chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose on 10/11/2019 and 2nd dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix on 11th October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-JUL-2022 Reporter's comment: The pharmacist reported that the patient (wife) had not been administered 2nd dose yet. The Healthcare Professional (HCP) did not had lot number or expiration date of Shingrix first dose. The Vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. This case was linked with case US2022103849 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022103849:Same reporter
Pt had shingrix vaccine given in her left arm but within a few days, developed rash on right arm with blisters. Rash has healed since then, but little dots of rash still visible. Pt denies any pain but experienced itching.  Pt states she had the same rash appear on her waist a few years back but did not know it was a case of shingles. Did not get evaluated at that time and did not get evaluated at this time.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 11:32 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 11:17 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.55 for dose administered on 14-Feb-2021 and 65.64 for dose administered on 21-Mar-2021.   No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature 32 degrees Fahrenheit at 09:00 AM 10:00 AM and 11:00 AM and 35 degrees Fahrenheit from 02:00 PM to 03:00 PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  Batch number 003B21A underwent temperature excursion on 21-Mar-2021 with temperature 34 degrees Fahrenheit at 09:00 AM, 32 degree Fahrenheit at 10:00 AM and 34 degree Fahrenheit at 11:00 AM. This vial was moved to fridge on 16-Mar-2021 and beyond use date for the vial was reported as 15-Apr-2021. Product moved to clinic on 21-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
?Dizziness almost immediately and still ongoing  ?Tongue tingling about 30 minutes after shot and subsiding around 1:51 ?Pain at injection site ?overall out of it ?off? feeling ?Feeling of panic  ?Fatigue  ?Chest feeling heavy at about 12pm on day of vaccine lasting about an hour
fever 104, shortness of breath, hearth arrhythmia all beginning around 4pm, fever still has not broke at 9:15am on 12/23/2022
22 month old child received live nasal H1N1 vaccine intended for age 2-49 years. No problems per patient on 11-17-09.
This is a spontaneous report from two contactable physicians via a Pfizer representative. A female patient of an unspecified age and race/ethnicity received the first dose of TRUMENBA on an unspecified date, at 0.5 ml single, for immunisation. No other vaccines were given on that day. The patient medical history and concomitant medications were not reported. On an unspecified date, immediately after vaccination, the patient experienced urination every hour for 48 hours, dizzy, headache, confusion, body aches and fever. The patient was not taken to the ER. The events resolved on an unspecified date.
Per mom, pts skin became redm and he started aching, eye swelled. Emesis x 1.
This pt received 2 doses of vax, 9 weeks apart form each other. On 02/11/2000, the pt experienced malaise, fever, muscle pain and presented to an ER.  CT scan showed pt suffered an ischemic stroke which caused the weakness." The physician considers this unrelated to vax.
My daughter had a fever which lasted 3 days and ranged from 99 to 103. This began 9 days after receiving a MMR vaccination after an exam where the provider stated that my daughter was perfectly well. My daughter had no other symptoms.
Patient had vaccine and had no reaction in 30m observation period. Three days later he developed rash on thighs. Likely unrelated but timing suspicious with history of anaphylaxis.
Fever 99.8° at onset, low-grade continues 98.9°. Muscle aches, injection site and throughout body. Fatigue and irritability.   Taking Tylenol (listed above) and resting lots.
Confusion, Myalgia, NauseaVomiting, FATIGUE, TENDERNESS AT INJECTION SITE, DISORIENTATION, Narrative:
1st and 2 nd  dose - 6pm got really sick in my stomach and arm was hurting. It only lasted for 2 days. Had diarreahe and low grade fever. Aches and nausea  In June or July - I felt had no energy from a blood source . Had  colonoscopy's  - white blood counts low and wasn't feeling well like passing out. Went to the ER. had UTI. Health care, had this issue from the past due Nsaid . Ongoing treatment with doctor .
This is in follow-up to report (s) previously submitted on 5/14/2004. Information has been received through the manufacturer pregnancy registry from a physician concerning a 30 year old  female, G2, P1 with no known drug allergies and no concurrent medical conditions who in Feb 02 and on 07/11/02 was vaccinated with a first and second dose of varicella virus vaccine live, respectively.  It was unknown if the pt was tested for varicella antibodies before vaccination.  It was unknown if there was a local reaction at the vaccination site, or if there were varicella or herpes zoster symptoms post vaccination. Concomitant therapy included prenatal vitamins.  The pt had her last menstrual period on 08/03/02.  Medical attention was sought and on 12/10/02 it was reported that the pt was currently pregnant and was exhibiting no untoward signs or symptoms.  On 12/03/02 a materal serum alpha fetal protein was normal. On 01/07/03, an ultrasound was performed for size and dates and was normal. No product quality complaint was involved.  On 05/02/03 the pt spontaneously delivered vaginally a normal, liveborn 7lbs, 3oz male. Apgar scores were 8 and 9.  The infant had no congenital anomalies or features of congenital varicella zoster syndrome. The mother developed gestational diabetes. There were no other reported complications, infections or illnesses during her pregnancy or labor/delivery. Medication used during the mother's pregnancy included supplemental prenatal vitamins and docusate calcium as a stool softener. On 03-May-2003 the infant had a circumcision per the parents desire. No further information is available.
I got the vaccine on Monday, March 29th around 1:30 pm, I was perfect, don't even arm pain. In the early morning of the 31st, around 2:00 am, I felt pain under my armpit that was reflecting towards the left breast. I also felt pressure in my left arm but more toward my forearm and a discomfort in the left side of my core and in my back (left side).  I sat up, raise my arm and felt a lump of about 3 inches in diameter, under my armpit. I took Naproxen of 500Mg.
pt recvd vax & exp swollen arm & red over area of imm; blisters w. clear  fluid appeared next night; skin appeared yellow after bruising; pt taken to MD;
Left arm redness, swelling and pain, it also feels warm to the touch. Pt tried some ice, it didn't help. Recommended pt to see MD ASAP.
acutely developed waves of lightheadedness 5 days after vaccination (10/27/21), with sensation of going to pass out . had some palpitations as well.  seen and treated in the ER.  basic labs (CBC CMP TSH Mg troponin) normal.  EKG showing PACs coinciding with the sensation of lightheadedness.  Seen by cardiology, diagnosed with pericarditis.  had TTE in ER, was normal.   sent home from ER with holter monitor.  placed on metoprolol succinate 25mg 1 week later for persistent lightheadedness coinciding with the PACs. associated severe fatigue, limiting daily activities. unable to work for 6 days after the event, now only able to do half days.
Began with headache in late evening on the 4th.  Woke up with extreme nausea, headache, fatigue.  Has continued through the day of 5th.
Flu shot was typed up incorrectly, as patient was actually requesting a Shingles vaccine, so this is the 2nd flu shot the patient received this year. She was fine and showed no injection site reaction or anything, just wasn't the shot she wanted.
Arm soreness started after 7 hours of vaccine, headache, fatigue, fever (101F), body ache started around 9 hours after the vaccine and lasted for almost 24 hours.  still have some headache, fatigue, temperature down to 99.6F, arm soreness still present.
Flu like sxs-during night 9/27/02. Treated with Advil. Full body rash-bumps/face: hives 9/27/02 am. ER 9/29/02 pm-tx with Benadryl. MD 9/30/02 am. Dx Prednisone, Allegra. Still on Prednisone. Total of three seizures on 9/22. 9/23 am woke up hungry, but would not beat wt. cranky wanted held, curled into fetal position on mother's lap. To ER on 9/23/02 per advise of his pediatrician. Had EEG on 9/24/02. After being admitted to medical center on 9/23/02 for dehydration and IV's given for dehydration. Was discharged from hospital 9/24/02. Will be followed up by MD pediatric neurologist.
This spontaneous report as received from an other health professional refers to a patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # J007096, K026533, L012838 and L004740 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1708USA000870: US-009507513-1708USA002370: US-009507513-1708USA002371: US-009507513-1708USA002373: US-009507513-1708USA002369.
Hepatitis B given at 16 days because we were not sure if hospital administered...and again at 2 months. Ran fever for 2 days and again a month later. Night fevers for week. Poor eye contact, unaffected physical versus verbal. No imaginary play, speech delay.  Nurse follow up on 07/20/04 states: "None."  Per annual report-Pt. has an official diagnosis of autism from AGRE year 2005.  Receiving special education services for kindergarten 2005-2006.  Eye contact improving, speech improving but still delayed.  Mom want to see extensive studies done on vaccines and thimersol.  Especially want to see studies to find out how children are affected when their mom received the same vaccines.
+ PCR covid 26Dec2021, mild dx; + PCR covid 26Dec2021, mild dx; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Lot number: EW0175) as dose 2, single and administration date 07Apr2021 (Lot number: ER8729) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "+ PCR covid 26Dec2021, mild dx". The event "+ pcr covid 26dec2021, mild dx" and "+ pcr covid 26dec2021, mild dx" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) positive, notes: if covid tested post vaccination: Yes. It was reported that, It is unknown if prior to the vaccination, the patient was diagnosed with COVID-19. It is unknown if the patient receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Vaccination failure, Covid-19  and suspect drug BNT162B2 cannot be excluded.
Narrative: Patient admitted for acute on chronic hypoxemic respiratory failure secondary to suspected AECOPD/AD IPF in the setting of COVID+ pneumonia. Vaccinated x3 with Moderna vaccine. No known COVID exposure. 2-3 word dyspnea and increased oxygen needs from 5L at baseline to 10L. Received ceftriaxone, doxycycline, dexamethasone, and Duoneb x3 in ER. Currently being reated albuterol PRN.
The patient noticed a red, hard lump on her left arm at the injection site/The redness has since subsided but the lump is still present; The patient noticed a red, hard lump on her left arm at the injection site/The redness has since subsided but the lump is still present; she reported that it was painful for about a day and a half after the injection; This spontaneous report was received from a to a 32-year-old female pharmacist referring on herself. The patient did not have any concurrent conditions or pertinent medical history, did not take any concomitant medications. The patient had an allergy to sulfa drugs.   On 22-MAY-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) on her left arm intramuscularly (strength, dose, frequency, lot # and expiration date were not reported) for prophylaxis.   On 23-MAY-2019, the patient began to notice a red, hard lump on her left arm at the injection site (injection site hard lump/Injection site erythema). The patient reported that the redness had subsided, but the lump was still present. She reported that the injection site was painful for about a day and a half after the injection (Injection site pain). At the reporting time, the patient was recovering from injection site hard lump and Injection site erythema.   The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) regarding the events was not applicable.   Furthermore, it was reported that the patient did not received any treatment for the event, no laboratory diagnostic or studies were performed or sought for medical attention.   The relatedness between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events was not provided.
October 8th... Muscle pain mid back, then fibro pain in upper back and shoulders. After 4 or 5 days, increased pain in elbow, hand and finger joints started hurting. Mid October full blown fibromyalgia exacerbation. All trigger points hurt, all joints hurt, constant pain. Have not had one this severe in over 10 years. Flu vaccine on October 11th. Tried different medicines for the fibromyalgia. Celebrex, Skelaxin, diclofenac cream, diclofenac tablet, Flexeril, lidocaine patch, ibuprofen. None of these helped. After seeing medical provider on November first, put on Lyrica and will continue Skelaxin as needed. Ordered physical therapy to include dry needling. I don't know if this is in relation to the moderna vaccine. I just have not had such a severe fibromyalgia episode for so long.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced general breakthrough chickenpox with 80 - 90 lesions.
Heart palpitations 1-2 weeks, beginning 3-4 days after dose 1 Dizziness beginning 3-4 days after dose one,  episodes of dizziness ongoing still at 6 weeks post dose. episodes last 5 minutes- two hours  at a time 5-7 days per week. Headaches- occasional pulsing side of head.  Head pain back of head, top of head, started fist week after dose 1, ongoing and headache intensifying 6 weeks post shot.
DAY 6:  Hives - 2 spots on nape of neck, at hairline. First thought to be mosquito bites.   DAY 7;  Awoke with hives/welts across torso, especially along  underwear lines, not itchy, took 2 Benadry, faded away after a few hours. DAY 8: Same as Day 7, woke about 2 am.  DAY 9:  Woke up at 3am with more widely spread hives/welts. Now on lower back as well as more on front & sides of torso.  itchy. Have taken 2 Benedryl first thing on Days 8, & 9 also.   Have eliminated possibility of food or environmental causes, including possible changes in laundry detergents, etc. Don't recall ever having this type of reaction to anything previously.
Was given 1/2 dose of Fluzone at 5 1/2 months vs 6 months.
Patient is here today with possible allergic reaction.  States that he received the Covid and RSV (GSK) vaccine Oct 30th.  Since then he has had some "shivers", and "frozen muscles".  Had woken up with the shivers after the vaccines.  When he woke up to go to bathroom, he had episodes of "shaking" and just frozen in place, like seizure without the body twitching.  Had sx for few days. Went on a walk with neighbor on Thursday 11/2 - was fine.   Monday 11/6 went walking and legs got weak about a block in and had to go home. Didn't check sugar when got home. Before went on walk sugar was 130 and ate a yogurt and kind bar.  With one of his episodes, (keeps saying seizure), his BS was over 250 which is out of his normal range. States Monday episode was after took another dose of Mounjaro. Today tried walking again and only able to go about a block before sx started.   He also started new dose of the Mounjaro (12.5mg) 2 wk's before this. Has been on mounjaro for over 6 months before this.   Has been having more sob "for a while." Last few weeks. No chest pain. Hard to catch breath - showering, didn't notice any more then expected with walking. States mostly just when showering but "maybe some with walking but not more then I would expect."
cough, runny nose, fluid filled vessicles, started out as red bumps;using APAP, taken out of school;noted 10AM 6OCT96;
Patient received Pfizer COVID vaccine on 10/22/21 and 11/11/21.  On 1/11/22, patient tested positive to COVID and admitted to our inpatient facility with COVID-19 pneumonia, acute hypoxic respiratory failure, and sepsis due to COVID-19. Patient reports her daughter is in the hospital since this past weekend with COVID19. She lives at home with 9 other people, says granddaughter now is feeling sick. Patient discharged home on 1/13/22.
Pt recv vax on 10/26/98; on 11/1/98 pt exp swollen, warm, red LA; tx=Keflex
Flu like symptoms; Fever of 101.5 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever of 101.5 degrees Farenheight) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A, 039B21A and 034F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever of 101.5 degrees Farenheight). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever of 101.5 degrees Farenheight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Body temperature: 101.5 (High) 101.5 degrees Farenheight..         No concomitant products were reported.   No treatment information was reported.   This case was linked to MOD-2022-456661 (Patient Link).
A while after injection and getting worse as the hours went by I experienced a very sore left upper arm around injection area and further down upper arm all day after injection and the next day. Approximately 10 pm evening of vaccine I started feeling very sore and achy all over like I had the flu.  I got progressively worse as the evening went on. I developed a fever of 101.6 degrees and had very bad chills and some dizziness. I felt tenderness and mild pain under both arms. I could not sleep or get comfortable so I took 3  200 mg Advil  at 4 am. an hour later fever came down 1 degree and achiness and pain was less severe. I was able to go to sleep at 6:30 am the following morning. The day after vaccine I was still experiencing some mild flu like symptoms. Today I feel fine except for mild left arm pain and some red spots on left arm. I am apprehensive about getting the 2nd vaccine in the series in 2-6 months.
This spontaneous report was received from a licensed practical nurse refers to a 70 years old female patient with no pertinent medical history and allergy to "statins" and epinephrine who on 11-SEP-2012, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number not reported) at zoster clinic. Concomitant medications included unspecified medications that the patient had been on a long time, nothing new. The licensed practical nurse reported that on 12-SEP-2012, the patient noticed a pin pricking sensation all over her body. The patient had an office visit that same day, on 12-SEP-2012, where physician decided to observe the patient. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The relatedness for the patient noticed a pin picking sensation all over body was unknown for ZOSTAVAX. Additional information has been requested.