chrisvoncsefalvay/vaers-outcomes huggingface dataset:
one vial who was been administered after 30 days on fridge; Arm Discomfort; Fatigued; Very sore arm at the injection site; Patient received vaccine 4 days after use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of LIMB DISCOMFORT (Arm Discomfort), FATIGUE (Fatigued), VACCINATION SITE PAIN (Very sore arm at the injection site), POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine 4 days after use by date) and PRODUCT STORAGE ERROR (one vial who was been administered after 30 days on fridge) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.    Co-suspect product included non-company product PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23) for an unknown indication.    Concurrent medical conditions included Blood pressure abnormal and Penicillin allergy. Concomitant products included AMLODIPINE for Blood pressure abnormal.   On 10-Feb-2022, the patient received first dose of PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23) (Intramuscular) 1 dosage form. On 10-Feb-2022 at 12:18 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Feb-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine 4 days after use by date). On 11-Feb-2022, the patient experienced LIMB DISCOMFORT (Arm Discomfort), FATIGUE (Fatigued) and VACCINATION SITE PAIN (Very sore arm at the injection site). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (one vial who was been administered after 30 days on fridge). On 11-Feb-2022, FATIGUE (Fatigued) had resolved. On 12-Feb-2022, LIMB DISCOMFORT (Arm Discomfort) and VACCINATION SITE PAIN (Very sore arm at the injection site) had resolved. At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine 4 days after use by date) and PRODUCT STORAGE ERROR (one vial who was been administered after 30 days on fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered FATIGUE (Fatigued) and VACCINATION SITE PAIN (Very sore arm at the injection site) to be related. No further causality assessments were provided for LIMB DISCOMFORT (Arm Discomfort), POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine 4 days after use by date) and PRODUCT STORAGE ERROR (one vial who was been administered after 30 days on fridge).    Treatment information was not provided by the reporter.   This case was linked to MOD-2022-500102 (Patient Link).
This spontaneous report as received from a 69 year old pharmacist referring himself. The patient had no pertinent medical history, drug reactions/allergies and concomitant medications. On an unknown date in July 2017 (reported as" two and a half weeks ago") the patient was vaccinated with ZOSTAVAX (strength, dose, route of administration, lot/batch# and expiration date were not reported) for vaccination and Sterile diluent (lot# and expiration date were not provided) was used to reconstitute the vaccine. On an unknown date in July 2017 (reported as 5 days after the vaccine administration) the patient developed "a swollen lymph node behind his left ear, width is a "dime" size." On an unspecified date, the patient developed a "swollen gland behind his right ear" and he had never had this issue before. No lab diagnostics/studies were performed. The outcome of swollen lymph node behind his left ear was reported as not recovered. The outcome of swollen gland behind his right ear was unknown.  The causality assessment was not provided by the reporter.
Information has been received from a physician via a company representative referring to 4 patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. Over the last four years, on unspecified dates, four patients were vaccinated with GARDASIL (lot#, dose, route and dose number were unspecified). On unspecified dates, the 4 patients experienced syncope after receiving GARDASIL. The outcome of the event was unspecified. Additional information is not expected because there was no consent to contact physician.
Pfizer-BioNTech COVID-19 Vaccine EUA Fast Heartbeat - initially after injection but I thought it was a panic attack. But it subsided and I drove home.     About 1.5 hours after the injection I realized my heart was pounding. I felt the pounding/racing heartbeat  for about another hour. My BP was normal, pulse was 90 but it has often been 90 on other occasions.
Information has been received from a nurse practitioner concerning a female who a month ago, on approximately 16-FEB-2007, was vaccinated with 0.5 ml Gardasil. When the patient received Gardasil therapy her arm got sore for over a month. As of 16-MAR-2007 the patient had not recovered, and the patient rejected to have a second dose of Gardasil. Additional information has been requested.
Hives covering her back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14 year-old female patient received bnt162b2 (BNT162B2), administration date 30Sep2021 (Lot number: EW0164) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Lot Number: EW0164), for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "Hives covering her back".  Additional Context: NDC number, RA Number and expiry date of COVID-19 Vaccine was Unknown Reporter was just wondering if this was going to get worst or she is gonna be okay tonight or if reporter should call anybody else. Reporter was informed if urgent they can visit the Hospital or Emergency room. Further probing could not be initiated as reporter was unwilling to complete the report. Hence, product details, purchase details and other details were unknown and limited information was available over the call.  Follow-up attempts completed. No further information expected.
Chills; Severe headache/headache worse when bending over; Fever; Queasy stomach/nausea; Diarrhea; Severe arm pain; Achiness; Stuffy nose; Sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 12Sep2021 at 12:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, spinal stenosis, interstitial cystitis, lichen sclerosus and known allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive concomitant medications. On 12Sep2021 at 23:00, the patient experienced chills, severe headache, fever, queasy stomach/diarrhea, severe arm pain, achiness, stuffy nose, sore throat, nausea. It was reported as headache was worse when bending over. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, severe headache/headache worse when bending over, fever, queasy stomach/nausea, diarrhea, severe arm pain, achiness, stuffy nose, and sore throat was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Low grade fever for 3 days, sweating, nausea, severe fatigue (i slept for 20 hours yesterday which is not normal for me), muscle pain throughout body (cramping pain, not a burning or stabbing pain). Got the vaccine Thursday, its Monday and I still feel absolutely drained.
Information has been received from a office receptionist concerning a female who in March 2008, was vaccinated with ZOSTER (Oka-Merck) 0.65 mL, subcutaneously.  A short time later, the patient developed a bilateral wrist pain and neck pain.  The patient's bilateral wrist pain and neck pain persisted.  The patient was referred to a neurologist for evaluation.  The patient sought medical attention in office.  Additional information has been requested.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-03-16.
redness at injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at injection site) and FATIGUE (fatigue) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included hormonal IUD for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 11-Feb-2021, FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Aches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 at 17:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no allergies to food, medications or other products. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), fluoxetine hydrochloride (PROZAC), cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE) all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 11:30, the patient experienced aches and chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of aches and chills and included treatment with ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events aches and chills was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
EXTREME ABDOMINAL CRAMPS lasting for 24 hrs,  intermittent , MUSCLE SORENESS IN BOTH ARMS
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 11-MAR-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok w Tip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -2.11 Celsius Degrees for 504 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
No additional adverse effect reported; expired VAQTA (Lot S023220 Exp 10/20/2020) was inadvertently administered to a patient; This spontaneous report was received from a nurse practitioner, also reported as nurse prescriber who was reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 24-OCT-2020, the patient was inadvertently vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) vial (strength, exact dose, route of administration and anatomical location were not reported; lot number S023220 was confirmed to be valid, expiration date 20-OCT-2020 was confirmed) for prophylaxis. There was no additional adverse event reported.
Fever, weakness, inflamed sinuses with trouble breathing, severe headaches, no appetite.  Night of vaccine and all of the following day.
Received the Jynnoes Vaccine via incorrect route, IM instead of SQ.  Left arm was swollen, red, and painful at injection site upon waking on 8/9 around 0520.  Took ibuprofen, used an Ice-Pack on 8/9 with some relieve.  Left arm is still swollen and tender at injection site.  Upon doing some research, found out I received the vaccine incorrectly.  Should have been SQ or TD.
Cold chills, high fever, headache.  Stay home and rest.  Last about 24 hours
Urticarial lesion with central decrease blood flow started 2 hours after vaccine given BENADRYL.
14 hrs post/vax, child found by mom w/tactile fever, limp, unreponsive, pale, eyes rolling back, resp. pattern irregular. Gave Tylenol & episode ended approx 20 min later w/pt falling asleep. 1 episode of ataxia next am. Lcl rxn at inj site
shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder pain) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (shoulder pain). The patient was treated with GABAPENTIN ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: TCR. added. NNI.
Intussusception - failed enema reduction X3. Abd surgery to reduce, also found mass (duplication of cecum). Final Dx intussusception duplicate cecum.
SEVERE BODY ACHES, CHILLS, FEVER, MALAISE, EXACERBATION OF ASTHMA
Mild fever for the first day only.  Severe fatigue, headache, loss of appetite, joint pain, nausea x5 days now.  Sweating after eating.  Gradually improving after x5 days, though I continue to sweat every time I eat now and my appetite is still significantly decreased.  Fatigue is finally improving.  Joint pain is gone now.
numbness on my right foot right after the injection ( it went away) 30 min after swelling of right side of my face and droopy right eye ( swelling went away but my eye is still droopy) little body pain, head ache and body felt warm ( took Tylenol and it all went away). I'm just a little worried about my eye. Not sure how long it will take this to go away. I didn't take any allergy med because I'm not sure if I can.
Got heavy period 6 days later while in middle of birth control pack. Also had the common fever for about 36 hours afterwards.
pt recv vax 20SEP98 & 27SEP98 pt c/o of full body rash;
Itchy rash on much of the body, especially where clothing touches the skin. Joint pain and swelling. Dizzy spell.
TDAT GIVEN 5/9/08. INFECTION AT SITE ON 5/13/08
Mother reported that approximately 2 hrs after injection, developed a quarter sized welt with bumps at injection site that was very red. It continued to increase in size, up to the size of a softball, was very red and warm to touch. The swelling subsided 4 days later but remained red and warm, as well as arm soreness. on 4/11/11 complained of a sore throat. On 4/12/11 awoke with difficulty breathing, and the back of the tongue was swollen and noticed that evening noticed two large pus pockets to the back of the throat. No temp. Saw Dr. on 4/13/11 and was diagnosed with Strep throat and put on antibiotic.
Had heart palpitations one hour after FLUZONE HD injection continued for about an hour after. Since this disappeared pt did not go to hospital. Went for check up with cardiologist one month later who advised pt to contact us for VAERS.
At 8:54 client complained of feeling dizzy, spotted vision, client looked pale, diaphoretic while sitting. BP at 8:55 was 80/61, HR 76, RR 18, 02 sat 96% on RA. Client was then put on transdelenburg position immediately at 8:56 with vital signs taken BP 118/70, HR 75, RR 20, 02 sat 96% on RA. Back on sitting position at 8:59 BP 120/76, HR 83, RR 20, 02 sat 98% on RA. Client denies any dizziness or spotty vision at this time. No further treatment was necessary. Advice to call 911 client refused. husband will drive client home. leaving at 9:20. Total observation time is 41 min.
Information was received from a female consumer who on 07OCT2010 was vaccinated with a dose of PNEUMOVAX 23 (lot #09332, Exp. Date 25FEB12). The patient suffered itching and swelling to her arm. The patient was hospitalized for 3 days and diagnosed with cellulitis. The outcome was not reported. Additional information is expected.
Prior to getting the shot, I had only ever experienced a single episode of seizure.  Since getting the shot, I have experienced 4 episodes of nearly all day focal seizures (where I never lose consciousness, nor the memory of events, and I seem to slip in and out of the focal seizures - in a dream like state with heightened awareness- but no sensory experiences - like smell, taste, etc... during the period I'm actually in aura/dream state).
This spontaneous report as received from a female pharmacist of unknown age (reporting on herself). It was reported that in 1996 the patient was vaccinated with the first dose of VARIVAX (Merck) (lot number and expiration date not reported) (dose and route not reported). Also, in 2009 the patient received the second dose of VARIVAX (Merck) (lot number and expiration date not reported) (dose and route not reported). Concomitant therapies were not reported. The patient had two negative titers for Varicella immunity, the first negative titer was in 2008 and the second negative titer was in 2010. The pharmacist did not know what titer test was used to provide the negative titers of Varicella. No adverse event reported, other than the negative titers. Additional information has been requested.
TINGLING OF FACE (CHEEKS AND MOUTH) AND BOTH HANDS AND ARMS; BAD POUNDING HEADACHE (FELT LIKE BRAIN WANTED TO COME OUT OF MY HEAD); FEVER; NAUSEA (FELT LIKE PREGNANT AND SMELLS WERE BOTHERING); CONFUSED; FEELING SPACED OUT/ FEELING WEIRD; SLEPT FOR 2 DAYS STRAIGHT; DIZZY BUT NOT UNBALANCE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. 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 14-AUG-2021 for prophylactic vaccination. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate for drug used for unknown indication, estrogens conjugated for drug used for unknown indication, levothyroxine for drug used for unknown indication, liothyronine sodium for drug used for unknown indication, and progesterone for drug used for unknown indication.  On 14-AUG-2021, the patient experienced confused. On 14-AUG-2021, the patient experienced feeling spaced out/ feeling weird. On 14-AUG-2021, the patient experienced slept for 2 days straight. On 14-AUG-2021, the patient experienced dizzy but not unbalance. On 14-AUG-2021, the patient experienced nausea (felt like pregnant and smells were bothering). On 14-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 16-AUG-2021, Laboratory data included: Body temperature (NR: not provided) 99 F. On 18-AUG-2021, the patient experienced bad pounding headache (felt like brain wanted to come out of my head). On 18-AUG-2021 21:10, treatment medications included: paracetamol. On 19-AUG-2021, the patient experienced tingling of face (cheeks and mouth) and both hands and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 16-AUG-2021, was recovering from bad pounding headache (felt like brain wanted to come out of my head), had not recovered from confused, tingling of face (cheeks and mouth) and both hands and arms, nausea (felt like pregnant and smells were bothering), and feeling spaced out/ feeling weird, and the outcome of slept for 2 days straight and dizzy but not unbalance was not reported. This report was non-serious.
pt w/ history of malaise and allergies during summer. pt recv vax devel swelling @ the inject site, bronchitis type sx & had a fever.reporter felt that pt sx were r/t vax;
Area surrounding injection very swollen, skin above area red and inflamed in appearance.  Arm mildly painful and tender in swollen area. Initially improved over about three days.  Arm seemed normal.  Same reaction about one week later lasting about one week. Currently much improved. No treatment given
About 3 hours after getting the second vaccine, I began to experience strong menstrual- like cramping. I am post-menopausal, so this was unexpected and very noticeable. The cramping was followed by a very loose bowel movement, which was very much like what I would experience with my monthly menstrual cycle years ago. The cramping lasted for the day,  and the next morning I felt completely normal. Please note that my first vaccine dose had zero side effects.
Observed for 15 minutes without incident but while waiting for appointment scheduling pt began to feel unwell.  right and left upper quadrant ABD pain, N&V,  diaphoretic, 30-40 ml emesis.  Hypotensive 100/62 (baseline 144/90).  No breakfast this AM.  Kept under observation for additional 20 minutes. Pain resolving at time of discharge.
Information has been received from a physician concerning a male patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported). The physician reported that the patient received the pneumococcal 23v polysaccharide vaccine and broke out in a rash all over his body. No further information was provided. Additional information has been requested.
Case number PHEH2014US015677 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 12 year old patient of an unspecified gender. The past medical history and concomitant medications of the patient was not reported. On 28 Jul 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) which had multiple temperature excursion while in storage. The temperature of the vaccine reached a maximum of 47.5 F for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 F for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration (incorrect storage of drug).