chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient outside of 6 month window; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.  Additional Information: GSK Receipt Date: 15-Aug-2022. Reporter's comment: The registered pharmacist (RPH) reported that the patient was outside of 6 month window, for receiving 2nd dose of Shingrix. Since reporter was not clear if the 2nd dose was administrated or not. The reporter did not consent to follow up. Additional Supportive Information: The patient was outside of 6 month window, for receiving 2nd dose of Shingrix, which led to inappropriate schedule of vaccine administered.
Early in the morning, I was having severe headache pain.  When I tried to turn over in bed, my entire body was wracked with pain.  My joint hurt, my back, etc., I tried to set on the edge of the bed and I was totally spent.  I laid back down for a few minutes and then tried again.  It hurt, but I got up to take some tylenol and/or excedrin migrain medicine.  I took it and laid down.  My head continued to hurt, but not as severe, but my body hurt.  I hated to get up to go to the bathroom,  I did not want to get up.  When I tried to shower later on in the day, it was a monumental task.  I was chilled and laid back down.  I kept take aspirin/tylenol throughout the day.  Sunday morning my body felt more like normal.  Slight headache, but eventually subsided.   Awful, I am wondering if this will happen for my second shot.
General malaise, sweats and chills, anorexia in am. Extreme fatigue by noon, red, swollen, hot arm on injection side with hives and itching.
This spontaneous report was received from a medical assistant referring to an adult patient of unknown age and gender. The patient's concurrent  conditions and medical history were not reported. On 16-SEP-2016, the patient was vaccinated with an expired dose of M-M-R II lot # K010318, expiration date 22-JUL-2016 (dose, dose number, route and anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported. A Product Quality Complained was not involved. Additional information is not expected since the physician cannot be contacted.
Blistered area approx 1 inch in length at injection site- was observed the day after receiving vaccine.  States that she has taken OTC Benadryl for symptoms.
11/23/11 Pt seen in office for fever elevated 105, irritable, decreased appetite and runny nose. While in office T 101.7 ET at 355P and at 4P increased 103.6 ET. Pt had acute febrile seizure. Had Ibuprofen last at 1200.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 at 12:00 as dose 1, single (Lot number: En6198), in right arm, on 21Mar2021 at 12:00 as dose 2, single (Lot number: Er8727), in right arm, on 24Sep2021 at 12:00 as dose 3 (booster), single (Lot number: Ff8834), in right arm and on 06May2022 at 11:00 as dose 4 (booster), single (Lot number: Fj4989) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild copd" (unspecified if ongoing); "known allergies: Sausage" (unspecified if ongoing). Concomitant medication(s) included: SPIRIVA RESPIMAT, start date: 02Jun2021, stop date: 14Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Clinical course: The patient was treated with Paxlovid from 03Jun2022 to 08Jun2022.  No follow-up attempts are possible. No further information is expected.
Had 2nd Covid vaccine 2-6-21 Elevated BP, Rapid Heart Rate at work 2/9/21. Morning of 2-9-21. Pt also stated she had loosE stools and felt generally unwell Sunday morning 2-7-21. Took Monday off from work (2/8/21) Brought to Health Center by another Staff Member. BP's & HR's checked154,89 (1), 137/90 (2), 142/80 (3), 135/85 (4) HR 97 BPM Given 25mg Benadryl & 20 mg Prednisone PO- EKG Performed
Burning when injected, hot for two hours later, tinnitus in three to four days.
nodule under arm pit; warm to the touch; arm been hurting; hurts under arm pit; red mark further down arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (nodule under arm pit), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (arm been hurting), AXILLARY PAIN (hurts under arm pit) and VACCINATION SITE ERYTHEMA (red mark further down arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced VACCINATION SITE NODULE (nodule under arm pit), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (arm been hurting), AXILLARY PAIN (hurts under arm pit) and VACCINATION SITE ERYTHEMA (red mark further down arm). At the time of the report, VACCINATION SITE NODULE (nodule under arm pit), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (arm been hurting), AXILLARY PAIN (hurts under arm pit) and VACCINATION SITE ERYTHEMA (red mark further down arm) outcome was unknown.            No Concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2022-568203 (Patient Link).
Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient descibes pain in shoulder after receiving flu shot. Patient states that the pain bothers him most at bedtime. The patient has taken tylenol for his pain but does not help much. Patient is able to move arm around.
Redness at vaccine site 2.5 inches in diameter hard, warm to touch, reaction is to varicella vaccine.
Caller said the BUD of the vial was 27Mar2022 then was administered on 28Mar2022 at 10AM to 4 patients; the vials are kept in a refrigerator with a temperature of 39 degrees F.; Caller said the BUD of the vial was 27Mar2022 then was administered on 28Mar2022 at 10AM to 4 patients; the vials are kept in a refrigerator with a temperature of 39 degrees F.; Caller said the BUD of the vial was 27Mar2022 then was administered on 28Mar2022 at 10AM to 4 patients; the vials are kept in a refrigerator with a temperature of 39 degrees F.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 28Mar2022 10:00 (Batch/Lot number: unknown) as dose number unknown , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 28Mar2022 10:00, outcome "unknown" and all described as "Caller said the BUD of the vial was 27Mar2022 then was administered on 28Mar2022 at 10AM to 4 patients; the vials are kept in a refrigerator with a temperature of 39 degrees F.".  Additional information: BUD of the vial was 27Mar2022 then was administered on 28Mar2022 at 10AM to 4 patients; the vials are kept in a refrigerator with a temperature of 39 degrees F. Caller would want to know if there is extended stability info for the vial to know if they should do revaccination for the people who got the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
I received the first Covid vaccine on 2/25/21. I had bloodwork drawn related to my yearly physical on 3/11/21. They ran a CBC and basic metabolic panel. My CBC was normal and my levels specifically my Creatinine was completely normal. I received the second vaccine on 3/18/21. On 3/20/21 I started feeling a lot of pain in my abdomen area and was feeling really bloated. I was having a little difficulty breathing. I went to my PCP on Monday 3/22/21. They ran a CBC and a basic metabolic panel again. That afternoon, my PCP sent me for a CT scan of my abdominal and pelvic area. On the morning of 3/23/21, my PCP called me my Creatinine level ran the day before was at 5. Also my CT scan had come back.  I also had moderate ascites (fluid in my abdomen).  I also had a large right pleural effusion.  On 3/23/21, my PCP sent me to the ER for hospital admission.  I was in the hospital for 12 days.  I was in acute kidney failure.  They drained the fluid from my abdomen.  They inserted a temporary port and I had 4 rounds of dialysis.  On my 9th day in the hospital, the kidney doctor started me on 80 mg of Lasix per day.  My urine output increased dramatically and my creatinine levels began to drop. I had not had any issues prior to the kidney failure that would typically cause it to happen.  The only new medicine or change had been the Covid vaccine administration.  The kidney doctor and the hospitalist dismissed this idea.  I am reporting it because it was the only thing new and my levels had been normal less than 2 weeks before.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient was coherent after shot sat down passed out. Hit head trauma scrape on head and knees and called ems showed up 5 minutes took pt walking away.
Muscle pain (L) deltoid - Started  1 1/2 days after injection still very painful 4/26/10 even with MOTRIN use. Pt using MOTRIN 3 tabs q 6 hours - provider suggested 4 tabs q 8 hours - No redness - No swelling - Pt states she has used cold pack.
Hives in the left armpit. Still have the hives there. Nowhere else. Didn't itch at first; now itching a lot 48 hours after noticing the hives
28SEP92 had vax & 1 wk later pt devel t100 & next day temp went up to 102; pt was seen by MD in ER; no origin of fever found; spinal tap was done but was neg; UA done & kidney infection was noted;
High fever (102.2 F underarm temp), listlessness/fatigue, administered fever reducing pain killer.
Experienced pain within minutes in right kidney area and the right and left sides of her head. She then had a low blood sugar attack. For the following 3 days, she suffered from chills and many low blood sugar attacks. Also upset stomach and diarrhea for a few days, as well as headache and body aches.  April 12th, left side of face was puffy and more headaches; continued into April 13th; also some sinus pressure/overall stuffiness June 4th- Vertigo attack; had another back in May Continues to have chills, body aches, and headaches, and tired with low energy
A week after my dentist appointment in October, I was having dry mouth. I pretty much was having no saliva. I contacted my doctor, and she suggested I contacted my dentist. On 12/12/2022, I saw the dentist we decided to stop all fluoride sources and continued that until 01/16/2023, when I met up with my doctor. Quitting fluoride did nothing, we decided to take me off the buspirone and I was weaned off of that for a about four weeks. There was no change, so she had me come in for blood work. She had me tested for Sjogren's Syndrome and it was positive. She had me a referral to a rheumatologist. On 03/16/2023 I met with them and that's where I'm at, but there is really nothing that they can do. I have no relief there is nothing I'm on hydroxychloroquine and see if that helps and it can take up to three months and the chances are pretty low. This is mostly discomfort and occasional pain if it gets to dry or aggravated. It's hard to concentrate.
EXTREMELY LOUD TINNITUS.  LOUD RINGING BILATERALLY.  EXTREMELY DISTURBING
Pain at injection site, somewhat limited range of motion, pain up into shoulder.  Had several thousand dollars of PT, some pain still exists during some motions and positions.
Hives broke out the day after vaccines were given, from head to toe. No breathing difficulties.
Sudden onset if chills, body aches, fever 101.4 degrees with nasal congestion and cough, nausea, and vomiting - scratchy sore throat. Coincidental (R/o H1N1?  influenza?) - Pt. had regular seasonal influenza but not H1N1.
Erythema & induration 30 x30 mm over R arm.  No treatment except for warm compress.
23 mo old child given flu vaccine for "3 yrs check up" by error. Child with wgt of 41 lbs. 10/17/13 per T.C. with mother. No noted adverse reaction.
Patient came by pharmacy to report that after shot right arm became inflamed and itchy. This had been going on for over a month. Skin had discoloration down to wrist but had been receding  from point of max inflammation. Patient states it is getting better and pain is lessoning.
The next morning, I tried to get up from bed, wet myself and fell on the floor and hit my head. I was  not able to move. I was confused and needed help. My daughter tried getting me up for awhile and took me to the ER.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EL9263), in left arm, on 10Apr2021 as dose 2, single (Lot number: ER8729), in left arm and on 15Oct2021 as dose 3 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 13May2022 as dose 4 (booster), single (Lot number: 057M21A), in left arm and on 28Sep2022 as dose 5 (booster), single (Lot number: 057M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "PSVT" (unspecified if ongoing); "mild kidney disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "known allergies: Erythromycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive, notes: Tested positive on a home test less than 48 hrs later, on Mar2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.
This is a spontaneous report received from a contactable Nurse via Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash following the injection on an unspecified date with outcome of unknown.
Myalgia Narrative: Pain at injection site evening of injection. Worsened next day with mild swelling. Ice packs and Ibuprofen were used.
17JUL93 PM achy, pains in back & knees tired, cold sweats, chills, vomiting; rash on stomach, chest;
Initial misuse report received from a healthcare professional  on 13 November 2013. On unspecified date a 16 year patient received 0.25 ml of FLUZONE. Under dose was administered to the patient. No adverse event was reported. List of documents held by sender: none.
TASTE ALTERATION; SWOLLEN ARM; RED ARM; HOT ARM; HEADACHES; FATIGUE; FEVER; SORE ARM; INFLAMED ARM; ITCHY ARM; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with Percocet (oxycodone hydrochloride;paracetamol), morphine ,diphenhydramine, Demerol (pethidine hydrochloride) ,Biaxin (clarithromycin), Levaquin (levofloxacin). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced itchy arm. On APR-2021, the subject experienced inflamed arm. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced swollen arm. On 10-APR-2021, the subject experienced red arm. On 10-APR-2021, the subject experienced hot arm. On 10-APR-2021, the subject experienced headaches. On 10-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced taste alteration. Treatment medications (dates unspecified) included: hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headaches, and fatigue on 12-APR-2021, had not recovered from taste alteration, swollen arm, red arm, hot arm, and fever, and the outcome of itchy arm, sore arm and inflamed arm was not reported. This report was non-serious.
This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. It was reported that the patient received a first dose of GARDASIL (dose, route and lot# not reported) on an unknown date in January 2008, a second dose of GARDASIL (dose, route and lot# not reported) on unknown date in April 2008 and a third dose of GARDASIL (dose, route and lot # not reported) in 2010. No adverse effects reported. Additional information has been requested.
DOCUMENTATION ONLY:  PATIENT BOOSTER IS ADMINISTERED EARLY THAN THE SCHEDULED TIME. GIVEN AT 3 MONTHS FROM LAST DOSE INSTEAD OF 5 MONTHS
no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 17-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA006537: US-009507513-2109USA006582: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006594: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2110USA005066:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 61-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. On 8th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site swelling and injection site discoloration. On an unknown date, the outcome of the injection site swelling and injection site discoloration were recovered/resolved. It was unknown if the reporter considered the injection site swelling and injection site discoloration to be related to SHINGRIX. Additional details were provided as follows: The pharmacist had a consumer that experienced significant swelling at the injection site that lasted for two weeks after receiving the first dose of the SHINGRIX vaccine into the right deltoid. After that, the injection site was somewhat discolored for about one month. The pharmacist did not provide the consent to follow up.
ER REPORTS 5/11/23 CHILD HAS LEFT PAROTITIS-PRESENTS WITH FEVER (100.3) AND LEFT SIDED FACE SWELLING AND PAIN. Child returned to ER 5/12/23 FOR INCREASED SWELLING AND PAIN AND VOMITING.
Patient had no known side effects; Vaccine Coordinator reported a temperature excursion for VAQTA which was supported; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided.  On 03-JAN-2022, the patient was vaccinated with incorrectly stored hepatitis a vaccine, inactivated (VAQTA) lot # U024505, expiration date 15-OCT-2022 (formulation, dose, route of administration, anatomical location were not reported) for prophylaxis (product storage error). The patient had no known side effects (no adverse event).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2201USA005595: US-009507513-2201USA005673: US-009507513-2201USA005751: US-009507513-2201USA005901: US-009507513-2201USA006295: US-009507513-2201USA006305: US-009507513-2201USA006322: US-009507513-2201USA006342: US-009507513-2201USA006419: US-009507513-2201USA006445: US-009507513-2201USA006536:
caller stated that  she had fever, chills, vomiting, diarrhea and fatigue. Caller took Tylenol and slept for 20 hours and awoke this morning  feeling rested.
Pain in arm ... moderate/sever nausea ... fatigue ... aches.  The nausea came on within a few hours of the shot. I have just awakened the next day and am still nauseated. Hard to keep down required morning medication taken with water.
red area at injection site; swollen area at injection site; Believes the vaccine was given subq; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 72AA3, expiry date 10th October 2021) for prophylaxis.   On 30th July 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient had a reaction and believes the vaccine was given subcutaneously instead of intramuscular, which led to intramuscular formulation administered by other route. The reaction was a red slightly swollen area at injection site the reaction has at the time of reporting were resolved.
Almost exactly 12 hrs after 2nd vaccine, had chills, moderate headache, nausea. Able to sleep but in the AM had severe headache, nausea, malaise, muscle aches, soreness at injection site