chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sudden hearing loss; Tinnitus; This case was received via FDA VAERS (Reference number: 1422022) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This regulatory authority case was reported by a health care professional and describes the occurrence of SUDDEN HEARING LOSS (Sudden hearing loss) in a 53-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.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included LOSARTAN and MELOXICAM for an unknown indication.    On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced SUDDEN HEARING LOSS (Sudden hearing loss) (seriousness criterion medically significant) and TINNITUS (Tinnitus). At the time of the report, SUDDEN HEARING LOSS (Sudden hearing loss) and TINNITUS (Tinnitus) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had flu symptoms after shingles vaccine.  On an unknown date, the patient did a 15 day oral steroid dose which did not help. That was followed by 3 steroid injections through the ear drum. On an unknown date, about 1 month after the second Moderna vaccine the patient had ringing in left ear ended with substantial sudden hearing loss.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt recvd 2 Engerix-B on 8AUG91 & 23SEP91 following 2nd inject on 23SEP91 beginning @ noon pt c/o severe h/a & joint pain & muscle aches; pt sought medical help due to sx; 28OCT91 pt is still c/o pain (head, muscle & some joint);
A lot of pain at the injection site; This spontaneous report was received from a company representative concerning an elderly, female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On an unknown date, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, expiration date and formulation were not provided).         On an unknown date, the patient experienced a lot of pain at the injection site (vaccination site pain), and after 15 minutes, the pain went away.      The outcome of vaccination site pain was reported as recovered.  The causal relationship between the suspect vaccine and the event occurrence was not reported.
Welt on arm for first few days. It seemed to go away and came back itchy and red after a week.  It seems to have gotten slightly bigger the last day or two.
Patient positive for COVID-19 on 04/08/21 after completing vaccination. Loss of taste and smell, headache, runny nose, sore throat, and fatigue.
Patient fainted post flu vaccination. Vitals taken, offered water, repositioned patient to the floor.
This case was reported by a pharmacist and described the occurrence of injection site muscle soreness in a 64-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included high blood pressure. On 26 September 2011 at 15:30 the subject received a dose of FLULAVAL in the left arm. On 26 September 2011, immediately following vaccination with FLULAVAL, the subject experienced injection site muscle soreness (general soreness, muscle soreness reported as same event). The outcome of the event was unknown. In the reporter's opinion, injection site muscle soreness was probably related to vaccination with FLULAVAL. It was reported that the subject did not receive the full dose of FLULAVAL. This was a vaccine underdose.
the next day developed cough, runny nose and chest congestion; the next day developed cough, runny nose and chest congestion; the next day developed cough, runny nose and chest congestion; Has bruise and knot at injection site; Has bruise and knot at injection site; This is a spontaneous report from a contactable consumer (patient). This female consumer of an unspecified age received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on 23Sep2020 at single dose for immunisation. Relevant medical history and concomitant medications were not reported. The day after the vaccination, on 24Sep2020, the patient developed cough, runny nose and chest congestion and on an unspecified date in 2020 she had  bruise and knot at injection site. The patient stated that she was awaiting test results for Corona Virus, as she was exposed to a friend that was positive. At the time of the report, the outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
about 4 days after vaccine, I developed chest pain and shortness of breath.  Both increased in subsequent days. I took ibuprofen for  heaviness and chest pain along with shortness of breath.
patient reports itching in arms, chest and legs.  Benadryl given, symptoms resolved completely.
Developed Bell's Palsy - started on 2/21/21 w/ ear pain and stiff neck, progressed to numbness and tingling in face and lips on 2/22/21, then hearing loss and left sided facial paralysis. Went to ED, r/o stroke, neck/facial trauma. Given course of prednisone and acyclovir. No improvement noted to date.
Severe nausea, mild vomiting, severe aches, severe joint pain, mild dizziness, moderate fatigue, mild fever (101.2F), moderate chills, moderate runny nose
The same day of the booster shot, I developed at night bad chill, headache, body and joint aching though I did not have these symptoms in my previous two shots.  I became better the second day.  However on third day in the morning, I developed unusual nosebleed.  I managed to stop it.  Two days after on Wednesday, first in the morning, nosebleed developed again, which I managed to stop in about 5 minutes.  Then in the late afternoon, severe nosebleed occurred and can not be stopped.  I had to go into emergency room.  The doctor shot something into nose.  But even though the nosebleed slowed but not completely stopped, I will check in tomorrow afternoon with the hospital again.  I have never had nosebleed before, not to mention this kind.  It seems that each time, the bleeding has gotten worse.  The doctor at emergency room does not think it is Covid booster shot reaction.    However the coincident is not explainable.
Mom states pt. started  itching her left leg on 4/12/22. She said it was swollen about twice it normally is. No fever. She said her left leg is red and you can see where the vaccines were given. She hasn't complained of it at all. She is walking on her leg normally. Advised mom to give her Benadryl and see if that helps. Spoke to mom on 4/13/22 at 1015am. She states her leg "looks worse" and is really red. It is not purple looking. Pt. still has not complained of it hurting. Scheduled appt for patient to be seen today in office at 130om. Patient was seen in office 4/13/22 at 130pm. See providers recommendations below.
Pt developed chicken pox around 2-26-02 Was seen in ER on 2-26-03
Suspected GUILLAIN BARRE - treatment / workup pending.  11/23/09 Extensive ED, hospital, and rehab records received. Multiple evaluations. Service dates 9/18/09 to 10/12/09. Assessment: Guillain-Barre Syndrome. Patient seen in ED several days prior and dx'd with neuropathy. Now presents for pain control of ongoing leg pain of 14 days duration. Myalgias, appears uncomfortable. Lower extremity pitting edema. calves tender. ROM limited. Severe pain in feet, ankles, gastrocs worsened by movement. Weakness in legs. Decreased reflexes. Joint swelling. Renal insufficiency, anemia. Breath sounds diminished. Abdomen tender, distended. Nausea. Bruises to extremities. Urinary frequency. Several days later develops softness in voice, dyspnea, unable to walk, pain in hands. Respiratory failure, hospital acquired pneumonia. Fevers. Intubated / ICU. Delirium. Atrial fibrillation. PEG tube.
I had fever and chills for about 48 hours after vaccination from Friday evening and ended Monday morning. from Monday on, I had a pressure headache nonstop essentially. A vice like pressure around my head that doesn't remit with any sort of over the counter medication. One week after, the headache started on Monday the 15th. I had an urgent care virtual, and they told me to go in to urgent care. They gave me Toradol, Benadryl and Zofran, and they said if it didn't clear up when I woke up to go to the ER. I went to the ER and they did more medications - more Toradol, Magnesium and anti-inflammatory. I went to my PCP the next day, and he prescribed pain and anti-inflammatory (Cyclobenzaprine) medications and pain continued. They brought me in for an MRI, which was normal and then I saw a neurologist. He gave me a decongestant and Gabapentin. Dr. - PCP Neurologist
3/10 "Welts" in upper arm surrounding the site of injection. 3/11 Numerous urticarial lesion surrounding the site, with about 4 cm diameter of rancid erythema. Rash appeared and cleared and reappeared over 24 hour period. 3/12 Examined in office - no urticaria; about 4 cm diameter induration.
Z small fiber neuropathy 2 weeks after Tetany in 2008 - resolving  5/20/08 Reviewed ER medical records of 6/20/06. FINAL ER dx: twitching/paresthesias ? etiology. Records reveal patient gradual onset of paresthesias, started 2 wks prior & are intermittent.  started as twitching of right toes after episode of dizziness & diarrhea. Progressed to twitching of legs w/numbness of bilateral anterior thighs.  Saw PCP who did lab work & started on magnesium supplements. Twitching improved but still w/paresthesias of legs, now left hand & left face x 1 day.  Patient had been out of state previous month & had received tetanus booster 2 wks prior.  Patient w/appt w/neurologist for following week & was to have MRI done prior to appointment.  D/C to home w/planned neuro & PCP f/u.  5/23/08 Reviewed ER medical records of 7/5/06. FINAL ER DX: diarrhea & muscle twitching. Records reveal patient referred to neuro clinic.  6/20/08 Reviewed neurology clinic records of 7/7/06-4/5/07. FINAL DX: dysesthesias bilaterally; possible small fiber neuropathy aggravated by tetanus vaccine. Records reveal patient experienced twitching of toes & discomfort in thighs, loose stools, poor appetite, unable to work.  By April, 2007 was improved w/meds to return to work & able to exercise again.
pain, swelling, redness, hotness, hardened area increasing over several days. started antibiotics on 3/6/09; symptoms resolved by 3/8/09
Mild shortness of breath, mild chest pain, localized skin irritation 3 inches in diameter that is red, raised, and itching/sore with no open areas of skin. Ice applied to arm and ibuprofen given per Medical Director.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 15-MAY-2009, patient received improperly stored VARIVAX dose 2, from lot # 663710/0219Y expiry date: 13-FEB-2011. No adverse effects reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one the several reports received from the same reporter. Additional information has been requested.
Arm red, painful, swollen and hot at site of injection. Patient also stated that she vomited.
Received H1N1 injection at 1:30 PM.  At 1:45 PM felt a wave of dizziness with difficulty formulating words.  PB was taken by nurse and was 131/99 with HR of 70.  Also complained of an unusual taste in her mouth.  Describes it as a medicine taste.
Shingles; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and COVID-19 (COVID-19) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced HERPES ZOSTER (Shingles) and COVID-19 (COVID-19). At the time of the report, HERPES ZOSTER (Shingles) and COVID-19 (COVID-19) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  On an unknown date, patient experienced Shingles and COVID-19. The patient had a breakthrough case of covid after being vaccinated. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
One day subsequent to receiving the second dose of Engerix B the pt experienced erythema, induration and pruritis at the injection site. The pt was thought to have a possible cellulitis. She was seen by her physician and treated with an antibiotic. The physician does not recommend the third Dose of Engerix B. The most recent information received reports the symptoms fully resolved.
received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired doses) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Fever, fussy, inconsoleable, crying, drawing up legs, gassy, refusing to eat, refusing to sleep. Infant TYLENOL did not alleviate symptoms. Symptoms persisted throughout the day.
about 2 days of flu-like symptoms beginning at about 8 hours after receiving the second dose of vaccine. symptoms included fever, chills, body aches, mild headache, tiredness, and light shortness of breath, all of which began tapering off  going into day 3. chest pain and intense shortness of breath began at approximately 72 hours after receiving the second dose. went to hospital and was treated for possible heart attack until diagnosed with myocarditis.
This spontaneous report as received from an executive refers to unspecified number of patients of unknown age and gender. No information on concurrent conditions and medical history were provided. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL (unknown route, strength and dose) lot # K023432 and expiry date of 18-JUN-2016. Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Shortly after getting  vaccinated the patient complained of his head hurting and feeling nauseous. Within a few more minutes the patient said that their chest felt tight and was having shortness of breath. The patient was given water and a cold compress. The patient started breathing heavily. The patient was starting to sweat on their forehead. The temperature was taken and was 97.3 degree F. The patient was given a bucket at which time they proceeded to spit a small amount of mucus and bile into the bucket. The patient denied needing an ambulance. The patient called their mother who came and transported the patient to the hospital. The patient was watched for a total of 25 minutes and left the pharmacy at around 12:50.
pt recv vax 4SEP96 & 7SEP96 pt achy & sick;8SEP96 pt devel 2 lesions on abd, followed by lesions on buttocks & a tiny vesicle on palm of hand;pt also exp low grade fever, swollen neck glands;
LMP 2/5/08 GARDASIL #3 given 2/20/08 pt. current pregnant.
Itchy bumpy rash on mid torso; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 14Mar2021 at 09:15 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, the patient experienced itchy bumpy rash on mid torso. The treatment received for the event itchy bumpy rash included BENADRYL. The clinical outcome of the event itchy bumpy rash was recovering.   No follow-up attempts are needed. No further information is expected.
PATIENT WAS GIVEN PFIZER 1ST DOSE 21 DAYS PREVIOUS, CAME TO RECEIVE 2ND DOSE PFIZER AND WAS GIVEN MODERNA
Patient fainted about 5 minutes after receiving immunization. Patient came to with in a minute of fainting and felt fine shortly after.
Patient received Pfizer Vaccine approx 2 months ago. Was diagnosed as COVID positive; Patient received Pfizer Vaccine approx 2 months ago. Was diagnosed as COVID positive/loss of smell and nasal congestion; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on Mar2021 (reported as approximately 2 months ago) (Batch/Lot number was not reported) as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received Pfizer Vaccine approximately 2 months ago (Mar2021). The patient was diagnosed as COVID positive today (25May2021) after experiencing loss of smell and nasal congestion. Nurse Practitioner was aware as the test was completed at MD office. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
rash; Warm to touch; This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2019, the patient received Shingrix. On 5th October 2019, 1 days after receiving Shingrix, the patient experienced injection site rash and skin warm. On an unknown date, the outcome of the injection site rash and skin warm were unknown.   It was unknown if the reporter considered the injection site rash and skin warm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the pharmacy intern. The age at vaccination was not reported. Right after receiving the Shingrix, the patient experienced rash on the vaccinated arm. Warm to touch appeared quickly a day after vaccination. The rash was worst on the first day, and had gotten smaller by the time the patient went to the pharmacy on the 2nd or 3rd day. The reporter was unable to provide full details. The reporter did not consent to follow up. Time to onset had been considered precisely in this case instead of immediately as it seems a general statement and there was a discrepancy in 2 source documents. This case is for 1 of the 3 patients, reported by the same reporter.
Bruising and swelling in affected area. With warm temperature. (Left arm - swollen from shoulder to mid forearm).
Insomnia; Fatigue; This is a spontaneous report from a contactable nurse, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 22Apr2021 at 11:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included meloxicam (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), multivitamin, vitamin d nos (VIT D) and ascorbic acid (VIT C); all from unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 01Apr2021 at 11:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 21:00 the patient experienced insomnia and fatigue. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events insomnia and fatigue was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
PT HAD IMMEDIATE SITE SWELLING AND C/O DIZZINESS AND INJECTION SITE PAIN
Information has been received from a health professional concerning a patient who was vaccinated subcutaneously with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced chicken pox. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
A report has been received from a Pharmacist concerning a Child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced UPPER RESPIRATORY TRACT INFECTION. The outcome of the event of UPPER RESPIRATORY TRACT INFECTION is unknown. The report was considered to be non-serious.
Firm red nodule left lateral thigh 4.5x3.0cm. Macular/Reticular rash inner thigh left 11x10cm and Macular reticular rash inner thigh right 25x11 cm = urticaria resolved per mom. 4/15/2004 PM.