chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2011US04709 is an initial spontaneous report received from a health care professional on 16 Sep 2011. This report refers to a 24-year-old male patient. He was a soldier and he was bitten by a stray dog on his hand while breaking up a dog fight and had a likely canine exposure three months prior to redeployment on an unspecified date. It was reported that the doctor who treated him stated that he would have given exposed soldier expired rabies vaccine shots (manufacturer and batch number: unknown) on an undetermined date. It was also noted that he received incomplete post exposure schedule of vaccine. Three months after redeployment symptoms began making the overall incubation period of nearly six months. He was admitted for suspected rabies on 19 Aug 2011 and it was confirmed on 21 Aug 2011. Typing was consistent with foreign canine rabies. He expired on 31 Aug 2011.
Dizziness, nausea, foot cramps, 5 days later symptoms still persist.
Case number PHEH2015US026839, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 24 year old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 29 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not known why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Shingles Vaccine Left Arm - Large red circle, warm to touch, raised and swollen at injection site.  Mild fever (99.7).  Constipation.  General malaise.  On 9/30, fever resolved and area on arm is less red and swollen, but now it has became itchy.  Constipation resolved on 9/29.  I have not called doctor yet, as this seems consistent with the vaccine information sheet. Flu vaccine was given in right arm, but I have had that before with no reaction.  That injection site is fine - no reaction.  I do not know the name of the flu vaccine but it is quadrivalent.
Information has been received from a nurse practitioner concerning a patient who was vaccinated PO with the first 2.0 ml dose of ROTATEQ.  Subsequently the patient experienced a rotavirus infection.  The patient sought medical attention through an ER visit.  Subsequently, the patient recovered.  There was no product quality complaint.  Additional information has been requested.
I broke out in hives.  5 days later, I still have the hives and they are spreading all over my body.
Lethargy, febrille sezuires, electrolyte imbalence high Potassium, low Sodium, extremely Elevated WBC 23,000-53,000, low grade fever 99.0, apnea, starring off into space, unresponsive,diarreha, vomiting, teal-green meatalic colored stools, High-pitched scream, needed Blood Transfusions. HOSPITALIZED 21 DAYS. Still has elevated liver functions abnormalities. Had GERD for months after shots.  03/23/2007 MR received for 17 day hospital stay following transfer from another facility.  Initially seen in local ER 3 days after 2 month vax. with low grade temps (101.2), fussiness, emesis, lethergy, and multiple loose stools. Transfered to current pediatric facility after multiple unsuccessful LPs. Verified with PCP-NO Rotateq given. Multiple interdisciplinary consults:  Endocrine: Unlikely primary endocrine problem.  Likely that primary gastrointestinal illness led to severe protein losing enteropathy and consequent metabolic derangement.    Heme/Onc. consulted to R/O leukemia.  Elevated WBCs thought to be margination from steroid administration and dehydration.  Prolonged PT/PTT possibly due to severe protein losses and inadequate production of factors by the liver.  Coag studies normalized after FFPx1 and Vit. K on 6/4/06.  Infectious Disease consulted for undetectable IgG level of <50.  Low IgG probably 2' to GI losses of protein.  Given IVIG for hypogammaglobulinemia. (NO live vaccines to be given x 11 months s/p IVIG).  Gastroenterology consult with DX of severe acute gastroenteritis leading to protein losing enteropathy.  Received albumin x1.  Principal DX:  Sepsis Additional DXs: Electrolyte Imbalance, Endocrine Imbalance, Viral Gastroenteritis, Protein losing enteropathy.
Extreme Diarrhea, Nausea. Started 2.5 hours after shot was given  Explosive .............
Onset 5 hrs ago. Erythematous and urticarial rash; location is abdomen, both arms and both legs. Denies cough, diarrhea, fever, painful rash and vomiting. No treatment at this time.
Patient received 2 vaccines on 1/30/12. On 3/26/12 came in for second dose in series, reported that on left arm can still feel a lump and has soreness. Reports one week after vaccine had numbness in (L) arm and (L) face lasting 1-2 days. No external swelling or lump noted.
This spontaneous report as received from a Nurse refers to a 16 year old male patient. On 05-SEP-2014 the patient received a dose of PROQUAD (lot # J011330, exp. date 13-MAR-2015, 0.5 ml, subcutaneous) in error. No adverse effects to patient. This is one of several reports received from the same source. Additional information has been requested.
Received phone call from Pt. Co-workers that the pt. is in the SCU at the hospital due to hives, rash and swollen tongue. Pt. returned to work after injections and coworkers stated she was fine when she left but later in the P.M. symptoms started. Pt. received both VIS sheets prior to injections. State Immunization Program notified of pt. reaction.
13 days after receiving the second dose I was walking my trash can to the street and I could not breath very well. I went to the Urgent Care and was told I had blood clots in my lungs. I was hospitalized and given treatment for the blood clots.
Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by reporter.     On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: Em9809), on 05Mar2021 as dose 2, single (Lot number: Eme199) and on 29Oct2021 as dose 3 (booster), single (Lot number: Ff2587) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre diabetic" (unspecified if ongoing), notes: Other medical history: Pre-diabetic. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I came up positive for Covid 19 around 21May or 22May2022; Negative, notes: I showed negative after the 5 days and then went back to work; Positive, notes: About 4-6 days later I took a home test/ The test was again positive with Covid; Positive, notes: I have been quarantined for 10 days since and now I am still showing positive for Covid via home test. Therapeutic measures were taken as a result of vaccination failure, covid-19 with antiviral treatment drug Paxlovid, starting from 23May2022, till 28May2022.  Clinical course: Patient came up positive for Covid 19 around 21May2022 or 22May2022. He began taking PAXLOVID on approximately 23May2022 and took the 5 day course. He showed negative after the 5 days and then went back to work. About 4-6 days later he took a home test after feeling dizzy and having a headache, low grade fever (same type of symptoms as when he had Covid). The test was again positive with Covid. Patient have been quarantined for 10 days since and now he is still showing positive for Covid via home test.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot FF2587, EM9809 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF2587, EM9809 fill lot FF2556, EM9807 and the formulated drug product lot FE5315, EM9805. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Approximately 2 minutes after administration of COVID-19 immunization, patient began feeling weakness in knees and legs. He had nausea/vomiting and shakiness. Patient was moved back to seated area where oral fluids were administered. Patient was monitored for approximately 2 minutes longer. He began sweating, getting cold and clammy. Next, his lips began turning blue. At this point, his blood pressure was taken and we called EMS. While waiting on EMS to arrive (shortly after blood pressure was taken), patient began talking again and feeling better. Father reported the patient has some anxiety issues with needles and intense events in the past. EMS arrived and confirmed patient was okay.
WITHIN 3 MINUTES OF ADMINISTERING VACCINE, PATIENT ALERTED ME THAT SHE FELT DIZZY; SAT HER BACK DOWN IN IMZ BOOTH; WITHIN SECONDS SHE FAINTED; CALLED EMS; LOWERED HER TO THE FLOOR; POSSIBLE SEIZURE (NOT CONFIRMED) BUT LOOKED AS THOUGH HER ARM STIFFENED; PT HAD NO HX OF EPILEPSY; MADE GURGLING NOISES B4 SHE REGAINIED CONSCIOUSNESS; ROLLED HER ONTO HER SIDE SO SHE WOULDN'T ASPIRATE; SHE STATED THAT SHE WAS IN A DREAM STATE WHEN SHE WAS SITTING IN THE POST VACCINATION SEATING; BODY FELT NUMB& THROAT FELT TIGHT BUT BOTH RESOLVED WITH NO NEED FOR EPIPEN; FELT QUEEZY FOR  CONTINUING OBSERVATIONS;  EMS ROLLED HER OUT ON THE STRETCHER TO CONTINUE OBSERVING HER IN THE TRUCK & THEN RELEASED HER INTO HER FATHER'S CARE;
Chronic urticaria with Angioedema, currently on antihistamines and prednisone.
Patient developed injection site related rash which spread from site of injection to patient's back. ER stated this a common injection site reaction and would treat appropriately
School sent patient with family to public health clinic to be vaccinated. Among 4 vaccines admin., DTaP was expired; received 3/3/08; expired 2/1/08; school and family notified - to re-vax in one month
6/11/08 VARIVAX given right arm SQ.  Child had 4" x 4" red erythematous area - 48 hours after shot on 6/9/08.  Seen by us and advised to use compress and Advil for comfort.  A dose of Benadryl one teaspoon to be given if itching.
This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M010475, expiration date: 01-SEP-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 0.5 degrees Celsius for 7 hours and 46 minutes. Additionally, it was also stated that separate doses from the same lot (lot # M010475, expiration date: 01-SEP-2017) of PROQUAD were exposed to a temperature excursion of 0.5 degrees Celsius for 4 hours. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. Additional information has been requested.
The day of and after I had severe muscle and joint pain, tired, headache and stomach pain.  A week later I developed chest pain on the right side of my chest, wheezing and breathlessness.  Deep breaths hurt. I had to take my asthma pump.  I almost never use it and have never had a flare up like this.  I am still achy and have joint pain but it is better than earlier in the week.  The chest pain and breathing issues are new and concerning.
Vaccine was injected approximately 7:20 am. Patient was in observation area for 15 minutes and left the facility. 7:50 am patient was in the employee parking lot and complained of shortness of breath. Parking security radioed back to the facility. The doctor and onsite EMS staff ran to assist, and found patient short of breath with stridor, o2 sat in 70's with heart rate 140. Epi pen was administered. Patient was transported to Medical Center. EMS who transported him reported improved breathing and O2sat in 90's, heart rate 120's. The Occupational Health RN will follow-up with the patient.
Had vaccine on a Tuesday & Friday started having heart issues by Friday.  Was recommended to go to the ER by her PCP.  She was admitted to the hospital, stayed 8 days & 3 of the days were in ICU.  She states that her Na (sodium) was 116 and her WBCs (white blood cells) were low.  She was diagnosed with CHF (congestive heart disease), AF (atrial fibrillation), & was told that her left ventricle was functioning at 25%.  Her father has a history of 2 massive heart attacks, but she has never had any heart issues.
Per father (who is an EMT) patient did well all day following shots, until approximately 10 pm. Pt was on bed found to be "soaking wet" from sweating, curled in fetal position with arms shaking (jerking, carried downstairs, was "post ictal" around 2 minutes- talked for few minutes, then eyes rolled back and did same thing. Shorter than 1 time. Alert upon arrive to ER around 10 minutes later.
Temp 102 through night. Given Tylenol every 4 hours, decreased by 3:30pm. Left leg swelling with decrease in swelling by 3:30pm. Crying for 8 hours-difficult to console. Ok with comfort by 10am, ok and happy by 3:30pm 3/9/07.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUL-2017, the patient was vaccinated with improperly stored dose of ARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Felt fine the rest of the day after receiving, but woke up with rash. States it was a red, scaly, itchy, patchy rash. Covered body area from chin to navel level on front and back of body. She did not take any medication to treat the rash. Rash lasted approximately 5 days.
dizzy sick to her stomach chills, muscle pain (myalgia) Global Headache, low back pain chest pain tachycardia
This is a spontaneous report received from a contactable consumer (patient). 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 10 Mar 2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 10Mar2021 patient received shot 1. Patient experienced very minor lip tingling on 10 Mar 2021, while waiting 15 min, reported it to the nurse, the nurse had patient wait an extra 15 min. Patient left and was fine. Patient went back for the 2nd dose on the 31st. Patient was asked If she experienced any side effects after the 1st dose , patient told the doctors about the lip tingling. Patient was refused the 2nd dose. Outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient admitted to the hospital with a platelet count of <2 on 8/7/2021.  Previous known platelet count at a doctors office prior to vaccine was 188 on 7/19/2021.  Patient received the vaccine on 7/27/2021.
Patient started experiencing pain in the vaccinated arm as well as redness below the injection site on the left upper arm.
Intussusception - 1 day of projectile vomiting, back arching, fussiness and black tarry stool.
pain was different than that and he wanted to know if it could be related to vaccine. He asked if having joint pain after is that a side effect. He was having terrible joint pain in his right knee. He mentioned it is more common on the left and was not worried about his left but more in his right foot. He used to have this, but this time is something different. He wasn't sure if the joint pain in the right foot was normal or abnormal. Therapeutic measure was taken as a result of joint pain with pain medication. The outcome of the event was unknown.  Information about batch/Lot number has been requested.
4 days after administration of vaccine developed urticaria, generalized, no fever, no respiratory distress, no mouth/throat swelling, no joint swelling or limp. No intercurrent illness.  Started on backs of legs, generalizing to chest, stomach. Initially no itching, but persisted a month, became itchy, and eventually resolved with long acting antihistamine (clarinex).
Blood in the urine; vaginal bleeding; Frequent urination; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (Blood in the urine), VAGINAL HAEMORRHAGE (vaginal bleeding) and POLLAKIURIA (Frequent urination) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE, LISINOPRIL, ESCITALOPRAM, ATORVASTATIN, LEVOTHYROXINE and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication, ANASTROZOLE.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced HAEMATURIA (Blood in the urine), VAGINAL HAEMORRHAGE (vaginal bleeding) and POLLAKIURIA (Frequent urination). At the time of the report, HAEMATURIA (Blood in the urine), VAGINAL HAEMORRHAGE (vaginal bleeding) and POLLAKIURIA (Frequent urination) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Urine analysis: negative (Negative) negative for UTI infection.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information regarding corrective treatment was reported by the patient. Caller reported patient's doctor's visit is scheduled for the first week of July.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received :New event was added, lab test added, AE outcomes and contact email was updated. Clinical course updated.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date Vaccine was initially stored in refrigerator 6 Oct 2021.  No concomitant medication were reported.  No treatment medication were reported.
Information has been received from a RN concerning a 28 yr old pt who was vaccinated with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) in 1978 (date not specified). On 08Jul05, the pt was vaccinated SC with a 0.5mL second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 648479/0635P) and twelve days later developed a rash on his head and arms, had one swollen node and itching. The pt sought unspecified medical attention. It was reported that the pt was not recovered at the time of the report. There was no product quality complaint involved. Additional information has been requested.
Fever 3° above my normal, nausea, belly pain/cramps, zero appetite, headache, cramp in left buttock, pain in left arm near shoulder, intermittent chills, weakness (couldn't walk dogs down the block), couldn't sleep all night because of discomfort that first night. On Dec 7th, couldn't eat anything but water, continued symptoms but took ibuprofen so felt less cramps/pain/nausea and was able to sleep most of day.  No fever in a.m., mild fever in eve.  Was able to sleep overnight. On Dec 8th,  still not strong, and could only eat toast, oatmeal, broth with rice.  Stayed mostly in bed but felt much improved. This morning (Dec 9th) still mild headache and nausea.
Injection site very sore with large area of swelling and skin redness by AM of 05/16.  Skin very warm to touch.  AM of 5/17 less soreness reduced swelling and redness. Skin still warm and symptoms moved down the arm closer to elbow.  Am of 5/18 redness and swelling almost gone, some soreness remained. Used hot and cold packs on site.
This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 7-year-old female patient who had received KINRIX (batch number 5TD93, expiry date 10th September 2017). This case was associated with a product complaint.  On 9th October 2015, the patient received KINRIX (intramuscular). On 9th October 2015, less than a day after receiving KINRIX, the patient experienced injection site swelling, injection site redness and inappropriate age at vaccine administration. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site swelling, injection site redness, inappropriate age at vaccine administration and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site swelling and injection site redness to be related to KINRIX. Additional details provided were as follows: The 7 years old patient received a dose of KINRIX, which led to an inappropriate age at vaccination. The patient experienced swelling and redness at an unspecified injection site. This case is linked to 2 other cases US2015144654 and US2015144657 (reported by the same reporter). As a precaution QA report was filed for all cases (see case US2015144654 for more details).