chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHE; SYMPTOMS OF SEVERE CHILLS; FEVER (100-101F); HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis, and hypothyroidism, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced symptoms of severe chills. On 10-MAR-2021, the subject experienced fever (100-101f). On 10-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100-101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from symptoms of severe chills, and headache on 11-MAR-2021, and was recovering from fever (100-101f), and body ache. This report was non-serious.
the last flu shot I got I got very very sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media) in the on 24-Nov-2020.  This case involves a patient of unknown demographics who got very very sick for about 35 hours years ago (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got very very sick for about 35 hours years ago, (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported that the patient will never get another flu shot. When people I know get the flu I have them take vitamin B6 and drink some warm green tea and their flu goes way.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
The patient experienced no symptoms; administered an improperly stored dose of PROQUAD; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions and allergies were unknown.   On 15-JUN-2020, the patients were vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) (lot # S030215 and expiration date: 25-MAR-2021; strength, dose, frequency, anatomical location were not reported) subcutaneously for prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (lot # S038697 and expiration date: 10-AUG-2022). It was reported that the vaccine was exposed to a temperature of 6.8 degree Fahrenheit (F) for 20 minutes. There was previous temperature excursion for the vaccine. It was reported that digital data logger was involved. No additional symptoms reported (no adverse event).
On March 6, 2022, I began to experience severe stomach pains and a burning sensation directly across the top of my stomach area. I immediately began to vomit uncontrollably. The vomiting continued for approximately 1. 5 hours. Family member transported me to the Medical Center Emergency Room as it is 5 mins from my residence. I was diagnosed with acute appendicitis and immediately scheduled for emergency surgery. Surgery completed several hours later.  No family history of appendicitis, no issues in the past with severe stomach issues other than the occasional acid reflux. From onset to diagnoses was within 3 hours. Several coworkers have experienced the same symptoms and have had an emergency appendectomy after receiving the 3rd booster shot., After speaking with one coworker, our symptoms and experience is almost identical with no history of any stomach issues in the past nor any family history of appendicitis.
Pt received the Covid-19 vaccine. He reports symptoms of pain left arm "red dots" on both arms. Verbalized burning tingling sensation of his bilateral legs. Patient came to the clinic on 3/30 to cancel his appointment.Pateint had his Pfizer  vaccine on 3/13. Treatment/intervention Patient declined to receive his second of Pfizer vaccine.
Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours after second dose.
COVID Vaccine Breakthrough. COVID+ on 10/5/21. Symptom onset 9/24/21. Patient is not hospitalized due to COVID, but due to other factors. At this time, the patient has no fevers and is on room air.
2nd day I woke up  at midnight, with uncontrollable severe chills and 102.8 fever.  It took 2  Tylenol, 2 Advil and a washcloth on my forehead all night, to control the fever.  Next day had a bad headache.  3rd night same exact thing, chills & high fever.  Next day I was good.   Day 5, arm swelled and was swollen red from shoulder to elbow and warm.  That lasted for 3 days and then I was fine...
G40.802 APHASIA W EPILEPSY 12/18/2022 BRAIN MASS G40.909 EPILEPSY, UNSPECIFIED 11/8/2022 BRAIN MASS J96.00 ACUTE RESPIRATORY FAILURE 12/17/2022 BRAIN MASS G40.802 APHASIA W EPILEPSY 12/18/2022 GLIOBLASTOMA MULTIFORME, TEMPORAL LOBE G40.909 EPILEPSY, UNSPECIFIED 11/8/2022 GLIOBLASTOMA MULTIFORME, TEMPORAL LOBE J96.00 ACUTE RESPIRATORY FAILURE 12/17/2022 GLIOBLASTOMA MULTIFORME, TEMPORAL LOBE G40.802 APHASIA W EPILEPSY 12/18/2022 APHASIA W EPILEPSY G40.909 EPILEPSY, UNSPECIFIED 11/8/2022 APHASIA W EPILEPSY J96.00 ACUTE RESPIRATORY FAILURE 12/17/2022 APHASIA W EPILEPSY G40.802 APHASIA W EPILEPSY 12/18/2022 GLIOBLASTOMA MULTIFORME, TEMPORAL LOBE G40.909 EPILEPSY, UNSPECIFIED 11/8/2022 GLIOBLASTOMA MULTIFORME, TEMPORAL LOBE J96.00 ACUTE RESPIRATORY FAILURE 12/17/2022 GLIOBLASTOMA MULTIFORME, TEMPORAL LOBE
This spontaneous report was received from a nurse who referred to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored dose of VARIVAX, dose and route of administration were not reported (lot # M041080 with expiration date 06-OCT-2018). No adverse effects were reported. VARIVAX was stored between -14 Celsius degrees (C) and 10 C for 132 hours. There was no previous temperature excursion reported. The digital data logger was involved in recording the excursion. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent for follow up. Sender's Comments: US-009507513-1707USA002941.
Vials storage error; 10 patients were vaccinated from that vial; A spontaneous report  was received from a pharmacist, concerning ten patients who were administered Moderna's COVID-19 vaccine from a vial temporarily stored at 17.7 °F/product storage error and out of specification product use.  The patients' medical histories were not provided. Concomitant product use was not provided by the reporter.  On 16 Feb 2021, ten patients received one of two planned doses of mRNA-1273 (Batch number 029L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Feb 2021, the freezer door at the pharmacy was left slightly open which resulted in a temperature increase to 17.7 °F for one hour and 25 minutes. After visual inspection by the pharmacist, all vial were reportedly still frozen. The pharmacist thawed 1 vial, and 10 patients were vaccinated from that vial. The pharmacist noted that the temperature of the freezer containing the remaining 29 vials was -11.0 °F at the time of reporting.  Action taken with mRNA-1273 in response to the event was not provided.  The event, 10 patients vaccinated from a vial temporarily stored at 17.7 °F, was considered resolved on 16 Feb 2021.; Reporter's Comments: This report refers to a case of Product storage error (vaccine from a vial temporarily stored at 17.7 °F, and administered to ten patients) for mRNA-1273, lot # 029L20A with no associated AEs.
This spontaneous report was received from a nurse and refers to a 51 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies or concomitant therapies was provided. On an unknown date, the patient was vaccinated with PROQUAD (lot#, expiration date, dose and route of administration were not provided) for prophylaxis. No adverse events were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Additional Details: REACTION HAPPENED 13 DAYS AFTER INJECTION, LASTED 2 TO 3 DAYS
Vaccination given appx. 2PM on Tuesday, 11/29. At 2:15 PM, went to ED w/throat swelling, dizziness (to the point of near fainting); clamminess. Symptoms resolved by the time seen in ER-no treatment received.
my feet began to cramp a week after receiving the vaccine. I felt a sensation of tingling and cramping, accompanied by an unbearable burning. I was diagnosed with transverse myelitis caused by the vaccine. The treatment is with steroids, gabapentin, tramadol, pantoprasol, duloxetine. I could not walk. using a wheelchair with therapies and on the way with the help of a walker. I'm going for 5 months in this condition
Severe bruising; This is a spontaneous report from a Pfizer sponsored program regulatory authority. A non-contactable female consumer (patient) reported for herself.  A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 20Sep2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date on Sep2021 the patient experienced severe bruising. She had the 1st dose of the vaccine on 20Sep2021 and within a week she developed severe bruising, after vaccination ever since then she has had severe bruising - She called her pharmacist and told her that it is a rare side effect of the vaccine. She went to her primary care who said it was not a side effect of the Pfizer COVID19 vaccine. Her primary care physician told her that it is not vaccine related - She wants to know if severe bruising is side effect of the vaccine. The reporter asked if it could be side effect. She just wanted to see if it is a possibility that it is a side effect. The reporter stated that it doesn't matter what lot number she got. The pharmacist seems to be in agreement or has first-hand knowledge of reports of this with people. It has been rare. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
He was having some neck issues, went to the clinic a couple of times and during one of the visits he was given the Shingrix vaccine o 5/14/22.  They were giving him Motrin for the neck pain and he went back four times in a row, they also gave him Flexeril and Robaxin.  He then went back again and was given Tramadol as he was hurting so bad and while he was there last night they also gave him Acyclovir for shingles, which they informed him that he had.  They also gave him some Tylenol as well.  He just wants to know how he got the shingles after getting the vaccine.
my right arm still hurts; bottle was freeze dried; all of it didn't dissolve; Inappropriate dose of vaccine administered; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain, product storage error, inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the product storage error, inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in right arm. The patient still hurts over one year later at the injection site and on day of reporting patient moving throughout his or her arm making it week had this ever happened to anyone before. The patient did notice that the pharmacist was shaking the bottle and patient asked him why he did that, then he said because it was freeze dried, which led to product storage error. The pharmacist had to add liquid or something, the patient was wondering if might be all of it did not dissolve when it was injected into patient's arm and could that have caused the problems, which led to reconstitution technique and inappropriate dose of vaccine administered. The patient thought something's not right in his or her arm and did not even know what kind of physician would know what to do. The patient mentioned it to regular doctor and they just shrugged like they never heard of it before this was not normal. The patient enquired what should he or she do in this situation. The requesting consent to follow up.
patient received Adacel vaccine at the age of 9 years and 10 months in error which should be administered at 11 years of age/no AE; Initial information regarding an unsolicited valid non-serious case was received on 25-Feb-2021 from a Nurse via Agency (Reference number- 00493530) and transmitted to Sanofi on 25-FEB-2021.  This case involves a 9 years 10 months old female patient who was vaccinated with first dose 0.5 mL DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [Strength- Standard] in error which should be administered at 11 years of age (batch number and expiry date not reported) lot number not reported via unknown route in unknown administration site for prophylactic vaccination on 01-Jul-2016 (Inappropriate schedule of product administration).  At the time of reporting, the patient was 14 year-old and the nurse asked if patient could receive next Adacel vaccine.  The patient's past vaccination(s) included TD and DTAP for prophylactic vaccination. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  No adverse event reported at the time of reporting.  Reporter wanted to know if they need to revaccinate the patient at 11 years old. Nurse was at lunch at the time of the call. Left contact information with the front desk. If the nurse calls back, it was mentioned please provide information from "Catch Up Schedule" standard. It was not sure if it was relevant as it sounded like from the call that the patient may have already had her TD and DTAP vaccines for prophylactic vaccination  Product used: Used; First time product used: Yes; Still using product: No  It was a case of actual medication error due to inappropriate schedule of product administration (latency was on same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  There will be no information available on batch number for this case.
I had the usual side effects: chills, headache, major soreness at the site of injection but I also had sharp pains randomly running down only the left side of my body.  Sharp pains in my rib cage when trying to take a deep breath, jolting pain from my left hip to my ankle (specifically on the outside on my left knee) and the top of my left foot ached for about an hour.  It's now 22 hours after injection and I still have a headache and feel very weak.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 84-year-old male patient who received SHINGRIX (batch number H547E, expiry date 22nd February 2021) for prophylaxis. On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th September 2018, 1 days after receiving SHINGRIX, the patient experienced rash and pruritus. On an unknown date, the outcome of the rash and pruritus were unchanged. It was unknown if the reporter considered the rash and pruritus to be related to SHINGRIX. Additional information was reported as follows: The patient experienced a rash and itching on knees, thighs and behind the arms after vaccination. No further details were provided by the reporter.
Call received from child's mother on 7/29/2015 stating that child had developed extensive redness and taut edema to upper R arm (site of injection of varicella and TDaP vaccines on 7/28/2015) from acromian process to lower biceps region). Child's mother is a RN.  No other SE's reported.  I checked with her again on 8/4/15.  She stated the swelling had about resolved but that there was still an area of deep red discoloration at one of the injection sites.  No other adverse effects were reported.  Did not seek medical attention.
Breakthrough case admission after 2 vaccines Pfizer 4/7/21 Lot# Ew0150;  Pfizer 4/28/21 Lot# Ew0162
pt recv vax 24JUN95 & no problems reported w/arm until 2JUL95 lt arm became inflamed and hot to touch in area of inj; pt had a h/a; pt saw MD who said it was a poss rxn to Tetanus & prescribed rx; arm is much better today;
Tested positive for Covid, 10 days after receiving the vaccine; Tested positive for Covid, 10 days after receiving the vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID on an unspecified date 10 days after receiving the vaccine. The patient underwent lab tests and procedures which included Covid test: positive on an unspecified date. The outcome of the events was unknown.  The information on the batch/lot number has been requested.
covid positive.  HPI  73 year old female tested positive for covid at home- daughter just discharged from hospital after being treated for covid-19- patient's husband admitted to hospital with covid infection- patient denies sob,cp,abd pain, sorethroat, n/v. denies abd pain/ diarrhea
I had various rashes with blisters and extreme itching  They popped up daily for 3 1/2 weeks within 18 hours of vaccine.
Information has been received from a RN concerning a 5 year old male with allergies to amoxicillin, potatoes and okra who on 04/02/02, was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccinations on that same day included diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid, MMRII, inactivated poliovirus vaccine. The RN reported that, on the morning of 03/18/03, the pt developed chickenpox. The pt visited the physician's office and the RN indicated that the case was mild characterized by two lesions on the pt's head and a couple lesions on his shoulders. The pt was also noted to be afebrile. The pt was treated with hydroxyzine HC1 (Atarax), 3/4 teaspoon three times daily. On 03/24/03, the pt recovered from the chickenpox. Additional information is not expected.
This spontaneous report as received from a licensed practical nurse refers to an unknown age patient. Pertinent medical history, drug reactions or allergies were not reported. On 09-OCT-2013, the patient was vaccinated with an expired dose of ROTATEQ, 2 ml oral, lot # 0059AE, expiration date: 23-SEP-2013. Concomitant medication was not reported. No adverse event was reported. The outcome of the patient receiving an expired vaccine dose was not reported. Additional information has been requested.
developed vertigo type symptoms; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 09Apr2021 at 08:15 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hemolytic anemia (currently not active) and penicillin allergy. Concomitant medications included montelukast (MANUFACTURER UNKNOWN) and loratadine (MANUFACTURER UNKNOWN); from an unknown date for unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 19Mar2021 at 08:30(at the age of 36-year-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 11Apr2021 at 06:00, second day after the vaccination, the patient developed vertigo type symptoms. she was currently on day 5 of these symptoms, though it seems to be getting better each day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event vertigo type symptoms was recovering.  No follow-up attempts are needed. No further information is expected.
11/29/2000, started at 12:30, itching, redness (everywhere), increased BP and temperature. Went to her own MD. She reported she was treated with 40mg of prednisone and Benadryl and also a breathing treatment.
Fever for 48 hours ranging from 103-104 degrees. Managed with Motrin down to 100-101.  Onset of rash on 10/10/2010 over trunk and eventually all of body.
mild dizziness (at time of injection); injection site soreness (12 hours after injection; duration 1 day); 3 says after injection: nausea, dizziness and weakness, headache, tiredness, feeling unwell.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (pain at the site of the injection, upper left arm) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 019C21A) for COVID-19 immunization. No medical history reported. On Sep 1, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced vaccination site pain (pain at the site of the injection, upper left arm). At the time of the report, vaccination site pain (pain at the site of the injection, upper left arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.