chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccines administered 9/11/09 LT Anterior thigh. Mother reported swelling and redness of  LT Anterior thigh 9/14/09. Evaluated 9/14/09 12 x 12 cm area of erythema swelling & swelling tenderness - pruritic with central area of papulo vesicles 1 mm 4cm x 4cm. A febrile ambulatory - no lump. BENEDRYL & cool compresses, CEPHALEXIN warm to touch back to normal 9/15/09
15JAN AM pt c/o rt arm hurting-refusing to use it; sl swelling & minimal redness @ inject site; 15JAN PM mom indicates rt arm is now reddened from 1" below inject site to just above elbow; 17JAN redness resolving limited use of rt arm cont;
The M-M-R II was expired. Patient was contacted and wants to come in in 4 weeks for revaccination. No reported reactions.
Exposed at school, symptoms two days later, Paxlovid  for 5 days.  !01 degree fever for a couple of days, returned to work within 10 days.   Phone consult only.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 10-APR-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J007930, expiration date: 28-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
temp excursion; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Herpes zoster (Shingrix) for prophylaxis and pneumococcal 13 valent conjugate vaccine (Prevenar13) for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Shingrix and Prevenar13 at an unknown dose and frequency. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Health care professional reported that the Shingrix and Bexsero were stored other than recommended temperature, which led to incorrect storage of drug. Also temperature excursion was reported for Prevenar13. Over the phone call there was no mention that the medication was given to any patients after the temperature excursion. No other information was provided. The reporter consented to follow up.
Patient's father called at 1:15pm asking to speak to a nurse. Reports his daughter received vaccines yesterday and now is unable to move her leg. He reports she is in pain and is unable to walk. No additional s/s reported. Nurse informs parent to take  patient to the emergency room immediately.
A report has been received from a Health Professional concerning a 5 year old, male subject, who had been receiving FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. it was reported that the patient experienced three patients inadvertently expired FLUMIST QUADRIVALENT which started on 04-DEC-2014. The outcome of the event of three patient's inadvertently received expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
PT WANTED TO RECEIVE PFIZER AS HER BOOSTER BUT WAS SIGNED UP FOR MODERNA INSTEAD.
Patient was a walk in for her second (booster) dose. At check in patient did not have vaccine card.  Patient was checked in, sent to receive vaccine and had not yet been added to the schedule. Her vaccination card was being filled out while being sent to receive second dose. Vaccination was administered (Moderna Covid-19 Vaccine) and patient was being monitored for 15 minutes. When writer was told patient had been added to the schedule and went to chart administration, writer noticed that patient had received her first dose on  02/05/2021 of Pfizer Covid-19 Vaccine.
JOINT PAIN, BODY MALAISE, HEADACHE, SWOLLEN INJECTION SITE
Patient received vaccine 10/21/04 about 2:00 PM. On 10/22/04 at 04:00, patient was found dead in bed.  Autopsy report received on 11/22/2004 states pt had SIDS.
Tired; This case was reported by a consumer via other manufacturer and described the occurrence of tiredness in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included intervertebral disc protrusion, spondylitis, inguinal hernia and clot blood. Concurrent medical conditions included sarcoidosis, blood pressure high, blood cholesterol increased, looked pale, dizziness, numbness and multiple sclerosis relapse. Concomitant products included ocrelizumab (Ocrevus), brimonidine tartrate + timolol maleate (Combigan), travoprost (Travatan), rivaroxaban (Xarelto), rosuvastatin calcium (Crestor), ezetimibe (Zetia), ambiguous medication nos (Provigil (Nos)), tizanidine hydrochloride, hydrochlorothiazide (Hydrochloorthiazide), lisinopril and gabapentin.   On 22nd March 2021, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were reported as follows: No further information was reported. Consent to follow up was not asked.
Liver processing reactions and sensitity. Facial, neck and chest rash ( the same way liver sends toxins to integumentary system in order to process a new introduced toxin, for example alcohol); hive bump on neck inferior to lymph nodes on same side of injection site.  4 days later, liver sensitivity (feels bruised as if I fell on my side).  8 days later, noticed mild yellowing of skin all over body.  11 days later, redness on chest and neck have faded, but redness in cheeks remain as well as jaundice tone. No previous liver history, disease, or infections.
No adverse reaction.  Pt was 4yrs 10months and thought she could get the 5-11 yr dose
pain in the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic to cats" (unspecified if ongoing), notes: highly allergic to cats; "allergic to holm oak" (unspecified if ongoing), notes: moderately to holm oak; "allergic to almonds" (unspecified if ongoing), notes: mildly to almonds. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain in the injection site".  Additional information: The patient reported she did not have an allergic reaction to vaccine administration but a pain in the injection site for a couple of days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 9OCT95 & devel redness @ the inj site;no tx was necessary;pt has recovered;
the vaccine burned and hurt; This spontaneous report has received from a physician's assistant via a company employee, referring to herself. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On unknown dates in approximately August 2011 (reported as 9 years ago), the patient was vaccinated her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) boosters (lot #, expiration date, route and dose details were unknown) for prophylaxis.         On an unknown date in approximately August 2011 (reported upon each administration as well as for a few days afterwards), the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine burned and hurt. The reaction would resolve within a few days without treatment.      The causality assessment between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was considered as related.
On or about 06 March I began to experience slight dizziness, and noticed that SOME things I was seeing were apparently moving. A neighbor is experiencing very SIMILAR symptoms. He is also 77 years old, and had his MODERNA booster shot about a week or so before I had mine, and we chatted this morning, so I concluded that our symptoms APPEAR to be related to the MODERNA booster.
pt reports dizziness and diarrhea on day 1 of vaccination. Pt reported injection site tenderness, fatigue, on days 3 and 4.  Narrative:
The morning after 2nd does left lymph gland under jaw line started to swell. Kept swelling, tried Tylenol and warm compresses. By Saturday morning 5/8 drove myself into the ER Was admitted with severe pain, swelling, high white count, difficulty swallowing and opening mouth with neck restrictions. Treated with numerous IV antibiotics, c scan first day and another on Friday  Discovered abscess and removed some puss to further test. Still in hospital, swelling remaining the same Waiting for test results
Weakness and tingling in arms and legs, difficulty walking, numbness on left side (including face) severe back pain, difficulty in swallowing increased, difficult to speak, severe migraines, dizzy, nausea, memory loss, cognitive problems. Treatment-medicine given while hospitalized, meds taken currently from follow up appointments. Still has some symptoms, and being treated by multiple doctors.
pt recv vax 18DEC95 & 29DEC95 pt exp approx 30 gen lesions starting on face & progressing to chest a low grade fever, vomiting & watery stools & was dx w/chicken pox;pt recovered;
5/25/22: woke up with chest pain. Seen in ED.  EKG and US performed 6/4/22: chest pain continuing. Seen in ED. EKG, x-ray and blood work performed. 6/7/22: still c/o chest pain during exhalating
This spontaneous report was received from a licensed nurse practitioner via company representative regarding a patient of unknown demographics. Pertinent medical history, drug reaction/allergies and concomitant medication information was not reported. On an unknown date, the patient was administered improperly stored VARIVAX 0.5 ml subcutaneously. The lot numbers involved were Lot# M004328 with expiry date: 26-JAN-2018, Lot# M009765 with expiry date: 23-FEB-2018 and Lot# M005971 with expiry date: 02-FEB-2018. Temperature: -9.6 degree Celsius. Time frame: 5 hours. The temperature was back in range. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. This is one of the two reports. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were inadvertently vaccinated with doses of oral, ROTATEQ (lots # reported as L010859 exp date 19-JAN-2017, L004456 exp date 07-AUG-2016, K019370 exp date 16-JUL-2016 and L008054 exp date 30-NOV-2016) (Lot # L010859 is an invalid lot for oral) (route not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
I gave MENACTRA instead of giving second dose MMR. Patient did not have any adverse effects after receiving both immunizations.
This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patient's pertinent medical history reported and concurrent conditions. The patient's concomitant therapies included sterile diluent which was properly stored.  On an unknown dates started on or after 29-MAR-2017, the patients were vaccinated with improperly stored doses of VARIVAX, lot number M037642 with expiration date 09-JAN-2018, (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperatures between -9 Celsius (C) and 8 Celsius (C)) during 39 hours, there was no previous temperature excursion and digital data logger was filed. This is one of two reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA002207:
Pins and needles sensation in hands and feet; Headache; Hazy vision; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Pins and needles sensation in hands and feet), HEADACHE (Headache) and VISION BLURRED (Hazy vision) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Enlarged thyroid.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PARAESTHESIA (Pins and needles sensation in hands and feet), HEADACHE (Headache) and VISION BLURRED (Hazy vision). At the time of the report, PARAESTHESIA (Pins and needles sensation in hands and feet), HEADACHE (Headache) and VISION BLURRED (Hazy vision) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 26-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient has COVID-19 Treatment with Paxlovid, treatment start date was on 01Feb2023, treatment stop date was on 05Feb2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
tested positive for COVID as well/started to feel real sick; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN9581), via an unspecified route of administration (injection) into left arm on 27Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD), he has chronic bronchitis and was diagnosed with COPD probably over a year ago and stated that he takes inhalers, but no further details were provided by the caller, ongoing prediabetes diagnosed about two to three years ago, ongoing high blood pressure from 2008 and he stated that he takes 95 mg of three different types of blood pressure medications; but no further details on medication names or exact dosing of each were provided by the caller, and ongoing high cholesterol from 2008. Concomitant medication included metformin for prediabetes, started the product about two to three years ago and ongoing. The patient would like to know if he may take the second dose of the COVID vaccine after testing positive for COVID. He stated that he received the 1st dose of the COVID vaccine on 27Jan2021, started to feel real sick on 31Jan2021 and tested positive for COVID. It was further reported that he got his first shot of the COVID vaccine on Wednesday last week. On Friday, he stated that his wife tested positive for COVID, and then the caller got real sick on Sunday, and he then tested positive for COVID as well. He was wondering if that will affect the second dose or if there were recommendations about the second dose for people who got COVID in between doses. He stated that he has breathing problems anyway. He was planning to call yesterday but he still was not feeling up to it yesterday. He was starting to come over the hill today though. He reported that he just went online and scheduled the appointment himself for the vaccine because he has COPD, and they were allowing people with underlying issues to get the vaccine. He provided his primary care information as they were the ones who tested him for COVID on Sunday. He reported that he got his COVID vaccine on 27Jan2021, and he was tested for COVID on Sunday 31Jan2021. He stated that the clinic told him that the test takes about 15 minutes but they came back in about 10 minutes and told him that he was positive for COVID. The outcome of the events was unknown.
Numbness and swollenness of my lips. the top lip was worse. About a week later this started to extend down to the cheeks in my face. It was even difficult to drink
Terrible headache, body aches, nausea, diarrhea, no appetite, tiredness, rundown
Rash on site, warm to touch, irritated, swollen, rash about 6" in diameter, face had few patches. Hydroxide given on 11/13/06.
muscle tiredness in muscles of arms, legs; Joint achiness/ Soreness in right shoulder area; Injection site area sore; mild Muscle achiness,; Arm was sore; Feels like a bruise; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), CONTUSION (Feels like a bruise), MUSCLE FATIGUE (muscle tiredness in muscles of arms, legs), ARTHRALGIA (Joint achiness/ Soreness in right shoulder area) and VACCINATION SITE PAIN (Injection site area sore) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD. Concurrent medical conditions included Cholesterol blood excessive, Pollen allergy, Dust allergy, Allergy to animal dander, Penicillin allergy, Allergy to antibiotic, Pollen allergy, Dust allergy, Allergy to animal dander, Penicillin allergy and Sulfonamide allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), METHOCARBAMOL (ROBAXIN) and FAMOTIDINE (PEPCID AC) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore), CONTUSION (Feels like a bruise), ARTHRALGIA (Joint achiness/ Soreness in right shoulder area), VACCINATION SITE PAIN (Injection site area sore) and MYALGIA (mild Muscle achiness,). On 17-Jan-2021, the patient experienced MUSCLE FATIGUE (muscle tiredness in muscles of arms, legs). At the time of the report, PAIN IN EXTREMITY (Arm was sore), CONTUSION (Feels like a bruise), MUSCLE FATIGUE (muscle tiredness in muscles of arms, legs), ARTHRALGIA (Joint achiness/ Soreness in right shoulder area), VACCINATION SITE PAIN (Injection site area sore) and MYALGIA (mild Muscle achiness,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided
This is a spontaneous report from a contactable nurse via a company representative. This nurse reported same events for two patients. This is the first of two reports. A patient of unspecified age ethnicity and gender received TRUMENBA (Lot R56659), via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea, vomiting, chills, hot flash, abdominal pain, shakes and turn very pale on an unspecified date. The outcome for all the events was unknown. The reporter considered all the events related to meningococcal group b rlp2086. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017181830 same reporter/drug/event, different patient.
Initial and follow up information has been received from an office manager for the physician and a physician concerning a 65 year old retired female with no known adverse drug reactions, no known allergies and no pertinent medical history reported.  On 20-Jul-2005, in the morning, the patient was vaccinated in the left arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P).  There were no no concomitant medications reported.  That same day, following vaccination in the morning, the patient developed pain and redness at the injection site, was warm to touch at injection site and had difficulty moving her arm.  The patient sought unspecified medical attention.  The office manager reported that she believed the patient had recovered from the events(date unknown).  The physician reported a concern regarding the lot.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  No further information is available.
Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.