chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administration of vaccines involved during a temperature excursion; no adverse event; This spontaneous report was received from a medical assistant and refers to unknown patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant medications was provided. On unknown dates, the patients were vaccinated with incorrectly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0,5 ml, lot # S033308 with expiration date on 08-APR-2022 (route of administration was unknown) and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2ml, orally, lot # 1684157 with expiration date on 23-JUN-2021, both for prophylaxis. The suspected vaccines underwent temperature excursions of 1.8 degrees Celsius for 30 minutes, 1.1 degrees Celsius for 30 minutes and 1.7 degrees Celsius for 30 minutes on unknown dates. No additional adverse events reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033308; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
On November 7, 2022, about 3:30AM I got up to use the restroom my hands became exceedingly itchy. They were bright red. My peridium was also exceedingly itchy and bright red as well as the bottoms of my feet. My eyelids were a bit puffy, and my lips were a bit puffy. I took some BENADRYL. As I swallowed the tiny pills it felt like ice cubes in my throat. I went to the emergency room and waited about 15 minutes for triage. By that time my hands and feet were not so itchy so maybe the BENADRYL was working. After another 15-20 minutes I saw the doctors and they gave me dexamethasone via intravenous as well as PEPCID. I was monitored for another hour and a half. After that night I have not had any symptoms like that again.
patient had varicella and Shingrix vaccines a day prior to the scheduled 2nd dose of the Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient had varicella and Shingrix vaccines a day prior to the scheduled 2nd dose of the Moderna) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX on 05-May-2021 and VARICELLA VACCINE on 05-May-2021.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient had varicella and Shingrix vaccines a day prior to the scheduled 2nd dose of the Moderna). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient had varicella and Shingrix vaccines a day prior to the scheduled 2nd dose of the Moderna) 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.   No concomitant product use was reported No treatment information was provided
PFIZER COVID VACCINE #3 GIVEN 6/27/2021, LOT #FF2587; pt passed away at home; pt had a positive COVID test 6/15/22; no medical records on this patient; PCP is unknown
Patient presented to ER with c/o nausea, poor oral intake. Found to have Covid-19 and dehydration. IV Hydration, IV nausea medication. Vitamin supplements.
extreme tiredness; headaches; body aches; This is a spontaneous report based on information received by Pfizer. A contactable consumer (patient) reported a 49-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration around 19Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced extreme tiredness, headaches, and body aches that caused her not to be able to get out of bed. The outcomes of extreme tiredness, headaches, and body aches were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Muscle cramps in hamstrings, biceps, and abdomen. Itching all over. No rash.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). Concomitant therapies included sterile diluent (manufacturer unknown). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions of: -14 to -10 degrees Celsius for 3 hours and 45 minutes; -9 to 8 degrees Celsius for 3 hours and 30 minutes. There were no previous excursions reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA008347:
Starting at about 8:00 p.m. last night, pain in the arm continuing to get worse as the night went on, by the time I went to bed at 11:00 my whole body hurt. I had severe chills and severe headache. The chills ended sometime in the middle of the night but the headache continues to now. Most of the body aches are gone.
Malaise/feeling sick; Low grade fever; Sore arm; Swelling; This non-serious case was reported by a physician via sales rep and described the occurrence of feeling unwell in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-DEC-2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: Malaise/feeling sick), low grade fever (Verbatim: Low grade fever), pain in arm (Verbatim: Sore arm) and swelling (Verbatim: Swelling). The outcome of the feeling unwell was resolved (duration 1 week) and the outcome of the low grade fever, pain in arm and swelling were resolved (duration 2 weeks).   It was unknown if the reporter considered the feeling unwell, low grade fever, pain in arm and swelling to be related to Shingrix.     It was unknown if the company considered the feeling unwell, low grade fever, pain in arm and swelling to be related to Shingrix.   Additional Information: GSK receipt date: 17-May-2023 The physician reported that the patient received dose of Shingrix in clinic.  The patient experienced feeling sick for 1 week afterwards, malaise, low grade fever, sore arm and swelling for 2 weeks.  The patient refused 2nd dose.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 36-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 06-Feb-2022 at 9:54 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022 at 9:54 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021. Booster dose was given on 06-FEB-2022 09:54:28.  Treatment information was not provided.   This case was linked to MOD-2022-542869 (Patient Link).
Pt had significant swelling of upper left arm, starting 24 hours, post vax, 2nd dose of Anthrax vaccine.
hardly a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 101-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Lot number: HG4659), in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (A couple of weeks before both of them had got the flu vaccine), for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "hardly a sore arm". Additional information: This report is for caller's mother. Calling about new booster, the latest one. Caller clarified she is calling about the Corona booster vaccine. On vaccine card they wrote the number H64659 unless it a G. Caller is looking at her mom's, because she had it too. The girl didn't have good printing on the vaccine card. Caller clarified the number on the vaccine card is HG4659. On the 01Oct caller and her 101 year old mother went and had the booster. A couple of weeks before both of them had got the flu vaccine at the same location which was (name withheld) in (city withheld). Neither of them had a problem with the flu vaccine. Caller had the Corona virus booster on 01Oct2023 in right arm. Right away that day caller started to get bruising. It was sore. 8 or 9 days later and caller's arm is more sore and hurts when she lifts it. Her mom that is 101 and thin with sensitive skin that bruises easily didn't get bruise or hardly a sore arm.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
pt inadvertently recv vax & devel an inj site rxn;sx were resolving as of the date of this report;
Pt developed severe left arm /shoulder pain, limiting range of motion, and edema in whole arm 4 days after recieving the vaccine with decreased left radial pulse, with intermittant pale/numb hand. She had an elevated D-Dimer on 5/17/2021, negative work up for thrombus. Left arm pain continues to worsen with extremely limited range of motion. Tylenol is ineffective in managing pain. Cool packs and hot packs have helped slightly. Enlarge lymph nodes noted in left axilla and supraclavicular.
pt recv vax 1JAN97 & titers were drawn which revealed no seroconversion;1DEC97 pt was re-vaccinated;titer was positive (date unk);
About 5 hours after receiving vaccine, a rash appeared on my torso and upper arms, prickly skin sensation, thready pulse 80/min, felt occasional palpitations,  Couldn't get accurate BP because it was faint and hard to hear pulse.  I took Benedyl 25mg orally at 10 pm.
606 doses were given after expiration date; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date place in refrigerator 4-10-21. No concomitant medication were provided No treatment details were provided
By 1:27 PM I started feeling drowsy and very warm from my chest. (From the time of my vaccine-20 minutes after I left I drove to the courthouse to pay a bill and then I drove to public works to pay water bill, by the time I started driving from paying the second bill for a max of 5 1/2 miles I started feeling the symptoms) at 1:27 PM drove back home took off my clothes took a shower and went directly to bed no medication nothing I was knocked out from the vaccine. A few minutes past 6:30 PM I felt really bad really really really bad. I had needle like pain behind both my ears, the same pain persisted to the back of my head and in my mid chest area/ upper chest was constant aching poking stick like pain. My stomach on the left and right sides what is aching pain between 10 to every 20 minutes. As for my knees and my elbows I could not feel they felt like jelly/ like Jell-O and very hard to hold the TV remote or cell phone (no type of energy) , forget about walking but pushed myself every now and then to motivate.   From the day I got vaccinated till Saturday morning I was in bed no clothes on besides underwear and or with basketball shorts And a queen size comforter 100% organic cotton pro this and that with all that fancy approval stuff Half the time window open half the time closed with the weather being between 89 & 93 degrees barbecues music going on and I couldn?t bear to even stand the TV to be on with the volume on number five never mind the normal volume between numbers 19- 35. I?ve had the flu three time is my whole life and this was 20 times that? yikes  P.s.  Also the Monday after that weekend I had a crazy ear infection on the left side that lasted for two weeks, in which it?s only 90 percent back
Lost sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Lost sense of smell) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ANOSMIA (Lost sense of smell). At the time of the report, ANOSMIA (Lost sense of smell) outcome was unknown.            No concomitants medications was reported.  No treatments medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Follow-up included no new information.
330PM started screaming lt leg swelled up-looked like size of softball-couldn't get attention-then about 6:00-6:30 sent to ER-cried cont up to that time; to ER given APAP d/t fever-temp over 100 ? how much
Information has been received from a 24 year old female consumer who on 25-JUL-2007 was vaccinated with her first dose of Gardasil (Lot # 658490/0802U).  On 25-SEP-2007, the patient was vaccinated with her second dose of Gardasil (Lot # 656050/0245U).  On 25-Jan-2008, the patient was vaccinated with her third dose of Gardasil (Lot # 659439/1267U).  There was no concomitant medication.  On an unspecified date, the patient found out she was pregnant (LMP approximately 12-OCT-2007).  The patient had unspecified blood work performed.  On an unspecified date, the patient had to go to the emergency room where she was informed that she had a miscarriage.  No additional information was provided.  Upon internal review, miscarriage was considered to be an other important medical event.  Additional information has been requested.
Patient received vaccine on 2/5/21- wasn't feeling well ( day after headache, on and off fever, sore throat) We discussed that symptoms could correlate to other possible illnesses and discussed being seen , possibly getting COVID testing as well.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 15-SEP-2014, the patient ws vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # J014131 and expiry date: 07-NOV-2015, reported as 01-JUL-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Severe headache, chills, fever, loss appetite; hiccups non-stop for 8 days; weight loss approx 10lbs; 2 visits to ER; atrial fibrillation; and near resp. arrest due to hiccups exacerbation; phrenic nerve damage.
Patient is a 67 y.o. male who presented with low oxygen readings at home, noted to be in the 70s on room air, does not use oxygen at home.  In the ER noted to be hypoxic, placed on supplemental O2, COVID19 positive.  Patient was admitted, Infectious Disease consulted, treated with Decadron, 3 doses of Remdesivir.  Patient had significant improvement symptoms, was weaned off of supplemental O2, passed walk study.  During hospital course, noted to be bradycardic, metoprolol and Imdur doses adjusted with hold parameters.  Patient did not have any symptoms of bradycardia.  He was  Discharged home in stable condition.
This case was reported by a nurse via call center representative and described the occurrence of injection site tenderness in a adult patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number EF4Z9, expiry date 22nd June 2019) for prophylaxis. On 1st October 2018, the patient received FLULAVAL QUARIVALENT 2018-2019 season (subcutaneous) .5 ml. On 1st October 2018, unknown after receiving FLULAVAL QUARIVALENT 2018-2019 season, the patient experienced intramuscular formulation administered by other route. On 2nd October 2018, the patient experienced injection site tenderness, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site tenderness, injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site tenderness, injection site swelling and injection site erythema to be related to FLULAVAL QUARIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) stated that her co-worker was inadvertently administered FLULAVAL QUARIVALENT 2018-2019 season subcutaneously instead of the indicated intramuscular route, which led to inappropriate route of vaccination. The HCP stated that the patient had redness, swelling, and tenderness at the injection site on the date of reporting, one day later. The HCP did not provide the patient information for this adverse event but did provide the lot number and expiry date for the adverse. This case is 1 of 15 cases, reported by the same reporter.
Area around injection site appeared slightly inflamed and warm to touch - an area approx. 4cm diameter.
The patient explains to the nurse that the previous time her BP went up and the Lt presented hemiparesis, she went to the hospital and had PTB. Received TX and resolved after the BP patient is vaccinated in area. Approx. 10 min patient reports that he begins to feel numbness in the chest and arm L side, patient has PMS in extremity, feels cold, pulse movement and sensation in extremity. Evaluated patient is left under monitoring patient does not want to go to hospital and wants to leave patient was oriented.
The night after receiving the vaccine I woke up in the middle of the night with fever, night sweats, headache, and malaise. The full body fever and headache persisted for the next few days. The fever went away but I continued to have intermittent pulsatile headaches for the next 1-2 months. These headaches have since resolved.  A week and a half ago I had a long car ride of 8 hours and developed calf pain that felt like a DVT. These symptoms have persisted off and on since then and not resolved.  Most recently, for the past week I have had intermittent chest pain localized to my left chest that feels  like it is from inflammation in my heart. Associated intermittent palpitations with stress. So far the pain has been mild but it is the symptom I am most concerned about that motivated me to fill out this report.  This pain has not resolved since its onset about one week ago.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 10-AUG-2009 (at the age of 80), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) by a healthcare provider at a health center for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient was treated by a healthcare provider at the same health center for the following injuries resulting from her use of zoster vaccine live (ZOSTAVAX): shingles.  The outcome of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   .
Noticed redness, swelling at injection site on L deltoid then started spreading to head, abd. legs. Treated with steroid and benadryl and referral to allergist.
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain, tiredness, joint pain, fever (mild), nausea
COVID 19-Pfizer was mixed with only 0.8ml of saline instead of 1.8ml. Pt was given 0.3ml of mixed vaccine
Pt describes redness and swelling at injection site with an onset of <24 hours. The area was also severely sore. The redness/swelling/pain spread over the next 3 days until becoming hives/welts within 3 days diffuse over her entire left arm.
Vaccine administered past manufacture expiration date.   Lot # FL8095 manufacture expiration date 8/31/2022   Response from Pfizer: ?Currently available stability data demonstrate product quality  is maintained for 12 months plus and additional week after  the date of manufacture. Lot number FL8095 was  manufactured on 28-Sep-2021. Based on the actual date of  manufacture, product quality should be maintained through  24-Sep-22, provided that the vaccine has been stored  according to labeled storage conditions.?