chrisvoncsefalvay/vaers-outcomes huggingface dataset:
exposure to freezing temperatures; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 60-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 24BM2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th September 2021, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: The reporter called due to their discovery that patient was inadvertently administered on 16th September 2021 the vaccines that were in the temperature excursion, which led to incorrect storage of drug. The MI agent informed pharmacist the vaccines should be discarded due to exposure to freezing temperatures 31.5 Fahrenheit for 13 hours. The reporter did not consent to follow up. This is 1 of 7 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021198148:same reporter US-GLAXOSMITHKLINE-US2021198147:same reporter US-GLAXOSMITHKLINE-US2021198139:same reporter US-GLAXOSMITHKLINE-US2021198149:same reporter US-GLAXOSMITHKLINE-US2021198144:same reporter
16 year old Patient was give unauthorized Pfizer Booster dose. Patient said he was 18 years old.
DOSE 3 (BOOSTER); I had a rash as a side effect of the COVID booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1 single), for Covid-19 Immunization; Bnt162b2 (Dose 2 single), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "DOSE 3 (BOOSTER)"; RASH (non-serious), outcome "unknown", described as "I had a rash as a side effect of the COVID booster".  Additional information: Consumer stated, "Yes and I was wondering if you have any information suggestion as what to do about the rash." Consumer was informed about the role of  Drug Safety and  Medical Information Department. Consumer hung up abruptly. Further probing could not be done. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness, swelling. Warm to the touch. Skin tight. 10 mL prednisolone, 25 mg BENADRYL.
This spontaneous report as received from a nurse refers to a 9 months  10 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ, lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contaca6t details were provided.
I started my period 4 days early, finished my period 5 days later, and spotted for an additional 6 days. This is HIGHLY unusual for me. My cycles are normally 27-29 days each month and I never have spotting. I have never been more than 2 days early or 2 days late.
Dose #2 overnight I experienced extreme soreness in my arm, probably around midnight to 2 AM.  It progressed overnight to similar symptoms as I had the 1st vaccine:  with body aches, chills, headache, fatigue but this time no tongue tingling and no strange taste in my mouth. The symptoms lasted 3 days. I did develop joint pain and extended muscle soreness that I did not have with the first dose and those are still present.
Lightheaded and flushed, slightly dizzy when standing.  3:56pm evaluated by EMS.  BP 140/92,  HR-98,  O2-98% on room air.  4 pm so resolved and discharged.
blurry vision  it's like looking through a straw hole; it's like looking through a straw hole; hoarseness in voice; high fever of 100F; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurry vision  it's like looking through a straw hole), VISUAL IMPAIRMENT (it's like looking through a straw hole), DYSPHONIA (hoarseness in voice) and PYREXIA (high fever of 100F) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Clot blood and Fatigue. Concomitant products included APIXABAN (ELIQUIS), FLUOXETINE HYDROCHLORIDE (PROZAC), FLUOXETINE, PIROXICAM (MAXIDENE), FAMOTIDINE (PEPCID AC), LEVOTHYROXINE and CLONIDINE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VISION BLURRED (blurry vision  it's like looking through a straw hole), VISUAL IMPAIRMENT (it's like looking through a straw hole), DYSPHONIA (hoarseness in voice) and PYREXIA (high fever of 100F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VISION BLURRED (blurry vision  it's like looking through a straw hole), VISUAL IMPAIRMENT (it's like looking through a straw hole), DYSPHONIA (hoarseness in voice) and PYREXIA (high fever of 100F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Body temperature: 100 (High) 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had a total of 31 symptoms from it at that time. treatment information was not provided
Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer (Office Staff). This case involves a 12 years (also reported as 13 years) old male patient who received a 0.5 mL dose of vaccine IPOL lot N1A45, expiry date: 05-Feb-2019 via intramuscular route in the right deltoid on 28-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was GARDASIL, MENACTRA, HIBERIX and PROQUAD. It was an actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
For my 2nd dose vaccine, the first night I experienced seizures and was trembling a lot; also developed headaches and fatigue. I also displayed symptoms of dizziness and blacked out. I have trouble breathing and I am now diabetic. I have congestive heart failure. I cannot go outside to the heat because I black out. I am on an albuterol treatment due to coughing spasms. My arms also get stiff, and I feel when I black out, I am out for a couple of minutes. They performed lab work, EKG, stress test and I am following up with a cardiologist. My blood pressure went up to 210/178. I have to follow up with my cardiologist in two months to monitor my heart. For my 1st dose vaccine, I had two seizures the same night. I could not breathe and gurgled. I went to see my PCP who placed me on high blood pressure medications. I lost 67 pounds of fluid in my chest. I swelled up so bad that I could not put on my shoes. I did not have these problems before receiving the MODERNA vaccine, dose 1 and dose 2. I also got lab work down and found out I had type II diabetes.
Flu-like aches in muscles & joints. Temp >100. Mainly focused in joints of prior trauma/injury, bedridden x 2 days.
Patient developed intussusception on 2/25/08.  Reduced with air contrast b.e. same day. 7/30/08-records received for DOS  2/26/08 DX:Intussusception. Presented with colicky abdominal pain. Heme positive stools, 15-20 episodes of emesis last one streaked with blood and yellow color bilious emesis. Normal BM earlier in day then loose BM at 1700.
Dizziness, fast heartbeat, lips felt funny like they were thick, headache, and tongue felt thick.
Difficulty breathing started 3 minutes after injection. At minute 13 I was transferred to the Emergency Room at  Hospital, followed by admission to the Intensive Care Unit.
Onset of shortness of breath/rapid heart rate upon moderate activity/mild exertion (dyspnea; tachycardia), 1st noticed in April 2021.  Multiple, ongoing episodes to date.
Case number PHEH2014US003754, is an initial spontaneous report received from a pharmacist on 20 FEB 2014 with a follow-up received on 16 MAR 2014 with the follow-up received on 20 MAR 2014. This report refers to a 14-year-old female patient who was inadvertently vaccinated with one dose of FLUCELVAX (batch number: 004011A) at 0.5 ml, intramuscularly in to the left deltoid on 20 JAN 2014 at 16:00 PM. This was an initial application of FLUCELVAX. No adverse event was reported following his administration error.  Follow-up received from the pharmacist on 16 MAR 2014: Updated patient gender and batch number and site of application of FLUCELVAX.  Follow-up received from the pharmacist on 20 MAR 2014: Updated vaccination time.  Following an internal review on 18 AUG 2014, a significant correction wad done for the information received on 20 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration"  was erroneously captured as listed and hence the labeling was now changed as unlisted and second indication off-label use was added to the case.
Left sided flank pain.  Diagnosed now as shingles.  Still active. Definitely brought on by vaccine.  In extreme pain
Terrible headache all day, all night for 2 weeks straight.  I had it when I woke up and when I went to bed and when I woke up in the middle of the night.  No over the counter medicine could take the pain away.  It was still there in week 3 but not as debilitating.  The first few days after the booster, I was useless for work or my kids as my head hurt to move.  I was a little dizzy, nauseous and the headache wasn't like a caffeine headache, it was like pressure in my head.  My neck to the base of my skull and shoulders were tight and felt like I had whiplash.  I got massages and now 4 weeks later, that still hurts the same and the headaches come and go randomly. My vision is blurrier as well.
Patient is not exhibiting any signs/symptoms of adverse event; Expired GARDASIL 9 (expiration date 04/09/2023) was administered today to patient; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  On 11-APR-2023, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (2nd dose) lot number T036444 with expiration date on 09-APR-2023 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The patient was not exhibiting any signs/symptoms of adverse event.
Sjogren's reacted; Sjogren's reacted, asthma kicked in; headache; rash; nodule; dizziness; blood pressure erratic (jumped up and down); asthma; nausea; had trouble with the left eye/very blurred; had trouble with the left eye/very painful; This is a spontaneous report from a contactable consumer (patient) reported for self. A 69-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Medical history included bilateral hearing loss, having a little bit of trouble hearing, autoimmune disorder, 5 autoimmune diseases, asthma, heart, sjogren's disease all from an unknown date and unknown if ongoing. Concomitant medications included rheumatology drugs. Historical vaccine included NT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 Immunization and MMR Immunization and has no immunity. The patient experienced Sjogren's reacted, and asthma kicked in, difficulty hearing, headache, rash, nodule, dizziness, blood pressure erratic (jumped up and down), asthma, had trouble with the left eye/very blurred, had trouble with the left eye/very painful and nausea all on an unspecified date. The seriousness of the events was not reported. It was reported that patient has sjogren's disease and after the vaccine she had trouble with the left eye: very painful and got very blurred after vaccine 2 blurriness lasted for over 7 days. Sjogren's reacted" because of her underlying conditions she needs to get a booster dose because they do not know how long her immunity may last or how much immunity she has due to her condition. The outcome of the events had trouble with the left eye/very painful/very blurred were recovered on an unknown date in 2021 and it was unknown for other events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt recvd vax at clinic;pt returned to clinic w/ some concern of rt arm at site of flu inject;expressed feelings of discomfort & aching in bones ever since recvd flu needle;has not consulted PMD;
Dose #3 given too soon.  Dose #3 given 8 weeks from Dose#1 (not dose#2).   Family notified.  Pt doing well.  No adverse affects as of 10/3/22.
Mother called to find out about vaccine given to her child. Allegeedly child had adverse reactions that she was seen in ER and was hospitalized. Symptoms included generalized skin rash, abd. pain, vomiting, fainting and high blood pressure. Allegedly child was diagnosed with Steven-Johnson syndrome and is being referred to specialists for follow up. Per 60 day follow up: Unknown recovery for pt. Letter states: spoke to pt recently, claim to still have rash on and off. Still uses Rx skin cream to resolve symptoms. She also claim that she still have headaches on and off but resolves with Tylenol. Otherwise, she claim to be doing well.
Person was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc.DOH notified and Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement from DOH are to notify all of the recipients that received an incorrect dose and submit an agency report for each.
the 2nd dose kicked my Husband's butt; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 8-Apr-2022 Reporter's comments: This case was received from social media page. This case was reported for the patient's husband. The patient did not have much of a reaction with the first one but the second one kicked butt. The reporter hoped the second was not so bad for other. Additional Supportive Information: This case was linked with case US2022AMR064629, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR064629:Same Reporter
Left leg (quadriceps) area of erythema, induration around vaccine site measuring 5cm diameter. Hib booster #4 placed 07/22/02-swelling noted 07/23 and brought in today 07/24/02.
3/21/2021   Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  Chest pain, she reports that she is asthmatic .but does not have her inhaler.   Assessment : Time of assessment 1615pm Alert and oriented and Anxious. No visible respiratory issues, no wheezing or stridor heard.   Actions taken: took to stretcher, 1615 VS taken at 1615 BP- 144/58. P 84, O2 98%, 1625 recheck VS- BP- 114/65, P-74, O2- 94%, lying on stretcher family in the room, she reports feeling better.       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/21/2021  3:45 PM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc
Information has been received from a physician concerning a female (age not reported) with and unspecified immune system disorder who was vaccinated IM with the second dose of Gardasil vaccine. On an unspecified date the patient experience diarrhea. The outcome was not reported. Additional information has been requested.
Information has been received from a allergist concerning a patient who in 2007. also reported as last year, was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported).  Subsequently in 2007, also reported as last year, the patient developed an allergic reaction.  The patient went to the allergist's office and got tested for allergy.  The outcome of the patient's experience was unknown.  No further information is available.
Injection site warm, itchy and sore. Large bump across width of upper arm at injection site.
neck and jaw pain; neck and jaw pain; has clicking in her jaw; concerned  these symptoms following vaccine could be Bell's Palsy/Palsy; dull ear; She stated she could not walk on her left foot on 11Mar2021 but recovered the next day; This is a spontaneous report from a contactable consumer (the patient).  This 39-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EN6204), via an unspecified route of administration, in the right arm on 10Mar2021 at 10:45 AM (at the age of 39 years) as a single dose for COVID-19 immunization. Medical history included skin wrinkling. Concomitant medication taken within two weeks of vaccination included botulinum toxin type a (BOTOX) taken for skin wrinkling, and unspecified birth control pills. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot # EN6200, on 18Feb2021, in the right arm COVID-19 immunization, and experienced fatigue. The patient reported that while she was sleeping last night on 11Mar2021 around 02:00-3:00, she had onset of dull ear, neck and jaw pain on left side. She had clicking in her jaw. The patient mentioned she never had a droopy face. She stated she could not walk on her left foot on 11Mar2021 but recovered the next day. She's concerned these symptoms following vaccine could be Bell's Palsy - what should I do. She looked online and saw that these are some of the first symptoms of Bell's palsy. She called to ask if these events could be Bell's palsy, and for information on events and Bell's palsy relative to the COVID-19 Vaccine. She informed that she had an upcoming appointment with her doctor "today" at 14:00 to see if she has Bell's palsy. The patient stated she went to the doctor on 11Mar2021 at 03:00 pm. Event term of Palsy with onset date of 11Mar2021 was reported. The physician did not prescribe medication, no treatment given. The clinical outcome of dull ear, neck and jaw pain, has clicking in her jaw, and palsy was recovered on 13Mar2021
No additional AEs or PQC reported; expired dose of GARDASIL 9 administered; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.  On 24-APR-2022, the patient was vaccinated with an expired dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml, lot # S026372, expiration date 01-APR-2022; strength and anatomical location were not reported) intramuscularly (IM) for prophylaxis (expired product administered). No additional adverse events (AEs) or product quality complaint (PQC) was reported.
arm is tiny bit sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is tiny bit sore) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy to antibiotic. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) for Allergy NOS.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm is tiny bit sore). At the time of the report, VACCINATION SITE PAIN (arm is tiny bit sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitent medicines include Claritin D for his allergies every other day, protein powder for his shakes.
After receiving my first dose I broke out in red hives across my chest. I had a high fever and my throat swelled up