chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anaphylactic response to Covid vaccine; stopped breathing; fever; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sales representative.  An adult female patient of unspecified age (reported as mid-twenties) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included allergy to steroids. The patient's concomitant medications were not reported. The patient previously took propylene glycol and the patient was allergic to propylene glycol. On an unspecified date, the patient had an anaphylactic response to Covid vaccine. The patient stopped breathing. She was treated with epinephrine and transported to the hospital. The patient received other fluids and was and was released a day later when her fever was below 100F. The patient had similar allergy to steroids and did not connect that she was allergic to propylene glycol. It was reported that the events took place after use of the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Chills; Shortness of Breath; Back ache on left side; nausea; lack of appetite; no energy; red, itchy rash on entire torso of my body. Low grade ever (100). Treatment: Methylpred 4mg Pak Trige; Began treatment on 9/17/2018
This spontaneous report was received from a 73 year old Retired Registered Nurse (# US18-023886)referring to herself. The patient's medical conditions and drug history included she was generally in good health and had a "PNEUMOVAX 13" vaccine in 2017 (reported as last year). The patient's concomitant medications include Vitamin D3, magnesium, calcium, and probiotics. Prior to the vaccination patient's blood pressure and heart rate was normal (blood pressure105/68 and pulse was 70 units not reported). On 02-JUL-2018, the patient was vaccinated with PNEUMOVAX 23, in her left arm via intramuscular route for pneumococcal prevention(dosing details and lot/batch# not reported). On 02-JUL-2018 (also reported as 03-JUL-2018) she reported that, after receiving the vaccine "It's like the world went upside down" (feeling abnormal), her "blood pressure was 135/80 (heart rate increased) and her heart rate was 90 (heart rate increased) and she considered it as a severe reaction. She reported that she had sharp pains in the middle of her back just under her waist that lasted 5 minutes vertigo where she had difficulty keeping her balance but did not state she was nauseated. She reported that she sat down on a bench, because she would have passed out if she hadn't sat down. This feeling lasted about 10 minutes and stated that, she slowly felt better, pain and vertigo went away, she was able to eat and gave herself fluids. She later experienced bilateral aching, muscle aches that were "somewhat debilitating" along with an aching arm and headache. The reporter also stated that, she took TYLENOL, increased fluid intake and resting then later felt better. She reported that she just did not feel great. The outcome of heart rate increased, headache, pain in extremity, myalgia and blood pressure increased was reported as recovering/resolving. The outcome of back pain, vertigo and feeling abnormal was reported as recovered. The outcome of malaise was reported as not recovered. Causality assessment was not given by the reporter.
After receiving covid-19 Pfizer updated pediatric vaccine (between 15 to 30 minutes after receiving the dose), she fainted, fell on the ground and broke/chipped two front teeth.  The mother brought the girl to the emergency dentist and got treated.
intermittent chest pain after vaccine 6/20/21-7/12/21 skin rash on back of legs starting after vaccine 7/5/21- 7/19/21
Pt recvd vax 6OCT92 & approx 6 hrs p/inject exp itchiness of the eyes & GI discomfort which lasted for about 12 hrs; No further details were provided;
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient got Fluzone high-dose on 08/26/22. She reported to pharmacy on 8/29/22 that she had bright red itchiness and rash on her neck from her flu vaccine on 8/27/22 and it went away 1 day after she got her flu shot. She used Benadryl to alleviate red itchiness on her neck after getting the vaccine
Vaccine immediately felt hot going into my arm.  For 3 days experienced chills & hot flashes, nausea, muscle aches, fatigue, pain in arm.
Rash and Erythema; spots on face, arms, arm pits, torso (front and back), buttock and legs.  Face of baby swelled up slightly in cheeks and around the eyes.  No temperature.
Pt began experiencing involuntary shaking of her right hand 22 hours after the vaccine administration. She's also reporting a pulsating sensation from her hand up to her right forearm.
Patient is presenting at the pharmacy with redness and swelling on left shoulder. Has 2 blotched spots. Patient decided to contact  Dr for advice. Will not go to urgent care as suggested.
9-28-21 Began running a fever. Highest temp was 102.6.  9-29-21 left arm below injection site has become red, hot and sore and is about 3" long by about 2" wide. The injection site is also red, but is a smaller area.  I am still running a temp. Today's temp is about 101.
My left arm was sore. Then, it went to the right side of my neck. My tongue became numb and it was difficult to swallow. I became fatigued. The right side of my eye and mouth began to droop and it didn't work. Then, I couldn't close my eye. My ear and face on the right felt numb. My right side of the face didn't work and right eye became dry and with some blurriness. I went to the ER and was diagnosed with Bell's Palsy. I saw my family doctor the next day and my eye doctor the day after that who all diagnosed me with Bells Palsy. I was told it would take up to 6 months to get better. I have been using eye drops, Prednisone, and taping my eye shut at night as well as resting.
The patients left upper arm was sore on Wednesday and was slightly red Thursday and by Friday afternoon the upper arm was red from about an inch below her shoulder extending to about 2 inches above the elbow. She said it is warm to touch. I told her to seek medical care and she said she was getting in touch with her doctor. I suggested taking an antihistamine and then follow her doctors instructions.
Had COVID 19 from July to Oct of 2020. Never had a fever. Received the 1st shot on 04/13/2021 with no issues. Received 2nd shot on 05/04/2021 and 12 hours later (in a matter of an hour) went to 101 and felts sick. Fever went away in like six hours and felt tired for the next 48 hours. Just reporting so that folks can be track/see trends for the future.
Initial report received from a healthcare professional on 27 June 2013. An 18-month-old male patient had received an intramuscular dose 4 of DAPTACEL vaccine (Batch number-unknown) in the left thigh and Hepatitis A vaccine (Manufacturer, batch number, dose number and route of administration were not reported) in the right thigh on 25 June 2013. The patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at the time of vaccination. Details of the concomitant medications were not reported. On 27 June 2013, the patient presented swollen and slightly red left thigh injection sire some branching out from the injection site. Corrective treatments and laboratory investigations were not reported. The patient had not recovered from the events at the time of this report. Documents held by sender: none.
Mom reports pt did get fever 101-102 F and rash approximately 2 wk after his 1yr vaccines lasting about 3 days. His behavior also changed with irritability, crying and refusal to play for approximately one month after vaccines.
I had a sinus infection, and I went to the doctor. They did a CAT scan and found swollen lymph nodes in my neck and chest. I was diagnosed with sarcoidosis. It also could be from my medication I am taking called SIMPONI. They are still trying to figure out how to treat this. I have inflammation, fatigue, and more arthritis.
TWO WEEKS AFTER 2ND SHOT FELT TERRIBLE AND ASKED TO GO TO HOSPITAL.  FLAT LINED TWICE IN AMBULANCE AND ONE OTHER TIME AT FACILITY.  OXYGEN LEVER LOW;  SUSPECTED PNEUMONIA BUT RULED OUT.   LOST ALL FACILITY AND WAS ASLEEP FOR ABOUT 3 DAYS.  IN HOSPITAL ICU AND REHAB FROM 4-20-21 RELEASED 8-27-21.  MUCH RESIDUAL;    CAN'T WALK,  VERY WEAK IN MUSCLES;  MUSCLE PAIN  NEED OXYGEN 24/7.   LOSS  OF MEMORY;  SMELL OFF AND ON;  NO FEVER; BI AND STATS ALL OK OTHER THAN OXYGEN LEVEL.  IT IS NOW OCTOBER 2 AND DISABILITY IS EVIDENT AND IMPROVEMENT IS VERY SLOW IF AT ALL.
kidney infection; back was still hurting; heart rate at the second ER visit was 42 bpm; fell about 4 feet off a ladder onto his back; inflamed back; This spontaneous case was reported by a non-health professional and describes the occurrence of KIDNEY INFECTION (kidney infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history reported).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced FALL (fell about 4 feet off a ladder onto his back) and INFLAMMATION (inflamed back). On 03-Apr-2021, the patient experienced BACK PAIN (back was still hurting) and HEART RATE DECREASED (heart rate at the second ER visit was 42 bpm). On an unknown date, the patient experienced KIDNEY INFECTION (kidney infection) (seriousness criterion medically significant). On 19-Mar-2021, FALL (fell about 4 feet off a ladder onto his back) had resolved. At the time of the report, KIDNEY INFECTION (kidney infection), INFLAMMATION (inflamed back) and HEART RATE DECREASED (heart rate at the second ER visit was 42 bpm) outcome was unknown and BACK PAIN (back was still hurting) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Heart rate: 42 (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  On 03 Apr 2021, he was prescribed ciprofloxacin and hydrocodone/acetaminophen which he has completed.  Based on the current available information and temporal association between the use of the product and the start date of the events fall, kidney infection and heart rate decreased, a causal relationship cannot be excluded. The event: inflamed back is unlikely related.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events fall, kidney infection and heart rate decreased, a causal relationship cannot be excluded. The event: inflamed back is unlikely related.
This case was reported by a consumer via a sales representative and described the occurrence of anaphylaxis in a subject of unspecified age and gender who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject was not sensitive to latex. A few years ago, the subject received unspecified dose of Influenza vaccine (unknown route, injection site and batch number). At an unspecified time after vaccination with Influenza vaccine, the subject experienced anaphylaxis. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Site: Itching at Injection Site-Mild, Additional Details: Patient describes red itchy rash after receiving vaccine, not relieved by hydrocortisone.
1) fever/chills/feverish ~96 h 2) severe myalgia ~36h 3) Chest Pain ~1-2 h 4) SOA ~24 h 5) Altered taste ~12h 6) No appetite ~48h 7) Fatigue (couldn't stay out of bed) ~24h 8) Nausea, intermittent ~24h 9) Brain fog ~6h 10) Nasal congestion ~72h 11) Full body COVID like rash with itching on 1/2 ~36h 12) Arm sore/stiff (severe) ~24h 13) Vasovagal episode ~10min
she is afraid she might die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  An 87-year-old female patient received bnt162b2 (BNT162B2; Formulation: Solution for Injection), administration date 03Feb2021 (Batch/Lot number: unknown) as single dose for covid-19 immunization. Relevant medical history included: "aneurysm" (unspecified if ongoing), notes: has an aneurysm. The patient's concomitant medications were not reported.  The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "she is afraid she might die". Action taken for bnt162b2 (BNT162B2) was not applicable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Gradually started tried feeling and progressed to chills that become serious about 9:00 PM. Went to bed with to get rest and warm with numerous blankets. Did not take temperature but suspect high fever that lasted for about 2 to 3 hours. Continued to have a very restless night and hard to sleep. Took 2 aspirins prior to going to bed.
After 5 minutes receiving the 2nd dose of Covid 19 vaccine, both eye pupils of patient got smaller. Patient informed that she had the same reaction when receiving the first dose but she ignored it. Patient expressed that she was tired and had mild difficulty breathing. I provided 2 tablets of Benadryl 25 mg (Total 50 mg). Patient recovered from the adverse condition after resting for 30 minutes.
Body and skin aches; Body and skin aches; Headaches; Fever; Chills; Lymph node under both arms; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8730) via an unspecified route of administration in the left arm on 05Apr2021 at 09:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to Cox-2 inhibitors and some NSAIDs. Concomitant medications included  estradiol (ESTROGEN), progesterone (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 05Mar2021 at 11:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 20:00, the patient experienced headaches, body and skin aches, fever, chills and lymph node under both arms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ADVIL. The clinical outcome of the events headaches, body and skin aches, fever, chills and lymph node under both arms was resolved with sequelae on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038471, 2020SA038470, 2020SA038469, 2020SA038468, 2020SA038351, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038350 and 2020SA038352.  This case involves a two months old female patient who received 0.5 ml dose of IPV (VERO) [IPOL] lot PIF541M (Expiry date 07-Dec-2020) (lot PIF541M) via intramuscular route in an unknown administration site for Prophylactic vaccination on 16-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient in spite of being compromised.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt exp swelling @ inj site, warm @ inj site;pt perm disabled w/fragile x synd;
Varicella - Information has been received from a physician concerning a 4 year old male patient with no medical history of allergies who on 12 Apr 2000 was vaccinated with a 0.5 cc dose of varicella virus vaccine live in the left leg.  Concomitant vaccinations that same day included a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid in the left leg.  On 19 Apr 2000, the patient developed with rash at the injection site that included swelling and an unknown number of vesicles.  On 26 Apr 2000 the patient presented to a physician with varicella with swelling and crusted vesicles.  A dry, crusted vesicle was obtainted for PCR analysis at columbia University and the preliminary result was found to be VZV positive.  Subsequently, the patient recovered.  Follow up information from a laboratory indicated that the isolated speciment analyzed via pcr was found to be OKA/Vaccine strain.  Additional information has been requested.
Continued left deltoid discomfort with sharp, pinching pain when arm is abducted. Pain has persisted with gradual but slow improvement over the last 5 weeks. Rest and ibuprofen taken but not helping much.
Pfizer biontech covid vaccine dose 1. About 12 hrs in, fever, nausea, tachycardia, body aches and chills started
Tiredness/fatigue headache muscle pain/body aches chills low grade fever Overall feeling unwell injection site pain/arm pain and redness Note: Symptoms lasted 36-48 hours
40min after receiving her second Pfizer vaccine, pt reported numbness on left side of tongue, down next and into upper chest.
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an 85 years old female patient who received vaccine FLUZONE HIGH DOSE instead of PNEUMONIA SHOT. The patients past medical history, concomitant medication and family history were not provided. On 03-Oct-2018, the patient received a first dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date she also received a second dose of the same vaccine lot UJ037AA, expiry date 12-May-2019 via intramuscular route in the right deltoid instead of suspect PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur lot number not reported. It was an actual medication error due to extra dose administered and wrong vaccine administered. It was reported that patient came into pharmacy and was administered the FLUZONE HD vaccine and then stated I am glad I received my pneumonia shot, when the pharmacist asked the patient for further information, the patient thought she was receiving the pneumonia injection today and reported she had previously received the FLUZONE HD. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
LOST MOTION RANGE IN THE RIGHT ARM,  EXPERINCING PAIN  AT THE INJECTION SITE. HEADACHES
Cellulitis. Allergic Rx (L) thigh with yellow blister like lesion at site of vaccine like bug bite with erythema to inner thigh 3d after vaccine.
Patient (now deceased) received 1st dose of Pfizer-BioNTech vaccine around December 21, 2020 and was noticed to be scratching, fatigued, and unresponsive by a family member on December 24, 2020. He received the second dose of the same vaccine around January 22, 2021. Pockmarks and bleeding scratch marks were noted by a family member on the patient's face prior to this second dose. On January 28, 2021 a family member was alerted that the patient was suffering from severe bullous pemphigoid- a skin condition that has never been experienced by the patient, has been reported to be related to COVID-19 viral infection, and to T-cell responses promoted by vaccines. A corticosteroid was given, but did not work. Blisters developed to the point hands had to be dressed.
After about 5 days the site where I got the vaccine got red, swollen, warm and felt like it was throbbing. My arm was very sore, but that was all.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 19-AUG-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (strength, dose and frequency were not reported) lot # L008355, expiration date 11-SEP-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (got a little stronger diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced DIARRHOEA (got a little stronger diarrhea). At the time of the report, DIARRHOEA (got a little stronger diarrhea) outcome was unknown. No concomitant medications were reported. Patient did not want to provide further  details and ended the call. No treatment medications were reported.
C/O chills, elevated temperature, headache, runny nose and/or congestion, myalgia, nausea, and vomiting.