chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever Narrative:  He reports the following after the initial vaccination all started about 3x hours afterwards: *Throat dryness: clarified as more dry feeling, not tightness. Lasted for <1 minute prior to spontaneously resolving. No associated increase in salivation, difficulty breathing, issues with eating/drinking or swelling reported. *Myalgia and pain over injection site: no therapies tried or applied (other than acetaminophen) *Episode of fever to 101: resolved after acetaminophen administration. Patient denies past immediate allergic reactions to other vaccinations or injectable medications + denied other s/sx concerning for immediate allergic reaction and swelling/angioedema.
anaphylactic reaction; patient was breastfeeding when she received the first dose; patient was breastfeeding when she received the first dose; This is a spontaneous report from contactable pharmacists. These pharmacists reported information for both mother and baby. This is the mother report.   A female patient of an unspecified age received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was breastfeeding when she received the first dose and had an anaphylactic reaction. The reporter wanted to know if the patient can start breastfeeding again. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of anaphylactic reaction due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided.,Linked Report(s) : PFIZER-2021308459 baby case
On 1/23/2021, one day after receiving the mentioned vaccination, I was working as a volunteer and at about 11;30 am I became very dizzy and nearly passed out.  a passerby helped me to a seat, a coworker brought me water, and called security for assistance,  An EMT came and checked my vitals, gave me a small package of raw honey, and checked my blood sugar.  Everything  checked out ok, except my blood sugar was slightly low.  I quickly soon felt better, and resumed my volunteer shift. I don't know if the vaccine was related to this incident, but felt it best to report it to you.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-month-old patient of unknown gender. On 24-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020) and a dose of VARIVAX lot number N027002 (expiration date: 28-SEP-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Pt recvd vax 1JUN92 & exp dizziness, SOB & lightheadedness for approx  15 mins; also exp sore arm;
swelling @ site w/in 24-48hr;pain @ site;h/a;backache;
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a 4 year old patient. On an unspecified date, the patient was vaccinated with the 2nd dose of VARIVAX (Merck) (strength, dose and lot # not reported). On 02-MAY-2014 the patient was vaccinated with the 2nd dose of VARIVAX (Merck) (lot # J009166, expiration date: 24-JUL-2015, strength and dose not reported) which was improperly stored at -11 Celsius degree for an unspecified number of hours. No adverse effects reported. This is one of the several reports from the same source. Additional information has been requested.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 28-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012479, expiration date: 10-APR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Immediately post vax pt's eyes rolled back, appeared to lose consciousness & became limp; fists clinched & arms & body became rigid, appeared to be in sz, lasted approx 15sec; Pulse dropped to 46 & pt appeared extremely tired;
Initial pregnancy report received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 36 years old female patient who was exposed to expired vaccine FLUZONE QUADRIVALENT while she was pregnant. Pregnant currently. occurred at unknown gestation period, the date of last menstrual period was not reported, the estimated due date is 10-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines received on that day. On 26-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5934NA (expiry date: 30-Jun-2018) via intramuscular route. It was a case of actual medication error due to expired vaccine used. It was also a case of Vaccine exposure during pregnancy. It was unknown whether patient experienced any adverse event. Pregnancy outcome is unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Flu like symptoms after the 2nd shot- muscle aches, congestion, headache, nausea, extreme fatigue for 1 day. Continuing leg aches
This spontaneous consumer report (initial receipt: 19-Sep-2012) concerns a male patient. On an unknown date the patient received a flu shot (manufacturer, brand name and lot number were not provided). After the shot, the patient's arm swelled up. Three weeks later he was diagnosed with multiple sclerosis. The event outcome was not reported.
Within 24 hours left thigh at site of vaccination was swelling and a large rash. Within 48 hours rash had double to be about 4?x4? and was warm to the touch. Within 72 hours rash had covered top of entire thigh and into inside of thigh and was very warm to touch, tender, and red. Child was vomiting and running high fever.
*****************COVID BREAKTHROUGH CASE********************** It started with a sore throat then the next day I did a home test it was positive for COVID. I had fever and headache that lasted for 2 days and was very tired. Then I had a video visit with the doctor and she prescribed Paxlovid. I complete another test in 7 days time after the medication and I was negative.
Chills followed by extreme nausea (throwing up) diarrhea, extreme headache and injection site swollen red and itchy
had a reaction; Aches; Pains; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a reaction), PAIN (Aches) and PAIN (Pains) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect and COVID-19 (hospitalized.) in December 2020.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had a reaction), PAIN (Aches) and PAIN (Pains). At the time of the report, VACCINATION COMPLICATION (had a reaction), PAIN (Aches) and PAIN (Pains) outcome was unknown. Not Provided          No concomitant medicine reported. treatment include Aleve.
diarrhea; muscle weakness; she has a constant urgency for bowel movement every hour and the feeling in my belly is uncomfortable; she has a constant urgency for bowel movement every hour and the feeling in my belly is uncomfortable; the feeling in my belly is uncomfortable' very discomforting and almost pain at some point; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 95-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bad colon issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "muscle weakness"; DEFAECATION URGENCY (non-serious), ABDOMINAL DISCOMFORT (non-serious), outcome "unknown" and all described as "she has a constant urgency for bowel movement every hour and the feeling in my belly is uncomfortable"; ABDOMINAL PAIN (non-serious), outcome "unknown", described as "the feeling in my belly is uncomfortable' very discomforting and almost pain at some point".  Additional information: The patient had a very bad colon issues. And all of a sudden, especially yesterday, she  felt like she had to go all the time, a constant urgency for bowel movement every hour and the feeling in her belly was uncomfortable, very discomforting and almost pain at some point.  It's not really diarrhea but it bordered on it a couple of times. That was very unusual for her because she have not been having good bowel movements at all. This all started the night before last and it has abated. She had not started taking anything different like lactulose for this condition and it can't be what she am eating since she have not changed that. she have had this condition for so long.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Patient had an adverse reaction at the injection site.  The injection site formed a purplish lump. The deltoid muscle in her left arm was swollen around the injection site.
Started with Sore throat friday night.  Chest pain started Started 8/27/11, come and going.  by August 30, 2011 had sharp chest pains with SOB.
Second shot got caller down for three days.; She was weak; fatigued; flu-like symptoms; aching all day; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), via an unspecified route of administration on 19Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included pain from 26Feb2021 to 03Mar2021 (Recovered completely), influenza like illness from 26Feb2021 to 03Mar2021 (Recovered completely). The patient's concomitant medications were not reported. The patient experienced second shot got caller down for three days, she was weak, fatigued and flu-like symptoms on an unspecified date, aching all day on 20Mar2021. Outcome of the events Second shot got caller down for three days, She was weak, fatigued and flu-like symptoms was unknown and for aching all day was Recovered on 22MAR2021.  Follow up#01: This is a spontaneous report received from a contactable consumer.  Follow up#02: This is a spontaneous report received from a contactable consumer.  No follow-up attempts are needed. No further information is expected.
Information has been received from an office manager at the physician's office concerning a 6 month old male patient who was vaccinated PO with a dose of ROTATEQ. Subsequently the patient had stool specimen done and it came back positive for salmonella. At the time of reporting, the outcome was unknown. It is unknown if the patient sought medical attention. It was also reported that the patient's twin experienced adverse event on ROTATEQ (WAES #0906USA00842). Additional information has been requested.
Red, irritated skin under bandage around vaccination site. Individual, isolated rash clusters under arm & across chest and abdomen.
hives w/1st dose of vax approx 20min p/vax;thought 1st episode secondary to MMR vax;
At bedtime I noticed a slight queasiness. Just enough to make me close my eyes to go to sleep. I also felt 'off'.  About 30 mins to an hour later I notice that every move I make, the joints I'm moving hurt. Like EVERY joint is now sore when I move. (With the exception of fingers/toes) I tossed and turned all night and got a headache. The queasiness was very mild, but happened any time I moved.  This morning now my joints no longer hurt, but I still have the headache.
Client was very nervous and kept moving around to prevent administration of vaccinations. Both he and his mother spoke different language so it was hard to communicate but a coworker translated and mother wanted him to have all five vaccines. Mother raised her voice to him to cooperate and sit still, although as soon as he would sit for the vaccination he would move away and jump up out of the chair. Finally his mother convinced him to sit still for the vaccinations. A few minutes later I asked if he was feeling dizzy as he looked a little dazed (translator not in the room anymore and other nurses busy with clients so I did the best I could to communicate). He shook his head yes, so I utilized an ammonia packet which seemed to bring him to alertness and an ice pack for the back of his neck and forehead.  After a minute or two he shook it off and indicated he was fine. When mom went out to pay at the front desk I asked the desk person to translate to mom to have him sit down in the lobby while she paid.  He was fine and they left.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 14-JUL-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 4644, unknown and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Developed chills and rigors lasting approximately 15 minutes.  Followed by fatigue  also had arm pain at injection site which subsided after episode of rigors.
Initially patient denied ever receiving a covid vaccine. She then stated she did but it was 5 months ago and she received the Pfizer vaccine. She thought she needed to start the series over again because of the length of time that had gone by. Nurse informed patient she didn't need to start series over and after this shot she would be fully vaccinated. After questioning the patient for quite some time, she stated she did have a vaccination card and handed it to the nurse. It was then realized that the patient had received Moderna for her first dose, after the nurse had already administered a dose of Pfizer for her second dose.
tongue; I guess it's reap; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Aug2021 (Lot number: EW0175, Expiration Date: Nov2021) at the age of 41 years 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: TONGUE DISORDER (non-serious) with onset Aug2021, outcome "unknown", described as "tongue; I guess it's reap". Therapeutic measures were not taken as a result of tongue disorder.  Additional information: no prior vaccinations within 4 weeks. No follow-up attempts are possible. No further information is expected.
experienced nausea; experience shivering; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included breast cancer. Previously experienced adverse reactions included shingles. Concurrent medical conditions included diabetes mellitus (had medical history of Diabetes Melatus Type 1.).   In January 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent unspecified season. In January 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced nausea and shivering. On an unknown date, the outcome of the nausea and shivering were recovered/resolved.   It was unknown if the reporter considered the nausea and shivering to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient received Shingrix on mid January 2020 and within hours on the same day she started to experience shivering and nausea that lasted for 7 hours and then resolved.  She stated that she ended up in the Emergency Room due to these symptoms because she did not know it would happen. The reporter consented to follow up. Emergency room visit was required. The consumer did not know the details of the vaccines for this adverse event.
Acid indigestion/heart burn Irregular EKG Blood work - no heart attack Stress test - results - heart normal  prescription for excess stomach acid ongoing
Extreme pain in bone, not muscle,  of left arm started approximately 30 minutes after injection.  4 hours later chills started .  Both symptoms continue 12 days later.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, malaise, fever and injection site erythema. On an unknown date, the outcome of the injection site pain, malaise, fever and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, malaise, fever and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter reported through online chat that, the patient's received SHINGRIX dose induced a bunch of the typical side effects (4 days of site pain and erythema, 1 to 2 days of malaise and low grade fever). The reporter wanted to known that, whether the patient would likely to have a similar post-vaccination course for the second dose as well. The reporter did not had time to provide more information. Due to imminent time constraints, reporter appreciated an answer to his question. The reporter did not had much time to provide additional background information at the time of reporting. He could provide it later.
She got her vaccine, at 3:31 when she was exiting the store she had a nauseous GI uncomfortableness.  Then by the time she got out of the store into the parking lot she had severe back spasms to the point that she could hardly stand, and had to have people support her from falling.  They took her back into the pharmacy where she sat for while.  The personnel got her some water, still had some back spasms.  They checked her BP which was not overly high 133/85, and sat there for another 10-15 minutes and was able to get up and go home.  Since then she has not had anything else occur.  She has not had problems with her back prior to the vaccine.
Stiffness in shoulders and neck area; Some upset stomach problems; This case was reported by a consumer via call center representative and described the occurrence of musculoskeletal stiffness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced musculoskeletal stiffness and upset stomach. On an unknown date, the outcome of the musculoskeletal stiffness and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the musculoskeletal stiffness and upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had stiffness in shoulders and neck area plus some upset stomach problems.
Like nausea is just a day and don't feel very well; Like nausea is just a day and don't feel very well; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated, I was wondering, I got my booster (Unspecified Vaccine) on the 2nd and I did not know how long after you had booster that you could experience side effects, like nausea was just a day and you did not feel very well on an unspecified date and I did not know then the reason why I should. So, I was just wondering can you experience side effects 11 days afterwards. The clinical outcome of events was unknown.  Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].
Given Pediarix, Hib and Prevnar at 9:00 am on 2/16/2006 at 3pm OT therapist was doing stimulations/treatment and noted head jerking and eye blinking for 4-5 seconds x 4. Taken to the ER. Temp was 98.3 on admission.