chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt returned to the clinic 48 hours post-vaccine with 2.5 x 3 cm area of red, hot, very tender induration with 3x4 cm surrounding erythema, LUE at injection site
Information has been received from a consumer concerning an 87 year old wife with no drug reactions/allergies, who on 22-JUL-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported). Consumer reported that on 15-SEP-2010 in "mid September" his wife had developed a rash on her right arm, the rash was from her wrist to her shoulder. Consumer also reported that she also developed a "frozen shoulder". Consumer stated that they had gone to dermatologist since he administered the ZOSTAVAX (Merck) (Lot # not reported). Dermatologist prescribed her a "cream" to apply to the rash and he also gave her a "pill". Consumer reported that the physician called the rash "Herpes something" and then he said "shingles" Consumer reported that his wife also had seen their primary care physician , who had prescribed a "patch" for his wife to wear. Consumer reported that the rash had resolved although there were marks on her arm where you could still tell where the rash was. Consumer stated that the "frozen shoulder" was better but still present and his wife continued physical therapy. Additional information has been requested.
Menstrual cycle was 3 weeks late after receiving the first dose; This is a spontaneous report from a non-contactable consumer, the patient. An adult non-pregnant female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. 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 any concomitant medications. On an unknown date, the patient's menstrual cycle was 3 weeks late after receiving the first dose. 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 event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent the COVID-19 test and the result was negative. The clinical outcome of the event menstrual cycle was 3 weeks late after receiving the first dose was unknown at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
No adverse symptoms reported; the patient received an improperly stored dose of PROQUAD on 5/4/2020; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.   On 04-MAY-2020, the patient received an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: recombinant Human albumin (rHA)) (PROQUAD) (lot#S031883 with expiration date: 07-APR-2021; dose, frequency, strength and route of administration were not provided) with sterile diluent for prophylaxis. No adverse symptoms reported.  Administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) experienced the temperature excursion under -14 degrees Celsius (C) to -10 degrees Celsius (-12.9C) for 1 hour 8 minutes. There was no previous temperature excursion. The digital data logger was involved to capture the temperature excursion.
My daughter received all three injections of GARDASIL.  Since receiving the last injection,  she has been hospitalized with severe kidney infections and now has an odd mass on her head.  We are seeing a surgeon on Friday 8/28/09 about removing the the mass on her head.  My daughter has NEVER been sick before.  She is 14 years old and only became sick since receiving the GARDASIL vaccine.  Please help us to put an end to this horrible drug.  Thank you.   10/7/09: Vaccine record received for date of service 6/19/08, VAERS updated.  10/26/09:  Urgent Care Records received for date of service 6/25/09 and Hospital Records received for dates of service 4/21/09 to 4/24/09.  Dx:  UTI and Acute R Pyelonephritis.   Assessment:  Admitted for acute R pyelonephritis on 4/21/09 and started on IV antibiotic therapy.  Seen again on 6/25/09 for frequency and burning on urination:   UTI, prescribed amoxicillin.    ICD 9 Codes:  599.0, 041.02, 706.1, 590.80.
Information has been received from a nurse practitioner concerning a female who was vaccinated with a second dose of Recombivax HB. After receiving the second dose of Recombivax HB the patient experienced hives. Unspecified medical attention was sought. Subsequently, the patient recovered from hives. A product quality complaint was not involved. Additional information is expected.
pt recvd 1 & 2 dose of hep B;exp mid back pain,paresthesia of lower extremities & "bladder sxs";lab test showed elevated protein;dx w/ transverse myelitis;f/u indicated rxn found to be unrelated to vax & secondary to spinal meningioma;
Pt. states increased soreness at site 2 days later. Experiencing, dizziness, paleness of skin around mouth it hoarseness of voice. Pt. declined office visit, advised to go the urgent care.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA314176 and 2018SA314360 (same reporter). This case involves an 17-months old male patient who received an expired once dose of 0.25ml of vaccine FLUZONE QUADRIVALENT (batch number: UT5897MA, expiry date: 30-Jun-2018) via intramuscular route in the left thigh on 06-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was reported the patient received an expired dose of FLUZONE QUADRIVALENT. It was not reported that if any adverse reaction was experienced or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Red itchy rash on the back of my right thigh. It started small, but it is slowly spreading.
Received 2nd vaccine on 2/3/21. On 2/9/21 started having congestion, headache, and sore throat. Went to urgent care on 2/10/21. Diagnosed with upper respiratory tract infection.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer reported that no follow up is needed. The patient has recovered.   No treatment information was provided    Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: NNI   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: NNI
The minute I stood up after vaccine, I was very dizzy and my heart started pounding. Then I got nausea.  Was sent to Urgent Care office where I got EKG, which showed no problems with my heart. Went home, weak.  Woke at 2:00 am with night sweats. When I got up I noticed swelling on face, throat, hands & feet. Faint pink rash ran up both fore arms and I had welts rising on my wrists. Nurse line I called said to to to ER asap, Took me a few hours to find a ride, my throat was closing up more by that point. I could tell over a few hours that my throat was swelling up. Went to nearest ER where I was very mentally confused. They  gave me a shot of steroids and Benedryl.  Later that night I got chills and was VERY weak. Had night sweats again. After a few days of rest, am still weak.
SARCOIDOSIS; CREATININE LEVELS DANGEROUSLY HIGH; CHRONIC KIDNEY DISEASE; SCARRED LIVER; This spontaneous report received from a patient via a company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was hundred percent healthy before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, dose 1 administered on an unspecified date in APR-2021 for covid-19 prophylaxis. 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 in JUN-2021, the patient was admitted to hospital with dangerously high level of creatinine and calcium, and stayed (hospitalized) for 5 days. Laboratory data included: Calcium levels dangerously high, and Creatinine levels dangerously high. On an unspecified date followed by six months tests (Laboratory test), the patient was diagnosed with sarcoidosis. On an unspecified date, the patient also experienced chronic kidney disease, scarred liver and anemia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the creatinine levels dangerously high, sarcoidosis, chronic kidney disease and scarred liver was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). Sender's Comments: V0: 20230162472-Chronic kidney disease, scarred liver, Sarcoidosis. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  V0: 20230162472- Creatinine levels dangerously high. The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
I had taken her to the Dr. because she was teething and pulling at her ears. Also Throwing up every once in a while. We arrived and fill in Dr. was seeing her. She determined that the patient had an DOUBLE EAR INFECTION.  It was then that she said that the patient was behind on 4 immunization shots. Then she asked me if she could go ahead and update her on all four of the shots. I looked at her puzzled and replied "If she has a double ear infection and is ill aren't you suppose to wait until the infection is gone?" she just said to me "Well that's only if she has a fever!" Two or Three times she assured me that it was normal for them to do so and so I agreed unwillingly. The Next Morning at 9:00am she woke up trembling, shaking, her eyes twitching backs and forth, and was unable to stand, walk or even crawl. She couldn't even control her arms good enough to pick up her food to feed herself.  Everything listed are everyday things that she performed all by herself on a daily basis. From that day forward each day we watched her regress all the way back to an infant, as far as her skills.
Unaware patient was 14W3D pregnant at time of immunization. Patient was updating immunizations for nursing school
This is a 74-year-old female with a history GERD, depression, breast cancer in remission and osteoarthritis who was brought in via EMS has her husband stated that she had COVID and has been confused.  When EMS arrived she was hard to arouse.  Patient had a Moderna vaccines and booster.  Her husband states she was doing well up until today.  She has had no fever, cough or shortness of breath.  She has had decreased appetite but drinking water, confused and lethargic.  She denies any recent diarrhea, abdominal pain, dysuria frequency or hematuria.   In the emergency room her pH was 7.3, pCO2 23, PaO2 62, O2 sat 93% on room air.  WBC 7.14, hemoglobin 11.2, MCV 1 a 2.6, sodium 135, potassium 3.9, chloride 99, bicarb 14, anion gap 22, BUN 50, creatinine 2.79, calcium 8.3.  Troponin is 78, alkaline phosphatase 412, ALT 369, total bili 2.3 and lactic acid 8.4.  She is COVID positive.  Chest x-ray appears to be COVID pneumonia.  We do not have any baseline studies for comparison.   Patient denies any fever, cough, chills, rhinorrhea, sore throat, chest pain, shortness of breath, palpitations, orthopnea, paroxysmal nocturnal dyspnea, nausea, vomiting, diarrhea, constipation, hematuria, dysuria, frequency, melena, hematochezia or focal neurological complaints.  Tested positive on 01/10/2022
Dizzyness weakness tiredness. Ongoing. Muscle and joint pain headaches nausea  unwell
HEADACHE ALMOST MIGRAINE; MOSTLY SLEEPING; LITTLE TIRED; VOMITING EVERY WHERE; This spontaneous report received from a parent concerned a 25 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced vomiting every where. On 03-JUL-2021, the subject experienced mostly sleeping. On 03-JUL-2021, the subject experienced little tired. On 04-JUL-2021, the subject experienced headache almost migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting every where on 04-JUL-2021, and headache almost migraine on JUL-2021, and was recovering from little tired, and mostly sleeping. This report was non-serious.
Donor received rabies shot on 5/12/03 and had an elevated temp of 100.2 degrees F on 5/13/03. He stated not feeling well on the day after he received the shot. Temp on 5/14/03 was 102.5 degrees F and 203.2 degrees F on 5/15/03. In addition, donor reported that he vomited on 5/15/03 evening and felt better afterward.
Narrative: A 78yo male with PMH of Hypderlipidemia, Depression, Chronic PTSD, HTN, DM, HIV , ESRD and Hearing Los. On March 3, 2022, attending physician reported the patient had a historical ADR of Covid - 19 vaccine induced Urticaria classified as moderate. with occurrence date of 03/24/2021, He also reported the vaccine was administered at healthcare facility. No other detailed information regarding the vaccine was provided and unknown whether the patient received any treatment for the reaction.
Approximately 24 hrs after getting this flu shot I Suddenly got bad stomach knots. About 30 mins later I started feeling mildly nauseous. About 30 more mins later I was on the verge of throwing up and had to move minimally while I did self checkout. Vomited and had diarrhea about 1.5 hrs after stomach knots started. Headache started about 2 hrs after stomach knots. Severe headache and nausea lasted til 09/11/2020 5pm.
Pt developed vomiting, lethargic, neck hurts, local swelling and erythema.
She got her vaccine, had no problem, until a couple of hours later.  That night she had some chills, body aches on the right side of her body that went from the injection site down to her lower leg that came and went.  About a day after the pain has continued and stayed there. The pain stays in her right hip and goes down to her legs that causes her pain when she's sitting or standing, like muscle spasms.   She has not called her doctor yet.  She has been taking Tylenol for the symptoms.
Pain at site of injection has continued from 11/5/2015 until today, 11/11/2015. Pain is not severe but still felt.
Sudden chills and severe, uncontrollable shivering. I also had a fever that topped at 100.5 F.
Minor chest pain left side. Never had this feeling before. Read few reports online, feels like heart inflammation?
Severe headache, mild body aches, mild nausea, mild tiredness, starting about 3 hours after shot lasting about 8 hours. Arm pain at injection site worsened about 12 hours after injection, on the next day. Arm pain was enough that I had to favor arm and was sore for at least 4 days after shot.
Fainted then felt tired and weak.  Myasthenia Gravis symptoms were worsened.   Started episodes of tingling throughout body and lightheadedness.  These lasted two months until doctor prescribed Prednisone.  Prednisone lessened the symptoms, but MG symptoms still prevalent. Happy
States rash started on forearms only on Sat. evening. Small bumps rash noted both arms.
This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 26th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced blood pressure high. On an unknown date, the outcome of the blood pressure high was not recovered/not resolved. It was unknown if the reporter considered the blood pressure high to be related to SHINGRIX. Additional information was provided as follows: The patient received SHINGRIX in right arm. The reporter indicated that the patient experienced high blood pressure since receiving SHINGRIX vaccine on the morning. The same day she received the vaccine, she had her yearly physical and her blood pressure was 122 per74. This morning her blood pressure was 150 per 95. The reporter said that her blood pressure was 160 per 103 last week. He has a new blood pressure monitor and did not feel that there was any wrong with it. The reporter consented to follow up. The reporter unable to obtain additional information. This case linked with US2019057148, reported by same reporter. Lab Comments: lab test performed on unknown date.
no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 05-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) dose/ frequency: 1,  lot # T015598, expiration date 02-NOV-2021, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved. No adverse events.  This is one of multiples cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003878:Original Case : 2104USA003483 US-009507513-2104USA003483:Original Case : 2104USA003483 US-009507513-2104USA003880:Original Case : 2104USA003483 US-009507513-2104USA003881:Original Case : 2104USA003483 US-009507513-2104USA003882:Original Case : 2104USA003483 US-009507513-2104USA003883:Original Case : 2104USA003483 US-009507513-2104USA003884:Original Case : 2104USA003483 US-009507513-2104USA003877:Original Case : 2104USA003483 US-009507513-2104USA003876:Original Case : 2104USA003483 US-009507513-2104USA003879:Original Case : 2104USA003483
Next morning: Hives on trunk, flushing on neck and face, dry eyes, headache. No treatment. Resolved on its own in 7 days
24 hours after the first shot i got a 101 degree temperature for 1 day then second day 100 degree temp, third day I felt better but tired.
Hives, bumps, itchy and red on lower abdomen back, and upper thighs. Took Benadryl  itching still occurring.
positive for Coronavirus/COVID-19 test; positive for Coronavirus/COVID-19 test; not feeling well; This is a spontaneous report from a program received from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left in 2021 (at the age of 57-years) (Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medication included atenolol taken for blood pressure high. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient called to ask if he should take the second dose on 07Sep2021. He stated that on 28Aug2021, he was not feeling well, so the next day (29Aug2021) he went to the hospital (emergency department). They ran tests and took an EKG and did a CAT Scan, both with unknown results; then they told him he was positive for Coronavirus/COVID-19 test. He was there for about five hours and then he stayed for a few more hours and then they released him. He was not admitted to the hospital. The patient clarified that the events resulted in emergency room visit. Therapeutic measure was taken as the result of the events which included IV treatment (unspecified). The patient is on quarantine. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Pt received FLUMIST and approx 2 hours later felt tingling in face. Next day noted mild facial droop (L), worse next day. ER Dx'd (L) Bell's Palsy. Rx'd oral steroid consulted Ped. neurologist. Recovered uneventfully.