chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 28-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 72hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
"blisters on lips"; arm pain; joint pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of LIP BLISTER ("blisters on lips"), PAIN IN EXTREMITY (arm pain), ARTHRALGIA (joint pain), PYREXIA (fever) and CHILLS (chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced PAIN IN EXTREMITY (arm pain), ARTHRALGIA (joint pain), PYREXIA (fever) and CHILLS (chills). On 19-May-2021, the patient experienced LIP BLISTER ("blisters on lips"). The patient was treated with ACYCLOVIR [ACICLOVIR] ongoing since an unknown date for Lip blister, at an unspecified dose and frequency. On 17-May-2021, PAIN IN EXTREMITY (arm pain), ARTHRALGIA (joint pain), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, LIP BLISTER ("blisters on lips") outcome was unknown.            No concomitant medications were reported.
Rash - hive like started day following administration; also taking Amoxil for dental work and has sore throat; rash is maculopapular with confluence; Initally started near site of injection; Clearing there and appearing then on trunk and legs. to be seen if further difficulty.
On approximately 4/3/2021 I noticed pain behind my left ear.  On the morning of April 6, the left side of my face is numb.  I went to  (I have been traveling.)  They did a CT scan of my head and neck, x-ray of my heart, and blood tests to rule out stroke.  The diagnosis was Bell's Palsy.  The Dr. prescribed 50 mg Prendisone for 5 days and 1 tablet 400 mg Acyclovir by mouth 5 times a day.  I am on day 2 of the Prendisone and day 3 of the Acyclovir.
SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a consumer via social media via a company representative concerned a 92 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: surgery (At the time of vaccination patient was recovering from an unspecified surgery). The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer)(suspension for injection, route of administration and batch number were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 1). It was unspecified whether patient had any adverse reaction on covid-19 vaccine ad26.cov2.s.   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration batch number and expiration date were not reported) 1 total, dose and start therapy date were not reported for prophylactic vaccination (Dose number in series 2).  Patient  received the vaccine in the hospital where she was recovering from surgery. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On an unspecified date patient had covid-19 infection and suspected clinical vaccination failure. Patient tested positive but had very few symptoms  (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 infection and outcome for the suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report is associated the product quality compliant:90000206366. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified, based on the PQC evaluation/investigation performed.; Sender's Comments: V0 : 20211215353- covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
neck started stiffening on both sides; pain; zero range of motion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2022 11:00 (Lot number: FK9896) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: XARELTO; JARDIANCE; LANTUS; OXYCODONE; EZETIMIBE BIOGARAN. Past drug history included: Statin drugs, reaction(s): "Allergy". The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 25Feb2022 12:00, outcome "not recovered", described as "neck started stiffening on both sides"; PAIN (non-serious) with onset 25Feb2022 12:00, outcome "not recovered", described as "pain"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 25Feb2022 12:00, outcome "not recovered", described as "zero range of motion". The events "neck started stiffening on both sides", "pain" and "zero range of motion" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of musculoskeletal stiffness, pain, joint range of motion decreased. Additional information: The patient was prescribed valium, steroid shot, 800 mg Tylenol, horse liniment on neck, muscle relaxers and pain medication. No follow-up attempts are possible. No further information is expected.
2 yo child experienced swelling of the tongue/uvula & drooling within 1-2 hrs p/immun. Hospitalized for possible Epiglottis. Tx included Decadron IV & IV fluids. Child discharged from Hospital within 24 hrs.
The patient's upper arm became red, swollen, and warm to the touch. The patient's husband received from the same box and suffered no adverse event.
Received 1st series of injections 2/1/05 within 24 hours developed uncontrollable crying which lasted 2-3 days. Very fussy, irritable, decreased appetite. No fever, no swelling at injection site or tenderness. At same time developed URI.
COLD SWEAT; QUITE SEVERE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced cold sweat, and quite severe fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweat, and quite severe fever. This report was non-serious.
Rash and small red bumps on facial cheeks and neck that itch and feel irritated if I put on moisturizer on my face.
SARS-CoV-2 RdRp Resp Ql NAA+probe~COVID-19 rapid diagnostic test (nucleic acid amplification test NAAT) performed on 7/25/21. Most likely done. Came back positive. Case investigation interview completed and case manager documented they are asymptomatic. Will isolate safely at home.
BLOOD DID GO ALL OVER THE ROOM; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  It was reported that, on 14-MAY-2021, blood did go all over the room when patient got the first vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood did go all over the room was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211059801-COVID-19 VACCINE AD26.COV2.S- blood did go all over the room. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Redness, pain, swelling left arm onset day after rec'd VARICELLA vaccine in left arm.  Low grade fe.  T 99.2.  10 X 6 cm red tender lesion below inj site 6/5/09, had been 6 X 6 on 6/4/09 in ER.  Extends around upper arm.
Pain left breast/underarm/extending down arm. (Also had allergic reactions to the three shots: swelling upper part of arm, itchiness, redness, rash - lasted ~2 weeks, except for rash which persisted longer. I also got this allergic reaction to the Shingrix, flu, and pneumococcal vaccines, so this particular site reaction is not specific to the Moderna shots.)
About 2 hours after injection, I had extreme pain in left shoulder around joint and movement of left arm caused more intense pain.  I thought maybe I was having a heart attack so I put a nitroglycerin tablet under my tongue.  A few minutes later, my vision became blurry and I had a cold sweat (later learned these symptoms came from nitro tablet).  I had my wife call EMS,  Medics administered an EKG and the took my blood pressure.  Both were normal but medics said I should go to the ER.  ER doctor believed the pain was the result of the vaccine injection.  I was given a morphine injection prior to leaving the ER that reduced the pain by about 50%.  I was nauseated the following morning and vomited twice.  The nausea could have been caused by the morphine or the Shingrix injection.  I believe the pain was caused by the injection being given too high on my left arm and the vaccine got into the joint.  I had 2 bruises, one high up on the upper left arm and one on the shoulder.
Received shot at 0610. Started feeling cruddy around 1600 w/ severe headache, neck pain, and shoulder pain, with overall malaise. Symptoms intensified at 2000 with severe rigors until ~0400 accompanied by body aches. Intermittent fevers experienced during that time as well. Next day, general malaise and severe body aches until ~1500; then subsided to mild headache and mild malaise. Post vaccine day #2 left with mild malaise, all other symptoms subsided.
Irregularity of menstrual cycle; Increase in intensity of menstrual cycle; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP).   A 21 year-old female patient (not pregnant) received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), intramuscular, administration date an unknown date in Dec2021 (Lot number: unknown) at the age of 20 Years as dose 2; single for COVID-19 immunisation. It was unknow if the patient had any relevant medical history. Concomitant medications included: EFFEXOR. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation.  The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset an unknown date in Dec2021, outcome "not recovered", described as "Irregularity of menstrual cycle"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset an unknown date in Dec2021, outcome "unknown", described as "Increase in intensity of menstrual cycle". It was unknown if the patient had taken any therapeutic measures as a result of the events.  Additional Information: It was unknown if the patient had any known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had received any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a medical center concerning a 7-year-old white male who on 31-JAN-2000 was vaccinated with a first dose of Varivax. ON 26-MAR-2006 the patient experienced chickenpox. Unspecified medical attention was sought. No outcome was reported. Additional information has been requested.
This is a non-serious spontaneous case, initially received from other non-health professional (reporting on herself) on 12-Jan-2018, concerning a 14 weeks 5 days pregnant female patient of unspecified age. The patient's medical history and concomitant medication was not reported. On an unspecified date, the pregnant female patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). The outcome of the event was not reported.
Pt called to complain of swelling, warmth, and redness in left arm down to wrist and unable to bend arm.  Also has fever up to 104.0. Saw MD for symptoms. Was given steroids, antibiotics and a sling for his arm.  Taking Tylenol for fever.
The day after vaccine I lost my taste and started to nauseous with a headache. Went to urgent care and tested negative for COVID-19. Test was negative; Was given ondansetron; I kept having a horrible metallic taste in my mouth and was having a hard time eating; Saw a NP and was given omeprazole and ondansetron.
Cold; Nasal Discharge; Coughing; Aches; Slight fever; A spontaneous report was received from a consumer concerning a 70-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cold, nasal discharge, coughing, slight fever, aches, positive for covid 19.  The patient's medical history was not provided. Concomitant medications reported were Simvastatin for drug use for unknown indication.  On 5 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) cold . On 9 Feb 2021, the patient experienced the event(s) nasal discharge . On 9 Feb 2021, the patient experienced the event(s) coughing . On 9 Feb 2021, the patient experienced the event(s) slight fever . On 9 Feb 2021, the patient experienced the event(s) aches . On 12 Feb 2021, the patient experienced the event(s) positive for covid 19.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), cold was unknown.The outcome of event(s), nasal discharge was unknown.The outcome of event(s), coughing was unknown.The outcome of event(s), slight fever was unknown.The outcome of event(s), aches was unknown.The outcome of event(s), positive for covid 19 was unknown..
pt recv vax 2MAY96&pt devel swelling,redness&warmth;4MAY96 in ER 5MAY&cellulitis tx w/kelfex;7MAY95 19x17cm are of cellulitis w/pustules
Immediately after vaccine I became nauseous and dizzy with a headache. I went home and slept for the next three days. My body ached but the dizziness subsided.  Today 03/22 I still feel nauseous and mildly aches. However my left elbow has now swollen up. It hurts to bed it and pressure hurts. I have pins and needles going through my wrist into my fingers along with a full ache.
Received second dose of Moderna on 2/19/21. On 2/20/20 my father said he felt fatigue and nauseated but thought that was normal side effects. On 2/21/21 @ 0100, my father suffered a massive stroke. He passed away on 3/27/21.
Patient was registered under a parent's DOB and was administered the moderna vaccine LOT Number 046A21A by a volunteer physician. The patients of this vaccination clinic were scheduled by a partner organization  and the mobile vaccine site. The date of birth was not checked by the vaccinator, prior to vaccination, as it was not routine, and was only discovered while entering the patient's information into data base. The clinic was notified and the clinical guidance provided was to proceed with the second dose of moderna to complete the series. The second dose of moderna LOT Number 039A21A was administered on 04/20/21, as scheduled. The patient was contacted and reported no reactions to the 1st dose, Moderna Lot 46A21A. The patient also confirmed that she did not experience any reactions to the 1st dose at the time of the 2nd dose on 04/20/21. The patient was accompanied by a parent during both vaccinations.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 25-FEB-2016, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 16-MAY-2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with GARDASIL (lot # K006960 and expiration date 19-FEB-2017) (dose, frequency and route were not reported) that was stored outside recommended temperature range. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Client received Hep A, HPV, and MCV4 vaccine @ the Health Department Immunization Clinic on 07/12/21 @  1030. Nurse administered Hep A & MCV4 to the client's L arm. Client appeared calm, alert. Nurse administered HPV in the client's R arm and went to place band-aid over the injection site. Client had vasovagal reaction and fainted. Client was sitting on the vaccination table, but ended up fainting into nurse's arms/floor. Nurse caught most of the client's fall. Client was placed on step of table. This writer asked client if she could tell me her name, DOB, location. Client answered all of these questions correctly. Client stated "what happened? Did I pass out?" Nurse and this writer explained she had vasovagal reaction to the vaccine. Client was able to sit on table w/ legs elevated. Client reported feeling dizzy and was instructed to keep legs raised. Client denied hx of vasovagal reaction prior to administration. She was given juice as a supportive measure. This writer noted lips/skin appeared pale. Client's dad and brother were @ the bedside. Brother was laughing uncontrollably and was asked to wait in lobby. Client reported her R lower extremity "hurt." Nurse and this writer assessed leg and noted redness over chin area. Client was able to move LE w/ no difficulty. Client instructed to ice area and monitor. If symptoms worsen, f/u with PCP. Client informed this writer and Nurse that she pictured herself dying-"I pictured myself getting hit by a car to lessen the pain of the shot." Client reported she did not eat breakfast. She was encouraged to eat prior to all vaccines and let staff know about vasovagal hx from now on. Client finished her juice and reported feeling better. This writer noted lips/skin were no longer pale-WNL. Client was gradually brought from a lying position to sitting upright. Client walked with her dad and brother out of the clinic @ 1130. Nurse and this writer encouraged PCP f/u if needed. EMS was not called.
Fever of 100.8 (fluctuated but that was the high), body aches, pain at injection site (couldn't lift arm over shoulder), general malaise, slight cough.
The patient got the vaccination around 9:10 am and sat down and started to have symptoms of a scratchy throat, slight shortness of breath, and a rapid heart rate.  Pt was attended by Pharmacist, Paramedics were called and blood pressure was taken by Pharmacist and was 175/102.  Paramedics arrived and transported pt to the hospital emergency room.
Extreme fatigue (slept nearly the clock around); headache, mild fever (100.3)  Did not begin to feel 'normal' until about 26 hours after shot. Pain in left arm.  Pain still there at 1 pm May 18 (nearly two days later) but I guess that's normal.
Patient received flu vaccine at approximately 0700 and reported headache, nausea, feeling flushed, dizziness and "out of it." She was referred to the emergency dept for further evaluation and treatment - in the ED, TORADOL and ZOFRAN was given. Patient was advised to follow-up with PMD on 10/3/2015 - was also given antibiotics for UTI. Followed up with occupational health on 10/05/2015 - vital signs stable and feels better.
Pt. states received injection in (L) arm. Pt. states arm hurt at time of injection. C/o limited ROM.