chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red swollen lump at injection site - very hard - within 3 hrs. of injection. Proceeded by red swelling of entire upper arm. Pain & itching - severe. Hot to touch. Symptoms continued from 5/6/11 to 5/9/11 - as I decided to make an appt. with my doctor. He recognized and treated as an allergic reaction to ZOSTAVAX vaccine. Instructed: 3x daily 2.5% Hydrocortisone ointment 3 x daily - ice 3x daily & BENADRYL 2x daily painful from base of neck to forearm. Consulted with doctor on 5/13/11. Follow-up symptoms are getting better. Still itching - redness is now pink & lump shrinking. Ongoing symptoms to date.
Pt recvd 1st dose of Engerix-B on 08JUL91; Evening of 08JUL91 pt exp slight nausea which continues on & off, felt tired, had slight stomach cramps, slight diarrhea; 10JUL891 pt felt dizzy; No tx given;
Information has been received from a health professional concerning a pt who was vaccinated with a 2 ml dose of Rotavirus vaccine. Subsequently the pt vomited. It was noted that the dose was not repeated. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided.
2nd dose of vaccine administered more than 12 hours after vial was 1st punctured; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose of vaccine administered more than 12 hours after vial was 1st punctured) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose of vaccine administered more than 12 hours after vial was 1st punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose of vaccine administered more than 12 hours after vial was 1st punctured) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant and  treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up received and does not contains any significant information.
I think it was the patient's wife that told me that after the patient had his COVID vaccine, his mental status decreased. He wasn't able to add or subtract, thought they were moving, but they weren't moving. He has had symptoms for 2 weeks and getting worse. She told me that the doctor is doing a brain scan, not sure if patient has had a stroke.
This spontaneous report as received from a Registered Pharmacist who placed patient on the phone to provided adverse event information refers to a 57 year old female consumer reporting on herself with no pertinent medical history or drug allergies/reactions. On 18-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot # J006155, exp. date: 30-AUG-2014) 0.65 ml, subcutaneous in the left arm. There were no concomitant medications. On 20-OCT-2013, the patient experienced a big red spot at the left upper arm injection site, described as raised, tender to the touch and four inches in length, "about the size of a silver dollar". The patient did not seek medical attention. There was not given any treatment for the events and no laboratory tests were performed. The outcome of the events was reported as not recovered. Additional information has been requested.
This spontaneous report was received from a Registered Nurse referring to 4 patients of unknown age and gender. Information about the patient's medical histories and concurrent conditions was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L031069, expiration date: 18-AUG-2015 (dosage, dose no. and administration routes were not provided). No concomitant therapies were reported. No adverse effects reported. Additional information has been requested.
6/24 5pm: arm pain upon injection 6pm: abdomin and lower back pain Late at night time unknown: full body aches, nausea (with throw up), vertigo upon standing, difficulty sleeping, ringing in both ears that lasted a couple minutes, persistent arm pain 6/25 6:30 am nausea with throw up provoked upon smelling food (specifically Kashi raisin no sugar added wheat cereal) did not attempt eating, severe headache, persistent arm pain, hot flash sttong enough to cause hair to drip with sweat, drank small glasses each of water and berry 100% juice  8am-12:30 at work primarily sitting: noticable shivering, color alternated between flushed-deathly pallor-green (reported to self by coworkers 5 RNs/1 LPN/1 MA), severe headache persisted, arm pain persisted, nausea without throwing up, emotional, back pain, no hunger 12:30: napped for 30 min in car backseat with sunshades up and windows cracked.  1pm: reduced headache and nausea, ate .5 peanut butter sandwich and cheezit crackers with water, other sympotoms continued Rest of 6/25: mild headache, moderate arm pain, back pain, slight nausea 6/26: slight headache and sporatic leg weakness throughout the day.  No medications/herbal remedies were ever taken.
Patient received 1st dose of Pfizer 11/21/2021  at another facility and in error the 2nd dose was given early on 12/6/2021. Patient has had a fever of 101 and body aches since receiving the vaccine.
the usual lethargy & mild limp; * vomiting q 1hr x 3 & 2 more times a/830AM;
Tongue tingling; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GN6199) via an unspecified route of administration in the right arm on 12Mar2021 at 14:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic reaction to steroid medication in 2018 for sinus infection, various food allergies and latex allergy. 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 vaccination. Concomitant medications included calcium, colecalciferol (NATURES BOUNTY CALCIUM; VITAMIN D3), taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received doxycycline (MANUFACTURER UNKNOWN) and experienced drug allergy. On 12Mar2021 at 15:05, approximately 20 minutes after the vaccination, the patient experienced tongue tingling. The patient was not worried and just wanted to report, the event only lasted a few minutes. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tongue tingling was recovered on 12Mar2021.   No follow-up attempts are needed. No further information is expected.
I felt a little poorly in the evening of the vaccines, queasy and a little light headed.  When I got up at 3:45 a.m. I went to the bathroom and after voiding I felt like I was going to vomit.  I reached across for the sink and passed out.   My husband heard me fall and found me unconscious.  He called my name and slapped my face but I did not respond.  He grabbed the bedroom phone and came back and tried once again to rouse me.  He started to dial 9-1-1 when he heard me start to moan.  I gradually regained consciousness.  I had no recollection of feeling as if I were going to faint.  I just blacked out.
Service member went for training from June until August 2000. While she was attending training, she felt unusually fatigued. If an energy level of 100% is service member's baseline prior to June 2000, and a rating of 0 is bedridden due to lack of energy, patient rates her energy level while in training as level 10%. While there, she went home for lunch and napped. She went to bed shortly after her evening meal and she did not feel rested after at least 8 hours of sleep. At that time, she attributed her fatigue to the heat and the additional study requirements. (Service member found out she was pregnant in early June 2000.) While service member was at training, she began noting numbness and tingling in her hands and feet. After she returned home in August, these symptoms began to progress. Within two weeks of returning home, the tingling sensation extended to her calves and up to her hips and up her arms. Her muscles also felt weak. When she went for walks, she said her legs weighed a ton and she had to push her hips forward to get her legs to move. After sitting for more than 10-15 minutes, she felt too weak to get up. She was not able to hold her arms up to put in a pony tail. When the progression began, she sought evaluation in the clinic and was told that the symptoms were related to her sciatic nerve; later she was given a consult to neurology, but her appointment was not until October. In September, while doing Pregnancy PT, service member could not get up after doing exercises while sitting on the floor. She was taken to the hospital and after being evaluated, she was placed on 72 hours quarters and given an urgent neurology consult. By the time her neurology appointment, she had lost sensation in her face, she had lost her sense of taste, and she was having some burred vision and some problems swallowing. She also was experiencing some urinary incontinence. During her neurology evaluation she was told her EMG/NCV studies were abnormal, she had no reflexes, and the specimen from the lumbar puncture was consistent with Guillain Barre Syndrome. That same day she was admitted to the intensive care unit for observation and later, treatment. Patient recalls increased efforts to breathe, but never required assisted ventilation. After a few days of being hospitalized, she was treated with plasmaphoresis every other day, for a total of 5 treatments. Symptom: Paresthesia Comment: progressive numbness and tingling (ascending), Weakness Comment: ascending muscle weakness, Fatigue, Malaise > 60 days, Hyporeflexia Comment: absent DTRs per patient report, Sensation decrease: loss of sensation on face, Dysphagia, Blurred vision. Information from 60 day follow-up report states: 01/23/2006 Contacted patient by phone for update on status. She is essentially unchanged from our last encounter. She continues to experience muscle weakness and fatigue; no further evaluations or new treatments have been completed/inrelated by her PCM or Neurology. Recommended working with her PCM regarding evaluation of fatiuge to rule out underlying pathology like DM, anemia, hypothyroidism. Patient will be moving to another state in a few months.
Within 5 minutes of receiving the vaccination, I experienced a pain moving up both sides of my neck followed by swelling of my throat and tongue.  This lasted for about an hour, with no impediment in my ability to breathe.  About 4 to 5 hours after the vaccination, my head and face began to itch.  At that time, I took one 25 mg benadryl and the itching subsided.
Sore; Chills/Teeth Chattering; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, chills and fever. On an unknown date, the outcome of the injection site pain, chills and fever were resolved with sequelae.   It was unknown if the reporter considered the injection site pain, chills and fever to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's wife. The reporter stated that the patient experienced arm at the injection site, chills, teeth chattering, and fever. The reporter did not consent to follow up. This is 1 of the 2 linked cases reported by same reporter.
Vomiting; fever; dizziness; This is a spontaneous report from a contactable consumer reporting for himself.    A 22-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Feb2021 08:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  Medical history included covid-19  before the vaccine.  The patient's concomitant medications were not reported.  The patient experienced vomiting , fever and  dizziness all on 26Feb2021 21:00 with outcome of recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
About 6pm arm started to hurt by bedtime is was extremely painful to move up/down 6/4 in morning, arm sore to move and upper arm was swollen and bright red 6/5 in morning, was able to move arm more and there was still swelling, redness, itching. Patient contacted doctor and was directed to ER (Urgency Room).  Patient was diagnosed in urgent care with severe allergic reaction to vaccine and was prescribed Prednisone and ice packs.   Followed up with doctor via phone on 6/6 to get vaccine info. Medication has helped, swelling and redness has decreased. There still is itching but it improves with medicine. Patient is able to move arm fine now
1/26/21, 2/23/21 vaccine dates. second lot number is not 100% clearly written so may be incorrect.   1/5 power in finger extension and abduction. 4-/5 in finger adduction and flexion. Wrist extension 4/5 while wrist flexion is normal. Elbow flexion normal with 4/5 in extension. MSR are muted in the arm. Decreased tactile sensation in the hand and along medial aspect of the forearm. PR3-ANCA positive vasculitis presenting as isolated nerve damage to the right brachial plexus. 1. Wegeners granulomatosis   Start riTUXimab Solution, 500 MG/50ML, 1 gm, repeat in 14d then 500mg q 6 mos x 3, Intravenous, 7/2021-7/2023, Notes: 30 mins prior to treatment: solumedrol 125mg IV, Tylenol 1g PO, Benadryl 50mg PO Start methylPREDNISolone Sodium Succ Solution Reconstituted, 1000 MG, 1 gm, Injection, x 3d Start predniSONE Tablet, 5 MG, 1-2 tabs as directed per taper schedule, Orally, daily, remain on 5mg daily x 4 wks once tapered to that dose, 30 day(s), 60, Refills 5 Start predniSONE Tablet, 10 MG, 1-3 tabs per taper schedule given to patient, Orally, Once a day, 30 day(s), 90, Refills 5
4-5 lesions on trunk, erythematous vesicular rash. DX; modified varicella break out.
fever, parkinson's symptoms, gagging, vomiting, delirious, couldnt hold anything down
On October 2, 2006, patient had generalized tonic-clonic seizures-all limbs shaking and eyes rolling back.  He had two on the day of admission which each lasted 3-4 minutes and patient was in a post-ictal state.  Patient was noted to have fever at that time.  After second seizure, patient taken to ER.  At hospital Patient underwent, CBC, Blood Culture, CT Head without contrast, CXR and lumbar puncture.  All results were normal other than a microcytic anemia. On, October 3rd, patient had another seizure witnessed by mom and nurse noted post ictal state.  Patient was started on Phenobarbital.  This seizure was without fever.  10/31/2007 MR received for ER visit 10/2/07 for c/o febrile seizure which lasted ~ 4 minutes. PE (+) for reddened TMs. Reported fever and cough. Diagnostic Impression:  New Onset Seizure. 01/12/2010 Continues to have seizures occasionally.
Patient came in requesting updated 2023-2024 covid vaccine.  Administered vaccine 11/3/23.  Patient received the same vaccine at pharmacy as well on 09/29/2023.  Patient was not aware that she received the vaccine twice.  Said she thought she was receiving "the old" covid vaccine when she went to Pharmacy.
had body aches, headache, lethargy, fever 101 degrees.  It lasted the full day after I got the injection.  The 2nd day I had mostly recovered but had some body aches and faint headache.   I took Tylenol.
Broken in hives; intense itching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broken in hives) and PRURITUS (intense itching) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Broken in hives) and PRURITUS (intense itching). At the time of the report, URTICARIA (Broken in hives) and PRURITUS (intense itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information was provided
This spontaneous report was received from a nurse regarding a 4-year patient of an unknown gender. The patient's concurrent conditions and medical history were not provided. On 14-JAN-2019, the patient was vaccinated with an improperly stored dose of PROQUAD (route of administration and dose were not reported) for prophylaxis (lots # and expiration dates: R020676, 15-JAN-2020; R020816, 16-JAN-2020; R020677, 15-JAN-2020; R020814, 16-JAN-2020), however, it was unknown which specific lots the patient received. A sterile diluent was used to reconstitute the vaccines was properly stored. No adverse effects were reported. The vaccines were exposure to a temperature excursion of 9°C to 25°C (9.2°C) during 2 hours which was called by a data logger. There was not previous temperature excursion. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1901USA005742: US-009507513-1901USA005740: US-009507513-1901USA005743: US-009507513-1901USA005739: US-009507513-1901USA005573:
No additional AE; patient received an expired dose of MMR II and an expired dose of VARIVAX. The patient received both vaccines on 8/14/2023. The MMR II expired 8/4/2023 and the VARIVAX expired 8/10/2023. Caller stated the pro; This spontaneous report was received from a medical assistant and refers to a 50-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-AUG-2023, the patient was vaccinated with a first dose measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, which had a lot #U024229, with expiration date: 04-AUG-2023 (Expired drug administered), administered for prophylaxis (strength was not provided); and also vaccinated with a first dose of  varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #U024765, expiration date: 10-AUG-2023 (Expired drug administered), administered for prophylaxis (strength was not provided) both vaccines were given subcutaneously. No treatment was required for the experience. The reporter stated the vaccines had no temperature and the patient had not reported any symptoms or adverse event.
Patient had radiating pain down his arm. At 1pm the day of the shot he took a nap per his wife, then he woke up at 3pm and took advil due the pain. Later that night, he was seen by urgent care and they did EKG and found no results and gave him pain medicine for his shoulder and arm pain. Patient was doing better with pain medicine but patient reported that he is still having issues with his arm raising it and using it like before. Have asked patient wife on 05/14/21 and she has doing better but arm sore. Reminded patient to send us a picture of his shot site to assess further but have not heard back from the patient as of 06/02/21
Patient began experiencing pain and weakness in left arm within 1 day following vaccination and still having weakness in arm > 1 month from vaccination
A few days after shot got shingles all over my back.   Vaccine = SHINGRIX     ( GlaxoSmithKline )
pt recv vax & later that day devel swelling, redness & pain @ the inj site;also exp nausea & h/a;pt was seen by MD next day, dx cellulitis & prescribed an oral ATB;
Swelling, redness, itching at injection site for 3 days after administering.
Pt received first Moderna Covid vaccine.  About 15 minutes after vaccine administration pt reported feeling itching in her arms, fingers and chest.  Pharmacist was notified and 25 mg PO Benadryl was administered.  Pt is being monitored.  Advised pt to seek medical care if symptoms worsen when she gets home.
Lost Smell; Lost Taste; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Lost Smell) and AGEUSIA (Lost Taste) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0321A and 0321A) for COVID-19 vaccination.     The patient's past medical history included Brain operation NOS. Previously administered products included for Product used for unknown indication: FLU VACCINE. Past adverse reactions to the above products included No adverse event with FLU VACCINE. Concurrent medical conditions included Stroke, Aneurysm, Hypertension, Seizure, Diabetes and Broken hip. Concomitant products included LINAGLIPTIN, METFORMIN HYDROCHLORIDE (JENTADUETO) for Diabetes, LACOSAMIDE (VIMPAT) for Seizures, MENADIONE (KAPPA), CLOPIDOGREL BISULFATE (PLAVIX), MONTELUKAST, AMLODIPINE, ROSUVASTATIN CALCIUM (CRESTOR) and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced ANOSMIA (Lost Smell) and AGEUSIA (Lost Taste). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ANOSMIA (Lost Smell) and AGEUSIA (Lost Taste) had not resolved.            The patient received her vaccines in both left and right deltoid muscle. The patient also used a lotion as a treatment. The patient was 5' 4", had no allergies, never tested positive for Covid-19.  Company Comment: This spontaneous case concerns a 82-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI of Anosmia and Ageusia which occurred 1 day after receiving the second dose of mRNA-1273. The patient took Benadryl as a treatment. Its reported that patient was never tested positive for covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-538644, MOD-2022-538663 (Patient Link).; Sender's Comments: This spontaneous case concerns a 82-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI of Anosmia and Ageusia which occurred 1 day after receiving the second dose of mRNA-1273. The patient took Benadryl as a treatment. Its reported that patient was never tested positive for covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Tinnitus in both ears on and off the first 4 weeks after vaccination. Persistent tinnitus in both ears about a month after the shot and ongoing. The first few months I had some tingly-feeling of nerves in my left arm. So far I've visited an urgent care to make sure my ears were okay. Then followed up with an ENT for about 5 visits until the doctor said nothing was wrong from what he could see. Prescribed a drug for help sleeping.
Rash/hives, all over body, lasting over a week, despite treatment with Benadryl.
Administered high dose influenza vaccine for people over the age of 65 on 11/15/2022 to patient who is 64 years old .