chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning a 10 year old, Male subject, who had been receiving nasal FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. It was reported that patients received expired FLUMIST quadrivalent on 09-Dec-2014. The outcome of the event of two patients received expired FLUMIST quadrivalent was unknown. The report was considered to be non-serious.
Within 4 hours of receiving vaccine, patient developed fever to 103, nausea, vomiting, diarrhea.  Illness persisted for 4 days when began abating.  Went to ER for 3 liters IV hydration on day 2 of illness.  Ate possibly contaminated food day prior to onset of illness (and flu vaccine).  10/13/06 Received medical records from hospital which reveal patient seen in ER on 9/15 for fever 102.9, aches, weakness, lightheadedness, HA, malaise, chills, vomiting, diarrhea & abdominal pain & pain at injection site with paresthesias of left arm which began after flu vax same day.  Patient reported had similar s/s after previous flu shots but with longer time in between vax & onset of symptoms.  PMH: HIV +, recent c-diff infection s/p tx for sinus infection.  Kept in ER until following day when released home w/final ER dx: immunization reaction.  10/30/06 Received medical records from provider/reporter which reveal patient called on 9/19 & was seen on 9/20 with continued watery diarrhea, fever, chills & low BP. MD spoke with hospital for lab results & felt episode could be related to possibly contaminated food rather than flu shot; however, since it was patients 3rd negative reaction following flu shot, was not to receive any further flu shots./ss
Patient commented immediately after she received the injection that it was painful, within minutes of having a seat in the observation area she commented that her left arm was numb down to her fingertips, within mins the pharmacist administered Tylenol,  patient commented she was having issues breathing, at 12:07pm the pharmacist administered an epi pen.  After, she was brought to a room at the facility for observation.   Before we left, the center informed us that they believe she had a panic attack due to her history, we have contacted the patient for confirmation of final outcome but are awaiting a call back.
Patient came into pharmacy on 10-04-19 and her arm was red, slightly swollen, and hot to the touch from her elbow down but not painful. No other alarming symptoms no fever, breathing ok, no other feelings of distress. She stated that it started on 10-03-19 and has moved down her arm. Advised her to take a benadryl and if curremnt cymptoms got worse or she was feeling distress or having trouble breathing to go to the urgent care. Called pt on 10-06-19 to follow-up and she said after she took the benadryl the redness and swelling went away on 10-05-19 so she stopped the benadryl (only had one dose on the night of 10-4) but when she woke up sunday morning on 10-06-19 the redness was back. but she was still feeling otherwise fine. advised to take another benadryl and follow-up with provider on monday if needed.
Rash all over the body that lasted for a month; having diarrhea, 8 times already; feels really sick.; is breastfeeding; Vomiting; headache; Chills; pain in the arm; body hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), PAIN (body hurts), DIARRHOEA (having diarrhea, 8 times already), MALAISE (feels really sick.) and EXPOSURE VIA BREAST MILK (is breastfeeding) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-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 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), PAIN (body hurts), HEADACHE (headache) and CHILLS (Chills). On 01-Apr-2021, the patient experienced DIARRHOEA (having diarrhea, 8 times already), MALAISE (feels really sick.), EXPOSURE VIA BREAST MILK (is breastfeeding) and VOMITING (Vomiting). On an unknown date, the patient experienced RASH (Rash all over the body that lasted for a month). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in the arm), PAIN (body hurts), DIARRHOEA (having diarrhea, 8 times already), MALAISE (feels really sick.), EXPOSURE VIA BREAST MILK (is breastfeeding), VOMITING (Vomiting), HEADACHE (headache), CHILLS (Chills) and RASH (Rash all over the body that lasted for a month) outcome was unknown.            Concomitant product use was not provided by the reporter. The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.
This spontaneous report as received from a nurse refers to a 10 months 30 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
severe chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (severe chest pain) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (severe chest pain) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to CHEST PAIN. At the time of the report, CHEST PAIN (severe chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) clear and normal.         Concomitant medication was not provided.  Treatment information was not provided.  The patient had Laboratory test and X-ray. whose result were unknown  This is a spontaneous case concerning a 33-year-old male patient with no medical history reported, who experienced the unexpected event of chest pain. The event occurred approximately 2 days after the second dose of mRNA  1273 vaccine. Patient was hospitalized for 2 days because of chest pain and at the time of report outcome of the event was unknown. MRI results was clear and normal. The rechallenge is not applicable since no information about the first dose was provided. The reporter assessment was not provided. The benefit-risk relationship of mRNA  1273 vaccine  is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 33-year-old male patient with no medical history reported, who experienced the unexpected event of chest pain. The event occurred approximately 2 days after the second dose of mRNA  1273 vaccine. Patient was hospitalized for 2 days because of chest pain and at the time of report outcome of the event was unknown. MRI results was clear and normal. The rechallenge is not applicable since no information about the first dose was provided. The reporter assessment was not provided. The benefit-risk relationship of mRNA  1273 vaccine  is not affected by this report.
(L) arm soreness and decreased ROM, pain and mild redness to injection sites. Flu-like sx, temp 100.5-101, nausea, headache and mild dizziness. Pt managing at home w/MOTRIN, heat, rest, fluids.
The patient's mother states His right leg was found to be "swollen", noted 1 day after his immunization. He was given Benadryl and ice. On physical exam 2 days after noted to be larger but no swelling / edema or inflammation.
Client received initial vaccine on 03/29/21 and a second vaccine on 05/07/21. No side effects reported.
Information has been received from a RN concerning a 9 yr old white male with cerebral palsy, who on 27DEC96 was vaccinated (route unk) with a first dose of varicella virus vaccine (lot unk). There was no illness at the time of the vaccination. On 02Mar05, the mom indicated that her son had lesions on torso, face and genital area. He was also itchy with no fever. The report indicated that there was an outbreak of chicken pox at the school. Subsequently, the pt recovered on 12Mar05. No additional information has been requested.
Extreme pain at injection site, muscle spasms, numbness/tingling in left arm, symptoms still ongoing.
No adverse effects were reported; the patient was "inadvertently adminisered an expired dose of GARDASIL 9; This spontaneous report was received from a pharmacy intern referring to a 12 year old patient of an unknown gender. No information was provide regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On 24-JUL-2019, the patient was inadvertently administered an expired dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot number M042853 and expiration date on 17-JUL-2019, for prophylaxis (dose, dose number, anatomical injection site and route of administration were not reported) (expired product administered). No adverse effects were reported.
8 cm diameter induration and erythema to right thigh surrounding injection site, No fever, no irritability.
Approximately 2 weeks after the second dose, I have been extremely tired with no energy, muscle aches, sore, etc.
SLEEPY; ARM HURT; TIRED; LITTLE NAUSEOUS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case No concomitant medications were reported. On MAR-2021, the subject experienced sleepy. On MAR-2021, the subject experienced arm hurt. On MAR-2021, the subject experienced tired. On MAR-2021, the subject experienced little nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired, little nauseous, arm hurt and sleepy was not reported. This report was non-serious.
COVID-19 positive on 1/5. My whole family was positive. I had minor cold symptoms for a few days. By 1/9 I was feeling really bad with shortness of breath  and throwing up so I went to the hospital for 9 days. My blood pressure was so high that it was causing swelling of my brain and I was placed on seizure mediation. They kept me in the hospital until I was testing negative. Today I still have a little bit of exhaustion.
2 days post vaccination onset of acute arthritic symptoms symmetrically along body beginning in the hips, and escalating to back, neck, shoulders, wrists, hands, and knees, in that order. Right side is now becoming more severe for pain and stiffness, but still roughly symmetrical. Symptoms are more severe upon waking and some mobility is restored by regular movement within an hour, but it is becoming harder and more painful each day. Was taking ex str. Tylenol at 500mg 8 x3 times a day for pain management, have since switched to aspirin 500mg 4-5 x2 times per day but that too is becoming less effective. Severe mobility impact, cannot get groceries, walk dog, open bags, jars, cans, and am starting to develop anxiety around the worsening symptoms. No health coverage. No primary care physician. Sporadicly I have days that the symptoms are almost completely non-existent, but these ?relief days? are never consecutive and the next day will always have the symptoms worsen again.  I have always generally been in pretty good health, and I?ve never taken anything regularly, but this has me terrified.
the arm was very sore all the way down to her elbow; Queasy; pasty frequent stool; pasty frequent stool; the outside of her arm where the vaccine was put hurt that day; This is a spontaneous report from a contactable consumer.  A 81-year-old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1284), at single dose into the left arm on 16Jan2021 at 12:30PM for COVID-19 immunization.  Concomitant drugs included Levothyroxine 0.100mg once daily by mouth taking for years for thyroid and a week and half before the vaccine administration, she had a cortisone shot in her hip for bursitis but it didn't work, it was the first time she has had one in a long time. The patient reported that on 16Jan2021 the outside of her arm where the vaccine was put hurt that day, but then the next day the arm was very sore all the way down to her elbow. But it was bad, she couldn't roll in bed form the pain. Then she woke up on 17Jan2021 queasy like morning sickness that didn't go away until 21Jan2021. Adds she also noticed that day she was having more frequent and pasty stools. Mentions she expected her arm to be sore because with the second shingles vaccine her arm was sore. States this was years ago and she did not have any product or information for the shingles vaccine. The patient is scheduled for the second dose on 06Feb2021. Mentions she lives in a continuous care facility and they will give her the shot. The event arm hurt recoverd on 20Jan2021, the other events resolved on 21Jan2021.
Racing heart with PVCs , PSVTs and tachycardia that developed almost immediately after the second dose in Feb 2021.
The patient experienced a syncope event lasting <5 seconds a few minutes after receiving the vaccines, his blood pressure dropped to 70s/50s, student appeared slightly disoriented.
flu-like symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not applicable. The only time in the last 20 years the patient had flu-like symptoms was the one time The patient decided to take the flu vaccine.
temperature was 99.1°F/temperature not normal for them; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature was 99.1°F/temperature not normal for them) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient experienced PYREXIA (temperature was 99.1°F/temperature not normal for them). At the time of the report, PYREXIA (temperature was 99.1°F/temperature not normal for them) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2021, Body temperature: 99.1 (High) 99.1°F.         Concomitant medication of the patient included thyroid medication.  No treatment information was provided by the reporter.
Allergic reaction; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "recovered", described as "Allergic reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt staying in SNF; positive COVID test on 9/27/21; per death certificate, pt died in the facility with cause of death being SARS-COV-2 Related Pneumonia
Patient became pale and passed out 3 minutes after injection. BP;  86/60 Pulse: 53 RR: 20 O2 Sat: 98%
From day 1, the shot was red, sore and a little painful, which is the common symptoms. Day 10, still red, swollen and was still hurting. I asked a pharmacist, she said she has seen this happen. By day 13, my arm was red to from shot area to mid upper arm, with very painful effects of a hot needle was inserted in my arm with Hot Oil. I went into the Urgent Care. Outcome: Infection in arm. Prescription given of Keflex 500MG. 4Xday for 7 days. Followed up with primary dr. (That Friday) and he told me it wasn't an infection to stop taking prescription that it was just COVID ARM. I did finish prescription, which ended that Monday. I just received the 2nd shot today (in opposite arm) and did advise what I went thru. They advised that I report
My temperature was up to 101; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 23Feb2021, as 1st single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 06Mar2021, on day eleven after vaccination, the patient had little bit fever, diarrhoea, nausea and temperature was up to 101. At the time of report, on 07Mar2021, the patient was feeling good and temperature was 98.5 and had no more diarrhoea. The patient worked part time since patient had these symptoms and thought that was from the shot. The patient work as delivery driver and enquired if it was okay to go ahead and work. The patient felt good that the temperature was normal now. The reporter was not aware of the LOT number and second shot was scheduled on 16th. The outcome of the events fever and diarrhoea was as resolved on 07Mar2021 and outcome of the event nausea was unknown.   No follow up attempts are possible. Information about lot/batch number cannot been obtained.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 27-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 648 hours, the lowest recorded temperature was 20F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. Information concerning medical history, concurrent condition and concomitant therapy was not provided. On unknown dates, the patients were vaccinated with doses of ROTATEQ (oral, lot#, expiration date and dose not provided), which had been improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Fatigue; menstrual cycle (has not had a cycle in over 2 years); cramping; clotting. Healthcare provider advised patient to take hormone medication. Stated vaccine may have fluctuated hormones.
Pain on injection site, Head ache, Nausea, Discomfort in left arm/hands, some dizziness
I must have awakened with wide-spread joint pain and really severe pain. It was the worst in my left arm, shoulder, and hand. Both knees, with swelling and warmth in both knees, more in the right than the left. I had a headache and was feverish. I experienced some chills. My temperature was around 100 give or take. My normal body temp is 97.6. That was a temporal read for the 100 fever. I did an under arm read that was slightly higher as well (100.5) I also had great difficulty getting around. Ambulating was very difficult. I think I called the rheumatologist (not exactly sure which doctor I contacted, both listed below), and they gave me the weeklong Methylprednisolone standard pack for people with acute RA flares. 9/22 when this was prescribed to me. Over a weeks' time, the steroid basically took care of it. I already had set up a teleconference with the doctor before this happened.
Sedation, Fatigue, discomfort at injection site, swollen axillary nodes Narrative:
Sore arm; Red rash around injection site; Injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INJECTION SITE ERYTHEMA (Red rash around injection site) and INJECTION SITE PRURITUS (Injection site itching) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), INJECTION SITE ERYTHEMA (Red rash around injection site) and INJECTION SITE PRURITUS (Injection site itching). At the time of the report, PAIN IN EXTREMITY (Sore arm), INJECTION SITE ERYTHEMA (Red rash around injection site) and INJECTION SITE PRURITUS (Injection site itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Itchiness on scalp and ears, then neck, chest, arm pits, sides, back and waist.  When home from work at 2:30 pm hives were noticed as well as severe rashes in all previous mentioned itchy locations and a profound headache occurred.  Following day (10/21/2010) Chest pain and sore throat along with previous days symptoms.
Developed subsequent fever to 103.1, myalgias, headache and abdominal pain which resolved.  On 09/10/2010, she noted blood blister on buccal mucosa, bleeding sub-buccal bullae, large ecchymosis on arms.  On 09/12 she experienced epistaxis, vaginal bleeding and rectal bleeding.  Was admitted to hospital.  Diagnosis: ITP