chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse concerning an unspecified number of patient of unknown age and gender.  The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On an unknown date, 5 doses of improperly stored PROQUAD Lot# M035144, expiration date 30-JAN-2018 and lot # reported M038862, expiration date 01-SEP-2018, were administered to the patients for prophylaxis. It was reported that the doses were exposed to a range of temperature of 14°F and 46°F for 2 hours and 25 minutes. It was reported that there were no previous temperature excursions and the event was detected because a data logger. This is one of several reports from the same reporter. Additional information is not expected as the reporter did not consent for follow up attempts.; Sender's Comments: US-009507513-1702USA002401:
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. No adverse event was reported. Treatment information was not provided.   This case was linked to MOD-2022-501575 (Patient Link).
had the flu in the last 20 years was the one time I got conned into taking it; Initial information was received on 05-Oct-2021 regarding an unsolicited valid non-serious social media from a consumer/non-healthcare professional.  This case involves adult patient of unknown gender who "had the flu in the last 20 years was the one time I got conned into taking it" (influenza), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious "had the flu in the last 20 years was the one time I  got conned into taking it" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "this social media case was received. Since this is a public post on the flu shot campaign Flu Shot Fridays we are assuming the consumer is referring to the flu vaccine. Author/Reporter Comment: only time I have had the flu in the last 20 years was the ONE time I got conned into taking it never again."  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the lot number for this case.
1/9/2014-Mother called me; states child's arm started swelling and was red about 3 hrs after vaccines given; child was scratching at arm; denied difficulty breathing, stated child was playing normally. I told her to apply cool or warm compresses, give Tylenol or Motrin, monitor child and if no better or gets worse, to see MD. I phoned her at about 9:30 am next morning (1/10/14), she had client in ER because he had woken up with face, ears and under chin swollen; still no difficulty breathing. States she gave him 2 doses Benadryl on 1/9/14 in the afternoon sometime and last dose at 9pm, along with Tylenol and Motrin. States ER gave him some Keflex and steroid by mouth; she was unsure if they gave him Benadryl, but they had asked her if she had given him any. States they were going to monitor him at that time. I followed up again on 1/13/14, states the ER monitored him for a couple hours and sent him home with Keflex BID for 10 days and orders for cool compresses, Tylenol, Motrin, and to follow up with his MD in 2 weeks. His arm was still red and still had some swelling at the time of call on 1/13. I followed up again yesterday (1/14) and the swelling had gone down some. I followed up again today (phone call 1/15) and she states everything is resolved and he is still taking Keflex. I have reports from ER visit that were faxed to me-Diagnosis Localized reaction to immunizations and secondary cellulitis.
Vaccine given at 10:40 a.m. 10-29-08.  Headache in afternoon lasting until next day.  I never have headaches.  Tickle in throat during nap in afternoon.  Chills and fever at ll p.m bedtime.  Severe shivering until warmed by bed covers.  Achey that day and next day
Moderna COVID-19 Vaccine EUA Soreness near injection site lasted two days. Chills lasted first afternoon. Bad taste in mouth started 30 minutes after vaccination and lasted six hours.
Patient was seen in the emergency department with confusion, nausea, vomiting, and diarrhea 1 day after booster. The patient was diagnosed with acute adrenal insufficiency. Endocrinology instructed the patient to triple the dose of chronic steroids for 2 days, followed by a double dose for 2 days, then back to normal, chronic dosing.
This spontaneous report as received from a nurse concerning multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in October 2016 (reported as between 09-OCT-2016 to 21-OCT-2016 ), the patients were vaccinated with improperly stored PNEUMOVAX23 lot # M018766, expiry date: 15-OCT-2017, lot# M038216, expiry date: 09-MAY-2018 (dosing details and route were not reported) for prophylaxis. It was reported that the vaccines were exposed to the temperature of 30.2F during a time frame of 12 days. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003199.
a slight soreness in the arm later; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (father). A 91-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a slight soreness in the arm later. Reportedly, caller states she has a 10-year-old son and she is eager to get him vaccinated. Caller states she understands it is only approved for 12 and older but that her son is a tall 10-year-old and he is going back to school in 3 weeks. Caller states that she has had the Pfizer vaccine with no side effects and her dad had it and had no side effects only a slight soreness in the arm later that day and that it was fantastic. Caller asks if the dose for 12 and up is a different dose. Response: Read from attached FAQ-COVID-19 Vaccine use in children. When will the vaccine be authorized for use in children < 12 years of age. Caller wants to get her 10-year-old son vaccinated with Covid. When do you anticipate it being approved for under 12 years old. Is there a Covid trial she can get her son into. She added her parents, her husband and herself all got the Pfizer Covid vaccine and none of them had any problems other than a sore arm for just a couple of hours. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101031454 same reporter/drug/event, different patient.
Patient had prescription for the preservative free product. Thimerosal containing product was entered in computer and administered by immunizing RPh. No adverse event recorded. Just noting improper administration.
Client received her booster on 08/26, and was hospitalized on 10/29 for hypoxia, COVID-19 and sepsis.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 05/18/2023. I have a runny nose, cough and fatigue. I contacted my doctor and got a prescription for Paxlovid. I have taken two doses and so far, I am tolerating the medication.
Information has been received from a licensed practical nurse referring to a 57 years old patient of unknown gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided. On 14-FEB-2019, the patient was administered a dose of VAQTA (lot # R025518, expiration date was 15-NOV-2019; strength, dose and route were not reported) for prophylaxis. The VAQTA was too long in transit and deemed not viable by their distributor (Poor quality product administered). No adverse effects were reported. The call was not because of a "data logger" as this was a shipping issue.
Patient was diagnosed with erythema multiforme. I was instructed to give him BENADRYL and watch for further complications.
Severe FUO illness with temp > 103 for 4-5 weeks duration after 10 days of receipt of COVID vaccine. had developed pharyngitis symptoms, night sweats. work up negative for other etiologies.
Fever up to 101, vomiting, & rash for about 3wks.
pt recvd vax 29SEP95 & devel a sl rash of 10 pimple-like spots that itched, fever of 102, body aches & h/a's;p/2 days pt recovered;
doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021 at 8:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.  Vaccine Removed from freezer at 8 am on 15-Oct-2021.
My shoulder area became very sore 8 days after the injection (no symptoms prior).  It felt like I'd torn a muscle and couldn't lift my arm above my head or use it to carry or lift items.  It got sorer through the weekend so Sunday morning I applied Chinese cups to the area (I'm a licensed massage therapist) and the whole shoulder area (4 cups) turned dark purple - I've never experienced so big of an area turn purple.  It relieved a little but Monday I went to see a neurological chiropractor which relieved some.  On Sunday and Tuesday I took 800 mg/ibuprofen which seemed to help relieve some of the pain.
pt received vaccine at covid clinic on 12/30 at approximately 3:30, pt vomited 4 minutes after receiving shot--dark brown vomit, staff reported pt had vomited night before. Per staff report pt became short of breath between 6 and 7 pm that night.  Pt had DNR on file.  pt passed away at approximately  10pm.  Staff reported pt was 14 + days post covid
The day of the vaccine I experienced shortness of breathe and tightness in my chest. That lasted off and on for a couple weeks, it was like I had to force myself to breathe.  On 06/26/2021 I woke up a heart beat of 165/minute and I felt dizzy. I was rushed to the hospital, the ambulance showed I was having a mild heart attack. the hospital diagnosis it as a attrofiblation.
SICK; HAD AWFUL SIDE EFFECTS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sick, and had awful side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick and had awful side effects was not reported. This report was non-serious.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live significant follow up narrative updated.
felt a bump about the size of a marble in my armpit under my left arm.; soreness under my left arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (soreness under my left arm) and LYMPHADENOPATHY (felt a bump about the size of a marble in my armpit under my left arm.) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PROBIOTICS NOS from 01-Jun-2019 to an unknown date for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 06-Jan-2021 at 8:00 AM, the patient experienced PAIN IN EXTREMITY (soreness under my left arm). On 07-Jan-2021, the patient experienced LYMPHADENOPATHY (felt a bump about the size of a marble in my armpit under my left arm.). On 07-Jan-2021, PAIN IN EXTREMITY (soreness under my left arm) had resolved. On 08-Jan-2021, LYMPHADENOPATHY (felt a bump about the size of a marble in my armpit under my left arm.) had resolved.        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.   Patient stated that he was using Men's Multivitamin for vitamin supplement  orally2 chewables/day and probiotic for digestive supplement as a concomitant medication. Treatment details was not reported .   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Added  Concomitant medications. Updated  Reporter email address,patient demographics and event onset date for pain in extremity.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
fever; chills; feeling tired; sore throat; nasal congestion; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced fever, chills, tiredness, sore throat and nasal congestion. On an unknown date, the outcome of the fever, chills, tiredness, sore throat and nasal congestion were unknown.   It was unknown if the reporter considered the fever, chills, tiredness, sore throat and nasal congestion to be related to Shingrix.  Additional details were provided as follows: Yesterday from the date of reporting the patient received a dose of Shingrix and experienced slight fever and chills and was tired. The patient knows these are the side effects, but along with this the patient also had a bit of a sore throat and some nasal congestion. The patient asked whether the sore throat and nasal congestion are the side effects of the vaccine or not.
September 21, 2022 Around 7:00PM I started having abdominal pain, I was nauseated, cold sweats, hot sweats, & no bowel movement.
Loose stool, fever (101ºF), chills, sore arm at site, dizzy, nausea and fatigue. Oxygen SAT level of 87.
"patient is observed in the recovery area pale and diaphorectic.  v/s taken hr 71 initially,recheck was 51p.  ,o2 sat ra 97%, b/p 100/60, resp 18.  comfort provided.  13:00 v/s taken hr 80, resp 18, bp 120/80 o2sat ra 98%.  still looking pale. comfort and support is provided.  1315 v/s  taken hr 80,resp 20,b/p 130/80 02sat ra 100%.  after comfort and support provided pt reports feeling well.  13:30 pt continues to be monitored for possible changes.  patient reports feeling well.  v/a taken b/p 130/80 resp 20,hr 80,o2 sat ra 100% is oriented, and released accompanied by a family member", RN - support staff
Case number PHEH2013US005309 is an initial spontaneous report received from a medical assistant on 28 Feb 2013 with the follow-up received on 25 Mar 2013. This report refers to a 19-years-old female patient. It was reported that she was vaccinated intramuscularly with 0.5 ml of MENVEO (batch number: M11051, expiry date: 31 Mar 2014) that experienced temperature excursion on 25 Feb 2013. The first temperature excursion happened on 22 Jan 2013 and the vaccine was in a temperature of 54 F for less than 4 hours. It was reported that MENVEO was not reconstituted at the time of excursion. No adverse events were reported following the medication error. Reporter stated that, the MENVEO had a temperature excursion. She did not experience any adverse events as a result of the temperature excursion. She would be revaccinated. No further information was reported. Follow-up received on 25 Mar 2013. Updated reporter comments.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). On or about 26-JUL-2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.