chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023.; No adverse event; Patient had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated.), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023.) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated.), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated.) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023.).    Concomitant medication use information was not provided by reporter.  Patient administered expired vaccine on March 15,2023.  There was between 75 and 125 people vaccinated and then on 3/3/23. HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 people on 15MAR2023.   There was potentially a second lot number that was expired and was administered to patients on 3MAR2023, but HCP did not have any details on this event at this time.  Dose administered after 30-day use by date or after manufacturer date of expiry  Individual vials or intact cartons was unknown  Vial size was reported as 10 dose vial  Date the vial was initially stored in the refrigerator was reported as 14 March 2023  The vial did not undergo any temperature excursions.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Information has been received from a physician concerning a 12 year old female, who on 15-FEB-2008 was vaccinated IM with a third dose of GARDASIL. Concomitant suspect vaccination included the second dose of hepatitis A vaccine (inactive) (manufacturer unknown). On 15-FEB-2008 the patient passed out and had a seizure after administration of the vaccine. The patient was given a cold wash cloth, which was placed on her head. No laboratory diagnostics were performed. It was reported that the patient was fine before she left the office. The patient recovered on 15-FEB-2008. No product quality complaint was involved. Upon internal review the seizure was considered to be an other important medical event. Additional information has been requested.
24 hours post vax, the pt experienced a large area of redness and swelling which spread across the thigh approximately 11 1/2 x 6 cm. Pt was very irritable and ran a fever. Swelling starting to decrease.
Pt had DTaP in (R) thigh and Flu >3 in the (L) thigh. On 3/17/15 parent's noticed a lg red swollen area to (R) outer thigh and a smaller swollen area to the left thigh.
Information has been received through the Merck pregnancy registry from a nurse practitioner concerning a 20 weeks pregnant 14-year-old female whose last menstrual period was 19-Jun-2007 (she had a full period throughout) with a concurrent condition of asthma and has no known allergies. On 10-JUL-2007 she was vaccinated at an unknown site with a subcutaneous injection of 0.5 milliliters varicella virus vaccine live (Oka/Merck). Suspected vaccinations included Gardasil (MDS), (duration and dose not reported), hepatitis A virus vaccine inactivated (manufactured unspecified), (duration and dose not reported) and Menactra. On 14-JUL-2007, the patient found out she was 20 weeks pregnant. Medical attention was sought. No product quality complaint was involved. Additional information has been requested. Follow up information was recived. Patient did well with her pregnancy.She delivered between 19-NOV-2007 and 6-DEC-2007. The baby was healthy and fine with no congunital defects.
Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # J008427, expiration date: 09-APR-2016, route, dose and frequency were unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headaches, body-aches, intermittent fever, irritated eyes, swollen arm.
Pt was hospitalized from 8/12-8/18 for COVID-19 pneumonia. Pt received dexamethasone and oxygen during hospitalization. Pt had been at a Living facility and was mostly independent prior to hospitalization. After hospitalization, pt was moved to another facility due to decline in functional status. Pt was seen a the ER again after initial hospitalization for concern of a bowel obstruction. Patient is fully vaccinated.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Other medical history Rheumatoid arthritis; "Known allergies Sulfa" (unspecified if ongoing), notes: Known allergies Sulfa. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19; patient received anti viral treatment (Paxlovid) from 05Oct2022 to 10Oct2022 as COVID 19 Treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
When the vaccine was administered into the right deltoid muscle, a significant amount of vaccine (estimated to be more than half of the intended dose) leaked from the syringe where the needle attaches to the syringe. The patient experienced no symptoms related to this. No treatment was administered for this. Per the CDC guidelines, the dose was immediately was repeated and given minutes later in the opposite arm.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 66-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 22-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number; 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805437 was crossed linked to original cases 201804863 due to same reporter.
I had the vaccine on Saturday and on Sunday whenever I went to the bathroom my intimate parts will burn. On Monday I decided to go to the clinic, and they said I had a UTI, and they gave me some medication, Nitrofurantoin. I took 3 of those and I was feeling much better, so I did not finish the treatment. Yesterday they called me to ask how I was doing, and I told them that I did not finish the treatment, but I was feeling better, and they told me to continue with the medication. I took another pill and I started to feel bad at 1:30, I had chills, body aches, headaches and nausea. I do not know if this was because I took the medication again. I still have the same symptoms except chills. I feel like I have Covid again.
Spicy foods have become too hot. severe hot and cold flashes. Whenever I eat food I now become sick. Soon after leaving became lightheaded dizzy and irritable
Info has been received from a health professional concerning a 12 year old diabetic white male who on 4/20/05 was vaccinated with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 5/7/05, the pt experienced mild generalized chickenpox breakthrough rash, during a middle school outbreak, described as a mild with no fever. There were no complications. It was reported that the pt recovered without hospitalization. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info is not expected.
Patient was to be given moderna bivalent and was given pfizer bivalent . And because we thought we were giving moderna bivalent patient was given .5 ml pfizer bivalent instead of .3 pfizer bivalent
I was very sleepy, had a headache and a fever. I was having trouble getting up the next day. I had to ice my arm a lot. I had a lot of stiffness and pain and I was unable to get warm. I never turn up my heat and I was cold, I had to that. This lasted for about 3 days.
Woke up in the middle of the night with vomiting, diarrhea, and headache.  The injection site was red, raised and extremely sore to move at all.
Received Moderna lot 0225J20-2A on 12-29-2020 in the left arm.  1-5-2021 developed redness and soreness at insertion site. She state that one of her lymph node in her neck is also sore and swollen
Information has been received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not provided. On 16-AUG-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M006726, expiration date 08-FEB-2018; strength, dose and frequency were unknown), subcutaneously, which was exposed to temperature excursion of 11.5 degrees Fahrenheit for 1 hour and 52 minutes. Previous temperature excursion was 13.1 degrees Fahrenheit for 48 hours. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
HEARING LOSS OR IMPAIREMENT; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total administered, therapy start date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date (24 hours to within days after vaccination), the patient experienced hearing loss or impairement. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hearing loss or impairement was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210755980 and 20210758713.; Sender's Comments: V0:20210758691-COVID-19 VACCINE AD26.COV2.S-hearing loss or impairment. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
This case was reported by a nurse via sales rep and described the occurrence of swelling in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 8th February 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling, pruritus, fever, chills, influenza like illness, pain and erythema. On an unknown date, the outcome of the swelling, pain and erythema were recovered/resolved and the outcome of the pruritus, fever, chills and influenza like illness were unknown. It was unknown if the reporter considered the swelling, pruritus, fever, chills, influenza like illness, pain and erythema to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain redness swelling 3.5 to 4 weeks duration. The patient experienced itching has lasted since shot. The patient experienced fever, chills and described it like having the flu.
Dizziness, Fever, inj site soreness, swelling; fever, chills, no appetite, cold sweat, joint pain, stomach upset, stiff neck, back pain Narrative:
Client ( DOB:7/19/1962) received the 1st dose of Moderna COVID vaccine lot #021C21A and expiration date 5/26/21 at 1:10PM.  Client reports having history of anxiety, so client was seated in a gravity chair prior to injection. PHN  was notified by Nurse student that client is having dizziness. PHN finds patient sitting upright in gravity chair, alert and oriented x 4.  Client reports feeling dizziness and feeling "hot" sensation. Client denies chest pain, blurred vision, no headache, or shortness of breath. Client reports having a history of high blood pressure, history of severe panic attacks, anxiety, and borderline diabetes.  Client is taking lisinopril, metformin, aspirin and Xanax. Client reports eating lunch.  Vitals are taken at 1:18pm blood pressure: 124/80, pulse: 68 and oxygen: 97%.  PHN offer client water, client accepted water. At 1:21pm vitals: blood pressure:126/78, pulse:65, and oxygen:97%.  Client reports "feeling dizzy" when looking into her purse for vaccination card and reports feeling a dry throat.  Client reports no shortness of breath and no other symptoms. At 1:26pm client reports needing to take her Xanax to prevent a panic attack.  PHN advised client if she could get someone to pick her up drive due to the medication she is taking, client reports she has been taking her medication for years and it never makes her feel unable to drive; client stated she had no one available to pick her up.  At 1:27pm vitals: blood pressure:128/80, pulse:60, and oxygen:97%.  Client reports no changes in dizziness and dry throat, even with water.  Client reports no chest pain, no shortness of breath, and no headache.  At 1:32pm vitals: blood pressure:120/84, pulse:60, and oxygen:98%.  Client reports no changes. At 1:37pm vitals: blood pressure 118/80, pulse:60, and oxygen:96%. Client reports no chest pain, no headache, no dizziness, no trouble breathing, Client states that she "feels the same."  Client also reports having a pacemaker placed 10/2020.  At 1:40pm, PHN offers calling paramedics since there is no real improvement in her dizziness and PHN educated client that it is unsafe to drive while dizzy.  At 1:44pm vitals: blood pressure:110/80 and pulse:61 and oxygen: 97%.  Client reports feeling relaxed.  PHN discussed with client importance of following up with primary doctor about lack of improvement in dizziness post vaccine. PHN provided client with ER precautions.  At 1:51pm vitals: blood pressure:116/80, pulse:60, and oxygen:98%.  At 2:03pm vitals are blood pressure:118/80, pulse:60, and oxygen:97%. Client denies any chest pain, blurred vision, headache, or shortness of breath. Client reports no change in dizziness.  PHN offer paramedics again and at 2:04pm PHN calls 911. Fire and paramedics arrive at 2:14pm to assume care.  Client signed AMA with paramedics.  Client stayed seated a little longer due to dizziness-educated client about following up with provider and cardiologist and provided client with Crisis & Access Line. Also educated client about dangers of driving while dizzy.  Client reports her dizziness is somewhat improved.  Client accompanied to car walked out with a steady gait at 2:35pm.
4 X 4 cm raises red warm. Reactify R GUAD - no fever very unfable
Pt's girlfriend reported at time of flu shot whole body hives after he received flu shot last year on 9/28/17 but pt. did not report to pharmacy until his girlfriend told us this year. Pt. took BENADRYL for it.
Had a fever of 100.6.  Then wake up at 10:30 pm vomiting.  Had was hot and cold and felt clammy.  Then wake up the next morning with a fever of 101.  Contacted the doctor about this.  Arm was sore as well.  Doctor tested for COVID-19, flu, and strep, negative results for all three.
Pt sent to ER from cardiologist office for weakness, lightheadedness, low Hgb.
Slight fever, chills, headache, body ache, general weakness;  no treatment needed; duration of symptoms was about 36 hours; I had covid19 about 100 days earlier than the date of the administration of this first covid vaccination
1/4/02 Received DTaP injection Right upper arm 1/5/02 right arm red swollen, tendser at injection site 1/6/02 blisters develop @ injection site, increased swelling  & pain. Child seen in emergency room, started on cephalaxin antibiotic. 1/7/02 seen at our clinic-Rx pedrapred zyrtec 1.9.02 F/u visit-blisters healed, minimal redness, swelling, no pain 1/14/2002 Resolved
about an hour after vaccine administered arm was sore. around 1800, the injection site was hot to the touch, red, bumpy texture, rash, firm, and arm was sore. I did several arm circles throughout the day to help prevent discomfort. On Saturday 11/12, the injection site redness, bumpiness, warm to touch, and firmness spread larger on the upper arm, it continued to be sore, and started to itch significantly. On Sunday 11/13, arm was more itchy, more red rash, hot to touch , firmness, and bumpiness spread more on the arm. Motrin taken on Sunday afternoon. 11/14 & 11/15 the arm was still sore, redness lightened in color somewhat, still itchy, firm but less surface area
Arm pain (injection site); Fever; tiredness; Muscle ache; Joint pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EOW158) via an unspecified route of administration on the left arm on 13Apr2021 at 10:15(at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 13:00 the patient experienced  arm pain (injection site), fever, headache, tiredness, muscle ache and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events vaccination site pain, fever, headache, tiredness, muscle ache and joint pain was recovering.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates in the years 2015, 2016 and 2017, the patients were vaccinated with improperly stored doses of PROQUAD (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. There were multiple temperature excursions but the temperature and the time frame were unknown by the reporter. No data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005342: US-009507513-1705USA005384: US-009507513-1705USA005385: US-009507513-1705USA005386: US-009507513-1705USA005387: US-009507513-1705USA005388: US-009507513-1705USA005390:
Starting about 24 hours after injection I had slight fever and several spells of vomiting. Then that stopped. Starting about 52 hours after injection I had extensive hives all over my body. This lasted about 48 hours, and then cleared up. No problems since.
Expired dose administered more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered more than 12 hours post puncture) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered more than 12 hours post puncture). On 22-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered more than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Vision and hearing faded rapidly and suddenly became very dizzy.  Started sweating over entire body and had sweat dripping off arms and face in a room at 68 degrees.  Lasted for approx. 20 minutes and then was very cold and getting chills.  No fever, slight fatigue and headache.  Took 2 OTC Aspirin.
had an allergic reaction; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0217; Expiration Date: Sep2021), dose 1 via an unspecified route of administration on 21Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced had an allergic reaction on 21Jun2021. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected
3 days after second vaccination, had arthralgias feet, ankles, neck, shoulders and hands that has lasted 10 days, No swelling. No rash
Having muscle aches, chills, pain at injection site, NO fever. Sx coming on in waves. This is day 3 of symptoms, thinks getting better No redness or swelling around injection site.