chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates the patients were vaccinated with improperly stored doses of VARIVAX, lot# M008171 with expiry: 16-FEB-2018, (dose and route reported), for prophylaxis. No adverse effects reported. The vaccine was exposed to a temperature of 22 degree Fahrenheit for 4 hours 23 minutes. It had previous temperature excursions of 2 hours 5 minutes at a 32 degree Fahrenheit. The call was because of data logger. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005176.
Initial misuse report received from health care professional on 23 Oct 2013.  A 01 year 03 months old patient had received 0.5 ml dose of FLUZONE from MDV on unspecified date. No adverse event was reported. List of documents held by sender: none
This spontaneous report was received from a Certified Medical Assistant (C.M.A) referring to an unspecified number of patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with and improperly stored dose of ROTATEQ oral (strength, dose, were not provided) (lot # L037924 expiry date 22-JUN-2017, lot # L023870 expiry date 02-APR-2017 and reported lot # L029618 expiry date 20-MAY-2017). The Certified Medical Assistant (C.M.A) stated that oral ROTATEQ was exposed to the following temperature conditions: -7 C for 36 hours. There was no a previous temperature excursion. No adverse effects was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt devel shrill high ptiched cry p/DTP/OPV/HIB;
Patient received influenza vaccine 10/6/22.  On 10/7/22 awoke with vision issues and diagnosed with 4 th cranial nerve palsy
Asthma exacerbation; Cough; This Case has been made valid conservatively since patient experienced adverse events with Suspect product BNT162B2 in Follow up 01. This is a spontaneous report from a contactable other health care professional and nurse via Pfizer sponsored program. A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), via an unspecified route of administration on 21Apr2021 as dose 2, single (at the age of 17-years-old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included oral steroids for asthma. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Caller was not sure when the patient received the first dose, she did not get that date from the patient's mother. On an unspecified date, the patient experienced asthma exacerbation and cough. It was reported that he needed some oral steroids for an asthma exacerbation that had been going on for several weeks. Nurse didn't think the asthma flare up was due to the vaccine at all, but she wanted to know if there was any contradictions for giving oral steroids immediately following the second dose of vaccination. Nurse confirmed the asthma exacerbation was occurred prior to the first dose of the COVID-19 vaccine. It was not a severe exacerbation; he had been dealing with a cough for about 3 to 4 weeks. She did not believe that the cough was because of vaccine itself. The outcome of the events was unknown.  No further details were provided or obtained. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient recieved vaccine and talked with friends while waiting her 15 minutes, respirations appeared normal . She asked if her fifteen minutes were completed and I said yes and she left with her friend. Almost immediately her friend returned reporting she was feeling nauseous and not well. When I checked on her she was seated, increased respirations, clammy and had difficulty speaking. Attending physcian notified and she was admitted to the ER for monitoring. Elevated blood pressure, oxygen saturation and temperature within normal limits. Solumedrol given. MRA, CT and labs completed.
at 6:00 pm, my Uveitis flared up in my left eye, which has not happened in a year and a half. I put steroid drops in the eye for a week and it cleared up. eye still sensitive to bright light. My Psoriasis and arthritis have also flared up.
Pt states that immediately after the vaccine she felt pain in her L shoulder that radiated to R shoulder and then into her mid back.  She also felt nausous all evening and had tingling in her fingers on both hands.
Respiratory sx w/minimal bronchiolar infiltrate-needed hospitalization 9NOV91 to 11NOV91;
10:30 AM After receiving the COVID-19 vaccine, the patient experienced an anaphylaxis reaction that included, throat closing and tongue swelling sensation, itchiness, and hives on her bilateral arms and legs. Patient received 65 mg of Benadryl IV, 125 mg SoluMedrol IV, two doses of 0.3 epinephrine IM, 1 mg of Ativan, and 4 mg of Zofran, then taken to the ED for further monitoring. Patient was on 2L NC for comfort, sats in mid 90s off oxygen, and monitored the patient for a few hours. Patient discharged to home with stable vital signs off oxygen and a steady gait.
Incorrect vaccine administerd. Chiold had not recieved any previous COVID-19 vaccines. Vaccine administerd was Moderna COVID-19 Bivalent ages: 6 months through 5 years pink cap with yellow label 10mcg/0.2mL. No treatment required.
Body aches Migraine Cough High fever Massive Dizziness Runny nose Fatigue
Need to redo the 1st dose because of temp excursion; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Need to redo the 1st dose because of temp excursion) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Need to redo the 1st dose because of temp excursion). On 07-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Need to redo the 1st dose because of temp excursion) had resolved.            Treatment medication not provided. Concomitant medication not provided.
day 9: arm felt a little sore, then itchy at the vaccination site;  then on day 10 I looked in the mirror and saw a red splotch about 2 x 3 inches at the vaccination site.  I had no other reactions except for the site being sore to the touch on day 1 and 2, then fine. I read online about 'covid arm' and thought I'd document it.
left leg swelling on quad, unable to move with out pain. When i first got it, it felt like a cramp while in bed. I have gotten them before but nothing like this.  Left leg is swollen.  I thought that after one or two days it would go away but nothing and it has not improved.
arm soreness; substantial headache; A spontaneous report was received from a consumer concerning a unspecified age   of female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm soreness and substantial headache . The patient's medical history was not provided by the reporter. Concomitant medications  were not provided by the reporter. On 20 Feb 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273  via intra muscular  in unknown anatomical location  for prophylaxis of COVID-19 infection.  After receiving the first dose ,the patient experienced arm soreness and substantial headache . Action taken with mRNA-1273 in response to the events was  unknown. The events of outcome of the events  arm soreness and substantial headache was unknown.
Patient received ZOSTAVAX on 10/8/08. 2 days later - 10/10/08 she developed a rash on her thighs - no shortness of breath or other adverse reaction. On 10/13/08 she noticed a rash on her arms. She went into her hot tub and felt like her arms were "on fire." burning, today - better
Get FLUMIST on 10/16/13, c/o sore throat that night. Dry cough presented on Thursday 10/17/13 night, was worse the next day. Felt warm. Seen by Dr. on 10-18-13, dx with diffuse expiratory wheeze and scattered rhonchi, cough after FLUMIST with decreased spirometry now, that did respond to albuterol in office with increased values. Plan to treat with albuterol.
Blood in stool-- noted by parents with positive Hemoccult approximately 1 week after vaccine (on 4/14/08).
at 8pm patient had chills, fever, flu like symptoms, malaise fatigue exhaustion/leg weakness spoke to  md who believed she had an immune response to vaccine follow up with regular md 2 days later having a persistent cough/ md also believes had immune response currently patient is fine no untoward events/  patient believes pharmacy may have immunized with high dose flu not regular pharmacy looking back to clarify that claim
arm has red blotches; arm is hot to the touch; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (arm has red blotches) and SKIN WARM (arm is hot to the touch) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (arm has red blotches) and SKIN WARM (arm is hot to the touch). At the time of the report, RASH MACULAR (arm has red blotches) and SKIN WARM (arm is hot to the touch) outcome was unknown.            No concomitant medications were provided. No treatment details were provided.
Patient experienced body aches, specifically lower back aches; Patient experienced body aches, specifically lower back aches; Pain under arm gland of injection site.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her 50's 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: Bnt162b2 (First Dose), for Covid-19 immunization. The following information was reported: BACK PAIN (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "Patient experienced body aches, specifically lower back aches"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Pain under arm gland of injection site.".  Additional information: It was reported that patient experienced body aches, specifically lower back aches and pain under arm gland of injection site.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness, swelling at injection site. 7.0 cm in diameter red, macualr, slightly warm to touch.
This spontaneous report as received from a physician via a company representative refers to a 5 year old patient with unknown gender. On 22-OCT-2014 the patient was vaccinated with ZOSTAVAX (lot# and expiration date were unknown, dose 1 vial, subcutaneous) instead of VARIVAX (Merck) due to a human error. No adverse effects were reported. Additional information has been requested.
Hives all over body; itchiness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Dec2021 10:00 (Lot number: FK5127) at the age of 6 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "was diagnosed with influenza about 3 weeks prior" (unspecified if ongoing). Concomitant medication(s) included: ROBITUSSIN [GUAIFENESIN]; DAYQUIL. The following information was reported: URTICARIA (non-serious) with onset 12Dec2021 12:00, outcome "not recovered", described as "Hives all over body"; PRURITUS (non-serious) with onset 12Dec2021 12:00, outcome "not recovered", described as "itchiness". The events "hives all over body" and "itchiness" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of urticaria, pruritus.  Additional information:  The patient did not receive any other vaccine within 4 weeks. The patient was received adverse event treatment prednisone then Benadryl and allegra. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
no additional AEs; expired dose of MMR II was administered; vaccine was administered IM instead of the recommended SQ; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 18-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 mL, administered intramuscularly (IM) instead of the recommended subcutaneously (SQ) for prophylaxis (lot# T020656, expiration date: 16-JUN-2022; strength was not provided) (expired product administered, incorrect route of product administration). No other information or addition adverse event (AE) was reported.
Information has been received from a mother concerning her daughter who on 01/25/05 was vaccinated in the right upper thigh with a dose of varicella virus vaccine live. concomitant therapy administered on that same day 01/25/05 included diphtheria toxoid + pertussis vaccine + tetanus toxoid , and poliovirus vaccine. After receiving the vaccination the pt experienced a " bright red spot" that itches on the injection site (RUL) . It was noted that the mother will contact the pt's MD when he becomes available. It was noted that medical attention was sought. it was noted the adverse event did not improve. There was no product quality complaint reported. Additional information has been requested.
03/23/21  07:00 PM = pain at injection site apparent 03/ 24/21   01:00 AM = Chills with uncontrolled shivering; fever (no thermometer available to determine temp);     7:00 AM increased heart rate, > 120 bpm at rest - stayed high for first half of the day; remainder of day - lethargy, loss of appetite 03/25/21    08:00 AM = no further issues (some arm soreness at injection site only)
Pfizer vaccine was administered outside of our facility - reported by patient -------------------------------------------------------------------------------------------------  G62.9 PERIPHERAL NEUROPATHY 10/18/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 11/19/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) R09.02 HYPOXIA 5/20/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) R29.810 LEFT FACIAL MUSCLE WEAKNESS 10/18/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) G62.9 PERIPHERAL NEUROPATHY 10/18/2021 ACUTE PULMONARY EDEMA J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 11/19/2021 ACUTE PULMONARY EDEMA R09.02 HYPOXIA 5/20/2021 ACUTE PULMONARY EDEMA R29.810 LEFT FACIAL MUSCLE WEAKNESS 10/18/2021 ACUTE PULMONARY EDEMA G62.9 PERIPHERAL NEUROPATHY 10/18/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 11/19/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) R09.02 HYPOXIA 5/20/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) R29.810 LEFT FACIAL MUSCLE WEAKNESS 10/18/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) G62.9 PERIPHERAL NEUROPATHY 10/18/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 11/19/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) R09.02 HYPOXIA 5/20/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) R29.810 LEFT FACIAL MUSCLE WEAKNESS 10/18/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) G62.9 PERIPHERAL NEUROPATHY 10/18/2021 DYSPNEA J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 11/19/2021 DYSPNEA R09.02 HYPOXIA 5/20/2021 DYSPNEA R29.810 LEFT FACIAL MUSCLE WEAKNESS 10/18/2021 DYSPNEA G62.9 PERIPHERAL NEUROPATHY 10/18/2021 NUMBNESS AND TINGLING OF SKIN J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 11/19/2021 NUMBNESS AND TINGLING OF SKIN R09.02 HYPOXIA 5/20/2021 NUMBNESS AND TINGLING OF SKIN R29.810 LEFT FACIAL MUSCLE WEAKNESS 10/18/2021 NUMBNESS AND TINGLING OF SKIN G62.9 PERIPHERAL NEUROPATHY 10/18/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 11/19/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) R09.02 HYPOXIA 5/20/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) R29.810 LEFT FACIAL MUSCLE WEAKNESS 10/18/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) G62.9 PERIPHERAL NEUROPATHY 10/18/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 11/19/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) R09.02 HYPOXIA 5/20/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) R29.810 LEFT FACIAL MUSCLE WEAKNESS 10/18/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD)
On Saturday February 6 2021, I experienced some some mild shortness of breath and a cough for approximately 3 hours after receiving Moderna vaccine Thursday February 4. Cough, SOB completely resolved after approximately 3 hours. Looking over vaccination information, this is not an expected side effect.
Patient was given three immunizations, and then got in line and she just fell down while in line. I had patient come sit down on the bench. Patient states that she felt a little light headed. Her mom said her daughter has not eaten anything all day.
Reaction at the injection site - red, raised, swollen, and inflamed. Went away on its own after approximately 24 hours.
Soreness in arm lasting about 4 or 5 days after injection.  Also, slightly red and warm. On Feb.8, 2021 (12 days after injection) - redness and heat on large section of upper left arm.  Lasted about 4 days.  No treatment.
Started with some soreness at injection site early the next morning. Continued with redness, swelling and warmth st the injection site and then full upper arm soreness when trying to lift my arm. The redness, swelling and warmth at the site continued into day 2.
Heart issues - Palpatations, feeling of heart restarting multiple times over a 3 week period Severe shortness of breath Dizziness
5/10/13 Headache at 11:00 PM. 5/11/13 Fatigue and muscle aches. 5/12/13 Sudden onset pressure Headache at 11:00 am did not subside until PM on 5/15/11 after ER visit. 5/13/13 Light headed, occasional dizzy. 5/14/13 HA, Dizzy numb and tingly face and hands. 5/15/13 Dizziness worse, headache continues, balance off. 5/14/13 sent to clinic given Steroid. 5/15/13 went to ER CT done, given IV fluid, Toradol and Antivert.
A report has been received from a Health Professional concerning a 6 year old female patient. The relevant history and concomitant disease of the patient were not reported. The concomitant medications of the patient were not provided. The patient was receiving nasal FLUMIST Quadrivalent, on 27-Oct-2014. Reporter stated that we administered FLUMIST Quadrivalent to a 6 year old who moved so only one nostril received FLUMIST Quadrivalent. Reporter also explained patient did not receive full dose due to moving away from nurse. Patient's grandmother decided not to get full dose. Parents were called as of recommendation to repeat dose, but they decided to get the flu shot instead. The outcome of the event of patient moved so only one nostril received FLUMIST Quadrivalent was unknown. The reporter considered the event of patient moved so only one nostril received FLUMIST Quadrivalent as non-serious.
Urticaria on right arm, chest, and neck starting about 3.5 hours after injection. No concern at time of evaluation for anaphylaxis.
A spontaneous report has been received from a pharmacist concerning a 50 year old, male subject, who had been receiving nasal FLUMIST QUADRIVALENT. The patient's medical history included high blood pressure. Concomitant medications included Lisinopril. FLUMIST QUADRIVALENT started on 22-Nov-2013. The patient reported the following adverse event administered FLUMIST QUADRIVALENT to a 50 yo which started on 21-Nov-2013. The outcome of the event of administered FLUMIST QUADRIVALENT to a 50 yo is unknown. The report was considered to be non-serious by the reporter.
This spontaneous report as received from a physician refers to an unknown number of patients of unknown age. The patients were vaccinated with doses of GARDASIL (lot #, dose and route not reported) on unspecified dates. No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patients may have been vaccinated with GARDASIL doses that were exposed to temperatures of - 4 degree C. No adverse effect was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This solicited case was received from the investigator in a trial on 22 May 2015. A 25-year-old male subject, with medical history of chest pain and headaches, had received the following vaccines on 14 April 2015: a dose of ACAM2000 and a dose of Typhoid Vi (lot numbers, route and sites of administration not reported) and on 31 March 2015: a dose of Anthrax vaccine and Japanese Encephalitis vaccine (manufacturers, lot numbers, routes and sites of administration not reported). The subject was diagnosed with unspecified disease of pericardium on 25 April 2015 and non-specific myocarditis on 28 April 2015 i.e. 11 days and 14 days respectively post-vaccination. On 26 April 2015, troponin I was abnormal with highest value of 06.37, electrocardiogram (ECG) was abnormal and echocardiogram was normal. The outcome of the events were not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Company causality is associated. Documents held by sender: None.
This spontaneous report as received from a 52 years old female consumer refers to herself who on 02-OCT-2012 was vaccinated on the right arm with a dose of PNEUMOVAX23 (dose, route, indication and lot number were not reported) and a dose of Influenza Virus Vaccine (manufacturer unknown) (dose, route, indication and lot number were not reported). No concomitant medications were reported. The pharmacist reported that she developed large sore and hard area (6 cm by 10 cm) after receiving PNEUMOVAX23 and Influenza Virus Vaccine (manufacturer unknown) on the right arm. No treatment information was reported. An x-ray of the arm was performed as lab diagnostic studies (results was not provided). The patient sought medical attention, she saw the physician. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness for the adverse event was unknown for PNEUMOVAX23 and Influenza Virus Vaccine (manufacturer unknown). Additional information has been requested.