiration date was not reported) via an unspecified route of administration, administered in right arm on 05Mar2021 at 09:15 hours as dose 1, single (at the age of 69 years old) for Covid-19 immunisation. Patient had no medical history and had no known allergies. Patient did not receive any other vaccine in four weeks. Concomitant medication within two weeks included hydrochlorothiazide and atorvastatin (both taken for an unspecified indication, start and stop date were not reported). Patient was not diagnosed with Covid-19, prior to vaccination and had not been tested for Covid-19, post vaccination. On 05Mar2021, at 11:00 hours, patient arm was so sore as she could not lift it, felt like she had rotator cuff issues, sneezed about 200 times and stated that she was not exaggerating, and patient could not sleep for two nights. Patient received no treatment for all the events. The outcome of all the events was recovered on Mar2021.  No follow-up attempts are possible. No further information is expected.
4-3-21 APROX 11:15AM PT SHAKING, VERY ANXIOUS WITH REDNESS AND ITCHING ALL OVER - PT PLACED IN WHEELCHAIR AND TAKEN TO MEDIC TENT PER, RN. PT STATES SHE HAD A RASH LAST TIME SO SHE TOOK BENADRYL AT 6:30AM AND 10:30AM TODAY (PT TOOK 2 MORE OF HER OWN BENADRYL  AT 11:15AM). RAPID BREATHING, 'BAD HEADACHE'. SQUAD CALLED FOR TRANSPORT. PT W/D.  HUSBAND AT HER SIDE. COMFORT GIVEN. 11:27AM TO ER PER SQUAD, HUSBAND TO FOLLOW IN AUTO. 4-5-21 11:23AM TC: PT STATES SHE HAD A 'GRAND MAL SEIZURE IN THE SQUAD'. THEY TOLD HER SHE HAD LACTIC ACIDOSIS, ELEVATED POTASSIUM AND WAS DEHYDRATED.  'CT WAS NEG.' STATES HIVES/RASH IS GONE TODAY.
Later same day:  full body itch and tingle.  Since vaccine:  increased food allergies and multiple joint ache/stiffness
MMR 0.5cc administered to right arm, Immediate swelling and redness. Tender to palpate. Advised warm compresses to area. Tylenol every 6 hours and Benadryl every 6 hours.
unable to get his second dose due to a local shortage at his pharmacy; This case was reported by a consumer and described the occurrence of product supply issue in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 4 years ago in 2017).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The case was reported by the consumer for himself. The age at vaccination is not applicable for this report. The patient stated that, he was unable to get his second dose due to a local shortage at his pharmacy, which led to product supply issue. The reporter gave medical disclaimer, referred to health care professional. The patient stated that, he would speak to his health care professional before he go to get the second dose.  The reporter spoke per PI and content and gave caller PAP outside number and provided cold transfer. The reporter consented to follow up.
Rash +2 days after PCV13 at inject. site. Progressive fever from 6/22/11-6/23/11 (99 degrees-103 degrees); stayed at 103 degrees 6/23/11-6/26/11; lethargy; loss of appetite; irritability. 6/26/11 red bumps (chicken pox or measles resemblance) appear all over body; no fever, still very irritable (2 doctor visits).
Hot flashes 12:00 pm same day and went away after roughly 30 minutes. Then came dizziness 6:00 pm same day, tiredness, pain in area of kidneys, joint pain, body aches, fever, chills, upset stomach, but without nausea.  Symptoms lasted all of 05/22/2021 and dissipated throughout the night. As of 05/23/2021 arm of injection site is still painful and diarrhea has lasted all day with lack of appetite.
pt very fearful-jerked arm during inject w/mom holding arm; c/o loss of feeling in arm on the way home; mom took pt to MD who told her to give the pt APAP & DPH; mom called clinic & said pt was feeling better Friday afternoon;
In March 29 at approximately 10:05am a patient was at my station prepared to get Covid -19 vaccine. After asking pt the appropriate questions prior to getting vaccine I wiped the pt arm with alcohol pad  and injected the needle in patient left deltoid muscle. When I injected the ?vaccine? I felt no pressure from the injection as I would have any other vaccine I had given in the past. I instantly pulled the needle  out and pulled back the plunger I observed no residue in the barrel from the vaccine. I then used the other syringe that was at my station that did have the appropriate dose of vaccine and injected the patient. I  did indeed feel the pressure that I was familiar with when giving the pt the vaccine. I am very confident that the syringe did not have any vaccine in it. I instantly went to my team lead and reported the incident.   was made aware of the situation after the 2nd injection was given to the patient and did observe the syringe and it appeared to be dry. Pre-drawer consulted and reported did not pull air into the  syringe. Son was concerned that the needle was dirty, assured son/patient that the needle was not dirty. Patient remained in observation for 30 minutes w/no adverse reaction before leaving with  her son. pulled from the vaccination line by SNAP lead.
Nausea Dizziness Pain at the injection site Heart palpitations Headaches Muscles aches
soreness for about three days at the injection site; discolored vaccine; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (soreness for about three days at the injection site) and PRODUCT COLOUR ISSUE (discolored vaccine) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRODUCT COLOUR ISSUE (discolored vaccine). On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness for about three days at the injection site). On 03-Feb-2021, PRODUCT COLOUR ISSUE (discolored vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (soreness for about three days at the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment information was provided.  The patient had soreness for about three days at the injection site.   This case was linked to MOD-2021-034060 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2021: Follow-up information included Event of soreness at injection site from FU1 and  updated the action taken, dechallenge and rechallenge. Dose 2 case number was linked.
no adverse event; missed second dose; This spontaneous report has been received from a pharmacist referring to a 44-years-old male patient. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies was provided.  On 13-JAN-2022, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration were not reported, lot number 1775809 and expiration date 18-AUG-2023). It was reported that the patient missed his second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product dose omission issue). The patient had not received his second dose at the time of reporting. No other adverse events were reported (no adverse event).
Had a baby 4 months ago; Hair loss; Scalp feels tingly; This is a spontaneous report from a contactable other HCP. This other HCP (Mother) reported events for two patients (herself and baby). This is mother report. This 30 years old female other HCP (mother) reported for Herself.  A 30-year-old (non-pregnant) female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 12Mar2021 11:30 AM (at the age of 30-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14Mar2021 12:00 AM, after the vaccination, the patient experienced Hair loss and Scalp feels tingly. Patient also experienced maternal exposure during vaccination. No other vaccines taken in four weeks, no other medications taken in two weeks, covid was not diagnosed prior vaccination and covid was not tested post vaccination. No allergies reported. The outcome of the events alopecia and paraesthesia was not recovered. Outcome of the event maternal exposure was unknown.  No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021296513 same product, different pt.
Pt recvd 2 doses of Recomb vax & lab eval revealed a pos anti-HBc titer & was weakly pos HBsAg titer;
Patient was given the flu and Spikevax twice, the first shot was given on 9/20/23 and the second shot was given 09/27/23. The residence coordinator did not recall him getting any shots and patient was administer another dose. However it was later discovered that patient had received it already.
Pt recv vax on 6/10/97; on 6/15/97 pt exp fever, chills, red spots on neck & shoulders, lethargy, headache, muscle aches, lying around & sore throat
Left upper arm from shoulder to elbow, red, indurated, swollen, hot to touch.  Does complain of discomfort when touched.  No fever, active and playful.  Treatment:  cold compress.
fever 104.9 shot to get fever down; rash to face & body 10MAY94; on 13MAY94 t99.9 in AM & 3PM no fever; rash today diminished & only a few spots;
Pt. increasing SOB and wheezing requiring 2 puffs of albuterol inhaler
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    The case was reported for 64th patient out of 77 adult patients who had received the vaccine as reported by the reporter.  No concomitant medication was provided.  It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Information has been received from an LPN concerning a 30 year old female patient with anxiety who on 11-Sep-2006 was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), lot#654540/0800F. Concomitant therapy included ethinyl estradiol/norgestrel (LO/OVRAL). After receiving the vaccination on 11-Sep-2006, the patient complained of a lot of pain under the arm pit and also on the left arm (injection arm).  The arm hurt on and off, especially during workouts and while sleeping.  the pain wakes up the patient in the middle of the night. She sought medical attention and was told to take Ibuprofen, apply ice to the area, and no upper body exercises. The nurse stated the patient was still having moderate pain 4 weeks after the injection, and that she probably would not receive further doses. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
3 inch x 2 1/2 induration (L) thigh. Redness and warm to the touch.
pt had elevated blood pressure that persisted. bp 20/114 and repeat 5 min later 232/126
Discharge Provider:  DO Primary Care Provider:  MD Admission Date: 9/3/2022 Discharge Date: Sep 9, 2022   PRESENTING PROBLEM: Severe sepsis [A41.9, R65.20]   HOSPITAL COURSE: 85 yo male with PMH of chronic urinary retention with indewelling foley, BPH, MS, CVA, CAD, HTN, dementia and VTE who presented to the ED with 3 days of weakness. Patient lives at home with his spouse and patient unable to transfer from bed to wheelchair prompting ED visit.   In the ED, lab work demonstrated leukocytosis with unremarkable lactic acid and pro-calcitonin. He was noted to be febrile with HR >90. CXR demonstrated LLL opacification consistent with PNA and tested positive for COVID-19. He was admitted to the medicine service    # Sepsis on Presentation (Resolved) # COVID-19 PNA Patient was treated with Remdesivir and initially started on anitbiotics with IV Rocephin for presumed UTI. No steroids were given as patient was without hypoxia. He did well from a respiratory standpoint. As patient had completed 4 days of antibiotics for initially presumed UTI, he was given an additional day to complete therapy for possible bacterial PNA.  White count improved.   # Chronic Urinary Retention with BPH Patient follows with urology (Dr.) with catheter exchanged monthly (exchanged in the ED on presentation). Patient was treated with IV Ceftriaxone for presumed UTI and completed 4 days of antibiotics prior to urine culture being negative.    PT evaluated patient and recommended SAR.  Family opted for home with home care and additional caregivers.  The patient was discharged home on 09/09/2022.
Patient can rub area of arm and can feel nothing (numb) but if she lifts her arm there is a sharp pain in her shoulder. Pain ceases after arm is put back down.
I've had hives every day since; Itchy skin every day/I've had itchy hives every day since; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (I've had hives every day since) and PRURITUS (Itchy skin every day/I've had itchy hives every day since) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 003A21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included LISINOPRIL for Blood pressure.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, the patient experienced URTICARIA (I've had hives every day since) and PRURITUS (Itchy skin every day/I've had itchy hives every day since). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Hives and Itching, at an unspecified dose and frequency. At the time of the report, URTICARIA (I've had hives every day since) and PRURITUS (Itchy skin every day/I've had itchy hives every day since) outcome was unknown.            The patient has been treating the symptoms with over the counter medication. The patient had hives and itchy skin every day since, and had been treating the symptoms with over the counter medication.
6 x 4 cm induration & erythema @ inject site of DTP #4 & peripheral urticaria on upper extremities, match head size; Also unconsolable crying x 4 hrs;
Migraine; This is a spontaneous report from a contactable Other HCP. A 59-year-old female patient (Other HCP) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: unknown, Expiry date: unknown) via an unspecified route of administration on 20Apr2021 for COVID-19 immunization. The medical history included focal migraines. Concomitant medications were not reported. In Apr2021, she was experiencing a migraine at the moment, but she's had migraines in the past, specifically focal migraines, for which light was the factor. When she gets them, she "can't see very well", everything was "just too bright. The second dose schedule is on 05May2021. The events were reported as non-serious. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
DOSE #3 OF MODERNA COVID VACCINE #3 GIVEN 11/19/21, LOT #018F21A; 7/10/22  pt brought to ED via EMS from assisted living facility after falling out of bed; pt found to be tachycardic and with hypothermia; A Fib with RVR, treated with medication; found to have pneumonia; pt had a positive COVID test 6/1/22; not sure if pneumonia is new or from COVID infection; DNR/DNI; pt passed away in the hospital
mom states broke out in rash all over body-rash red w/whelps claims itches;
Initial symptoms Blurred vision, nausea, headaches, weakness, pain in legs. After third dose had severe flu-like symptoms, sleepiness, feeling shaky, ammonia smell
On Saturday, April 10, I noticed that my left arm around the injection spot for the COVID-19 vaccine started to itch and have a fever. On Sunday, April 11, my arm continues to itch and have a fever, but the injection site has also started to turn a dark red and become swollen.  I have done nothing (no ice, or OTC medicines) to treat the swelling, itching or fever.
COVID positive; CHILLS; FEVER; low oxygen levels; A spontaneous report was received from a other healthcare professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid positive, chills, fever, low oxygen levels.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date,  patient received first of two planned doses of mRNA-1273 (lot/batch: un known). On 17 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events  covid positive, chills, fever, low oxygen levels.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, covid positive, chills, fever, low oxygen levels was unknown.
Sore arm around injection site shortly after shot. Soreness continued but diminished through 3/22/2006. Limited movement of arm from 3/16/2006 to 3/20/2006.  Redness of the bicep area.  103 degree fever 3/17 - 3/19/2006,  101 degree  3/19 - 3/20/2006.