chrisvoncsefalvay/vaers-outcomes huggingface dataset:
As I got the Moderna 2nd dose vaccine on 4/2, I immediately felt pain shooting up from my left arm to my neck on the left side. This was a drive-through clinic & shot was given close to my shoulder. It started w/ minor pain in my arm, neck & shoulders. By 4/30 the pain was so bad that my GP got me muscle relaxers & anti-inflammatory drugs to sleep and function. I was also taking Lunesta & Unisom; sleep was still very erratic. Throughout the day & night I used BioFreeze, arnica, both hot and cold pads and elastic bandages. I was still in pain. Since 5/4, I have seen my chiropractor 3 times and have seen an acupuncturist 4 times which seems to be helping. (Can't get the calendar for Patient died to go away.)
fever 101.9.    Treated with tylenol.  Fever remained in range of 101 for 36 hours Extreme tenderness in left armpit.   Constant dull pressure in upper left arm.  I still have this 72 hrs after getting the vaccine.
This case was reported by a healthcare professional and described the occurrence of rash in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced rash, open wound and possibly allergic to thimerosal. The healthcare professional reported that the subject developed "a severe rash on his hands, and his physician thought that it might be from the thimerosal. The healthcare professional stated "we are having a difficult time treating him, and he continued to experience open wounds, which only clear up with prednisone. The subject was treated with prednisone. At the time of reporting the open wound was unresolved; rash and possibly allergic to thimerosal were unspecified.
Sick to stomach; Pain in arm; Headache; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 08Apr2021 at 12:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 18Mar2021 at 13:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. He also received piperacillin sodium; tazobactam sodium (ZOSYN) and promethazine (PHENERGAN), on an unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021 at 14:00, the patient experienced sick to stomach, pain in arm, headache and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of sick to stomach, pain in arm, headache and tiredness was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
administered flublok quadrivalent to a 14-year old patient with no reported adverse event; Initial information received on 06-Jan-2022 regarding an unsolicited valid  non-serious case received from nurse.   This case involves 14 years old male patient who was administered flublok quadrivalent with no reported adverse event while receiving influenza quadrivalent recombinant vaccine [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included tozinameran (PFIZER BIONTECH COVID-19 VACCINE) for Immunisation.  On 06-Jan-2022, the patient received a  0.5 ml dose of suspect influenza quadrivalent recombinant vaccine (lot: QFAA2134, expiry date: 30-Jun-2022) (strength reported as standard) via intramuscular route in the right deltoid once for immunization.  On 06-JAN-2022 the patient developed a non-serious administered flublok quadrivalent to a 14-year old patient with no reported adverse event (off label use) same day following the administration of influenza quadrivalent recombinant vaccine.  It was reported, Nurse reports that she administered FLUBLOK QUADRIVALENT to a 14-year old patient. Nurse asks how she should proceed in this situation. Nurse states the patient did not require any treatment after receiving the FLUBLOK.  Action taken with quadrivalent recombinant influenza vaccine (FLUBLOK QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered flublok quadrivalent to a 14-year old patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event administered flublok quadrivalent to a 14-year old patient with no reported adverse event.
Tiredness, or extremely fatigued; Numb feeling in mouth; Swelling and pain in right arm; Swelling and pain in right arm; Felt panicky; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb feeling in mouth), PERIPHERAL SWELLING (Swelling and pain in right arm), PAIN IN EXTREMITY (Swelling and pain in right arm), FEELING ABNORMAL (Felt panicky) and FATIGUE (Tiredness, or extremely fatigued) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (Numb feeling in mouth), PERIPHERAL SWELLING (Swelling and pain in right arm), PAIN IN EXTREMITY (Swelling and pain in right arm) and FEELING ABNORMAL (Felt panicky). On 19-Mar-2021, the patient experienced FATIGUE (Tiredness, or extremely fatigued). The patient was treated with DEXAMETHASONE on 18-Mar-2021 for Symptomatic treatment, at an unspecified dose and frequency and ACETAMINOPHEN on 18-Mar-2021 for Symptomatic treatment, at an unspecified dose and frequency. On 20-Mar-2021, HYPOAESTHESIA ORAL (Numb feeling in mouth), FEELING ABNORMAL (Felt panicky) and FATIGUE (Tiredness, or extremely fatigued) had resolved. On 24-Mar-2021, PERIPHERAL SWELLING (Swelling and pain in right arm) and PAIN IN EXTREMITY (Swelling and pain in right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        .     Reporter did not allow further contact
Had no symptoms of any kind up to the time of shot.   2 hours later I developed double vision in my right eye
Pruritic erythematous papular rash to both lower extremities consistent with a vasculitis, treated with oral prednisone and diphenhyramine
Patient was vaccinated on 12/18/03 with DTAP.  Three weeks later he became lethargic and continued to get worse.  When we took him to the hospital our pediatrician recognized the possibility that it was encephalitis and was transferred.  There, he was diagnosed with Acute Disseminated Encephalomyelitis.  Initially all the doctor's questions centered around his last vaccination.  However, he also tested positive for the flu although he had no flu sypmtoms other than an uncontrollable fever.  The final diagnosis was that it was a complication of the flu, but the doctors told us there was no way to know for sure if it was that or a reaction to the vaccination.  Nurse follow up on 06/30/04 states: "ADD: Nausea, vomiting, weakness, loss of speech."
Patient less than one minute after receiving vaccine started going faint then demonstrated what seemed to be a grand mal seizure. Parents were in the vaccine room with me.  Patient went very pale and unresponsive. Brought patient to floor and raised legs into chair. Mother cradled her and splashed water on face. When patient came to, she was very lethargic.  911 was called. Fire department arrived and evaluated patient. Ambulance arrived and escorted patient with parents out of pharmacy. Patient has had no prior medical issues except fainting with blood draw.
Hot to Touch; Hives; Swelling/ bump; Redness; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included food allergy and food allergy.   On 8th August 2019, the patient received the 1st dose of Shingrix. On 17th October 2019, 70 days after receiving Shingrix, the patient experienced hives. On an unknown date, the patient experienced swelling arm, erythema of extremities and skin warm. The patient was treated with cortisone (non-proprietary) (Cortisone 10). Shingrix was discontinued. On an unknown date, the outcome of the swelling arm and erythema of extremities were recovered/resolved and the outcome of the skin warm was unknown and the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities, skin warm and hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on right arm. Less than 3 months after receiving Shingrix, the patient experienced had swollen and red arm for approximately 1.5 weeks. The caller reported that it went away and then she had hotness in her arm. The patient started to have hives and had no past medical history of hives.  The caller mentioned around that time, the patient ate a few things that she never had before.  The patient also mentioned she is allergic to different things like chocolate and cheese which causes migraines and she had avoided it for approximately 35 years. The caller reported hives went away in a few days after putting Cortisone 10 on it and bathing and showering as usual, but at the reporting date a bump appeared every few days in different places. The caller declined to provide further information for safety report.  The caller did not consent to follow-up and did not not want to receive any correspondence.  The caller mentioned she may call back later to provide information after speaking with her doctor.  The provided MI phone number for her doctor's reference.  The caller reported never smoking or drinking. She was considering not receiving 2nd dose even if her doctor approved it.
Very painful arm.........Very weak whole body next day......had to urinate 4 times at night. (usually I only go once)  vision weakened for 24 hours
Pt. called office reporting feeling "heaviness" in her chest and some wheezing. 12/1/09  Medical records received for DOS 11/20/09 and OB records. Final DX: H1N1 Allergic reaction. C/O trouble breathing, felt wheezy. chest heaviness. Currently pregnant.  D/C to home. Stable.
Patient called today (2/22/18) stating that she still had intense pain in the area that she had the above vaccines.  This is the first time that she had contacted anyone regarding the discomfort.  She stated that she did not have any redness/swelling/warmth at the vaccine sites, but pain in the muscle significant enough that it was causing her to wake at night sometimes and it was difficult to perform some daily activities. The pain was not getting better or worse since the day after her vaccines. I suggested that she should call her doctor for further evaluation. Patient came in later today with 2 prescriptions after talking with her doctor. Patient will be following up with her doctor for monitoring and further treatment, if necessary.
10/19/10 woke up (L) arm sore to elbow w/pain 10/20/10 went to physician received shot. Drew blood for WBC 10/20/10 physician another shot 10/22/10 Urgent Care BACTRIM. 10/26/10 Stated cellulitis, severe swelling, pain but now markedly better...Reviewed product insert  "injection site cellulitis - like reactions" stated would complete VAERS Form (see attached insert).
Muscle pain, headache, low grade fever, chills,  stabing muscle pain, muscle weakness, muscle spasms, vertigo, numbness with pins and needles of bilateral feet, malase
9 months old patient gotten the Flublock quadrivalent instead of the Fluzone Quadrivalent, no advesre event; patient gotten the Flublock quadrivalent instead of the Fluzone Quadrivalent, no advesre event; the boxes and the syringes of these two vaccines were so similar; Initial information was received on 05-Nov-2019 regarding an unsolicited valid non-serious case from a physician.  This case involves a nine month old patient (gender not reported) who was vaccinated with a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] because the boxes and the syringes of these two vaccines were so similar (lot number and other dosing details were not reported).  Medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration, Product packaging confusion and wrong vaccine administered.  No adverse event was 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'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.  Information on the batch number was requested.
Fully vaccinated for COVID.  Last dose 4/16/2021.  Tested positive for COVID 9/14/2021.
Delayed onset full-body hives/urticaria. Intense itching daily, mostly on scalp, behind ears, on back and neck. Has not resolved in 2 months. Itchiness is manageable with Zyrtec and Pepcid every 8 hours but rash persists despite medication many days.
Received Engerix B that suffered a temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number P4DJ5, expiry date unknown) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number K2L79, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B. On an unknown date, unknown after receiving Engerix B and Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported that several patients had received Engerix B that suffered a temperature excursion.  No further information was available. The reporter consented to follow up
Site reaction - left upper arm ? site infection. Started approximately 12 hours after injections. Had subjective fevers, chills, SOB, cough, arm weakness/pain, leg weakness, HA, dizziness. Tx: Prednisone & Antibiotic.
Some redness and swelling at site, right deltoid, right side neck, torso sweating, cold/clammy, color pale on right side. Immunization administered 9/29/09. Evaluated in office 9/30.
Started to tremor alot more than usual and having breathing problems.  Ended up at the ER.
Fever, rash, Seen in urgent 5/8/16 and diagnosed with erythema multiforme. Seen again in PCP office 5/9/2016 and confirmed rash consistent with erythema multiforme. Fevers > 101 F persistent for 5 days so lab work ordered 5/11/2016.
This spontaneous report was received from a pharmacist and refers to a 17-year-old female patient with penicillin allergy. The patient's medical history included kidney transplantation on 02-DEC-2016. Concomitant therapies included calcitriol, cholecalciferol (reported as vitamin D3), ferrous sulfate, PLAQUENIL, labetalol, KEPPRA, MYFORTIC, PRILOSEC), VALCYTE, PROCARDIA and TYLENOL. On 24-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX23 injection, lot # M042324 with an expiration date on 10-JUN-2018, in the left deltoid for prevention of pneumonia (dose and route of administration were not reported). On the same day, the patient developed a fever and her left arm became "red, tender and had profound swelling". On 26-MAY-2017, the patient was admitted to hospital where she had an ultrasound scan of the left upper extremity done. The scan showed a possible cellulitis and infection at the site where the PNEUMOVAX23 was administered. During hospitalization, the patient was treated with unspecified antibiotics (details were not reported). On 30-MAY-2017, the patient was discharged to home with oral clindamycin for 7 days. The outcome of the events was reported as recovered on an unknown date in approximately 2017. The relatedness between the events and PNEUMOVAX23 was not reported. This is one of two reports received from this reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA008507.
We knew she has allergy problem. We went to an allergy asthma specialist to check whether she would have severe allergic reactions. They used Miralax to test potential reactions and the test went smoothly. They advised to take the vaccine. When she had first vaccine jab, she had allergic reactions, itching, sneezing and breathing problems. We introduced two 25 mg Benadryl. There was a medical team on site and they intervened from the beginning. checking her pulse, blood pressure and lungs. They were very helpful and after 30-45 minutes she was back to normal. We didn't go to hospital. After three weeks, we went for the second shot and informed medical staff what happened during the first shot of the vaccine. They said this level of reaction is OK. If I had reviewed this page in detail, I would advise her not to take the shot. Anyways, she received one Benadryl 25 mg before the second shot. This time the reaction was more severe but medical team on site supported us and she received 3 more Benadryl pills. Everything went back to normal.  Our problem started after 2 weeks. She started having allergic reactions to food that has become steadily more severe. We were not ended in a hospital but after a few interactions with our provider they brought forward our office call to tomorrow. Food from cooked meals such as meatballs to chicken wings to cheese, banana, apple, and strawberries. She was not allergic to none of these food.
Fever, 100.3, came on suddenly. Can't stop shaking. Took 2 extra strength Tylenol. Will go to doctor if it gets worse.
Case fully vaccinated with Pfizer. Second dose received on 3/22/2021. Tested positive for COVID on 9/14/2021. Admitted to Medical Center on 9/20/2021. Expired on 9/27/2021 while still hospitalized.
Tired- headache- achy 1st day, 2nd day exhausted & aches everywhere, missed work. Extreme fatigue like never before.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 9:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 10:12 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 90.95 for dose administered on 28-Feb-2021 and 91.02 for dose administered on 28-Mar-2021.   No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 degrees Fahrenheit at 09:00 AM and 26 degree Fahrenheit at 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021. Batch number 019B21A underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
vaccine was frozen while kept on the refrigerator that went too cold and reached 11°F; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Herpes zoster (Shingrix) (batch number Z22C5, expiry date unknown) for prophylaxis.   Additional patient notes included Race: Indigenous.   On 5th May 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follow: The reporter informed Shingrix vaccine was stored in pharmacy refrigerator which went out of temperature range down to a minimum of 11 degree F for up to 12 hours which led to incorrect storage of drug. Shingrix was moved to a second fridge and marked do not use but pharmacist did not see the sign. The pharmacist injected one dose to the patient before discovering the vaccine was exposed to the temperature excursion. The reporter consented to follow up.
Changes in vision; my eye vision has drastically decreased its hard to focus/see  words/letters. My eyes are very sensitive to light. I have became very forgetful this is not normal. This all happened within 30 minutes of receiving the vaccine.