chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a patient with asthma who on 26-OCT-2010 was vaccinated with single injection of PNEUMOVAX 23 (lot# 667418/0978Z). Subsequently the patient experienced fever, rash, headache, nausea and vomiting. The patient experienced these side effects for 3 to 4 days after the initial injection. This is one of several reports received from the same source. Additional information has been requested.
Immediately after injection of PCV-7 vaccine, leg became bright red and indurated. redness spread to lower abdomen and other leg within 1 minute. Benadryl given orally. Flush subsided within 10 minutes.
Swelling, redness, itchiness, warm to touch 1 day post - ZOSTAVAX wife reports improvement as of 12/22/13.
States she had headaches lasting several days, back and hip pain, shoulder and upper back soreness, chills. Took Ibuprofen, did not alleviate symptoms. Slept and rested until symptoms subsided. Symptoms lasted for about 3-4 days.
Pt. complained of rt upper arm swelling down to just below elbow. Had recv'd flu & pneumovax on 10/25/99.Tx on 10/26/99 w/Keflex, Solumedrol & Medrol Dose Pak.
STATIONED AT OCC VACCINATION SITE FOR PATIENT OBSERVATION POST VACCINE ADMINISTRATION. PATIENT WALKS WALKS UP TO MEDICAL EVALUATION STATING THAT SHE FEELS A BURNING SENSATION IN HER THROAT AND  WOULD LIKE TO BE EVALUATED DUE TO HER PRIOR HISTORY WITH ANAPHYLAXIS. PATIENT IS USHERED TO EVALUATION AREA. PATIENT IS ALERT AND ORIENTED X4. UPON EVALUATION IT IS FOUND THAT THE PATIENT IS HYPERTENSIVE AND TACHYCARDIAC. PATIENT HAS NO URTICARIA OR PRURITUS AT THIS TIME. PATIENT STATES THAT SHE FEELS THE BURNING SENSATION GET PROGRESSIVELY WORSE. PATIENT IS GIVEN 25 MG OF DIPHENHYDRAMINE IM TO OBSERVE IF THE SYMPTOMS SUBSIDE OR PROGRESS. PATIENT STATES THAT AFTER 10 MINS POST ADMINISTRATION IT SUBSIDED BUT CAME  BACK 15 MINS LATER. DUE TO PATIENT?S PROGRESSION, AND THE PATIENT STATING? THIS IS WHAT IT FELT LAST TIME I WENT INTO ANAPHYLAXIS? PATIENT IS TREATED VIA ANAPHYLAXIS PROTOCOL. 20 G IV IS ESTABLISHED IN THE PATIENT?S RIGHT AC. PATIENT IS GIVEN 25 MG OF DIPHENHYDRAMINE IV, 4 MG OF ZOFRAN FOR FOR NAUSEA, AND 10 MG OF DECADRON FOR THE SWELLING THAT SHE STATED WAS IN HER THROAT. PATIENT IS  TRANSFERRED ONTO THE STRETCHER AND IS TRANSPORTED TO MEDICAL CENTER. PATIENT STATES THAT IT WAS GETTING DIFFICULT TO BREATHE. 0.3 MG OF EPINEPHRINE IS ADMINISTERED TO  THE PATIENT IM. PATIENT STATES THAT SHE FELT IMPROVEMENT POST ALS INTERVENTIONS. PATIENT REMAINS  HYPERTENSIVE. PATIENT SHOWS NO SIGN OF RESPIRATORY OR CARDIAC COMPROMISE. PATIENT'S SKIN IS PINK,  WARM, AND DRY. PATIENT HAS NO CHANGE IN STATUS FOR THE DURATION OF TRANSPORT. PATIENT ARRIVES DESTINATION, IS TRANSFERRED TO ER, AND CARE IS TURNED OVER TO RECEIVING RN WITHOUT INCIDENT.
Bullous pemphigoid; Skull itches as well; Digs into rashes until he has marks on his legs and back. Rashes stop itching when they bleed; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PEMPHIGOID (Bullous pemphigoid) in a male patient of an unknown age 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 Drug allergy (Zithromax), Drug allergy (CT scan dye), Drug allergy (Cipro), Drug allergy (Macrolides), Drug allergy (Lansoprazole), Drug allergy (Phenytoin), Drug allergy (Ranitidine), Drug allergy (Sertraline), Drug allergy (Xarelto), Drug allergy (Eliquis) and Drug allergy (Bentyl). Concomitant products included DESMOPRESSIN, DOXAZOSIN, PREDNISONE, LEVOTHYROXINE, LORAZEPAM, LEVETIRACETAM, TRAMADOL, TESTOSTERONE CIPIONATE (TESTOSTERONE CYPIONATE), OMEPRAZOLE, TRIAMCINOLONE, ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN, ATENOLOL and VITAMIN D3 for an unknown indication.  On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Mar-2021, the patient experienced PEMPHIGOID (Bullous pemphigoid) (seriousness criterion medically significant), PRURITUS (Skull itches as well) and RASH PRURITIC (Digs into rashes until he has marks on his legs and back. Rashes stop itching when they bleed). At the time of the report, PEMPHIGOID (Bullous pemphigoid), PRURITUS (Skull itches as well) and RASH PRURITIC (Digs into rashes until he has marks on his legs and back. Rashes stop itching when they bleed) outcome was unknown. Not Provided   Treatment for the events included increased Hydroxyzine and Vaseline in hair.  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.
Menactra mixed with a dose of varicella vaccine and administered in error as a diluent for the varicella instead of sterile diluent, no AE; Menactra mixed with a dose of varicella vaccine and administered in error as a diluent for the varicella instead of sterile diluent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse.  The physician mixed/ reconstituted a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] with VARICELLA ZOSTER VACCINE [VARICELLA VACCINE] (not produced by Sanofi Pasteur) in error as he/she thought that the MENACTRA was the diluent for the varicella instead of sterile diluent and vaccinated to an 18 year old male patient on an unknown date for prophylactic vaccination (product preparation error, labelled drug-drug interaction medication error,  batch number and other dosing details were not reported).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.  This was an actual medication error case due to wrong solution used in drug reconstitution and labelled drug-drug interaction medication error (latency same day).  The nurse had no more information on the vaccine and no adverse event reported to the patient at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Patient recevided Janssen dose on 03/11/21 and then received one dose of Pfizer from hospital on 06/30/2021. No adverse events were noted.
After I had my second Covid vaccine shot in my right arm, 4 days later I started experiencing vertigo, dizziness, bad headaches and migraines and pain in my ears and balance issues. Few weeks later, I started suffering from Tinnitus, ringing in my ears and headaches and migraines, clogged ears and infections.  Tinnitus started the end of September and I still have it. It?s affecting my life in every way. I lost everything to this disease I saw 4 or 5 ENTs none of them is able to help me. I still experience pain my right ear and the last ENT I saw a week ago, said I have a high frequency hearing loss. I lost 50 lbs since September and I?ve been showering with ear plugs for the last 5 months. Tinnitus gave me anxiety, stress and depression. I visited the hospital 6 times since September. This disease affected me financially and socially. I am very close to become homeless because I spent all my money on surviving with this conditions for the past 6 months.
Information has been received from a nurse practitioner concerning a 68 yr old Hispanic female with diabetes mellitus and dizziness who on 23Sep05 was vaccinated IM in the right arm with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 650087/0815P, also reported as 650083/0746P). Concomitant therapy included atorvastatin calcium (Lipitor), trandolapril (Mavik), meclizine, estrogens, esterified (+) methyltestosterone (Estratest), vitamins (Centrum), aspirin, and rabeprazole NA (Aciphex). On 24Sep05, the day after her vaccination, the pt developed a very swollen, hot and red arm. The pt was so swollen she could not even see her elbow. The pt contacted the nurse practitioner for advice, and the nurse recommended that the pt to come into the office or to the ER to be examined. The pt chose not to go and instead treated herself with diphenhydramine HC1 (Benadryl). The nurse stated that the pt was never seen by medical personnel, and that the pt only received diphenhydramine HC1 for the experience. The swelling came down slowly, and she subsequently recovered. It was reported that the arm was swollen, hot and red for one day. No additional information is expected.
Case number PHEH2016US023715, is an initial spontaneous report received from a medical assistant on 14 Sep 2016. This report refers to a 68 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1514801, expiry date: May 2016) at a dose of 0.5 ml intramuscularly in deltoid on 15 Sep 2016 (earlier reported as 14 Sep 2016). It was reported that 8 patients received expired FLUVIRIN vaccine from last year over several days. No adverse event was reported following this administration error. The case was assessed as non serious by the medical assistant. Follow up report received from a medical assistant on 18 Oct 2016: Updated reporter details and suspect drug information (vaccination date and anatomical location).
8:00 p.m. day of injection - Fever & Severe Chills.  Chills eased about 3:00 a.m. 02/10/21 7:00 a.m.  02/10/21 - abdominal muscles and unable to function extremities very weak loss of bladder control improved very, very slowly until 02/11/21 - 3:00p.m. 02/11/21 return to normal 02/11/21. No lasting consequences
Hives that appear/disappear all over my body.  No previous history of having hives or any allergic reactions.  Hives started 9-10 after 2nd booster shot and still continue 9 weeks later
pt recv vax;swelling,pain,redness,heat at inject site;stiff neck;devel gen itching,redness;T 100;also devel malaise,gen achiness;sx persists for 72 hrs;
Extremely tired; headache; Arm was sore; upper body muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 11:15 (Lot number: EP6955) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19,, Brand=Pfizer,, lot number=EP6955,, lot unknown=False,, administration date: 24Mar2021,, administration time: 11:30,, vaccine location: Left arm,, dose number: 1), administration date: 24Mar2021, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 14Apr2021 22:00, outcome "recovered" (16Apr2021), described as "Extremely tired"; HEADACHE (non-serious) with onset 14Apr2021 22:00, outcome "recovered" (16Apr2021), described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 14Apr2021 22:00, outcome "recovered" (16Apr2021), described as "Arm was sore"; MYALGIA (non-serious) with onset 14Apr2021 22:00, outcome "recovered" (16Apr2021), described as "upper body muscle pain". Therapeutic measures were not taken as a result of fatigue, headache, pain in extremity, myalgia.  Additional information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine, patient did not take any other medications the patient received within 2 weeks of vaccination, Prior vaccination, patient was not diagnosed with COVID-19, patient does not have any allergies to medications, food, or other products.   No follow-up attempts are possible. No further information is expected.
On the second day after vaccine, about 25 hours later, I threw up, became disoriented, sleepy, and was slurring my words.  I have little recollection of the 2-3 hour period following throwing up and was in and out of consciousness, almost as if I had a concussion.  I continued with my day, not knowing that I was not making sense, and had professional interactions with coworkers and clients, who later reported that I sounded confused, sleepy, and disoriented.  I drove my car and received a parking ticket during that time. Since I did not have flu-like symptoms and felt fine for 24 hours directly following the vaccine, I thought I was fine. It actually scares me that I drove my car and that this could happen to others.  I was back to normal 4-5 hours after symptoms started, and still had hazy to no recollection of the afternoon. I had to piece together the conversations and interactions the following day. I had a headache the following day and was tired.
Stelara - received my initial infusion 8/17/2021. Started having intense, debilitating pain, stiffness, heat & swelling in my wrists. Moved from the wrists to my shoulders, then back to wrists, fingers & hands in general. During 2 day period it affected my entire right side. Over 2 week period it affected a different part of my body nearly every day. It then faded away I was pain free for 5 days, then pain in fingers started again & last 3 days. Stelara info: NDC #57894-0054-27 Lot#KKS2011 for 130mg dose. Other note worth info: Covid vaccine received 3/20/21 J&J Janssen lot#1805025 had 3 days of flu like symptoms and some of the same joint pain in knees & hips. I was diagnosed with Crons and prescribed Humria for which I built up immunities to, so my doctor changed me to Sterlara. My specialist Dr with Gastroenterology. Initial infusion of 130mg over 1 hour was given on Aug 17, 2021. Then a maintenance dose of 90mg injection to follow every 8 weeks - due around Oct 17, 2021. I explained to Dr my issues and he referred me to a rheumatologist. I refused this referral & made an appointment with my general physician for Sep 30th 2021. My general physician is NP.
Information has been received from a physician concerning a 16 year old  female who on 28-DEC-1995 was vaccinated with the first dose of MMR II (lot number not reported) and on 06-MAY-1999 was vaccinated with the second dose of MMR II (lot number not reported). The patient did not fever. On 26-DEC-2009 the patient experienced mumps. On 31-DEC-2009, blood work was performed without result reported. On the same date, the patient was diagnosed as parotitis. Follow-up information was received which reported that the patient on 22-NOV-2009 developed mumps. On 24-NOV-2009, the patient was was diagnosed and afebrile, and laboratory data revealed that IgM <1:10, IgG 5.73 and serum amylase 150. The patient had parotitis on both sides. At the time of the report, the patient's status was unknown. No further information is available.
Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
I had basically no side effects to this vaccine, except for a slightly sore arm.  After three weeks, my arm continues to be sore, and then my shoulder started feeling sore.  My arm muscle feels like it has gone to the gym and worked out heavily.  When I hold a coffee mug, or brush my teeth, my arm muscle is very weak.  Now I feel a tightness and ache in my right shoulder.
I developed classic shingles eruption  approximately T5 dermatome over left thorax late yesterday PM exactly one week after immunization. (previously immunized w zostrix approx 7 years ago). Developing vesicles at time of report.
Left thigh with blotchy erythematous area approx 3" in diameter at its widest - firm and swollen. The lateral portion of this noted faintly ecchymotic area approx dime size. Started on KEFLEX 250mg/5ml 2 tsp PO TID 7 days and BENADRYL for wt.
Exactly 7 days later, the area below the site of injection was slightly swollen, red, and itchy. I was prescribed a cortisone ointment and allergy medicine from my doctor. The doctor had the same reaction about 6-7 days after injection.
Swelling in R arm (upper) at site of pneumonia vaccine administration with pain radiating to R hand Dx: Neuritis Rx: MEDROL dose pk; Pain recurred one month later with minor weakness in hand grip. Dx neuralgia Rx: PREDNISONE 20 mg today/ 10 mg daily x 2 wks. ibuprofen 400 mg prn.
Hospitalization 4 days: High temperatures above 103.5, body aches, sweating, chills, shivering, dizzy, nauseous, apathetic, diarrhea, early onset septic, elevated white blood count, celluloses,  high blood pressure, and tenderness in arms.
Vomiting and rash covering legs 4 hrs after administration. Gave 1 dose ZOFRAN and 2 BENADRYL at home. Nausea gone in 1 hour vomiting gone by AM.
pt recvd vax 1PM on 29MAR95; @ 930PM until 3AM had fever, chills so bad that they were like mini szs, & then noc sweats p/the chills; not sick a/inj; this AM tired, h/a, arms only sl sore;
Patient experienced pain, redness and swelling around the injection that involved all of the lateral aspect of the left upper arm.
patient was "diagnosed with shingles, but had received the old shingles vaccine"; This spontaneous report has been received from a physician concerning to a female patient on her 70s. Her concomitant therapies included mepolizumab (NUCALA). There was no information about patient's concurrent conditions, drug allergy and pertinent medical history.   On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, lot # and expiration date were not provided).      On an unspecified date the patient experienced herpes zoster. The outcome was not reported.   Causality assessment between the event and the suspect therapy was not provided.
Pain in lower pelvis pain and crotch pain area worsened; Non-specific report of reaction to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain in lower pelvis pain and crotch pain area worsened) and VACCINATION COMPLICATION (Non-specific report of reaction to vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pelvic pain (Experiencing lower pelvic pain and crotch pain.) and Gallstones. Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]), MULTIVITAMIN [VITAMINS NOS], CALCIUM and NAPROXEN for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (Pain in lower pelvis pain and crotch pain area worsened) and VACCINATION COMPLICATION (Non-specific report of reaction to vaccine). At the time of the report, PAIN (Pain in lower pelvis pain and crotch pain area worsened) and VACCINATION COMPLICATION (Non-specific report of reaction to vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021:
Was given / after being reconstituted with sterile diluent; Was given / after being reconstituted with sterile diluent; Administration was intravenous instead of oral; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number AP7JT, expiry date 3rd May 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 2nd July 2021, the patient received Rotarix lyophilized formulation (intravenous) and Rotarix Oral Applicator Device. On 2nd July 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and inappropriate route of vaccination. On an unknown date, the outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and inappropriate route of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The Rotarix vaccine was given to the patient after being reconstituted with sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered   The administration was intravenous instead of oral, which led to inappropriate route of vaccination. No further details were provided. The reporter consented to follow up.
A couple of hours after the second Covid Vaccine I developed a headache, then body chills and low grade fever lasting 1 day.  The headache lasted for about 3 days, then when it went away I became dizzy and light headed and had trouble concentrating.  This dizziness lasted for over a month.  It got a little better, but then I had some short term memory loss.  After the MRI I had blurry vision for about an hour, then turned into dizziness and trouble concentrating.
3 hours after patient received vaccine on 12/27/2020 @ 2pm she started to feel flushed in the face and hands. She also started to get blisters on both hands. Pt. took a  25mg tab of Benadryl by mouth and symptoms resolved. She awoke at 3:30 am and felt that her carotid artery was pulsating.  Patient informed Primary Care Physician's office on 12/28/2020 of symptoms who then prescribed patient an Epi-pen.  Advised to receive emergency medical service if symptoms worsened.  On 12/29/2020 patient feels good and all symptoms have subsided.
At 2AM, woke up with a fever of 103.6 and had a fever till Tuesday 1/12/21.  Temp stayed between 102-103 till 1/10/21 and on 1/11/21, temp stayed in the 100?s.  I had redness from above the injection site down to my elbow x 4 days.  The area was raised 1/2 inch.  I had to take Benadryl to help with the reaction.  On 1/10/21, my lymph node in my axilla on the same arm where the injection was administered started swelling and had redness and had redness and tenderness that extended to the left breast.  Had a severe headache x 4 days with neck stiffness.  The swelling in my axilla improved by 1/15/21.  The redness and swelling in the arm resolved by 1/15/21.  Headache still lingered till 1/16/21.  Was out of work x 4 days
This spontaneous report as received from a pharmacy technician concerning a currently 25 years old patient. Gender was not reported. Medical history and concurrent conditions were not reported. On 04-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J005416; expiration date: 02-MAY-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
ABDOMINAL PAIN, CRAMPING, & SEVERE DIARRHEA OCCURED IN THE EVENING, SEVERAL HOURS AFTER SHE RECEIVED THE VACCINE. SYMPTOMS LASTED 1 1/2 DAYS TOTAL.  FAINTED NEXT AM.  PT SELF RECOVERED WITHOUT REQUIRING TREATMENT.
Headache, Myalgia, Fever, Angina, declined 2nd dose