chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sizable redness/rash  in arm about 2" below the injection site and was very itchy and warm and swollen.  This persisted for several days and became very red.  My physician worried about possible cellulitis and prescribed an antibiotic (Doxycyline HYC 100 mg) (7 days).  I did not have a fever.  After the antibiotic the symptoms largely disappeared.  My physician was astonished that the shot was in the same arm as the first shot, especially because there was a very small redness after the first shot.  She reasoned that the effects from the first shot are magnified in the second shot and has patients with similar responses when given the second shot in the same arm as the first shot.  The nurse asked where the first shot was given and then asked in which arm I wanted the second shot and, unaware of the risk, I said in the same arm.  My physician recommended that the normal protocol should be that the second shot be administered in the opposite arm unless there is a compelling reason not to do it.
contracted COVID/had a head cold with a runny nose and tiredness; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID/had a head cold with a runny nose and tiredness) and DRUG INEFFECTIVE (Lack of efficacy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included FLECAINIDE, APIXABAN (ELIQUIS), ATENOLOL and LISINOPRIL for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (contracted COVID/had a head cold with a runny nose and tiredness) and DRUG INEFFECTIVE (Lack of efficacy). The patient was treated with VITAMIN D [VITAMIN D NOS] for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (contracted COVID/had a head cold with a runny nose and tiredness) had resolved and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.            The patient contracted COVID-19 disease through the patient's grandson who contracted it in school. Patient did not experience any fever. The symptoms lasted for a week. Concomitant medication included cholesterol medication.  This spontaneous case concerns an 80-year-old female patient with no relevant medical history, who experienced non-serious unexpected event of special interest (AESI) of COVID-19. The event occurred more than four months after the second dose of properly scheduled second dose of mRNA-1723 vaccine. Symptoms of reported event included head cold with a runny nose and tiredness, which lasted for one week. The rechallenge is not applicable, as the event happened only after the second dose. The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns an 80-year-old female patient with no relevant medical history, who experienced non-serious unexpected event of special interest (AESI) of COVID-19. The event occurred more than four months after the second dose of properly scheduled second dose of mRNA-1723 vaccine. Symptoms of reported event included head cold with a runny nose and tiredness, which lasted for one week. The rechallenge is not applicable, as the event happened only after the second dose. The benefit-risk relationship of drug is not affected by this report.
Injection was at the top of the left arm/shoulder area.  Within hours I had severe pain and itching in the entire left biceps area.  My left arm biceps swelled and had blisters on the skin.  I went to bed that night and upon awakening I had SEVERE burning pain throughout my spinal cord area.  The spinal pain went away the day after the injection.  The rash and itching of the left bicep area skin lasted for less than one week.   I reported to my primary care physician at my annual exam, and the pharmacist when the second dose was due.  Due to the reaction we (the pharmacist and I) concluded I should not take the second dose.
On 03/05/2012 developed small, flat red spots all over body, concentrated on back of neck but present all over. On 03/07/2012 went 15 hours without urination and developed a fever of 101-102 degrees F.
I21.4 ACUTE NON ST ELEVATION MI 3/24/2023 ACUTE NON ST ELEVATION MI    CAD (CORONARY ARTERY DISEASE) WO ANGINA I24.9 ACUTE CORONARY SYNDROME, UNSPECIFIED 3/24/2023 ACUTE NON ST ELEVATION MI    CAD (CORONARY ARTERY DISEASE) WO ANGINA
Woke up from a nap around 5pm on 6/9/09 and noticed (L) arm was red, swollen, and warm to touch. Gave TYLENOL d/t LG fever of 99 per mother, and applied ice. Contacted Doctor on 6/10/09 after hrs. He advised her to take BENADRYL and bring her to the office the following morning.
I experienced 10 days after my vaccine, the vaccine sent me back to menopause, night sweats, mood changes, restless nights, weight gain. I went to see Dr. (Name) one month ago to check my symptoms. He does not feel it is my vaccine but rather my thyroid. He did extensive lab work, blood tests, B12, D3, thyroid levels, cholesterol levels, hormone levels.
This spontaneous report as received from a pharmacist refers to currently 71 year old male patient. Pertinent medical history and drug allergic reactions were none. Approximately in 2005 (almost 10 years ago), the patient was vaccinated with ZOSTAVAX (unknown route and dose) for prevention of shingles. Concomitant medications were none. The patient was seen in an unspecified emergency room on 12-APr-2015 due to pain in the back of his legs accompanied by mild rash on the back of legs, left eye and mouth drooping, right eye twitching and pain in face. All symptoms had started on an unspecified date and the patient was diagnosed with mild shingles and Bell's palsy. The patient was not hospitalized but went to Emergency Room because he wasn't feeling well. Lab diagnostic studies were none. The patient was treated with prednisone (unknown dose) for 5 days and acyclovir (unknown dose) for 10 days. The patient was discharged from the unspecified emergency room on an unknown date. The outcome of Bell's palsy was not recovered and the outcome of mild shingles was recovered on an unknown date in 2015 as the patient "no longer has shingles-like symptoms" but "still has the Bell's palsy-like symptoms". The outcome of the event wasn't feeling well was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
(L) deltoid red hot very swollen about 24 hr. shot administered. Using moist heat, NSAIDS. History of reaction to other vaccine in the past.
Narrative: Patient states arm pain at injection site, resolved within 48 hours  Other Relevant Hx: Symptoms: & arm pain Treatment:
Pt rec'd TWINRIX vaccine 9/22/10 & 10/28/10. Denied any problem w/ 9/22/10 vaccine. On 2/17/11 he contacted the health dept. to report severe upper arm pain after the 10/28/10 injection. Denied having any redness, swelling or other signs of inflammation. Pain lasted about 3 months. Pain had resolved by 2/28/11. Pt. did not seek medical care.
Second vaccine at 10 AM 3/31, headache and stomach ache around 3 PM, full body ache and chills around 1 AM 4/1 (most severe), effects lasted all day, mild after 6 PM 4/1.
hot, sweaty, room swirling. 1610 pulse 49, p ox 96%. No issues breathing. He was grey, felt faint, room swirling; stated felt like would pass out. Leaning back in chair. Rapid response called; BP 98/60. 1615 Treatment/intervention : given epi 0.3 mg in R thigh. BP 100/70; feeling better; pulse up to 64, p ox 96%. Still grey, sweating. Able to drink water. 1630 Pulse 68; p ox 93-94%, with mask off 96%. Patient reports past history of reaction to flu vaccine; no allergies noted. Agreeable to be monitored in ED; got in wheelchair without dizziness; still grey.
Bleeding from arm in spots of bug bites, BRBPR,  and unprovoked nose ~1 week after shot, plt count 6k in ER
FEVER AND SEIZURE ON THE DAY OF THE VACCINE. SEEN AT LOCAL ER AND DIAGNOSED WITH FEBRILE SEIZURE. NO FURTHER EVENTS OR SEIZURES SINCE THE INITIAL
Fever 102.3 for two days. Major joint and muscle pain, severe headache, major fatigue, inflammation in both eyes and continued eye inflammation of eyes and severe fatigue two weeks out
Pt recvd Hep B vax 16SEP91 & that evening devel stomach cramps & nausea; that noc pt devel diarrhea & loose stools for next 2 days; stomach cramps & nausea resolved; pt recovered;
Severe epigastric pain, flank pain, nausea, fever, body aches, headache   Onset 21 hours post injection.  Treatment: fluids, Tylenol, Protonix,
Aunt here today. States child broke out in rash day after shots on 09/17/2001. Rash covered neck and back. No fever. Did not see doctor or ER. No breathing difficulty Rash still there.
Developed large welts on arm 9 days after injection, 3/24/2021. On 3/25/2021 welts were much reduced, arm had diffuse redness. It seemed to be resolving. 03/27/2021 inflamed area became larger and redder. 03/28/2021 it was much larger, extending in streaks down to the elbow, raised, very deep red, hot, and painful.  I was seen by primary care, and presctibed clindamycin for erysipelas.
Arm pain started evening of 4/8 ,  rest started afternoon of 4/9 arm hard at site of injection, slight nausea, slight headache, slight body aches, slight chill, slight brain fog,  Everything cleared by morning of 4/10 except arm still slightly tender at time of this report
No symptoms or adverse effects reported.; patient received second dose in GARDASIL 9 immunization series off recommended schedule/First dose administered: 8/7/2018. Second dose administered: 8/12/2019; This spontaneous report was received from a pharmacist referring to a 23 years old patient of unknown gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.      On 07-AUG-2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot # N004799, expiration date 15-NOV-2019; dose, strength and route were not reported) for prophylaxis at a doctor's office. On 12-AUG-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot # 1581027, expiration date 03-JUN-2021; dose, strength and route were not reported) for prophylaxis at an unspecified women's health center(inappropriate schedule of product administration). The patient had been pursuing third dose with pharmacy. No symptoms or adverse effects were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1581027; expirationdate: 03-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
phone call from mom states pt had shot yesterday & today fever is 105 & pt won't stop crying; NP advised mom to call MD then take to ER;
Swelling of left thigh and warm to touch noted by patient's parent on the evening of the vaccination. Diagnosed with cellulitis two days after vaccination. Patient treated with cephalexin (weight-based dosing) by mouth every 8 hours for 5 days.
Fully vaccinated patient admitted for worsening RLE weakness.  Incidentally tested positive for COVID during routine admission testing.  Asymptomatic for any respiratory symptoms during stay.  Provider discharge note below:   "72 year old male with a history of CVA with residual right sided weakness. He presented to the ED on 10/24/21 due to worsening RLE weakness. He did test positive for COVID on arrival to the ED but was asymptomatic so did not require any COVID directed therapies, he completed his isolation period while hospitalized. On CT imaging he did have notable severe degenerative changes of there cervical spine with compressive myelomalacia and severe foraminal narrowing. He was seen by neurosurgery team who recommended surgical intervention after the patient completed his covid isolation. The patient had several extensive discussions with the neurosurgery team concerning risks and benefits of the surgery, who also spoke with his niece, they continued to recommend surgery as the patient is at risk of  Quadriparesis but the patient refused surgical intervention. It was then recommended that the patient go to rehab and then follow up with them in 2 weeks for further recommendations, he has a follow up appointment for later this month. The patient was reminded that he needs to wear his ASPEN collar any time he is out of bed which he was compliant with"
Two weeks after injection I got a big, red rash at injection site.  It was hard (at first) and painful, very itchy, and hot to the touch.  The redness is spreading after 24 hours but the ?heat? is dissapating.
10 days after I had the injection, my  upper left arm began to hurt spontaneously. Two days later, I noticed my arm was swollen, red, and felt warm at the injection site. I talked to my doctor who ultimately thought it might be cellulitus and gave me prednisone and another antibiotic. My arm stopped hurting around day 15 post vaccine, and the redness and most of the swelling went away.  My arm still has what looks like a shadow on the area that had been swollen.
Very ill 8 hours after. Site very painful, severe chills and headache.   Sleeplessness and body aches
mother gave incorrect date of birth   to make  pt elgible to get vaccine for 16 years old minimum, pt 15yrs 8 months
Patient received an expired dose of covid vaccine, Expired vaccine dose administered to a patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of covid vaccine, Expired vaccine dose administered to a patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of covid vaccine, Expired vaccine dose administered to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of covid vaccine, Expired vaccine dose administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported.   Reporter did not allow further contact
Sept. 28, 2011 got the vaccine. Sept. 30 pain in under rt. breast & upper stomach - through to Rt. shoulder and diarrhea that night. Oct. 1 continued diarrhea, 1 blister on back, pain continued under Rt breast & Rt shoulder. Oct. 2. Pain more intense in shoulder, a few (4) blisters on back. Pain in Rt breast. Oct. 3. Intense pain in Rt shoulder & Rt breast, rash & blisters across back & Rt breast. Severe pain during night. Oct. 4 went to walk in clinic, seen Dr. confirmed shingles. Prescribed Acyclovir & Hydrocodone with acetaminophen 5-500 tab. Pain in Rt shoulder, under Rt arm & Rt breast. Oct. 11 went to my Dr. as recommended by Dr. Dr. prescribed Gabapentin 30 mg, Hydro-codone & LIDODERM - 3 patches a day. Still have rash on Rt breast & back. Very painful on breast, under arm and back Rt shoulder. Oct 25 went back to Dr. for a recheck for the shingles. Rash better - still pain in Rt shoulder and Rt breast. Still on Gabapentin & LIDODERM patches, and sometimes Hydro-codone. Nov 10, 2011 still in a lot of pain Rt breast & Rt shoulder & down Rt arm from shoulder to elbow.
Hives with hot sensation; Hives with burning sensation; Soreness and Tenderness at the injection site; Hives, started on her forehead and traveled all the way down her body to her legs/ again on 08-mar-2022 started on her forehead and stopped at her chest.; experienced hives again on 3/8/2022 but this time the hives started on her forehead and stopped at her chest. Consumer reported that the hives faded away after 2 hours.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose in September 2021, refer link case US2022044816).   On 3rd March 2022, the patient received the 2nd dose of Shingrix. On 3rd March 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 6th March 2022, the patient experienced hives, feeling hot and burning sensation. On 8th March 2022, the patient experienced hives. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, hives and hives were recovered/resolved and the outcome of the feeling hot and burning sensation were unknown.   It was unknown if the reporter considered the injection site pain, hives, hives, feeling hot and burning sensation to be related to Shingrix.     Linked case(s) involving the same patient:  US2022044816  Additional details were provided as follows: The patient reported that with the 2nd dose, patient experienced tenderness and soreness at the injection site that resolved 2 days later.  Three days after receiving vaccination, the patient experienced hives, that started on her forehead, that were a hot and burning sensation, and traveled all the way down her body to her legs within an hour of the hives appearing and it was faded away after 3 hours.  Five days after receiving vaccination, the patient experienced hives again but this time the hives started on her forehead and stopped at her chest and it was faded away after 2 hours.  The representative spoke from content and package insert. The reporter consented to follow up. Consent obtained to contact health care professional and consumer for follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022044816:Same Reporter
She got very pale and lightheaded, felt like she was going to throw up; she felt cold & clammy; we had to have her lie down.
Three days after getting second vaccine, I started to feel worse than the symptoms normally experienced, I wasn't getting better. Chest tightness with cough, shortness of breath, fatigue, laying down most of the time, chest pain and head pain with head pressure when bending forward to pick up something. I waited, because I expected to get better. On the 9th day after the vaccine, I had a Telehealth appt with Dr. for an unrelated matter and he told me to go to the ER to be assessed for possible MI. I was in the ER for 8 hrs, where they found I had a bp of over 190/90, short of breath with small atelectasis and effusion L lung, signs of cardiac failure beginning with BNP elevated into the 300 range. I wasn't actively having chest pain for the past two days, and thought I was improving slightly, troponin were normal. After they were assured I didn't have. pulmonary embolism, they sent me home where I gradually improved, and by a week later felt pretty normal. I followed up at Medical Center with Dr. on May 24. 2021, where he did a stress echo, had me wear a heart monitor for two weeks, changed my carvedilol to amlodipine and determined my BNP was almost normal at 32, and no sign of heart failure or fluid on lung. I have returned to baseline. I continue to be followed up with Dr. in the same system.
Pt recvd vax & devel 3cm area of induration @inj site & fever lasting 1 wk.
No additional AEs or PQC reported.; Caller reported pediatric dose of VAQTA was administered to a 19 year old.; This spontaneous report was received from a medical assistant referring to a 19-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On 13-JAN-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 ml (pediatric dose), strength: 25/0.5 (unit not reported), lot #W007375, expiration date: 16-JAN-2023, intramuscularly for prophylaxis (incorrect dose administered). No additional adverse events (AEs) were reported (no adverse event).
Shingles vaccine administered 5/19/2011. Onset vesicular rash 5/25/2011. Vesicular lesion cultured positive varicella zoster.
Severe chills, unable to walk, unable to sleep, severe leg aches, severe backaches, unable to eat, symptoms lasted 32 hours. Fatigue continues. Husband had absolutely no symptoms.
Information has been received from a healthcare student referring to a currently 25 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On an unknown date the patient was vaccinated with her third dose of GARDASIL in her arm (dose, route and lot# were not reported) in a year, after her second dose of GARDASIL was administered (dose, route and lot# were not reported). No concomitant medication was given. On an unknown date the patient experienced irritation and red at the injection on the patient's arm. No treatment was given for the adverse events. No lab diagnostics studies were performed. The outcome of the events was reported as recovered on an unknown date. It was unknown if the patient sought medical attention. Additional information is not expected as there was no consent to be contact with physician.
Second pustule popped up directly below initial pustule. States his wife may have a pustule on her mouth.
INFLUENZA; This spontaneous case report was received from a nurse (PVX2019-346) on 07-Feb-2019 and an additional information on 11-Feb-2019. The report describes a 20-year-old adult male consumer who had influenza following the intake of oral Vivotif capsule (one dose every other day) for typhoid prophylaxis.   The consumer had a history of mono (Epstein Barr) about 4 to 5 years ago.  The consumer's concomitant medication included Tetanus shot (tetanus and diphtheria toxoid) which was received on Monday (04-Feb-2019).  It was reported that the consumer took the first dose of Vivotif on 04-Feb-2019. On 06-Feb-2019, he had high fever (102.6 degree Fahrenheit) and felt congestion. In the middle of the night, it was down to 100.6 degree Fahrenheit. On 07-Feb-2019, his temperature was 100 degree Fahrenheit. She stated that fever did not came back yet and was staying down.   An additional information was received on 11-Feb-2019 stated that the consumer was diagnosed with influenza. Furthermore, he did not take any other medications for his symptoms of congestion and fever.  The action taken with Vivotif with respect to the event influenza was dosage discontinued.  The clinical outcome of the event influenza was resolving.  Company's Comment: In this case, a 20-year-old male consumer developed influenza following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event influenza. However, the event influenza is an infectious condition with commonly viral etiology. Hence, the causality of the event influenza is assessed as unlikely with Vivotif vaccine. ; Sender's Comments: Company's Comment: In this case, a 20-year-old male consumer developed influenza following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event influenza. However, the event influenza is an infectious condition with commonly viral etiology. Hence, the causality of the event influenza is assessed as unlikely with Vivotif vaccine.