chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a health professional on 17 October 2008.  A 62-year-old female patient received a right deltoid intramuscular injection of FLUZONE SV 2008-2009 (lot number U2747AA) on 16 October 2008 (reported as 16 October 2007) and three hours later, she complained of injection site redness and "hotness".  The patient went to the emergency room later in the day due to shortness of breath.  She received Prednisone for the injection site redness and was released.  Outcome was reported as 'unknown'.  Documents held by sender: None.
20MAY94 inject site became red, hot & sore later had fever of 102 this was treated w/APAP; arm still red & hot area of 15cm x 15cm;
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with the 1st dose of GARDASIL (anatomical route of vaccination, lot # and expiration date were not provided) for prophylaxis. The nurse reported, that the patient might receive a second dose of GARDASIL 9 to complete the series that was started with GARDASIL. No adverse effects reported.
p/vax pt whole arm swollen & hot; ER recv benadryl; still has swelling 15mmx30mm; medial aspect of lt forearm;
Headache, Angina, Lightheadedness Narrative: Employee was seen in ED for treatment.
Patient menstrual cycle and hormones were severely impacted to the point of uncontrollable crying; Patient menstrual cycle and hormones were severely impacted to the point of uncontrollable crying; Patient menstrual cycle and hormones were severely impacted to the point of uncontrollable crying; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), HORMONE LEVEL ABNORMAL (non-serious), CRYING (non-serious), outcome "unknown" and all described as "Patient menstrual cycle and hormones were severely impacted to the point of uncontrollable crying". Additional Information: Patient menstrual cycle and hormones were severely impacted to the point of uncontrollable crying. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 3MAR96 & 5MAR97 pt devel a light case of chickenpox;
Day 3 post injection employee stated she had welts and then a rash down her left arm beneath the injection site. This was proceeded the day before with pain down the left arm the entire day.
Fever to 102 on day of vaccines. Fever lasted approx. 72 hours
Lot of anxiety; Very teary; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Lot of anxiety) and TEARFULNESS (Very teary) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced ANXIETY (Lot of anxiety) and TEARFULNESS (Very teary). At the time of the report, ANXIETY (Lot of anxiety) and TEARFULNESS (Very teary) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
This spontaneous report was received from a licensed practical nurse refers to an unknown number of patients that might have been vaccinated with a doses of GARDASIL (doses, route and lot numbers not reported) that were improperly stored. It was noted that the nurse was not sure how many patients would be involved and dates of administration were not available at the time of the report. No adverse events were reported. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Vomited soon after shot. At home-shower. Red rash neck-tummy. Child complained-tummy pain, (R) arm pain. Few bumps on chest.
No signs or symptoms reported; Administrator report a temperature excursion on ROTATEQ and the doses were administered.; This spontaneous report was received from a administrator referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 03-MAY-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose for prophylaxis (strength and route of administration were not reported; lot # 1742458 had been verified to be a valid number; expiration 22-JAN-2022). It was reported the temperature excursion was at 49.0 degrees Fahrenheit (F) on 09-APR-2021 and 48.7 degree F on 23-APR-2021, for a time frame of 1 hour 15 minutes and 0 seconds (cumulative) excursions. It was reported that no had previous temperature excursion. It was reported that the call was not due to data logger. No signs or symptoms reported.; Sender's Comments:  US-009507513-2105USA002898:
Weird red spot 2-3 inches in diameter below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Weird red spot 2-3 inches in diameter below the injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Weird red spot 2-3 inches in diameter below the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Weird red spot 2-3 inches in diameter below the injection site) outcome was unknown.            No concomitant and treatment medication were reported.  Action taken with mRNA-1273 in response to the event was not applicable
Fever, fatigue, muscle & body aches, chills, headache, nausea, tremors in both arms, sore throat.
No adverse affects reported; an improperly stored dose ofROTATEQ was administered; Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions/ allergies were not provided.   On 26-JUN-2019, the patient received an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number R033256 and expiration date 23-JUN-2020; frequency and dose number were unknown) orally for prophylaxis (product storage error). No adverse effects were reported. No product quality complaint (PQC) was involved.   The time frame was Temperature 65.102 Fahrenheit scale 1 hour. There was no previous temperature excursion. Data logger was involved.
Patients arm was very painful and he could not lift it after a dose of PNEUMOVAX23. He went to ER and M.D. said Inj. site was correct and he must be having a non-specific reaction to Inj/Serum. Prescribed Diazepam 5mg Q 8H.
Bilateral lymph node swelling under the armpits and at the elbows. Neck stiffness. Chest soreness.
Chills, arm pain up into my shoulder, rash at injection site that burns and itches
Moderna COVID 19 Vaccine EUA 9 days after vaccine red rash appeared on left arm at injection site. Rash slightly itchy and painful. 3 days later rash has increased by 50%  but lighter  appearance and no longer itchy or painful
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Batch/Lot number: unknown), on 12Mar2021 as dose 2, single (Batch/Lot number: unknown), on 31Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 15Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Patient stated that she had no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2023) Positive, notes: Day 1 is when I started taking paxlovid and received my first positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient received paxlovid as treatment drug from 25Apr2023 to 30Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300183094 same reporter/patient, different drug/AE (Paxlovid);
No other adverse event's were reported; Administration of an expired dose of MMR Il; This spontaneous report as received from an office manager referring to a patient of unknown age and gender. The patient's current condition, pertinent medical history and drug reactions or allergies were not reported.     On 02-FEB-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # S037497 and expiration date reported as 20-NOV-2021), 0.5 ml one time reconstituted with 0.5 ml sterile diluent one time (lot # T010321 and expiration date reported as 25-OCT-2022) for prophylaxis (expired product administered). measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) has not undergone a temperature excursion. No other adverse events were reported.
Pt complained of right shoulder abscess/ cellulitis. Fever incresed 103. Tx: Augmentin 10cmg treatment.
Generalized urticaria developed a couple of hours later.  No resolved with Benadryl.  Resolved with Atarax and Orapued.
Fever to 102 started 3/25 and continued through 4/5. Rash started 3/29, rapidly progressed, erythema multiforme, trunk extremities, face. 3/31 was completely covered. 4/6 rash improved healing and scarring.Treated with ibuprofen for fever 3/25-3/31.
Blurred Vision /Blind Spot in Right Eye in July 18th 2021 11:00PM  Headache on right side of head
Swelling and redness from top of arm to elbow, radiating heat. Lasted about 5 days. Nausea and vertigo occurred for about 2 days.
injection site: redness, swelling, itchy, raised area, very similar to a bee sting/ with the 1st dose, she had a similar reaction and a red spot; injection site: redness, swelling, itchy, raised area, very similar to a bee sting/ with the 1st dose, she had a similar reaction and a red spot; injection site: redness, swelling, itchy, raised area, very similar to a bee sting/ with the 1st dose, she had a similar reaction and a red spot; mild allergic reaction; This is a spontaneous report from a non-contactable consumer (pateint). A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 07Apr2021 09:00 as 1st dose, single; then on 06May2021 18:00 as 2nd dose, single; the patient received both doses via an unspecified route of administration on the left arm at the age of 27 years old (Batch/Lot number was not reported) for COVID-19 immunisation. Medical history included mental illness, anxiety, moderate depression, bipolar depression, post-traumatic stress disorder (PTSD), migraines, polycystic ovarian syndrome (PCOS) and sulfa drugs allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC), lamotrigine (LAMICTAL), cetirizine hydrochloride (ZYRTEC ALLERGY), rizatriptan benzoate (MAXALT); all for excendrine migraine. On 07May2021, the patient had injection site: redness, swelling, itchy, raised area, very similar to a bee sting. The patient stated that with the 1st dose, she had a similar reaction on an unspecified date and a red spot about 1 inch wide remained. The patient was treated with ice (as reported), diphenhydramine (BENADRYL) and ibuprofen for mild allergic reaction. The patient had no other vaccines in four weeks and was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received injection on 03/20/2019 and states it was hurting from day of, called office on 03/26/2019 to report and was seen that same day, no redness, swelling or knot noted on exam. Warm compresses and MOTRIN ordered along with follow up appointment given. Patient returned on 03/29/2019 and reports no change in symptoms. Rates pain 6/10 in the mornings and 4/10 by night time. Still no redness, swelling or knot noted. Rx for 5 day Prednisone therapy and follow up on 04/03/2019. Reports no weakness or pain anywhere else. If no improvement noted at next visit, will refer to MD.
odd pains just below the skin; "odd pains just below the skin. Almost felt like bee stings. On my legs and arms"; "odd pains just below the skin. Almost felt like bee stings. On my legs and arms. Some on back and abdomen."; "odd pains just below the skin. Almost felt like bee stings. On my legs and arms. Some on back and abdomen."; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 12Apr2021 at 09:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient had no known allergies. Concomitant medications included adalimumab (HUMIRA), methotrexate (RASUVO) and atenolol (TENORMIN); all taken from an unknown date and unknown if its ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 24Mar2021 at 13:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation and the patient had no reactions with first vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 19:30, 10 hours after the second vaccine, the patient started to have odd pains just below the skin. Almost felt like bee stings, on her legs and arms, some on back and abdomen. They continued through the night but stopped by 09:00. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events "odd pains just below the skin. Almost felt like bee stings. On the patient's legs and arms. Some on back and abdomen" were recovered on 13Apr2021 at 09:00.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Suspected metastatic disease of unknown origin, anticipate incurable course, doing very poorly in the hospital right now.  -CT chest, abd, pelvis: Multiple solid pulmonary nodules with the largest in the right upper lobe measuring up to 1.5 cm. These are suspicious for metastases. Loculated pleural fluid in the right major fissure. Additionally, there is adjacent bronchiectasis and streaky opacities of the right middle lobe and right lower lobe. The etiology for the fluid is not totally clear on this exam.  Metastatic disease versus infection seems most likely.  Lytic lesion in the right lateral ninth rib. Nodular soft tissue lesions of the right anterior chest wall and centered in the right gluteus musculature. Findings are most likely neoplastic or possibly infectious.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Around 1310, I had just exited the clinic and found that patient was sitting in the waiting room chair with mother by her side. Patient looked pale and clammy and was slow to respond. I immediately went to get my gloves, blood pressure cuff, stethoscope, and pulse ox. I then assisted the patient to lay on the floor also assisted by her mother. Feet elevated with chair. Immediately, patient's face color came back to pink and patient was able to speak to me when I asked questions. Blood pressure t
Patient had symptoms of Congestive Heart Failure about an hour after injections. Decreased heart rate and light pulse.
Pt recvd 5th dose of vax & 21SSEp92 c/o h/a, dizziness, local swelling, discomfort, & soreness @ the inject site;
pt recv vax 7/10/98 & 7/20/98 pt devel a fever & a rash on torso & extremities;
Previously did not have headaches or any disease conditions, no head injuries. After receiving 1st two doses (08/11/2011, 11/23/2010) of vaccine, she had severe headaches, physician ordered Motrin. Third dose was 03/24/2011.  1st witnessed seizure was 12/10/2011. Evidence of hidden soiled underwear in her room were found prior to this date, which suggest she had been having seizures prior to the 1st witnessed seizure.  Diagnosed with primary generalized seizure disorder now taking Keppra.  Had Stevens-Johnson reaction to taking Topamax. Her last witnessed seizure was 08/09/2012.
Diluent from Hib vaccine was drawn up but not mixed with powder. Pt was administered diluent only. Vaccine/component omission-Diluent without the vaccine. Diluent and powder not connected with a tie.
pt recvd vax 17FEB93 & presented to MD w/yellowish-orange tinge on nose, palms & soles; 20MAR93 lab eval revealed elevated liver function tests w/SGOT 41, LDH 493 & serum alkaline phosphatase 289; 26MAR93 lab eval revealed an elevated WBC ;
This spontaneous report as received from a registered nurse via company representative refers to a 9 week old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 19-SEP-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB, lot # M014926 (strength, dosing details, anatomical location and expiration date were unknown) for prophylaxis. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Information has been received from a physician referring to an unspecified number of unspecified patients. No medical history or concurrent conditions were included. Since 06-SEP-2016, the patients had been administered doses of PEDVAXHIB (lot # L042257, expiration date 17-AUG-2018, dose and route unspecified) which were improperly stored. No adverse effects reported. This is one of the reports received from the same reporter. Additional information has been requested.
pt recv vax; seen on 11apr96 w/ zoster lt thigh down to knee;low grade T;
APPROXIMATELY 5 MINUTES AFTER VACCINATION, PATIENT HAD EPISODE OF WHAT APPEARED TO BE VASOVAGAL SYNCOPE - PALLID, CLAMMY, SHAKY, WEAKNESS, FELL TO THE FLOOR AND QUICKLY CAME BACK TO CONSIOUSNESS.    BP WAS TAKEN IMMEDIATELY AFTER, WAS WITHIN NORMAL LIMITS.  PARAMEDICS AND STORE MANAGEMENT RESPONDED TO EPISODE.  PARAMEDICS ASSESSED AND MONITORED PATIENT, PATIENT DID NOT REQUIRE TRANSPORT TO HOSPITAL.    PATIENT REMAINED AT THE PHARMACY FOR A FEW MINUTES AFTER PARAMEDICS LEFT THE SCENE.  PARENTS WERE WITH HIM DURING VACCINATION AND ESCORTED HIM HOME.  ALTHOUGH STILL A LITTLE PALE, PATIENT HAD RECOVERED AND LEFT ON HIS OWN, WELL AFTER THE NORMAL 15 MINUTES MANDATED WAITING PERIOD.
Dizziness started exactly 24hrs after booster. Dizziness progressed over the next 3-4hrs and turned into vertigo. 30hrs after vaccine I was unable to walk unassisted, open my eyes (due to vertigo) and was uncontrollably vomiting (due to vertigo). 31hrs after vaccine I went to the hospitals emergency room and received fluids and meds. I?m 1wk since my vaccine and still suffering from ongoing dizziness and vertigo. I visited my doctor today and they confirmed it was due to the covid booster I received on 12-20-21
My reaction to the Moderna 2nd dose, was significant. I was sick with a fever and flu like symptoms, but felt better after a few days, but not 100pct. About 7 days later I had a deep pain just under my left shoulder blade, like a muscle or torn rib but more intense, about 3 days later I developed a painful and itchy rash on my right shoulder Blade. I remember feeling extraordinarily exhausted, extreme headaches and brain fog so bad that I could not focus, concentrate or remember what I was doing. I lost my temporary job because I was unable to comprehend or remember things. I was able to get into the doctor who confirmed it was Shingles. They gave me a steroid and anti viral. The rash went away, but the lethargy, weakness, and radiating pain in my back, right shoulder, neck and arm and chest is still there.
Immediate soreness (minor), intensifying to moderate soreness several hours later.   About 11 hours after dose: joint paint, fatigue, muscle aches;  After another hour: chills and shivering followed by low-grade fever (betwe. 100 and 101).  Alternating feelings of chills and fever continued with muscle aches and joint pain and what feels like a sinus headache. Acetaminophen taken and helpful.
Over the past few months, my vision has gotten worse. I went to my eye doctor (October 1) and she said I had dry eyes. She ended up giving me Punctal plugs, which has seemed to improve things for me.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PROGESTERONE from an unknown date to 08-Feb-2021, ESTRADIOL (ESTROGEN) from an unknown date to 08-Feb-2021 and VITAMINS NOS for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 27-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 27-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.