chrisvoncsefalvay/vaers-outcomes huggingface dataset:
previous reaction; Pneumovax was adminstrated on 11/11/2005 and 11/01/08; This spontaneous report was received from a physician referring to a currently 76-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-NOV-2005, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, lot #, expiry date, and route of administration were not provided), administered for prophylaxis. On 01-NOV-2008, the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration).  On an unknown date, the patient experienced reaction (adverse event). It was reported that the patient unable to get final dose due to the reaction. The outcome of the event was not reported. The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported. ; Sender's Comments:  US-009507513-2208USA004458: US-009507513-2208USA008360:
Vial had been initially stored in the refrigerator on 11-Mar-2022, expired on 16-Apr-2022 and administered on 22-Apr-2022; Dose administered after 30-day use by date and after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vial had been initially stored in the refrigerator on 11-Mar-2022, expired on 16-Apr-2022 and administered on 22-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date and after manufacturer date of expiry) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date and after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial had been initially stored in the refrigerator on 11-Mar-2022, expired on 16-Apr-2022 and administered on 22-Apr-2022). At the time of the report, PRODUCT STORAGE ERROR (Vial had been initially stored in the refrigerator on 11-Mar-2022, expired on 16-Apr-2022 and administered on 22-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date and after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported. The vial did not undergo any temperature excursions.
Pt started with headache that was relieved by taking Ibuprofen at 5am on the 28th. At first this was effective. Pt had to continue to use ibuprofen alternated with acetaminophen during the day.  By 6pm on the 28th, the headache became unbearable. No NSAIDS were helpful. Pt reports that it felt like the top of her head could pop off.  Pt slept restlessly for the next 12 hours, but would awaken when the arm that received the injection would get bumped - that injection site was throbbing. Pt continues to have dull throbbing headaches daily. At time pt continues to take NSAIDS and reports this will most often take the edge off the headache.
Arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm was sore at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INJECTION SITE PAIN (Arm was sore at the injection site). At the time of the report, INJECTION SITE PAIN (Arm was sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment drugs were reported.   Reporter did not allow further contact
Fever; Headache on the right side of head; Unable to sleep; This is a spontaneous report from a contactable patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0168; Expiration Date: Aug2021), via an unspecified route of administration on 13May2021 as dose 1, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. On 14May2021, the patient experienced fever, headache on the right side of head and unable to sleep. Patient stated event occurs after taking the first shot that night on the following day for 2 days. On 16May2021, patient had recovered from all the events.
Information has been received from a physician concerning a patient who was vaccinated at this colleague's office with a dose of Zostavax (Oka/Merck).  It was reported that the patient developed chickenpox after vaccination.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Improperly stored PROQUAD were administered to 10 patients; No additional adverse symptoms reported; This spontaneous report was received from an office manager concerning a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) lot # S013712 and expiration date 01-NOV-2020 (dose and route were not provided), reconstituted in sterile diluent (STERILE DILUENT), for prophylaxis. It was unknown if the sterile diluent (STERILE DILUENT) used to reconstitute the vaccine was stored at proper temperature. No additional adverse events symptoms were reported. The temperature excursions were reported as follows:  measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) (Lot #S013712, expiration date 01-NOV-2020)  Temperature  Total time in the range 6 degrees Fahrenheit (F) to 14 F (-14 degrees Celcius (C) to -l0 C) for 30 minutes Total time in the range 15 F to 46 F (-9 C to 8 C) for 7 hours;  Total time in the range 47 F to 77 F (9 C to 25 C) for 9 hours  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2001USA005479:
Information has been received from a female pharmacist in her 20's with no pertinent medical history or allergies who in 2000 was vaccinated with a first and second dose of Varivax. "About one month ago" in approximately June 2006, an antibody titer was drawn and the patient filed to seroconvert. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is available.
Right arm pain and swelling Fever and Chills  Body aches and Headache  Fatigue Nausea
17 year old was accidentally vaccinated; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old was accidentally vaccinated) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA), FLUTICASONE PROPIONATE (FLOVENT), SODIUM CHLORIDE (SALINE NASAL SPRAY), MONTELUKAST, Minerin cream, Albuterol inhaler                                              As needed and GUANFACINE for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old was accidentally vaccinated). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old was accidentally vaccinated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Hives over entire body, more so on face and chest with some swelling under eyes. Denies SOB or other discomfort. Time course-2 hours, post vax. Treated with Benadryl 50mg IM in right deltoid. Notified MD at 15:15.
Since the vaccine, patient has been sleeping about 50% more of the time or is drowsy, his appetite has decreased about 30%, he is much less alert, chokes while he is eating, eye contact has decreased significantly, he no longer want to take a bottle at all, he has moments where it seems he isn't there (spaced out), and he has for the most part stopped coo'ing.  These symptoms started the evening after the vaccine and have persisted to now.
Heart racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    There was no reported medical history.  The patient's past medical history included Staphylococcal infection (stapf infection after surgery) in 2015 and Surgery in 2015.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PALPITATIONS (Heart racing) (seriousness criterion medically significant). At the time of the report, PALPITATIONS (Heart racing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 125 to 140 beats.         No concomitant medication details were provided. No treatment medication details were provided.   Dosage form for HUMIRA was given as solution for injection in pre-filled pen.  The reporter's causality for the event was not provided with HUMIRA.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: METOPROLOL, start date: 01Nov2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no known allergies. She received anti-viral treatment (COVID 19 Treatment) as Paxlovid from 08Sep2022 to 13Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
vaccination site mass; This case was reported by a pharmacist via other manufacturer and described the occurrence of injection site lump in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown.   It was unknown if the reporter considered the injection site lump to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The pharmacist reported that the patient complained about a lump on the arm after receiving shingrix on unspecified dates. No clarification information was provided, no further information was provided. This is 1 of the 5 patient case linked through same reporter.
Red, swelling of left leg given CLARINEX 2 and one half teaspoon.  PREDNISOLONE 5 mg/ml
About 9 days after first dose I started to notice hives and redness on both side of my stomach, on both front lower legs and arms. Went to primary care Dr and he said he didn?t know we?re it came from but to take allergy med. which I have been doing and it started to clear up some but then I got my second dose and it really came on after that. It is not really a itch rash but taking a shower seems to make it worse and itchy. It has not gotten any better and seems to burn a little bit at times. I plan on giving it another week are so and if not better will be going to dermatologist. As far as I can remember I have never had a rash besides poison oak. I do not nor can I find any information online about a rash starting several days after vaccine unlike the allergic reaction some people are having soon after receiving vaccine. So it does have me a little worried mainly because I do not know what it is but I?m pretty sure it is from the vaccine considering the fact it started 9 days after first dose and never really went away and the second dose seems to have aggravated it to we?re it is worse.
2 minutes post immunization, pt experienced and seizure which lasted approx. 2 minutes. He required further medical attention and was treated by EMT and transported to E.R. Pt was treated there and released.
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date 02-APR-2022; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date 02-APR-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date 02-APR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date 02-APR-2022) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 12:32 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 12:32 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date 02-APR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date 02-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date 02-APR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date 02-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient ethnicity was reported. Concomitant medications were not reported by the reporter.  Patient received booster dose. Patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. Treatment medications were not reported by the reporter.
Rash surrounding injection site. Was diagnosed with shingles. Given VALTREX and BACTRIM.
70.4kg 157.5cm 59 yo F was given Pneumococcal conjugate vaccine 20 (Lot # GD8455) in the right deltoid by CMA on 12/8/22 at 1039 as part of regular office visit.  On the evening of vaccination, patient developed redness, itching and swelling at the site of injection, body aches and chills. Patient had been vaccinated with PCV23 in 2017 and had tolerated this vaccination without incident. As of 12/10/22, two days after the vaccination, patient reported that body aches and chills had resolved but then had arm pain in addition to erythema and itching at injection site. Patient described area impacted as 4-5 inch band around right arm. Patient requested to be seen and virtual visit was set up for 12/12/22 during which time the patient received reassurance and advice on symptomatic treatment.
The day after my second dose of Pfizer, my legs would get extremely weak and sort of half-numb after my evening shower, every night. This was most notable for about a week afterwards, but is still somewhat the case even now, 5 weeks later. The half-numb feeling also persists outside of showers, such as with casual walking around and taking longer walks. I have had this kind of feeling in the past, but it hasn't been a problem for several years. The leg weakness post-showers is new, as of taking the second dose of the vaccine.
was well after vaccine visit until he had his 1st seizure on 8/5/17.  no fever at that time.   In ER was 103.6.   No additional seizures.   All labs unremarkable.  NO trach culture but dx was tracheitis and he was started on amoxicillin.  Mom has diary of fevers: 8/6 tamp 100.7 8/7 temp 101.2 8/8 101.7;  Developed a cough  8/9 102.1 8/10 101.8
Pt recv vax on 6/17/98; on same day pt exp swelling,sore, itchy, red upper LA.  Pt tx= Benadryl 50mg PO.
Constant cough, Difficulty with breathing - heavy chest - nausea with no vomiting.
Blurred vision, could not talk, pale, hot, near syncope. Gave lollipop, took BP and laid down.
Rash developed 6/12/2006. Less than 50 "spots" per parent. Never blistered. Physician exam stating varicella. No lab work done.
3 days post 1st Pneumovax  vaccination local reaction consisting of 11x18cm red, indurated warm area at site of vaccination (L triceps). no fever, chills, etc.
4 hours after vaccination patient reported signs and symptoms of the flu. Extreme arm pain, chills, and malaise.
No additional adverse event; the patient was inadvertently administered a dose of VAQTA on 4/21/2020 that had been improperly stored; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided. This report included one patient and one combination product.    On 21-APR-2020, the patient was inadvertently administered a dose of improperly stored hepatitis A vaccine, inactivated (VAQTA) for prophylaxis lot # S032056, expiry date 09-NOV-2020) (exact dose, route of administration were not provided). No additional adverse event.  The  hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 47.7 degrees Farenheit for 12 minutes. Previous temperature excursion was 58.3 degrees Farenheit for 14 hours. The digital data logger was involved. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032056; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Symptoms flushing, palpitations, headache, "burning" both arms, weakness bilateral arms. Dx - fatigue, myalgia, paresthesia s/p influenza vaccine. Resolved after 3 weeks no further influenza vaccines per PCP.
Patients arm on the injection site was red; Patients arm on the injection site was swollen; vaccinated subcutaneous and not intramuscular; A spontaneous report was received from a consumer concerning a 38-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and was vaccinated subcutaneous route, and experienced injection site red and swollen.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 25 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) subcutaneously in the arm for prophylaxis of COVID-19 infection.  On 25 Jan 2021, the patient reported that they were vaccinated subcutaneous and not intramuscular. On 27 Jan 2021, the patient's arm on the injection site was red and swollen. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event, vaccinated subcutaneous and not intramuscular, was considered resolved on 25 Jan 2021. The outcome of events injection site red and swollen were unknown.; Reporter's Comments: This case concerns a 38-year-old female patient (gender to be clarified) who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect route of product administration and associated non-serious adverse events of Injection site erythema and Injection site swelling. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
paresthesia in L arm radiating down to finger  re-activation of tingling related to Bell's palsy (yrs before the covid vacc)
Exactly 24 hours later, my son's eyes were red and puffy. He could not focus his eyes, they were looking everywhere, but would not look me in the eyes. He would rub his eyes and say "itchy". He had a fever at that moment as well, of 102.5. His leg where he got the injection was red, swollen, hard, warm to the touch and painful. He was unable to walk normal- he limped and walked crooked. I contacted the nurse who told me to put a cool compress over eyes and give TYLENOL. I gave him ibuprofen to keep fever down and monitored. His fever went away in 24 hours. His eyes were not swollen after 48 hours. Then he broke out into cold sweats the second night (01/28/2018). The leg inflammation continued for three days and he finally had no more red swelling and pain on the morning of 01/30/2018.
On 7/16 c/o nausea and SOB , sent to the ER and admitted to hospital with:  Acute hypoxic respiratory failure due to fluid overload and pneumonia. He was placed on BIPAP,  received urgent HD and broad spectrum empiric antibiotics.  He weaned off of BIPAP to NC, fever resolved and cultures were negative.  On 7/20/21 Pt discharged from hospital and returned to Rehabilitation Center
Arm sore, woke up with severe chills.  A few hours later was really hot.   Took Advil.    Absolutely exhausted  and slight fever for 48 hours. 2 days later had pain in lymph nodes under arm that i received he booster shot.