chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 weeks later she developed shingles caused by the booster; developed an "infection deep inside my breast."; had a high fever of 102.5 for two days; Two weeks later she developed hives for 2 weeks.; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (2 weeks later she developed shingles caused by the booster), MASTITIS (developed an "infection deep inside my breast."), PYREXIA (had a high fever of 102.5 for two days) and URTICARIA (Two weeks later she developed hives for 2 weeks.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2022, the patient experienced PYREXIA (had a high fever of 102.5 for two days). In June 2022, the patient experienced URTICARIA (Two weeks later she developed hives for 2 weeks.). On an unknown date, the patient experienced HERPES ZOSTER (2 weeks later she developed shingles caused by the booster) and MASTITIS (developed an "infection deep inside my breast."). The patient was treated with CELECOXIB (CELEBREX) at an unspecified dose and frequency. On 07-Jun-2022, PYREXIA (had a high fever of 102.5 for two days) had resolved. At the time of the report, HERPES ZOSTER (2 weeks later she developed shingles caused by the booster), MASTITIS (developed an "infection deep inside my breast.") and URTICARIA (Two weeks later she developed hives for 2 weeks.) had resolved.            No concomitant medication was provided by reporter.  Patient treatment reported that, rinsed mouth out with salt water. The Lot number reported as, 058422-2A or 058A22-2A (illegible).   This case was linked to MOD-2022-682179, MOD-2021-168219 (Patient Link).
vaccine injected it into the hanging flesh of her arm; A spontaneous report was received from a consumer concerning an 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and expererienced the vaccine administered at the hanging flesh of her arm/inappropriate route of vaccination.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 011A21A) for prophylaxis of COVID-19 infection.  The patient stated that the vaccine was incorrectly administered, because they injected it into the hanging flesh of her arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, inappropriate route of vaccination was considered recovered/resolved.; Reporter's Comments: This report refers to a case of Inappropriate route of vaccination.  for mRNA-1273, lot #011A21Awith no associated AEs.
Patient has a red rash around her injection site about the size of a palm according to patient.  Maybe slightly warm to the touch.
No additional adverse events.; a patient was administered an improperly stored PNEUMOVAX 23; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 15-JUL-2020, the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S033516, expiration date 29-JUN-2021, (exact dose, injection site and route of administration were not reported)for prophylaxis. Administered dose of vaccine experienced the temperature excursion of below 32 degrees Fahrenheit/ 0 degrees Celsius (-0.2 degrees Celsius) for 4 hours and 48 minutes, 1 cycle. The digital data logger was not involved in recording the temperature excursion details. Administered dose of vaccine experienced the previous temperature excursion of below 2 degrees Celsius (0.5 degrees Celsius) for 23 minutes, above 9 degrees Celsius (8.9 degrees Celsius) for 14 minutes, below 32 degrees Fahrenheit/ 0 degrees Celsius (-0.4 degrees Celsius) for 11 hours and 2 minutes, 1 cycle, below 32 degrees Fahrenheit/ 0 degrees Celsius (-0.7 degrees Celsius) for 11 hours and 20 minutes, 1 cycle. There was no adverse events reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S033516; expirationdate: 29-JUN-2021; 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
Information has been received from a 59 year old female patient concerning herself who had drug reaction/allergy to PERCODAN and had no medical history. On 16-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, dose number, route and duration were unspecified). Concomitant therapies included lisinopril (manufacturer unknown), lithium, NEXIUM and ZOLOFT. On 17-JAN-2015, the patient experienced a hot, red, swelled up, ache at the injection site after receiving ZOSTAVAX. Her physician stated that she had a full allergic reaction to the vaccine. Afterward (unspecified date in 2015) she lost vision in her left eye and developed joint pain in her shoulder and elbows. The patient had sought medical attention via office visit. No treatment was given for the events. The outcome of the events was reported as not recovered. Upon internal review, lost vision in the left eye was considered to be medically significant. Additional information has been requested.
First day:  Sore arm, despite use of heat pad and Tylenol, excessive tiredness-not sleeping well. Second day:  Shivers and headache
p/vax pt exp severe edema; nausea; vomiting; fever; D; h/a; edema was size of grapefruit; severe malaise
Admitted on 10L o2 w/ COVID PNA. sx include shortness of breath, fever, chills, cough and congestion over a week ago; he has had aches and malaise.  Recieving dexamethasone and remdesivir
Arthralgia, Diarrhea,  fatigue, pain at inj site  Narrative:
2 days p/vax pt exp sore throat, cough, dizziness, weakness.
pt devel fever 105 morning p/vax;mom called MD who said to cont w/APAP & not to worry unless convuls occur;temp went down p/APAP;
Two days post vax pt developed redness, itching and warmth in left arm with no fever. Pt seen by physician - left arm brown bruise at injection site 2.5 cm ????? was 6 X 7 cm oval erythematous patch, warm, not tender. Pt treated with Benadryl and Motrin.
Extreme fatigue. I was advised to rest to stay hydrated and eat well. I was advised this as it was the end of its cycle and had run its course, Epstein Barr virus.
The night of the vaccine my arm started hurting and I had a bad headache and dizziness. The next day headache, pain in joints, severe cramps in feet, Bad cough, exhausting tiredness, extreme dizziness. This was severe for 3 weeks and the  end of the third week slowly started improving. This is the 4th week and still have cough and  tiredness. I had covid twice and this was much worse
Information has been received from a physician concerning a male infant who at a 4 month old visit was vaccinated with his second dose of Rotateq and later experienced intussusception. Unspecified medical attention was sought. The patient's recovery status was unknown. There was no product quality complaint. Upon internal review, intussusception was determined to be an other important medical event. Additional information has been requested. 11/6/07-records received for DOS 9/19-9/20/07-intussusception reduced by air enema. History of bloody stools and emesis. Observed after procedure, tolerated breast feeding, discharged.
Bad diarrhea for 2 weeks; felt like throat wanted to swell up; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Bad diarrhea for 2 weeks) and PHARYNGEAL SWELLING (felt like throat wanted to swell up) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027l20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included METFORMIN for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DIARRHOEA (Bad diarrhea for 2 weeks) and PHARYNGEAL SWELLING (felt like throat wanted to swell up). At the time of the report, DIARRHOEA (Bad diarrhea for 2 weeks) had resolved and PHARYNGEAL SWELLING (felt like throat wanted to swell up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
This patient has fatigue, very swollen hands and wrists, rendering joints very painful and stiff, making the use of the hands almost impossible. 60 day follow up states the pt still has symptoms.
HEADACHE; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 250 pounds, and height was 68 inches. 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: 1805031) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious. This case, involving the same patient is linked to 20211265893.
LAID DOWN FOR THE REST OF DAY; SORE ARM; CHILLS; TIRED; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: Patient had no known drug allergies, no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18005018 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the patient experienced sore arm. On 13-MAR-2021, the patient experienced chills. On 13-MAR-2021, the patient experienced tired. On 13-MAR-2021, the patient experienced laid down for the rest of day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, chills, tired, and laid down for the rest of day on 14-MAR-2021. This report was non-serious.
DTP vax - 2PM 2JAN91; vomited x 3 4-5PM; Seizure x2 430-530PM 29JAN91.
Vaginal ulcer. 1/4 inch diameter, flat, round, white, visually similar to canker sore. Painful when I?m contact with other surface. Visited gynecologist office and they suspected it was a STI, however I tested negative for everything (blood and swab tests). They told me I had low lactobacillus bacteria, but I am severely lactose intolerant with other sensitivities so that was not shocking/new information. While waiting for results, I soaked in a sitz bath which soothed the pain, and it went away within a few days.
SWELLING TO RIGHT ARM, FROM NEAR SHOULDER DOWN TO ELBOW, PAIN UNDER ARMPIT, PERSONAL PHYSICIAN PRESCRIBED DURICEF 500MG AND PREDNISONE 20 MG
The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 09-Mar-2022; Moderna COVID-19 vaccine that was beyond 30 day use by date was given to patient.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to patient.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 09-Mar-2022) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to patient.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 09-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that was beyond 30 day use by date was given to patient.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-Jan-2022 and administered to the patient on 09-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that date the vial was initially stored in the refrigerator on 31-Jan-2022. The vial did not undergo any temperature excursions.  No treatment medications were reported.   This case was linked to MOD-2022-525860 (Patient Link).
I experienced extreme pain in my left upper arm at not only site of injection but, down to my elbow and up into my neck. I had swelling and site was hot to touch. I also had a mild headache.
Body aches, fever 99.8, chills, chattering teeth, general feeling unwell. Pounding headache, fatigue, really sore arm. Night sweats. Lasted about 48 hours.  I'm still waking up with a pounding headache every morning.  Still lingering sense of  unwellness.
Herpes Zoster; Information was received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information regarding the pt's current condition, historical condition and concomitant medication was unknown. On or around 10-OCT-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a pustular itchy rash on back and was diagnosed with herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was considered as not recovered. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).    The event of herpes zoster was considered to be disabled.
large swollen muscle in armpit of the same side the shot was delivered (left).  flu symptoms 12 hours after shot delivery and lasted for 12 hours.
Wrong Vaccine given at time of administration: **NO ADVERSE REACTION NOTED** Patient was due to receive his anthrax vaccine but instead received a dose of Pfizer Covid 19 vaccine.
Migraine, followed by has, high heart rate, nausea , body aches and severe diarrhea  and fever.
SWEATING; SHORT OF BREATH; CHILLS; VERY NAUSEOUS; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: graves disease, no alcohol use, smoker, and fibromyalgia, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with hydromorphone hydrochloride, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 09-APR-2021, the patient experienced sweating. On 09-APR-2021, the patient experienced short of breath. On 09-APR-2021, the patient experienced chills. On 09-APR-2021, the patient experienced very nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, short of breath, chills, and very nauseous on 17-APR-2021. This report was non-serious.
After I had my vaccine, I came home and my heart was all over the place.  It was beating fast and hard and skipping beats.  I was uncomfortable.  I tried drinking water and switching positions.  I did have online conversation with my doctor's office via patient portal online but didn't do anything else.
Events were over the course of 4 days as follows:  May 14: migraine - overcame with rizatriptan May 15: migraine - overcame with rizatriptan May 16: woke up with dehydration, dry mouth, and cold sweat followed by: vomiting, extreme fatigue, very strong migraine; unable to overcome with rizatriptan and Aleve May 17: continued to recover from May 16's migraine and met with doctor; migraine eventually went away on its own around late afternoon; doctor prescribed Propranolol for migraine treatment and I started taking Propranolol the next day
Patient and her two children came in to receive Covid-19 vaccines, the Pfizer vaccine was billed through assistance and the patient's insurance for a first dose vaccine. After the Pfizer vaccine was given I entered it into system and realized the patient had received a Moderna first dose at a local urgent care despite marking no to ever receiving a dose of Covid-19 vaccine on the consent form. I proceeded to call urgent care to verify the patient actually got a dose and she did. I then called the patient and spoke to her daughter due to a language barrier and asked the daughter if the patient did in fact get a dose of Moderna at the urgent care because she marked no on the consent form. The daughter informed me that the patient purposely marked no on the form to get a series of the Pfizer vaccine due to missing her second appointment for the Moderna vaccine. I advised the daughter to inform the patient that she will not need a second dose of either vaccine per CDC guideline to not administer an additional dose.
currently have 38 units to be returned; This non-serious case was reported by a pharmacist and described the occurrence of intercepted product storage error in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) (batch number 52X45) for prophylaxis.   In AUG-2023, the patient received Menveo. On 11-AUG-2023, an unknown time after receiving Menveo, the patient experienced intercepted product storage error (Verbatim: currently have 38 units to be returned).  The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2023 The reporter stated that we would not be able to send back the 60 units of Menveo and currently had 38 units to be returned. We issued an investigation since the product was received in the system and customers were able to place orders (22 units). The feedback needed from Glaxo for investigation. The 22 units of Menveo vaccine temperature excursion on 11th August 2023. The tag alert alarm 2, 3 with 4 black squares. The Menveo vaccine had temperature excursion, which led to incorrect storage of vaccine.
Pt received vaccine @ 2:50 PM.  Pt reported feeling dizzy, hot and sweaty.  Pt has a history  of anxiety/ fainting when dealing with needle sticks.  VS 122/80 HR: 72 O2:  94. Patient  later reported feeling back to normal. Pt denied feeling dizzy, hot , and sweaty. Pt was d/c home with her husband.
The outside of my left started to tingle and went all the way down unto my hand and fingers, the outside of my palm from my little finger and up to about 2" above my wrist. After a couple of days only my hand felt and fingers were still numb. That lasted about a week and then the last week until the day that I got my 2nd injection (Feb. 5) only my little finger felt like that. I have that sensation in my hand again but it is very weak and it comes and goes. I have migraines and sometimes I have that feeling in my arm and hand.
This spontaneous report was received from a nurse, referring to a 4 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of  PROQUAD lot # N014948, with expiration date 11-NOV-2018 for prophylaxis (Strength, route, dose, frequency, and anatomical location were were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). The administered dose of vaccine experienced the temperature excursion of 6°F to 14°F (8.4F ) degrees Fahrenheit for 102 min. There was a digital data logger invloved, but there was no previous temperature excursion. No adverse effects reported. There was no adverse event reported. This is one of several reports received from the same reporte; Sender's Comments: US-009507513-1803USA001061:
Patient first developed painful mouth sores on lips, buccal mucus, and gingiva approximately 1 week after the second COVID vaccine.  Patient was initially treated for possible herpes without response to antiviral meds.  Was diagnosed with lichen planus by another provider.  Was placed on bentalin and mycostatin.  Labwork was completed.  Patient was then seen by me and underwent biopsy which was consistent with chronic lichen planus.  Patient is being maintained on bentalin and mycostatin with prn fucicort.
C/O feeling ill with inability "to get out of bed" day after vaccine administration. Now C/O ongoing left arm limited range of motion.
PT STARTED EXPERIENCING INTENSE HEADACHES ON THE MORNING OF 5/21/2021. THE HEADACHES CONTINUED ON AND OFF FOR SEVERAL DAYS UNTIL ON 5/24/2021 AT 3 PM, SHE HAD A DEBILITATING HEADACHE WITH DIZZINESS THAT COULD NOT BE RELIEVED. THEN ON THE AFTERNOON OF 5/25/2021, SHE STARTED EXPERIENCING VISUAL CHANGES WITH BLACK SPOTS IN HER VISION. SHE WAS ABLE TO SEE HER DOCTOR ON 5/27/2021 AT 10 AM. HE SENT HER FOR A CT SCAN OF HER HEAD WHICH WAS FOLLOWED BY A MRI OF HER BRAIN. THE MRI AND CT SCAN REVEALED THAT SHE HAD A LEFT FRONTAL ISCHEMIC STROKE. SHE WAS ADMITTED TO THE HOSPITAL ON 5/27 AND DISCHARGED HOME ON THE AFTERNOON OF 5/28. SHE HAD A CT ANGIOGRAM OF THE BRAIN, AN ECHO OF THE HEART, ULTRASOUND OF THE CAROTIDS AND A HYPERCOAGULATION BLOOD PANEL. ALL OF WHICH WERE NORMAL AND SHOWED NO EVIDENCE OF WHERE THE BLOOD CLOTS CAME FROM THAT CAUSED HER STROKE.  SHE CONTINUES TO HAVE HEADACHES WITH DIZZINESS, FATIGUE, AND NOW BAD ANXIETY.