chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient who is currently 63 years old. The patient did not have pertinent medical history or drug reactions. On 03-SEP-2008 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route were unknown). No concomitant therapies were reported. The pharmacist reproted that although the patient was administered the ZOSTAVAX but continued to have recurrent small patches of shingles on her back when she experienced "ongoing high stress periods." The onset date of the events was unspecified. Unspecified antiviral medications were given for the adverse event. No lab diagnostics studies were performed. The patient had sought for medical attention by seeing the pharmacist. The outcome of the events was unknown. Additional information has been requested.
I got the shot and the flu shot. My arm was sore for two days, I was a little tired the next day.  I had no symptoms when I tested positive. I started taking Paxlovid immediately because my doctor gave me a prescription because I would be traveling.  I also tested on the 6th and 7th and I was negative then. I tested because my husband tested positive and was experiencing symptoms. I am having some weakness in my legs and my heart seems to be unhappy.
EXPIRED PRODUCT USED; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203 21A, expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021, the subject experienced expired product used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product used was not reported. This report was non-serious.
Patient had immediate in her right arm starting at the shoulder and radiates to the elbow and hand. She had a fever for a week. Her family doctor prescribed antibiotics due to the fever. She went to the ER on 10/13/20 due to the pain in her right arm. The ER did blood work and ruled out infection. They determined it's likely "nerve related pain".
Pt with scarletiniform rash on 12/6/22 and noted by mom to have injected sclera. Upon testing pt found to have elevated transaminases. Hepatitis A/B/C testing done and negative. EBV negative. strep and ASO negative. no other symptoms at onset or during course of illness. Pt had associated nausea and anorexia with r sided abdominal pain for about a week but responded well to rest, fluids, supportive care and antiemetics.
Headache, Myalgia, NauseaVomiting, Sore arm, nausea, fatigue Narrative:  Reports right arm sore and radiating to neck, nausea- no vomiting, fatigue  Other Relevant History:
A Thursday, nerve pain on the left side, neck, arm and trunk and axillary region over the left breast truncal area; radiating over the shoulder and down the arm. Aching and a deep neuropathy kind of feeling; very weird feeling. I thought it was a pinched nerve. I went to my chiropractor first - Friday. He thought it was shingles even though there was no rash. I started to have a rash on Saturday,  on my breast, axillary under my armpit and left scapula. I went to Urgent Care, around the middle of February. I received an antiviral, Valtrex to take for two weeks. It was super high dosage. They could tell by the pattern; it follow a dermatome classic for shingles. I was better by the time I finished the medication.
Bilateral sensorineural hearing; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 23-JUL-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, anatomical location, lot number and expiration date were not provided). On an unknown date, the patient experienced bilateral sensorineural hearing loss. As a direct and proximate result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. In addition, the patient sustained severe and permanent personal injuries. The outcome of the event bilateral sensorineural hearing loss was considered as not recovered. The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event of bilateral sensorineural hearing loss was determined to be medically significant. The event of bilateral sensorineural hearing loss was considered to be disabling.
Received 3rd dose of Menveo; Received Menveo instead of MenB; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA824A, expiry date 31st January 2024) for prophylaxis.   Previously administered products included Menveo  (had completed a 2 dose series of Menveo in past ).   On 19th December 2022, the patient received the 3rd dose of Menveo. On 19th December 2022, unknown after receiving Menveo, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient had completed a 2 dose series of Menveo in the past, the day of the incident health care professional was planning on giving Meningococcal B but mistakenly gave Menveo, which led to extra dose administered and wrong vaccine administered.
Patient became lightheaded, fainted and lost consciousness for approx 5 seconds. Let patient lie down, gave juice and protein bar, patient left on own will approx 15-20 minutes later (patient has prior hx of fainting and had no morning breakfst)
for the first shot hives on shoulders, flanks, groin.  Blisters and lesions on hands and elbows, particularly in the joints.  Relived over time with anti hystamines and steroid pills. for the second shot, I started with anti hystamines daily and had minimal itching in the hands
Patient reported that the arm in which she had received the injection was "itchy" early Wednesday. The injection site was also red and hard to the touch. I offered her a loratadine tablet to help with the itching until she could leave work. The itching did not resolve in the afternoon and spread to her eyes. She visited the local emergency room where she was told she had cellulitis of the injection site, along with an allergic reaction to some component of the vaccine. She was treated with IM diphenhydramine and oral antibiotics and steroids. Her symptoms were subsiding the next day.
1).  Left arm sore, & stiff, from my elbow all the way to my collarbone...for 2.5 days after Vaccine date. 2).  Starting 8 days, after Vaccine date, my left bicep: -  developed a red area, about 6 inches below injection site, which doubled in size EVERY DAY for the next 7 days -  which developed into a rash -  was hot to the touch -  was hard in the center Dermatologist had the same response to the Pfizer Vaccine!  She prescribed Doxycycline, & Betamethasone.   Still recovering.
Fever 101-102, nasal congestion/runny nose earache right. Decreased hearing right. Permanent sensory neural hearing loss right ear.
Felt a pain in my upper left back shoulder area, shooting pain down my arm and fingers numb/tingle. It felt like nerve damage; Felt a pain in my upper left back shoulder area, shooting pain down my arm and fingers numb/tingle. It felt like nerve damage; Felt a pain in my upper left back shoulder area, shooting pain down my arm and fingers numb/tingle. It felt like nerve damage; Felt a pain in my upper left back shoulder area, shooting pain down my arm and fingers numb/tingle. It felt like nerve damage; Felt a pain in my upper left back shoulder area, shooting pain down my arm and fingers numb/tingle. It felt like nerve damage; feeling of pins and needles in her left hand; Shoulder and back pains; Muscle pain that radiates down her arm; Muscle pain that radiates down her arm; This is a spontaneous report received from a contactable consumer (the patient). A 54-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7533), via an unspecified route of administration, in left arm on 14Apr2021 at 09:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease. The patient's concomitant medications included vitamins (unspecified). The patient was not allergic to any medications, food, or other products. No other vaccines in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 14Apr2021 (reported as approximately 30 minutes after), the patient felt a pain in her upper left back shoulder area, shooting pain down her arm and fingers numb/tingle. It felt like nerve damage. On an unspecified date in Apr2021, she had shoulder and back pains, muscle pain that radiates down her arm. She will not be getting the second dose because of these. Clinical course included: the patient reported that she had a pain in back by shoulder by muscle that radiates down her left arm like stinger. She had shoulder and back pains. Stated that her fingers have feeling of pins and needles in left hand (numb). She wanted to find out what can be done to get pain to go away and if this is normal for her to experience. Stated that it brought her to tears. Stated that she has a muscle relaxer and a steroid, that both she has been on for three days and it still hurts on the pill. Later clarified muscle relaxer as methocarbamol (expiry date: 04Aug2022) pills in an orange-coloured bottle and the steroid as prednisone (expiry date: 20Apr2022) pills in an orange-coloured bottle. Stated that she normally uses her glasses to read the labels. It has been 8 days and she was still in pain. The adverse events resulted doctor or other healthcare professional office/clinic visit. The patient received treatment for adverse events with doctor prescribed methocarbamol pills and prednisone pills for pain. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not resolved.  No follow-up attempts are needed. No further information is expected.
Initial report was received 21 October 2010 from a health care professional, who is also the patient. A 47-year-old male patient had received an intramuscular left deltoid injection of FLUZONE SV, lot number UH214AC on 08 October 2010, and on the evening of vaccination he felt achy and weak and progressively felt weaker and weaker. The next morning, the patient fainted and experienced a hypotensive episode. His blood pressure was reported to have been below 100 which was low for him. He had no concurrent illness at the time of vaccination. The patient was evaluated by his physician and laboratory results were normal. Past medical history included high blood pressure, GERD (gastroesophageal reflux disease), asthma, hyperlipidemia and ADHD. He had no known allergies. He had been taking NORVASC, ZOLOFT, RITALIN, "Simvastatin", ASA, Acyclovir and ZYRTEC concomitantly. The patient also reported they had received Influenza vaccinations annually. At the time of the report, the patient was still not 100% and had not recovered. Documents held by sender: None.
Neuropathy, tingling, itchy skin, legs, upper torso, face, arms, skin sensitivity
The pt developed localized redness, swelling, warm to the touch, hardness a size of a golf ball on the right deltoid.
Twin given flu shot, about 15 min. later eating candy cane - neighbor noticed he put hands in air and fell on face. Mom picked up and ran to porch shaking him - seemed limp. He coughed and responded within 1 min. crying. Did not cough anything out. 16:20 - Talked with Mom - said was doing fine.
About 4 hours after the administration, patient developed a bruise the size of a half-dollar at the site, experienced throat pain and shortness of breath, and vomited. Patient used albuterol inhaler and it returned her breathing to normal. I advised use of ibuprofen and ice pack for injection site pain and Benadryl if any future allergic-type reaction. I also advised the patient to seek medical attention at urgent care or ER or to call primary care doctor is symptoms worsen or new symptoms arise.
Prolonged (4 hours) Vomit - screaming -low fever - resulted in double ear infection - given antibiotics.
Lightheadedness for at least 10 days that is constant but can be worse after a short period of standing
L thigh w/area of erythema about the size of a quarter, no tenderness, small area of induration. R thigh w/tiny area of erythema and induration. No tenderness. No discharge at b/l injection sites. No treatment needed.
Patient received an expired dose of Pfizer covid vaccine.  Vaccine expired on 10/21/21.  Nurse in clinic was confused over the expiration date, which had been extended to November 30th, if frozen.  She did not understand the 30 day expiration once refrigerated.
headache; fever; chills; arthralgia; This is a spontaneous report from a contactable non-healthcare professional reporting for a patient. A 57-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch no: EP7534) via unspecified route of administration in left arm on 16Mar2021 at 14:30 hours (at the age of 57-years approximately) as a single dose for COVID-19 immunisation. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patients medical history included asthma from an unknown date. The patient reported to be allergic to shellfish from an unknown date. The patients past drug history includes BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch no: EL9266) (1st dose, single) via unspecified route of administration in left arm on 24Feb2021 for COVID-19 immunisation. On 17Mar2021 at 04:00 hours, the patient experienced headache, fever (up to 101.8 degrees F), chills and arthralgia, that began approximately 12 hours after the vaccine was administered. Therapeutic measure for adverse event includes treatment with acetaminophen. The clinical outcome of the events headache, fever, chills and arthralgia was found to be recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
RHEUMATOID ARTHRITIS; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received booster dose with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, 6 weeks after booster, the patient experienced symptoms of rheumatoid arthritis and after 9 months of suffering patient was diagnosed with rheumatoid arthritis (Dose number in series 2). Laboratory data (dates unspecified) included: Laboratory test diagnosed with rheumatoid arthritis. It was reported as "6 weeks after the J and J booster, I had symptoms of Rheumatoid Arthritis. After 9 months of suffering, I was diagnosed. I am sure the booster made my immune system start attacking my joints. I have had to give up my job, and am paying a lot for medical treatments due to this". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rheumatoid arthritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221259577- Rheumatoid arthritis.  The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Started with a dry mouth and feeling thirsty then itching/rash on hands and arms. Pulse: 64 BP: 132/80. Gave employee benadryl cream and it helped with symptoms. Employee drank 2-3 bottles of water  and in 30-45 minutes was better.
Moderna vaccine inadvertently given to  a 16 y.o.  No adverse outcomes or symptoms  reported.  Mother notified + Advised chlid to  receive 2nd dose. of moderna.  On 3/23/2021 All nursing staFF reminded Moderna not Approved for under Age 18 only Pfizer.
dizziness to a point where she had to lay down; muscle between her elbow and wrist started "pulsing or jumping up and down" for 2-3 minutes; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness to a point where she had to lay down) and MUSCLE TWITCHING (muscle between her elbow and wrist started "pulsing or jumping up and down" for 2-3 minutes) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lyme disease (Patient had reaction like muscle twitches from Lyme disease) since an unknown date.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (dizziness to a point where she had to lay down) and MUSCLE TWITCHING (muscle between her elbow and wrist started "pulsing or jumping up and down" for 2-3 minutes). At the time of the report, DIZZINESS (dizziness to a point where she had to lay down) and MUSCLE TWITCHING (muscle between her elbow and wrist started "pulsing or jumping up and down" for 2-3 minutes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up received on 24-jun-2021 , contains no new information
5th dose of DTAP given and pt. acquired red round area to injection site on Lt. deltoid. NP aware instructed to do cooling measures and children's MOTRIN/childrens TYLENOL PRN. Verbalized understanding.
Information has been received from a health professional concerning an approximately 21 year old female pt who in approximately 1990 was vaccinated with a third dose of MMR II. Subsequently, the pt developed swollen glands and a fever and later recovered. On 10/29/02 at 3:00pm, the pt was vaccinated SC in the left arm with a fourth dose of MMR II (642539/0631M). At that time the pt was a 34 year old with depression and allergies to penicillin, Keflex, Cipro, Biaxin, erythromycin and Zithromax. There was no illness at the time of vaccination. On 10/29/02 approximately a half hour after vaccination, the pt developed a severe headache that lasted until the morning of 10/31/02. On 10/29/02 the pt also developed a fever of 99.7 F, fatigue, joint pain "in all of body" described as "achy" and she "felt like had the flu." On 10/29/02 at 7pm, the pt developed a "horse voice," glands in her throat became swollen and she became "disoriented for 24 hrs." On 10/31/02 the pt recovered. Additional info is not expected.
About 8 minutes into my 15 minute observation time after receiving my first COVID vaccine, my tongue started tingling.  The observation nurse gave be a Benadryl and water.  within the next minutes my whole body started tingling, I felt nauseas, and felt like I was going to pass out. The nurse laid me on the ground.  I asked her to take my BP and pulse.  For me it was high 145/98.  My pulse was also reported t be high.  I was able to swallow and breath.  I continued to have waves up and down my whole body of tingling, nasusea and cold sweats.  The nurse called my husband to come.  I was able to sit up after about 20 minutes.  The waves of feeling sick continued for about an hour.  After having some food and drink about 2 hours later I was able to drive home.  I was exhausted, nauseous, and had a headache the next 2 days.  I am concerned to get my second vaccine.
Woke up with hearing loss in the right ear. Went to ENT for a hearing test/evaluation. Was diagnosed with Sudden Sensory Hearing Loss. Went to 3 doctors, all 3 diagnosed with same.   I hear LOUD ringing in my right ear constantly. Unable to hear well.  Doctor recommended MRI, oral steroids, and steroid injection for the next 3 weeks.  I never had one issue with any ears. No infections, fluids, ringing, until now.
Case number PHEH2013US021314, is an initial spontaneous report received from the medical assistant on 10 OCT 2013 and a follow up report from the medical assistant received on 09 DEC 2013. This case refers to an 11 years old female patient. Past medical history was not reported. Concomitant vaccines included TDaP (other manufacturer, batch number AC52B676BA) and hepatitis A (other manufacturer, batch number: AHAVB703AA) and FLUMIST (other manufacturer, batch number M11081 and expiry date: 30 APR 2014) at a dose of 0.5 ml in the right arm intramuscularly on 07 OCT 2013, which had temperature excursion below 2 degree Celsius (two separate temperature excursions). On 04 SEP 2013, the temperature excursion was 0 degree Celsius for may be 10-15 minutes and on 09 SEP 2013, the temperature excursion was 0.5 degree Celsius for many be 10-15 minutes. Reporter stated that, she does not know if the vaccine was frozen. No adverse event was reported following this administration error.   Follow up report from the medical assistant received on 09 DEC 2013. The site of vaccination and concomitant vaccines were added.
9 cm x 8 cm raised, erythemic, hot-to-touch area on upper rt arm. Improved on 2-27-04 after Rocephin.
evening of vac administration body aches started got worse during the night with high fever, did not sleep at all still aching & with fever in the am finally got some sleep at 7am and felt better by 930am
patient stated she started having jaw pain that evening after receiving her Pfizer vaccine.  Stated the pain left and came back over the next several days.  Pain was not getting better so went to ER and was diagnosed with trigeminal pain and told it was a side effect from the vaccine.
Received vaccine on 11/7/06 woke up the next morning on 11/8/06 with Hives over entire body. She took Benadryl and they started to resolve. Instructed to call PCP is symptoms worsened. Denied Shortness or breath.
Tender, sore, heat at site, redness 2 1/2" x 4" oval, HA, tiredness, stomach ache, loose stools x 2 days.