chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Member had a metallic taste in his mouth about 30 min after receiving influenza vaccine. He was kept for 15 observation. After the 15 min his metallic taste disappeared. Was kept for another 30 min observation. In that time he just complained about cottonmouth. Was able to drink water which helped. It resolved after 45 min and pt was discharged.
Within a couple of minutes of receiving the injection I experienced pain and numbness in my left arm down through my hand. These symptoms are consistent with what I experience during a migraine. Approximately 10 minutes after receiving the vaccine the pain expanded to my neck and face on the left side, soon after followed by a mild headache.   Over the course of the day, within a couple of hours of vaccination, my headache remained mild but expanded to a general head pain that wasn?t confined to just one location. Also around this time I began experiencing neck muscle soreness and became very tired.  It is now approximately 10 hours post vaccination and I still have a mild headache. Migraine symptoms still present but not as notable. I feel run down, tired, an overall sense of malaise, and have full body mild muscle soreness.  No medications or treatments used so far to treat these symptoms.
Error made by vaccine administration nurse, 0.2ml given by nurse on 3/2/2021 at Clinic. Client was called at 4:16 pm on 3/2/2021 and incident was explained. PT understood situation and will be returning  on 3/3/2021 around 10am  to  receive  right dosage.
Initial unsolicited report received from a consumer on 27 Oct 2016. This case involves a 51-year-old male patient who was vaccinated with a dose of Fluzone (batch number: UH953AB, expiry date: 30 Jun 2014, route, dose not reported) on 20 Jan 2014. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) revealed that patient was allergic to severel food and no known drug allergies was reported. Medical history includes Eczema. Concomitant medications were not provided. On 21 Jan 2014, one day following the vaccination, the patient experienced joint and muscle pain all over body. Also reported that, the patient still had intermittent intervals of joint and muscle pain. Patient required ER and doctor visit. Lab data includes test for Lyme disease, arthritis and tests were negative. Corrective treatment was not reported. It was unknown if patient was recovered from the events. List of documents held by sender: none.
Severe chills  High Fever ( too sick to get thermometer) Muscle aches Headache Shooting pains Delerium Weak Pale Nauseous Had shot at aprox. 1:30 p.m.  At 10;00pm all these symptoms began.  By 10:00 a.m. I was back to normal. Weak
Blistering at injection site, fever, pain at injection site, swelling at and around the injection site, swelling at and around the injection site.
Got vaccine while Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 14-Jan-2021 and the estimated date of delivery was 22-Oct-2021. On 05-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  The patient was treated with MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care, at an unspecified dose and frequency. On 05-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications include allergies medication and rescue inhaler.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 40-year-old female. The patient's estimated due date is on 23 Mar 2021. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Rt thigh red, hard fever up to 102 deg. Erythema with scm induration. Area blanched well-non-tender warm compresses, Tylenol and ibuprofen MD seen 6/26. Baby seen 6/27 by staff-lt pink color with Sl induration-Healing well.
Muscle aches, chills, fever 101.2, fatigue severe head ache in back of head, neck and upper back ache from 03/18/2021 until 03/20/2021  Fatigue continued from 03/18/2021 until 04/10/2021
Employee received flu vaccination (2nd in her life time) 10/28/2003 about 11:30.  By 5 or 6 pm that same day, employee noted redness and swelling at site of injection.
adverse experience; Temperature excursion involving GARDASIL 9; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 11-year-old of female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 30-DEC-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T039467, expiration date: 20-MAY-2023, which have been verified to be valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) administered in right deltoid (strength, exact dose and route of administration was not provided) for prophylaxis. The vaccine was exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination. The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2201USA000582 :
Extreme intensification of fibro and polymyalgia symptoms (almost unable to do anything).  Need to use a walker and still do.  Also leg and foot swelling
Collapsed the evening after getting the shot.  Layed on the floor for 40 hours before family found him.  Take to ER by ambulance.  Ruled out stroke, heart attack.  Could not explain what happened.  We mentioned several times he had the shot, but were brushed off.
Chills with severe shaking, Fever 101.6, Sweats, Fatigue, Loss of appetite, Malaise, Spo2 on 8 liters of oxygen dropped to 70, coughing  increased shortness of breath
Adult Havrix given to 5 patients under age 19; Adult Havrix given to 5 patients under age 19; This case was reported by a other health professional via sales rep and described the occurrence of adult product administered to child in a patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.  Additional information was provided as follow: The patient was under 19 years of age and received Havrix adult, which led to adult product administered to child and overdose. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR137655:Same reporter US-GLAXOSMITHKLINE-US2021AMR137642:Same reporter US-GLAXOSMITHKLINE-US2021AMR137652:Same reporter US-GLAXOSMITHKLINE-US2021AMR137653:Same reporter
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2021 as dose number unknown, single (Lot number: EW0167), in left arm and on 08Dec2021 as dose number unknown, single (Lot number: FD7218) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 28Jan2023 the patient took Paxlovid for the treatment of event. The patient had no known allergy.  No follow-up attempts are possible. No further information is expected.
NUMBNESS AND TINGLING OF HANDS  AND LIPS; MUSCLE TWITCHING (ALL OVER BODY); This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1868609, and batch number: 1868609 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced muscle twitching (all over body). On 21-APR-2021, the subject experienced numbness and tingling of hands and lips. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from muscle twitching (all over body), and numbness and tingling of hands and lips. This report was non-serious.
With the first one had a ripping sensation on my bicep" then clarified "is not on the shot site; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (With the first one had a ripping sensation on my bicep" then clarified "is not on the shot site) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. RA6059) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (With the first one had a ripping sensation on my bicep" then clarified "is not on the shot site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (With the first one had a ripping sensation on my bicep" then clarified "is not on the shot site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was Healing peptides and BPC 157   This case was linked to MOD-2021-255606 (Patient Link).
pt recvd vax & exp shaking, weakness, malaise, nausea, vomiting, diarrhea & cramps which have subsided;
Parent reported that 1 1/2-2 hrs after immunization given swelling of lips.
Employee reports a tingling sensation through out body and noticeable hand weakness x 4 days so far.
within about 2 hours developed a large wheal on Right Deltoid.  About 2.5 inches in diameter, raised, hot, itchy, painful.   Next evening 5/8/21,  woke up in middle of night drenched  in sweat., fever, chills, pain at injection site. This lasted for a few hours and resolved with ibuprofen. As of 5/11/21, today, wheal on deltoid is no longer raised.  It has become more diffuse.  Remains itchy, but less painful. It appears to be resolving.
Patient suffered a mechanical fall at home 1 week prior to adverse event in which she then noticed progressive discomfort and pain with deep inspiration. Sought care from PCP who recommended come in to ER for further evaluation. In ER lab work unremarkable, CTA of the chest done showing bilateral sub-segmental pulmonary emboli. Patient admitted to the hospital and started on Lovenox 1mg/kg BID.
Started feeling shivers; fever; muscle ache; just I wasn't comfortable; like my body is going asleep; Very tired/feels run down; Little nervous; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 01Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 01Mar2021, the patient reported that until late night everything was going well, then the patient started feeling shivers, muscle ache, fever 100.3. The patient also reported that she wasn't comfortable, was feeling like body was going asleep, and very tired and feels runs down. On 01Mar2021, the patient had her body temperature checked and it was 100.3. The outcome of the events was reported as unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE)
I had a headache within an hour of the vaccination, followed shortly by nausea. My entire arm was extremely painful to the touch, not only the injection site,  It was painful to move my arm at all.  By 7:30 PM, I had a fever and chills.  By the morning of the 28th all symptoms were gone except sensitivity at the injection site.
All day had a hard time keeping it from going low or even crashing; All day had a hard time keeping it from going low or even crashing; Chills; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the right arm on 19Aug2021 at 14:45 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included type I diabetes. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included esomeprazole magnesium (MANUFACTURER UNKNOWN) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR); both for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Aug2021, the day after receiving the vaccine, all day the patient had a hard time keeping it from going low or even crashing along with the chills and headaches. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events all day had a hard time keeping it from going low or even, chills and headache was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Severe pain where shot was administered for 3 day.  Very Bad Sinus Headache for 4 days.  I still have this symptom not as severe but  every time I cough I get the pain in the center of my forehead or if I bend to get something from the floor. I never had this before till I received the first shot.
Night Sweats; This case was reported by a pharmacist via call center representative and described the occurrence of night sweat in a 69-year-old female patient who received Herpes zoster SHINGRIX for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of SHINGRIX. On 27th September 2020, 5 days after receiving SHINGRIX, the patient experienced night sweat. On an unknown date, the outcome of the night sweat was not recovered/not resolved.   It was unknown if the reporter considered the night sweat to be related to SHINGRIX.  Additional details were provided as follows: The patient was vaccinated with dose of SHINGRIX. 5 days after vaccination patient started to experience Night Sweats that occur every night and were ongoing. All information was not available. The reporter consent to follow up.
About 2-3 months after receiving my 2nd dose of the Moderna vaccine, I had a doctor's appt which they noticed that my blood pressure was unusually high. I have these appt's quarterly and my previous readings were normal. I am now prescribed Lisinopril 10mg per day. The medication is controlling my bp.
mixed with MMR Varicella Diluent / did not receive Menveo diluent; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 21st October 2021, the patient received Menveo. On 21st October 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.  Additional details were provided are as follows: The age at vaccination was not reported. The reporter reported that the patient received Menveo vaccine (lyophilized powder) which was incorrectly mixed with an MMR Varicella Diluent (no details on the patient or injection site), which led to wrong solution used in drug reconstitution. The patient did not received the Menveo diluent. No adverse events were reported. No lot, demographics of the patient were provided. It was not clear if the Health care professional reporting was the immunizer. The reporter did not consented to follow-up.
Patient presents with a rash that started after her 2nd covid immunization ( Pfizer ). Her first immunization was placed on 3/29/2021 and her 2nd was placed 4/19/2021. approximately 4 hours after her 2nd immunization she developed a warm sensation to her hands and they felt hot. She ran them under water but the warm water was painful. The symptoms did move to her feet as well so she went to the ER and was told she had an allergic reaction and was prescribed benadryl, pepcid and told if she did et any steroids her 2nd immunization would no be effective so she elected to not get any steroids and presents today for follow up care.  No shortness of breath but did feel her tongue was bigger and tingling - today her tongue feels normal , no Hives or rash but her fingers tips did peel.
Cellulitis of left thigh diagnosed 1-6-14 per mom red lump at vaccine site for 5 days. Swollen, tender. Febrile x 4-5 days.
Within 15 min of receiving vaccine, patient reported watery eyes and slight SOB. Patient was still able to talk and was given 50mg of diphenhydramine.  After approx 20 min. patient reported being better and left pharmacy
Fatigue. Muscle and joint aches, skin very sensitive - especially to cold touch, edginess
Five minutes, post vax, pt stood, walked a few steps and fell to the floor with slight tremors of extremities X 5 seconds.
vomiting; sore arm; chills; Fever; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101864732 (Pfizer).  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24Dec2021 13:45 (Batch/Lot number: unknown) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded), administration date: 22May2021, when the patient was 29 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded), administration date: 19Jun2021, when the patient was 29 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 24Dec2021 13:45, outcome "unknown", described as "booster"; VOMITING (non-serious) with onset 25Dec2021 03:00, outcome "recovering", described as "vomiting"; PAIN IN EXTREMITY (non-serious) with onset 25Dec2021 03:00, outcome "recovering", described as "sore arm"; CHILLS (non-serious) with onset 25Dec2021 03:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 25Dec2021 03:00, outcome "recovering", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information : Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events Reported: Fever, sore arm, chills, vomiting. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The injection site felt warm but I didn't notice the appearance until I started scratching the area on the 8th day after injection.  At that point, the site was dark pink and I became concerned.  I called the after hours nurse help line and she asked the doctor on call for recommendations.  I was told to use ice pack, take Tylenol and Benadryl.   After about the 11th day, the pinkness finally started diminishing and then a few days later there was no pinkness at all.
Administered boostrix that expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 75-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   On 19th July 2022, the patient received Boostrix. On 19th July 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-Jul-2022 Reporter's Comments: A medical assistant administered expired dose of Boostrix. The reporter did not consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Boostrix, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022108788:duplicate case