chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional (nurse) and described the occurrence of slight temperature in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), PENTACEL (non-gsk) and pneumococcal vaccines (non-gsk). Concurrent vaccination included rotavirus vaccine (non-gsk); non-GSK manufacturer; oral given in 2012. On 4 June 2012 the subject received a dose of ROTARIX (intramuscular, unknown) as 2nd dose in series, unspecified dose of PENTACEL (intramuscular, unknown), unspecified dose of Pneumococcal vaccines (Non-GSK) (intramuscular, unknown) and experienced inappropriate route of vaccination and interchange of vaccine products with ROTARIX. The ROTARIX was administered by intramuscular injection instead of orally as indicated. The subject had received 1st dose of Rotavirus with ROTATEQ (oral route) given correctly (interchange of vaccine products). On 4 June 2012, less than one day after vaccination with PENTACEL, Pneumococcal vaccines (Non-GSK) and ROTARIX, the subject experienced slight temperature and fussiness. A nurse gave the subject ROTARIX vaccine intramuscularly instead of orally. According to the reporter, the subject received other vaccines in addition to the ROTARIX. The subject experienced a mild temperature and some fussiness on the same day that resolved by the end of the day on 04 June 2012. According to the nurse, the mild fever and fussiness could have been caused by the other vaccines. The nurse planned to repeat the Rotavirus vaccine using the oral route. At the time of reporting the events were resolved. The healthcare professional explained that the vaccine was reconstituted correctly and a new needle and syringe were used to withdraw the vaccine from the vial and administer intramuscularly. The healthcare professional noted that the maladministration occurred because the nurse did not attend training in services or read given literature on ROTARIX. She thought she had overheard other staff talking about ROTARIX and thought they had told her to administer intramuscularly. It was reported that six subjects were administered ROTARIX by intramuscular injection. See cases A0981435A, A0983050A, A0983051A, A0983052A, and A0983053A for details regarding the other five cases.
Throat itchiness followed by flushing and full body itchiness. Took 3 benadryl.
This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, gender, race, and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total for prophylactic vaccination (Dose number series 1). 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, patient reported that "My eye was hemorrhaging, leaving me legally blind in one eye, very soon after the shot. I am going for a second opinion on the treatment and dismal outcome." The action taken with covid-19 vaccine was not applicable. The outcome of the hemorrhage eye and legally blind in one eye was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211261203-COVID-19 VACCINE hemorrhage eye, legally blind in one eye -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).
Pt states in day following vaccine experiences severe pain in BOTH shoulders, though only received vaccine in Left Shoulder. Difficult for pt to raise BOTH arms above shoulder height. Pain has persisted since vaccination 3 months ago and continues to today.
BODY ACHE; FEVER; HEADACHE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced body ache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, body ache and pain at injection site was not reported. This report was non-serious.
Flu like symptoms, headache, body aches, uncontrollable shivering the night after, muscle fatigue and soreness
83 y/o female, PMHx of Afib, HTN, DM, colon CA, presenting with worsening SOB and weakness related to Covid-19 infection. Pt was diagnosed with Covid on 1/22/21 and managed symptoms at home. Was sent to ER by home health due to low O2 sat without oxygen. Hypoxic at 86% on admission. Pt treated with supportive measures. Pt was discharged to skilled nursing facility on 2/1/21.
25 JAN 03 patient  RECEIVED A DIRECTED SMALLPOX IMMUNIZATION.  ON 2 FEB 03 HE EXPERIENCED SWOLLEN GLANDS IN HIS NECK AND SEVERE HEADACHE.  ON 5 fEB 03 AT 5:30 A.M. patient TRANSPORTED HIMSELF TO THE EMERGENCY ROOM  WITH A COMPLAINT OF CHEST PAIN.  HOSPITALIZATION THRU 7 FEB 03 FOLLOWED.  INDIVIDUAL WAS Dx WITH PRESUMPTIVE VACCINIA MYOCARDITIS.
Moderna COVID-19 Vaccine EUA  8 days post injection- erythematous, mildly hard, swollen, itchy reaction at injection site  consistent with a vaccine given as a subcutaneous injection, not an intramuscular injection. Began 1/4/21 at night, grew in size overnight. 1/5/21, iced the area and took an antihistamine. By 1/6/21 reaction was resolved.
No adverse event; product discoloration; Dose administered after the 30 day beyond use date; This spontaneous case was reported by an other health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after the 30 day beyond use date), NO ADVERSE EVENT (No adverse event) and PRODUCT COLOUR ISSUE (product discoloration) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 13-Jul-2021 and Moderna COVID-19 Vaccine on 02-Aug-2021; for an unreported indication: Moderna COVID-19 Vaccine on 09-Mar-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 13-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 13-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and PRODUCT COLOUR ISSUE (product discoloration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after the 30 day beyond use date), NO ADVERSE EVENT (No adverse event) and PRODUCT COLOUR ISSUE (product discoloration) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after the 30 day beyond use date) to have a relationship that was not reported, PRODUCT COLOUR ISSUE (product discoloration) to be not applicable.    Patient had vaccine on 02Aug2021, 13Jul2021 and 09Mar2022. No concomitant and treatment medication were reported.   Reporter did not allow further contact
Resident became increasingly somnolent and short of breath with bilateral lower extremity edema.  He was sent to the hospital for evaluation and treatment on 5/26/2021 where he was tested for COVID 19 and found to be positive.  Resident had a previous negative COVID 19 test 5/23/2021.
Patient was hospitalized 11/9/20-11/27/20 with probable Guillain-Barre Syndrome. He was discharged to long-term care for rehab.
Resident has pain, swelling, warmth, and redness  at injection site measuring 13.5inx85in. Resident is currently receiving benadryl with no relief.
swell up; redness; sore arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swell up), ERYTHEMA (redness), MYALGIA (sore arm) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-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 SWELLING (swell up), ERYTHEMA (redness), MYALGIA (sore arm) and PYREXIA (fever). At the time of the report, SWELLING (swell up), ERYTHEMA (redness), MYALGIA (sore arm) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no relevant concomitant medications was reported. No treatment information was provide
Hospitalized for liver transplant, positive testing probably residual shedding from infection on 10/30/2021.  No symptoms.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 03-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date-22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Information has been received from a registered nurse (also reported as a physician) concerning a female who was vaccinated  with her first dose of Gardasil vaccine (yeast) 0.5 ml. Subsequently the patient had a seizure. Subsequently, the patient recovered from the seizure. Therapy with Gardasil vaccine (yeast) will not be reintroduced. Upon internal review, seizure was considered an other important medical event. Additional information has been requested.
This non-serious spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with maximum temperature (Tmax) 8.2 degree Celsius for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree Celsius for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 06-Nov-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse effect after the vaccination. This case is linked to 201805262 (same reporter).
9/28/12 Nausea, headache, hoarseness, fatigue, temperature 101. 9/29/12 Muscle spasms lower legs, difficulty walking. 10/1/12 Went to MD. WBC (13.9), BUN 29, Bili (1.6), Glucose (160). Lost 7 lbs.
Patient stated 3 and a half hours after her Moderna Covid-19  vaccine she felt dizzy, heart beating fast, and chest pain. She went to the ER/urgent care.  The did an EKG and blood work.  All results were normal.
I've been generally asymptomatic. Having spent time in an airport, I took a COVID-19 test to be on the safe side. The result was positive. Other than some slight nasal congestion, I've had no symptoms. I had brief and very mild body aches. I took ibuprofen. They cleared up in two hours.
The day after vaccination  (4March21) pt. slept all day, and had the chills.  Got up next morning (5March21) feeling  better. By noon felt lethargic and slept the remainder of day. He experienced incontinence while sleeping. He had trouble walking, and could not make it to the bathroom without support. While in the bathroom he went to the floor, (did not fall), could not get up. I had him crawl on his hands and knees to the living room. It's a though his muscles went soft. Remained lethargic the remainder of the day. Did not see a doctor.  Stayed at home and waited for symptoms to pass.
Approximately  12 to 13 days post booster, I started to become itchy on various parts of my body. By November 26, I had broken out into hives and wheals primary on my lower torso. I felt (and have felt since) perfectly normal except for this itching. They come and go along with dermagraphia wherever I scratch or have any pressure on my skin. Zyrtec has controlled this issue well for me and allows me to go about my day, I can go a few days without it but then get itchy again. Previously I had ?moderna arm? with my first vaccine which occurred 7 days after my Shot and it took a couple weeks to fully resolve. The redness and streaking reminded me a lot of my Moderna Arm site, although this happens anywhere on my body and then disappears only to reappear somewhere else.
Embolism arterial; Thrombosis; Herpes zoster; Limb discomfort; Pain in extremity; Feeling hot; This case was received via VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EMBOLISM ARTERIAL (Embolism arterial), THROMBOSIS (Thrombosis), HERPES ZOSTER (Herpes zoster), LIMB DISCOMFORT (Limb discomfort), PAIN IN EXTREMITY (Pain in extremity) and FEELING HOT (Feeling hot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 31-Mar-2021, the patient experienced EMBOLISM ARTERIAL (Embolism arterial) (seriousness criteria hospitalization and medically significant), THROMBOSIS (Thrombosis) (seriousness criteria hospitalization and medically significant), HERPES ZOSTER (Herpes zoster) (seriousness criterion hospitalization), LIMB DISCOMFORT (Limb discomfort) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Pain in extremity) (seriousness criterion hospitalization) and FEELING HOT (Feeling hot) (seriousness criterion hospitalization). At the time of the report, EMBOLISM ARTERIAL (Embolism arterial), THROMBOSIS (Thrombosis), HERPES ZOSTER (Herpes zoster), LIMB DISCOMFORT (Limb discomfort), PAIN IN EXTREMITY (Pain in extremity) and FEELING HOT (Feeling hot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Full blood count: unknown (Inconclusive) Unknown. On 31-Mar-2021, Ultrasound Doppler: unknown (Inconclusive) Unknown. On 31-Mar-2021, Whole body scan: unknown (Inconclusive) Unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient went to hospital because of blood clots and he had an emergency surgery. It was a huge arterial clot and developed shingles.  Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I tested positive for Syphilis from a blood donation on November 3, 2021 with no sexual contacts.  The donation site was (Privacy). Following receipt of this information, I contacted the donor center and told them this result was a false positive because I have had no sexual contacts.  Their reply was that they have been seeing a lot of these results over the past few months and have been concerned that the cause is the COVID vaccine.  I hope you are able to investigate this, because it is the only explanation for me.  I am a long-time donor (over 10 gallons) and have never received a result such as this.  Thank you for your assistance.  I would appreciate feedback when you have completed an investigation.
Left arm severe pain and redness with lump. States she was unable to move her arm for approx. 2 days. She states she had a large lump on her arm. She was seen by me 5/29/18 she states it is much better at this time. Still with grape size lump left deltoid and mild erythema circular area around injection site with tenderness. No drainage. Does not appear to be infected. She did not come to the office to be treated for this. I am seeing her for a follow up visit for a different reason, and she wanted me to know about this reaction so I may report it. She is improving, not resolved yet. She is moving her left arm without difficulty now.
On 4 - 2-21, I had chills, swollen glands, and felt tired.  On 4-3-21, at night, for about 2 hours or so I felt like it was difficult to breath.  It felt like what I had when I had covid the year before.  I went to bed and it eventually resolved and has not happened again.  I just thought that I should report it because I have not heard of anyone else having this reaction.  I did not seek any medical help, as it did not seem life threatening, but I was scared.
Patient noted abdominal cramping and then later today vaginal bleeding. LMP two weeks ago.
Patient recently diagnosed with DVT and was taking enoxaparin 80mg subq q12h. Presented to ED after receiving vaccination  with increased swelling and redness in RLE. worsening of DVT on imaging.
I had the HPV vaccine Gardisil on March 31, 2009.  The next day I was feeling soar and tired, but did not think anything about it.  By Friday evening (April 3) I was still feeling tired, my body was aching, in general I did not feel well.  I also noticed that my lymph nodes in me neck and groin were very swollen and very painful.  This continued throughout the weekend and did not get better.  It became very painful to sit, stand and walk.  Pain radiated through my pelvis, so I went to an urgent care clinic on Monday March 6th.  There I went through a pelvic exam, palpation of my swollen glands, lab work and an ultrasound.  I recieved a shot of rochephin and rocephin to take at home for 10 days, in case there was some kind of infection.  I have had no fever.  My sonogram was normal, other than showing my swollen glands.  Labs are not back yet, but I believe they will be normal.  However I still have painful swollen neck and groin glands.  The groin glands are bothering me the most. 4/13/09-records received for DOS 9/6/08-C/O allergies. 4/6/09-C/O swollen glands and not feeling very good.
Coarse red raised rash resembling Pityriasis rosea on trunk and extremeties.
low blood pressure; head is foggy; felt like I had the flu; has no energy and very weak; has not eaten; chest pain; very sick; trouble breathing; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (head is foggy), INFLUENZA (felt like I had the flu), ASTHENIA (has no energy and very weak), DECREASED APPETITE (has not eaten) and CHEST PAIN (chest pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lung cancer stage IV and GERD. Concomitant products included LANSOPRAZOLE (GERD), FOLIC ACID and THYROID for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (head is foggy), INFLUENZA (felt like I had the flu), ASTHENIA (has no energy and very weak), DECREASED APPETITE (has not eaten), CHEST PAIN (chest pain), ILLNESS (very sick), DYSPNOEA (trouble breathing) and FATIGUE (fatigue). On 22-Apr-2021, the patient experienced HYPOTENSION (low blood pressure). At the time of the report, FEELING ABNORMAL (head is foggy), INFLUENZA (felt like I had the flu), ASTHENIA (has no energy and very weak), DECREASED APPETITE (has not eaten), CHEST PAIN (chest pain), ILLNESS (very sick), DYSPNOEA (trouble breathing), FATIGUE (fatigue) and HYPOTENSION (low blood pressure) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included: immunotherapy and chemotherapy every 3 weeks, maintenance medications, high blood pressure medication
Developed fever, anorexia and edema and induration of entire thigh including knee.
On 8/14/2021, case was hospitalized. Released 8/19/21.  Symptoms:  Fever, cough, sore throat, runny nose, congestion, poor appetite, nausea, vomiting, diarrhea, chest pain, wheezing, fatigue, muscle aches, chills.
Tinnitus developed suddenly two days later along with chills.  Patient is a music teacher, now unable to play piano without kicking up  noise in ears, symptoms persisting ever since.
Experiencing hives (welts) on right side of the body 3 days after the second dose of vaccine. No known allergies or other changes to food, clothing, or environment. Welts still persist nearly 1 month after second does of vaccine.
Patient received less than a full dose of vaccine on 09/12/2022, discovered on 09/13/2022. Called manufacturer whom referred pharmacy to call CDC for further guidance.
Patient was admitted on 3/04/22 because of increasing weakness of both upper and lower extremity that he was not able to ambulate.  He was recently discharged from the rehab facility.  He does have a chronic intermittent confusion because of hepatic encephalopathy and hyperammonemia.  He is also complaining of headache.  CT scan of the brain is negative on admission.  He has a no new focal weakness otherwise.  Patient was set for discharge the previous week but his COVID-19 test was positive so he required to finish isolation before he was accepted to nursing home.