chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Info has been received from an RN concerning a 9 year old female with no known medical history who on 8/12/97 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 2/23/06, the pt experienced moderate case of breakthrough. The pt had about 40 itchy lesions and a runny nose. Unspecified medical attention was sought and the treatment was Benadryl and Aveeno baths. At the time of the report, the pt was recovering. Additional info has been requested. Follow-up information indicated that on 23-FEB-2006 the patient developed, mild chickenpox disease. No additional information was provided. No further information was available.
little sore; little bit of a cough; light headache; injected in the way back of my arm far back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little sore), COUGH (little bit of a cough), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected in the way back of my arm far back) and HEADACHE (light headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected in the way back of my arm far back). On an unknown date, the patient experienced PAIN (little sore), COUGH (little bit of a cough) and HEADACHE (light headache). At the time of the report, PAIN (little sore) and COUGH (little bit of a cough) outcome was unknown and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (injected in the way back of my arm far back) and HEADACHE (light headache) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.
RIGHT ARM WAS FULLY NUMB FROM ELBOW TO HAND/ WHOLE PINKY IS STILL NUMB; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported 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 an unspecified date, the subject experienced right arm was fully numb from elbow to hand/ whole pinky is still numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm was fully numb from elbow to hand/ whole pinky is still numb. This report was non-serious.
PATIENT FEELS DIZZY POST 20 MIN VACCINATION STATES FELT O.K PRIOR TO VAX. SHE ATE THIS A.M. DENIES CHEST PAIN OR DIB. WISHES NO FURTHER TREATMENT AT THIS TIME 128/69 HR 85 RR 16 SAT 96%
diarrhea; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient reported that, after vaccination had extreme diarrhea for 48 hours. The reporter stated that, diarrhea might be from a pre existing condition prior to the vaccine. For the tollerence of 2nd dose refer case US2020037844, reported by same reporter for the same patient.
HBV/ Prevenar immunizations given 7-19-07 around 11:30am, 10:00pm began with fever up to 103.3 (r), had given Tylenol and put into lukewarm bath; by 11:30pm temp 101.1 (r); 7-20-07 0350 T 97 axillary, 0940 T 100 tympanic in office.
lost consciousness/unconscious; shaking; labored breath; pain in left arm where patient had the injection; felt weak; overheated; sweaty; numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient was a healthy person. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ASTHENIA (non-serious) with onset Nov2022, outcome "unknown", described as "felt weak"; DYSPNOEA (non-serious) with onset Nov2022, outcome "unknown", described as "labored breath"; LOSS OF CONSCIOUSNESS (medically significant) with onset Nov2022, outcome "unknown", described as "lost consciousness/unconscious"; HYPOAESTHESIA (non-serious) with onset Nov2022, outcome "unknown", described as "numb"; FEELING HOT (non-serious) with onset Nov2022, outcome "unknown", described as "overheated"; VACCINATION SITE PAIN (non-serious) with onset Nov2022, outcome "unknown", described as "pain in left arm where patient had the injection"; TREMOR (non-serious) with onset Nov2022, outcome "unknown", described as "shaking"; HYPERHIDROSIS (non-serious) with onset Nov2022, outcome "unknown", described as "sweaty".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
the existing rash she stated she got last year from the flu vaccine, became worse after the dose given on 10/19/2010
I had a bad headache on 07/02/2022 and took a few Advil and went to bed. I was feeling better the next day on Sunday. On Monday 07/04/2022 I took my temperature around 1pm several times and it ranged from 102 to 103. I took an at home COVID-19 test which came back positive. I then called my doctor who prescribed Paxlovid. I began taking the prescription that same afternoon and was still feeling sick. My fever came down and my body aches were improving. I still felt congested and sick for a few days though. I began feeling better on 07/06/22.
felt tinggling on tongue and jaw; Came home feeling with alot of energy; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (felt tinggling on tongue and jaw) and ENERGY INCREASED (Came home feeling with alot of energy) 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 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PARAESTHESIA (felt tinggling on tongue and jaw) and ENERGY INCREASED (Came home feeling with alot of energy). At the time of the report, PARAESTHESIA (felt tinggling on tongue and jaw) had resolved and ENERGY INCREASED (Came home feeling with alot of energy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
On 3/22 noticed a raised rash (maybe hives) on the back of both arms & heels; 3/25 rash was moving around the elbow toward the front forearms, the quadriceps right /left above knees, on each hip back area and around the middle of tummy near belly button.
She had a TIA 19 days later.  After recovering from that, she got the second shot and had another TIA 18 days after the second dose!
Injection site reaction : redness all along upper arm, hot to touch, muscle soreness radiating under arm to shoulder, pain, temp of 99.2 degrees.
Headache, Arthralgia, Shoulder pain, chills, headache, backpain
Within 4 hours, patient experienced redness, swelling and puffiness at the site of vaccination on the right thigh. 8 hours later, developed hives over the legs, private area and later in the day hives over trunk and neck and few areas on the back. No cough, stridor or difficulty breathing.
Patient was given 12 mo. shots. Came into clinic 13 days later showing red, raised area with few bumps in it on Lt. leg (1 1/2" x 1 1/4" area). Redness and raised area started 12-1-07 and resolved 12/7. Was put on an antibiotic 12-3-07 for ear infection.
Noticed right side facial tightness isolated to smile on February 7, 2021.  Sought medical attention on February 8,2021 from Urgent Care but was referred to Medical Center scan to rule out stroke. Official diagnoses were facial droop and muscle twitching. Prescribed prednisone 10 mg, 4 tablets (40mg) by mouth x 5 days.  Symptoms improved after full course of steroids, full use of smile returned by February 20,2021.
Patient is a 72 year old female who presents to the ED with chief complaint "dizziness, cough." The patient notes that yesterday she began experiencing light-headedness, a dry cough, rhinorrhea and left ear pain. The patient also endorses having a sore throat. She describes her dizziness as light-headedness and a sense of feeling off balance which she believes is related to dehydration. The coughing and left ear pain prevent4ed her from sleeping last night. She presented to the urgent care earlier today, who encouraged her to come to the ED due to low blood pressure and concern for dehydration. The patient denies fever and endorses feeling chills today. The patient denies chest pain, shortness of breath, nausea, vomiting, diarrhea, dysuria, hematuria, LE edema. She has no other complaitns at this time.
Patient received vaccine at approximately 13:50, about five minutes after patient starting feeling light headed and dizzy. Patient felt better after laying down for about 10 minutes. Vitals are as followed.
This initial non-serious spontaneous case, was received on 26-Nov-2017, from the other health care professional concerning an elderly male patient (reported as older than 65 years). On an unspecified date (reported as 6-10 years ago), patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported), at work place. On an unspecified date, after vaccination the patient had cough, difficulty in breathing, and runny nose. The reporter assessed the events as related to the vaccine.
Weakness upon waking  8am next day  1/17/2021, fever of 103.8 at 10AM.  Administered tylenol, cold drink, temperature went down to 101.3 within the hour. Temperature varied between 99.8 and 101.5 most of the day.   Vomited once after eating dairy. No fever today, 01/18/2021, experiencing tiredness and weakness.
We learned on 8/29/02 from a phone call from the mom that the child had been diagnosed with autism. She also reported that the mercury used as a preservative could have caused some of the problems and said all of this was related to the vaccines.
fever 100.8 headache altered right peripheral vision dizziness nausea  symptoms lasted 24 hours
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LORAZEPAM, start date: 01Jan2009, stop date: 30Jan2023. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Keflex, reaction(s): "Known allergies: keflex"; Tamiflu, reaction(s): "Known allergies: tamiflu". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Antiviral Product Brand Paxlovid for  COVID 19 Treatment started on 09Jan2023 stopped on 11Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pfizer was given to the client beyond date of vaccine handling and storing. CDC and Pfizer manufactory made aware, instruction was given to revaccinated. Supervisor made aware. I spoke to client and informed them of the vaccine and the need of revaccinated, clients agreed appointment is scheduled for clients and will follow up with care.
Right deltoid 1 cm warmth erythema over injection site (Hepatitis B), Left deltoid 1.5cm warmth erythema over injection site (Td)
Patient states that after receiving the 1st dose of Jansen J&J 03/06/2021, started experiencing symptoms 04/2021 of foot pain, nerve pain (Neuropathy). Primary visit 04/2021 prescribed Gabapentin 600mg. Still continuing to experience symptoms.
Pt c/o feeling feverish and weak on Saturday 10/12 R arm at site of vaccination and extending to elbow was red, swollen and itchy. She stated she did call the local ER for advice but was not seen by a physician. Saw personal physician 10/14/02.
The day after receiving vax, pt developed an erythematous, swollen, painful arm. He was prescribed warm compresses and elevation.
System of the Abrysvo that works for it broke/despite of using that correctly it broke for ABRYSVO SFDPO 5X0.5ML; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group, Program ID.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5019, Expiration Date: Feb2025) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "System of the Abrysvo that works for it broke/despite of using that correctly it broke for ABRYSVO SFDPO 5X0.5ML".  Causality for "system of the abrysvo that works for it broke/despite of using that correctly it broke for abrysvo sfdpo 5x0.5ml" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: The pharmacist tried to pull up a shot of Abrysvo today and the system of the Abrysvo that works for it broke and it was not yet administered but the pharmacist is asking for a replacement about it. The pharmacist would like to ask for information about this, about the packaging of this. Reportability Determination: This is Medical Device Related. This complaint for The caller is a Pharmacist calling because they tried to pull up a shot of Abrysvo today and the system of the Abrysvo that works for it broke and it was not yet administered but the caller is asking for a replacement about it. The caller would like to ask for information about this, about the packaging of this. It did not happen multiple times, it happens once and because we know how to try it up, we know we are supposed to put it down and how to use the equipment and despite of using that correctly it broke for ABRYSVO SFDPO 5X0.5ML GVL+SYR is a reportable malfunction. If it were to recur, it could likely cause or contribute to death or serious injury. This event is NOT a reportable malfunction for ROW since the deficiency of the device was found prior to use on the patient and the deficiency would always be detected.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Right anterior thigh red, raised, hard enlarging. Fever 99-100, cranky, decreased appetite. Rx KEFLEX 250/5ml oral suspension 1/2 tsp TID x10 days.
I am a healthy and highly active/athletic 66 woman. I had the ppsv-23 injection two days ago. Within 2 hours I began to have severe side effects. These have included extreme pain, edema, redness, and burning in the entire upper arm. I have greatly decreased arm mobility making dressing and performing even the smallest of tasks painful and nearly impossible.  I cannot lie in bed on that side thus rendering sleep tortuous. Additional side effects from this shot have included a bad headache, fatigue, myalgia, and chills. I have been taking Benadryl and Advil and have been icing the upper arm, all of which have helped somewhat. I hope these symptoms/side-effects will dissipate. I will never take this vaccine again nor can I recommend it to anyone. Merck Pharmaceutical, maker of ppsv23 should remove this money-maker from the market.
runny nose; headache; Stomach ache; positive COVID-19 test with symptoms; her head felt heavy/foggy; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6200), via an unspecified route of administration, administered in left arm on 04Mar2021 (at the age of 52-years-old) approximately at 14:00 (maybe 14:30), at single dose for covid-19 immunisation. The patient had no relevant medical history and no concomitant medications. On 09Mar2021 the patient was tested positive for COVID-19. On the same day the patient had sore throat, body aches, headache, back ache and stomach ache. On 11Mar2021 the patient experienced arm pain and sneezing and on 12Mar2021 she had runny nose. The patient reported that she received the dose with her husband and she was a few days behind him and had the same symptoms. At the time of reporting she had a sore throat and runny nose, but the body aches and headache were gone. She stated that she was still experiencing symptoms. Body aches were not severe, she took paracetamol (TYLENOL) and then they were gone. She reported that the arm pain was for a short amount of time, maybe half of the day on Thursday, 11Mar2021. She stated that it felt like muscle aches. The body aches and back ache were not severe. She reported that she took a couple of Tylenol and they were under control. The headache was never major except for maybe one night. She stated that other than that one occurrence, her head felt heavy/foggy and that she didn't feel like herself. She has been experiencing a sore throat in the middle of the night and stated that it was pretty heavy the night before reporting. She stated that she has had a minor sore throat during the day but it was worse at night from the air being dry. She sneezed some on 11Mar2021 but that it was worse today. Mentioned during the day she was congested. She took Tylenol and that it helped with the headache and body aches, denied taking any other medications. The patient reported also that she received the covid test at a drive through testing site. Headache and stomach ache were resolved, runny nose was not resolved and the outcome of other events was unknown.
MUSCLE CRAMPS IN LEGS; HEADACHE; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd, asthma, cat allergy, dog allergy, and allergic to medicines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1085025, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced muscle cramps in legs. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on MAR-2021, and had not recovered from muscle cramps in legs. This report was non-serious.
No adverse event after first shot on 17 March 2021.  Second shot on 14 April 2021 with following symptoms:  redness and pain at the injection site; general symptoms were headache, joint pain, body aches, fatigue, fever, and chills.
Pt received shots on 2/29/04. Reportedly received on visit and Dx'd/Tx'd for cellulitis at injection site. Pt has not been seen for follow up.
My husband was starting to experience some symptoms of aching and slight cough so we used a at home kit and he tested positive for COVID-19 my husband went to the Urgent Care center and they prescribed Paxlovid so I of course made an appointment as well my at home test kit was negative but I tested again at the Doctors office with my husband and the lab test kit from the Doctors was positive I had a bad taste in my mouth from the COVID-19 and after that it was over I did have a bad headache at the time and I was prescribed Paxloviod as well along with Tylenol to alleviate the headache and other body aches.
Case number PHEH2016US033285, is an initial spontaneous report received from a nurse on 16 Dec 2016. This report refers to an adult female patient. Historical and current conditions were not reported. The concomitant medications included BCP, multivitamins, zinc, Vit D, Fe and probiotics. The patient was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (batch number: 186685) at a dose of 0.5 ml intramuscularly on 02 Nov 2016. It was reported that the patient had experienced symptoms of soreness and difficulty raising her arm. The symptoms began on an unknown date after vaccination but was believed within about a week after vaccination. It was reported that the patient still had the symptoms including difficulty sleeping. On an unknown date, the patient felt little tingling on outside of the arm to fingers and it persist for couple of days. The patient felt soreness while lifting arm and this condition persist for couple of months. The patient went to chiropractor for stretches and felt better. After the administration of the vaccine it was also reported that the vaccine was tolerated by the patient in the past. The events were resolved around the beginning of Feb 2017. The seriousness and causality of the events were not reported. Follow up received from the nurse on 12-Apr-2017: Added concomitant medications (BCP, multivitamins, zinc, Vit D, Fe and probiotics), treatment procedure (chiropractor for stretches), added event (felt little tingling on outside of the arm to fingers and it persist for couple of days), updated outcome of the events tingling in arm and soreness (as recovered) and updated narrative accordingly.
shortness of breath, chest pain, weakness, brain fog, headache, leg swelling, pneumonia
Moderna vaccine - second shot adverse reaction started seizures 6 days after the second shot and continue weekly - 911 calls
Red, warm, swollen arm.  Chills and nausea.  Went to ED and Dr. for follow up and put on antibiotics.
48 hours after vaccination numbness in the facial area... including lips, left ear, forehead and cheek.  Not severe and no visual effects to date.