chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 39 y.o. male came to our Hospital/ ER with complaints of bilateral lower extremity weakness. A week after the vaccination, patient reportedly developed headache, myalgias, congestion, neck and shoulder pain, weakness and tingling of his hands. Subsequently he developed numbness tingling and weakness of both lower extremities. His weakness has progressed to the point that he needs assistance to go to the bathroom. He also complained of low back pain that is chronic. He also mentions of numbness of the tongue described as a sensation as if he has burned his tongue. There are no visual changes speech changes facial droop or difficulty swallowing. He did not have any fever chills urine or bowel symptoms. No saddle anesthesia. No history of steroid use or drug use. He is a current occasional smoker. His wife also had similar symptoms but she is not vaccinated.  He had a CT and CTA of the brain at hospital that showed no acute process and an LP was attempted but unsuccessful. The patient was then transferred to Larger hospital and was see by neurology, who obtained MRI of the L spine and EMG, LP was preformed and showed no infectious cause. The patient was placed on IVIG and was also given neurontin. Patient went into respiratory distress and was intubated on the night of 11/11.  With no improvement of symptoms with 5 days of IVIG, the patient is now currently doing 5 PLEX sessions and will be reassessed after completion of therapy.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received FLUARIX QUADRIVALENT (2018-2019 season) (batch number 5T943, expiry date 30th June 2019) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site swelling, erythema and injection site erythema. On an unknown date, the outcome of the injection site swelling, erythema and injection site erythema were not reported. It was unknown if the reporter considered the injection site swelling, erythema and injection site erythema to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional information was reported as follows: The age at vaccination was not reported. On an unknown date in 2018, the patient was vaccinated with a dose of FLUARIX QUADRIVALENT 2018-2019 season.  Pharmacist reported that they had been giving FLUARIX QUADRIVALENT at work for years. However, this year they had been seeing a lot of local reaction which was not normal. The pharmacist reported this case for one of her employee that she knew. The patient experienced a two inch diameter redness at the injection site and raised area around the injection site. A few inches away the injection site the patient also started seeing some redness. This case was linked with case US2018176517 and US2018176519 reported by the same reporter.
Information had been received on 07-JUL-2016 from a medical assistant who reported that on unspecified dates, an unspecified number of patients received an improperly stored dose of RECOMBIVAX HB 2.5/0.5 (lot# L038018, expiration date 13-SEP-2017), ROTATEQ (lot# L033543, expiration date 30-MAY-2017) or VAQTA (lot# M009377, expiration date 17-JUN-2017). Temperature for all products was reported as 0.9C and time frame was seven hours. Call was because of a data logger. No adverse effect reported. Additional information has been requested.
Hives all over body (left arm, both legs - inner thighs and calves, ribs, chest, back, shoulder blades, neck, hairline). Began approx. 24 hours after vaccine. Pt took Benadryl 9:30pm on 11/21 and woke up and rash disappeared overnight.  Swollen lymph node in left armpit. Very sore to move. Began approx. 12 hours after vaccine. Still occurring.
Injection site at 830pm started itching intensely. Injection site expanded to darkened bruise nickel to quarter to half dollar size. Became darker within 4 hours of injection to almost deep blue black with 2 small lumps that turned to the feeling of a very hard solid flat feeling like that of a flat quarter underneath the skin. Outside the bruise hives started in the size of mosquito bites but reduced with benadryl. Next day outside the bruised are a larger secondary rash started. Pain and itch is intermitment and goes up and down with benadryl and tylenol and ibprofen. Also the 7th. awoke extremly stomach sick and horrible headache. Same issues thru to 1/11 then felt overly lethargic tired sleepy all day on and off with runny nose and headache. 1/12 add diarrhea to the list of issues.
Case number PHEH2014US015873 is an initial spontaneous report received from a pharmacist on 06 AUG 2014. This report refers to a patient of an unspecified age and gender. The past medical history and concomitant medications of the patient were not reported. The patient received only MEN CWY-135 liquid conjugate component of MENVEO (batch number: not reported) intramuscularly without reconstitution with MEN A lyophilized powder component on an unspecified date. One week after the maladministration, the patient received a complete dose of MENVEO. No adverse events were reported following this maladministration (inappropriate preparation of medication).
A report was received from a health care professional on 11/08/02, concerning a female vaccinee who inadvertently received Fluvirin Subcutaneously on 11/07/02. No adverse reaction was reported in relation to the incident. There was insufficient information to determine the reporter's causality assessment. Cross reference with: PJP200200731, PJP200200741 and PJP200200749.
Pt developed a widespread, confluent urticarial rash with sandpaper feel on abdomen and back. There was no involvement of extremities or face. It lasted about 24 hrs and improved with Benadryl.
Systemic: Nausea-Medium, Systemic: Vomiting-Severe, Additional Details: patient looked pale, was advised to be seated and wait it out - and he was given gatorade to help replenish electrolytes and keep hydrated.  He did wear a very thick jacket and the store is stuffy, with low ventilation
FAINTED 5 MINUTES AFTER VACCINATION FOR A FEW SECONDS. ONCE SHE CAME TOO WAS FEELING CLAMY AND WAS PALE. VOMITED 5 MINUTES LATER AND FELT IMMEDIATLEY BETTER.
Pt states woke up with arm red and as day went on became swollen. Later began to have chest pain and shortness of breath and nauseated. She stated she ate to see if that would help and took aspirin without relief. Left arm at time was now red, swollen, and had an elevated bump that was hard with knots in the center of it that was tender to touch. She did apply ice to the area. Patient did take Tylenol for pain. Patient states sharp pains continued in the chest area but were subtle if she was not moving much but intensified with movement. Pain to the left arm was to touch only. Patient wanted to go to the Urgent Care but was referred to ED due to chest pain. Patient was worked up for cardiac with all negative results but admitted for 24 hour observation. She was given pain medications during admission per patient. She was discharge the next morning with an antibiotic, Cefadroxil 500mg twice a day for ten days.
3/24, 8 a.m. shot 5p, right arm was a little sore 6p, right arm, shoulder, and neck could not move 8p, massive chills all through the night. 3/25, 6a, clammy, whole body sore, back ache, headache 7a, massive chills again, went back to bed. 11a, then a slight fever all day, stayed in bed 5p, chilled again. laid on couch all day until going to bed 3/26, Morning started out foggy, arm hurts just a bit, by my back aches terrible. Hoping by 3/27, I am back to normal.
Positive covid test; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive covid test) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive covid test). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive covid test) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. On 15-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of Covid-19 test positive after vaccination, this event is assessed as unlikely related to mRNA-1273.
husband's blood count was very low, was bleeding in colon; husband's blood count was very low, was bleeding in colon; his platelet count became too low; This is a spontaneous report received from a contactable consumer (patient's wife) and from the Pfizer-sponsored program. An 86-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 86-years-old on 06Feb2021 (also reported as 13Feb2021, pending clarification, Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included heart condition. Concomitant medication included warfarin sodium (COUMADIN) taken for heart condition, start and stop date were not reported. The patient received the 1st dose on 06Feb2021 (also reported as 13Feb2021) but missed the 2nd dose on 06Mar2021 (lot reported as "EL9269") because he was hospitalized. She mentioned that he is taking Coumadin everyday for his heart condition and his platelet count became too low. Wife wanted to know timing of the second dose. Her husband's blood count was very low, was bleeding in colon. He was on Coumadin after the hospital he will be going to the rehab. The patient underwent lab tests and procedures which included blood count: very low and platelet count: too low on unspecified dates. Therapeutic measures were taken as a result of Colonic hemorrhage and Platelet count low. The outcome of the events was unknown. The case was assessed as serious due to hospitalization (husband's blood count was very low, was bleeding in colon).  Information on the lot/batch number has been requested.
Pt did not report adverse reaction to us until her next visit to the pharmacy. She said that her Right arm was red, swollen and very sore. She also stated that there was a small sore where the injection site was located. She did not have a definite length of time, but said it lasted for about a week. She did not seek medical attention at that time. Symptoms have resolved now.
4-5 cm area of induration and erythema with some petechiae at margins, temp 102. No apparent infection, above all developed within 24 hours of getting PCV7 #4 and Varivax.
Small flare hives around injection sites (legs) and back - improved w/in 24 hours (occurred night of vaccines given).
pt recv vax & devel a lt facial droop, lt eye watering & inability to close eye on 7NOV96 2 days p/vax;pt went to MD & dx w/Bell's palsy;
Case number PHHY2012US013526 is an initial literature report received on 14 Feb 2012. Authors published the adverse events following administration of H1N1 vaccine to pregnant women that were reported to Vaccine Adverse Event Reporting System. This case refers to a female patient (age not specified). She was vaccinated with H1N1 (manufacturer and batch number: unknown) between 01 Oct 2009 and 28 Feb 2010. She was pregnant at the time of vaccination. On an unspecified date the patient had an intrauterine fetal death. It was reported that it could not be categorized as spontaneous abortion or stillbirth because the gestational age was not known. Authors concluded that the pregnant women who were vaccinated with H1N1 vaccination with inactivated and live vaccines did not show unusual pattern of maternal or fetal outcomes. The most common pregnancy specific adverse event was spontaneous abortion (SAB) and stillbirth, and more than a third of women who experienced SAB had at least one risk factor (advance maternal age). Seventy two percent of women who had stillbirth had at least one risk factor or had a pathological finding in the fetus or placenta, suggesting factor other than vaccination that may be contributed to the fetal demise. This suggested that women with higher risk were overrepresented in VAERS database.
LT THIGH SWOLLEN & RED 1 - 2 CM LARGER IN DIAMETER THAN RT THIGH
pt recvd vax 530PM 30JAN96 & father states around 1030-11AM noticed pt had unusual breathing -heavy breathing & went to check-eyes wide open but pt limp tried slapping cheeks, pinching & water on face-unable to arouse x 2-3min
Information has been received from a 61 year old female consumer with no pertinent medical history and no known drug allergies, who on 15-APR-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot not reported). There was no concomitant medication. On 16-APR-2009 the patient experienced "blisters" on the left side of her face above her lip and "it is just a little sore". She had not spoken or seen her physician yet to determine a diagnosis. At the time of reporting, 17-APR-2009, the patient's symptoms persisted. Additional information has been requested.
Significant muscle pain and muscle fatigue.  Initially only at injection site, but spread to entire left arm within 24 hours.
Woke with body aches, muscle aches, very sore arm. Now have Fever of 3 degrees,  body aches, headache, muscle ache, queasy
approximately 30 minutes following administration of vaccination (at the time I was released from observation), I began feeling a tingling sensation in my face as well as  itching at my temples, corner of eye, nostrils, and behind and inside my ears. I have previously experienced similar sensations after receiving immunotherapy allergy shots (and received epinephrine following those reactions).
mom stated diff to arouse fr sleep swelling w/redness of neck & mouth area w/redness;MD notes fr hosp erythema cheeks, ears, triceps-vax rxn;pt alert no swelling;given DPH IM & oral elixir
sore arm; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 17-Apr-2021, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-132192 (Patient Link).
Change in behavior, periods of fussiness, irritability, temper tantrums and urticaria. Referred to a neurologist for evaluation.
Patient reports dizzy feeling with some flushing almost immediately after injection. Symptoms prescribed for approximately 45 minutes. Patient appeared to have diminishing symptoms upon exit.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (unknown route and strength) Lot # K015827 with expiry date of 11-MAR-2016. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Got flu shot (L) arm on 10/12/10. here on 10/18/10 with father for his flu shot and mentions "rash" on (L) arm wrists. (L) hip and chin day after shot! 1st flu shot in her life. Possible rash from shot
1st shot Moderna lot 044A21A itchy immediately  2nd shot Moderna lot 036B21A itchy and dizzy 2nd day
I had my shot performed on 10/17 and found out I was pregnant shortly after my first dose. At 9 weeks pregnant on 12/9 there were some issues on our first ultrasound. 1) enlarged yolk sac 2) cyst on the umbilical cord and 3)hematoma. We were told likely we would miscarry, which today 12/21 our baby no longer has a heart beat and we were given a preliminary diagnosis of a nuchal cystic hygroma. The nuchal cystic hygroma is an extremely rare anomonly. We lost our baby.
Starting 06/16/2022, I was feeling really tired but thought I was just feeling tired due to my lupus and being busy. By Sunday, the fatigue was much worse, my head was hurting and I was having a hard time keeping up with the rest of the family on a hike. I went to bed early and by next morning I woke up and felt the same. So I took the at home test that day (06/20/2022) and it was positive. I contacted my doctor and he told me to isolate, and to wait until he consulted with the rheumatologist. So, after consulting, they decided the best course of action would be to do Paxlovid. I have 2 more doses left of the Paxlovid. I feel much better but still am having fatigue and a sore/hoarse throat. The cough and headache are almost gone but still slightly bothersome.
Pt recvd 3 doses of Engerix-B vax & did not seroconvert; booster doses were administered; no tx was given;
Rash at injection site - raised, red, warm, circular in shape - started 8 days after injection, started as small hives and formed the red circular shape over 24 hours.  Rash lasted for 48 hours and then disappeared
Initially, both hips became very painful. My Doctor said it was bursitis, and it probably is, but I thought you should know that it became apparent soon after the vaccine was administered and I had never had a problem like this before. The right hip has improved markedly, but the left continues to be an issue. I've done everything expected; stretching, ice, strengthening, but don't seem to be making much headway.
cough; headache; tested positive for Covid-19 after first dose of vaccine; This is a spontaneous report received from a female contactable consumer (Patient herself) of 34-years-old received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection, lot number; ER8729, Expiration date: Unknown) via unspecified route of administration on 10Apr2021 (at the age of 34-years-old) in right arm at 1ST dose with unknown dosage as single for covid -19 immunization. No information of other Products. Patient medical history and concomitant medication were not reported. No Investigation Assessment was reported. Healthcare professional details were declined. On an unspecified date, patient stated that she took the Pfizer Covid vaccine on 10Apr2021 and on 13Apr2021 she tested positive for Covid and on 29Apr2021 the test was negative. Patient was asked that whether she can take the second vaccine where still she had some cough and headache. Outcome of the event for covid-19 was recovered on 29Apr2021 and cough, headache was unknown.  Description of complaint: Patient stated that she took the vaccine, the Pfizer Covid vaccine about 4 weeks ago and two days after the vaccine she tested positive for Covid, one week ago the test was negative, was supposed to take second dose last Saturday but still has some cough and headache does not know if she should get the second dose. Product Details as follows: received first dose on 10 APR 2021, NDC, expiration and dosage unknown. Product strength and count size dispensed was not provided. Additional lot numbers were not provided. No Sample of the product available to be returned if requested. Details of packaging sealed and intact were not provided.  No follow-up attempts are needed. No further information is expected
Clinic Lead did not use Qualified Container and Pack-out for the initial vaccine transfer of 10 doses of Moderna. Moderna was transferred from one site to another site (travel time total 15 min).
This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.      No concomitant medications were reported.  The pharmacist reported that, temperature excursion occurred several days ago in the freezer. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer, and they just found out about the excursion in an audit.   No adverse event reported for the patient.  No treatment medications were reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 60 years 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: High blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.