chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 06-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012720 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Starting 12/2021, every evening around 6 or 7pm, I would get chills and a small fever (only 2 times). I would get a mild sore throat and a headache. If I took Advil, I would feel better, but without it I would feel like I had the flu. Since it wasn't present during the day, I waited for a while to see anyone due to it being only present at night. So, when I did go to the doctor's office, they thought I may have had a strain of strep going around. They did a test, but it came back negative. They did a blood test and the results indicated high inflammatory markers and possible strep bacteria in my body. So, I was put on Amoxicillin x 10 days. That didn't help much so he didn't think I had an infection, so I was sent to a rheumatologist and an infectious disease doctor. The infection disease doctor did a bunch of tests and noticed that my inflammation markers kept going up, but no infection. So, the rheumatologist did more tests and kept seeing the inflammatory markers going higher. So, they thought I might have giant cell arteritis. They did a biopsy and put me on prednisone. I was on 60mg of prednisone a day immediately. The results of the biopsy were negative. So, they weaned me off the prednisone, but I was on it for about 16 days. As soon as I went on prednisone all of my symptoms disappeared. After that treatment, the inflammatory markers came down quickly and haven't gone back up since then. They ruled out all autoimmune issues and are unsure of the exact route case of the inflammation but theorize it could be a mix of different things going on that added up together to cause the inflammation. This episode has yet to come back.
Within 5 min. of vaccine got vomiting, itching, flushing and trouble breathing - gave Epipen 13:53 and BENADRYL 25mg, ORAPRED 45mg, then second Epipen - 4:30 and then went to ER for observation.
She has been dry heaving; She has been dizzy also; Arm was sore; Been nauseated; She had a fever; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (She has been dry heaving), DIZZINESS (She has been dizzy also), PAIN IN EXTREMITY (Arm was sore), NAUSEA (Been nauseated) and PYREXIA (She had a fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced RETCHING (She has been dry heaving), DIZZINESS (She has been dizzy also), PAIN IN EXTREMITY (Arm was sore), NAUSEA (Been nauseated) and PYREXIA (She had a fever). At the time of the report, RETCHING (She has been dry heaving), DIZZINESS (She has been dizzy also), PAIN IN EXTREMITY (Arm was sore), NAUSEA (Been nauseated) and PYREXIA (She had a fever) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable. .
Large red bump on arm getting worse; This case was reported by a consumer via interactive digital media and described the occurrence of local swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was not recovered/not resolved.   It was unknown if the reporter considered the local swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient had a large red bump on his/her arm post vaccine that's keeps getting worse. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Patient was given  0.3 ml of undiluted Pfizer COVID-19 vaccine for an appointment for her Booster dose.  1st dose 3/27/21 2nd dose 4/24/21
Patient experienced an episode of emesis and loss of consciousness several hours after vaccine on 2/16/21.  He was taken by EMS to the hospital and was noted to be hypoxic and hypotensive.  He was admitted to the hospital and subsequently intubated.  He was also found to have a small bowel obstruction and a nasogastric tube was placed to decompress the bowel.  He required pressor support as well.  He expired on 2/17/21.
Tinnitus Narrative: Head ache, diarrhea, weakness day after injection. Also ringing in both ears. Went to PCP regarding ringing and was advised not to get 2nd dose.
AFTER THE VACCINE WAS ADMINISTERED IT WAS FOUND THAT IT WAS EXPIRED BASED ON THE 10 WEEK VIABILITY THAT ENDED ON 11/18/22
cold sore on her lip; gastrointestinal symptoms; nausea; vomiting; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valtrex) tablet for uveitis.   Concurrent medical conditions included uveitis.   On an unknown date, the patient received Shingrix and Valtrex at an unknown dose and frequency. On 6th January 2022, unknown after receiving Shingrix and Valtrex, the patient experienced nausea, vomiting and diarrhea. On an unknown date, the patient experienced cold sores lip and gastrointestinal disorder. Valtrex was continued with no change. On an unknown date, the outcome of the nausea, vomiting, diarrhea, cold sores lip and gastrointestinal disorder were not recovered/not resolved.   It was unknown if the reporter considered the nausea, vomiting, diarrhea, cold sores lip and gastrointestinal disorder to be related to Shingrix and Valtrex.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient got the Shingrix vaccine while on Valtrex.  She asked the physician who ordered the Valtrex whether it was contraindicated and he said it was ok.  The patient had nausea, vomiting and diarrhea this am. She indicated that her gastrointestinal symptoms had not yet resolved. She indicated she was still taking Valtrex.  She said it was prescribed for uveitis and that she also had a cold sore on her lip.
UTI; A spontaneous report was received from a patient of unknown age and gender on 06MAY2023 who developed "UTI" (PT: Urinary tract infection) following the administration of Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunization.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient received two doses of Vivotif vaccine following which the patient developed urinary tract infection and started antibiotic treatment. Reportedly, the Vivotif was stopped.  The outcome of the reported event was unknown, at the time of this report.   The action taken with Vivotif with respect to the reported event was drug withdrawn.   No additional information was reported.  Company comment: It was reported that a consumer developed UTI (urinary tract infection) following the administration of two doses of Vivotif. In response to this, Vivotif was discontinued and was started with antibiotic treatment. Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of urinary tract infection is assessed as possible with Vivotif.; Sender's Comments: It was reported that a consumer developed UTI (urinary tract infection) following the administration of two doses of Vivotif. In response to this, Vivotif was discontinued and was started with antibiotic treatment. Further information regarding the event is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of urinary tract infection is assessed as possible with Vivotif.
A non-serious, spontaneous report of fever and rash that caused itching has been received from a consumer concerning a five-year-old female, subsequent to FLUMIST. Neither medical history nor concomitant medications were reported for this patient. The patient received FLUMIST on 17-Sep-2010. On 18-Sep-2010 the patient experienced a high fever of 105 degrees Fahrenheit and a rash that caused itching. The fever was treated with acetaminophen and ibuprofen although the fever did not resolve and the patient was taken to the emergency room on 22-Sep-2010. In the emergency room the patient was treated with oral diphenhydramine and hydroxyzine for itching and intravenous saline. The subject was discharged home and on 23-Sep-2010 the patient was prescribed a cream for the rash. The event of fever resolved on 24-Sep-2010, although the event of rash that caused itching was ongoing.
"I feel itchy" belly, legs. Sm. hive noted on the back of the neck. BENADRYL 12.5mg meltable given.
Arm was sore & swollen 8cm x 10cm below injection site on 2/22.  Early morning I woke up shivering, unable to get warm. Put on fleece pants and shirt, & sox and wore to bed to get warm.  I was awake on & off for about 5 hrs, shivering.  Woke up 7 AM with bad headache (I rarely get headaches.)
This case was considered medically important (OMIC). This case has been reclassified as serious as a result of follow up information received from an attorney who provided specified products, diagnosis, names and dates of concomitantly administered vaccines, date of birth and patient history. Information regarding HIB-TITER vaccine was received from an attorney regarding a male patient who received a dose of HIB-TITER on 3/17/00 and 5/19/00. The child also received a dose of Acel-Imune vaccine on the same dates. In addition, other childhood vaccines were administered between 3/17/00 and 7/25/01. On 10/2/02, the child was diagnosed with severe autism. The child also experienced mercury poisoning, mental and intellectual impairment, developmental incapacity, neurological incapacity, learning disability and affect disorder. The patient has a past history of having been a normal newborn (reported as a perfectly normal, healthy baby boy). Indication for Hib-Titer and Acel-Imune was immunization. The dose regimen was 1 dose, administered on 3/17/00 and 5/19/00. Additional suspect vaccines included Infanrix administered on 7/25/01, MMR administered on 7/25/01, Act-Hib administered on 7/21/00, Tripedia administered on 7/21/00, Engerix B administered on 3/17/00, 5/19/00 and 7/21/00, and IPOL administered on 3/17/00, 5/19/00, and 7/25/01. Concomitant medications were not reported. An attorney reported that a male child received a dose of Hib-TITER on 3/17/00 and 5/19/00. The patient also received a dose of Acel-Imune on the same dates. In addition, the reporter indicated that the patient received other childhood vaccines approximately 14 doses administered to him between 3/17/00 and 7/25/01. It is alleged, that as a result of exposure to mercury in the thimerosal-containing vaccine(s), the child suffers from mercury poisoning, mental and intellectual impairment, developmental incapacity, neurological incapacity, learning disability and affect disorder. The child was diagnosed with severe autism on 10/2/02. No additional information was available at the time of this report.
Her left arm started getting sore about 7PM. and became itchy. The next day redness started from shoulder to above the elbow and could not lift her arm easily. Patient went to a walk in clinic on 2/23/2016 and MD mis-diagnosed with cellulitis according to the second Dr she visited on 2/25/2016.  She started on Prednisone 20 mg daily for 5 days and the Dr gave her 3 more days that she picked up on 2/27/2016. The Dr gave her clindamycin on 2/23/16 which she did not take and she stated she is allergic to it. Her allergy file was updated 2/27/2016. The arm currently has a slight redness and no itching or swelling. She will take 3 more days of prednisone and does not have to return to the walkin clinic.
received 2nd dose too soon - dose 1  - 4/9 and dose 2- 4/24.
HAD ANTIPHOSPHOLIPID ANTIBODY; ANTICARDIOLIPIN WENT HIGH; This spontaneous report received from a patient concerned a female 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, and batch number were not reported) dose, start therapy date were not reported 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, the patient experienced had antiphospholipid antibody, and anticardiolipin went high. Laboratory data (dates unspecified) included: Anticardiolipin antibodies High, and had antiphospholipid antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had antiphospholipid antibody and anticardiolipin went high was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
FLUZONE administered 9am 10/14/08 onset hives 7pm 10/14/08 BENADRYL with short term relief
Anaphylactic reaction; she was going to faint; severe headache; pressure in chest; trouble breathing; fever; throat was closing up; butterfly rash on face; rash on chest; Initial information received on 01-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp (office staff).  This case involves a female patient who experienced anaphylactic reaction (anaphylactic reaction), faint (syncope), severe headache (headache), pressure in chest (chest discomfort), trouble breathing (dyspnoea), throat was closing up (throat tightness), fever (pyrexia), butterfly rash on face (butterfly rash) and rash on chest (rash), while she received vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot R2A262M via unknown route in unknown administration site.  On an unknown date, the patient had anaphylactic reaction (anaphylactic reaction), faint (syncope), severe headache (headache), pressure in chest (chest discomfort), trouble breathing (dyspnoea), throat was closing up (throat tightness) immediately following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  On an unknown date, the patient had butterfly rash on face (butterfly rash) and rash on chest (rash) (within 24 hours) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  On an unknown date, the patient had fever (pyrexia) (within 48 hours) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE. These events were assessed as medically significant.  Lab data was not reported.  Final diagnosis was anaphylactic reaction based upon the reported symptoms.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for all the reactions.  List of document held by sender: none.; Sender's Comments: This case concerns a female patient who had possible anaphylactic reaction with its reported symptoms of syncope, headache, chest discomfort, dyspnoea, throat tightness, pyrexia, butterfly rash and rash on trunk following the vaccination with TYPHIM VI. The time to onset is compatible. The patient's past allergic history, concomitant medications and lab data ruling out predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 20Dec2021 at 13:00 as dose 3 (booster), single (Lot number: FD7218) at the age of 51 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reporter is the patient. No known allergies. Patient received anti viral treatment with Paxlovid from 15Sep2023 to 19Sep2023.
Pain upon injection unlike first shot.    Soreness and swelling grew worse into shoulder and down arm during next 36 hours. Red raised rash noticed next evening (36 hours) surrounding injection site approx 7 cm across. Fading this morning 48 hours after injection.    Tylenol taken 5 times for pain spaced out over the 36 hours.
When she woke up two mornings after date of shot, she had painless, puffy swelling under her left eye and slightly itchy mild rash on both hands (slightly worse on right hand than on left hand).  These symptoms decreased over the course of the day, but when she woke up this morning (3rd morning after shot) the symptoms reappeared.
Headache, Myalgia, Chills, body aches, headache Narrative
The first symptom I noticed was extreme brain fog and forgetfulness. Then, 6 days after the vaccine, I started having terrifying episodes of acute dysautonomia and panic attacks that included dissociation. These episodes persisted intermittently for 3 weeks. Between the episodes, I was extremely fatigued, brain dead, and unable to concentrate, with a fine resting tremor and constant heart palpitations. I am finally getting treatment from a chiropractic neurologist for subacute encephalitis that caused the dysautonomia and limbic system derangement. A month later, I am still restricted in my activities and have some remaining symptoms of ANS and brain dysfunction, but I am getting better.
5JUN96 pt seen in office w/measles type rash x 4 days-itchy, MMR given 24MAY96 ? roseola;7JUN96 seen in MD office w/full body rash red
PATIENT DID NOT MEET AGE REQUIREMENT TO RECEIVE MODERNA VACCINE.  WHEN PATIENT PRESENTED FOR DOSE TWO OF COVID VACCINE SERIES, THE PATIENT RECEIVED APPROPRIATE BRAND BASED ON AGE (PFIZER LOT#EWO162). NO ADVERSE REACTIONS OR SIDE EFFECTS REPORTED BY PATIENT.
Patient received the first does of the moderna vaccine on 4/20/21. She had some bruising at the injection site. Her arm started developing a rash that increased over time. On 5/5/21, patients left arm is swollen from 2 inches abouve injection site to her elbow, warm to the touch, rash present, patient states her arm is painful, bruising still present at injection site. Patient is being seen by provider on 5/5/21 to assess reaction.
Health Dept went off-site to jail to provide H1N1 to employees and in-mates. Patient were asked prior to vaccination if they had received H1N1 vaccination previously. All answered no. Vaccination was provided to patient. As clerks keyed dates into system realized patient had received H1N1 vaccination previously in 12-09. Patient had no problems from vaccination, just received 2 doses.
shivering; soreness; feel bad; This case was reported by a consumer via call center representative and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering, pain and malaise. On an unknown date, the outcome of the shivering, pain and malaise were not recovered/not resolved.   It was unknown if the reporter considered the shivering, pain and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported but selected as an adult as per vaccine indication. The patient received Shingrix vaccine and felt bad, no fever but shivering and soreness. The patient asked, how long did the side effects last.
Very Painful, Hurt to wash hair, get dressed. Muscle is swollen, red, hot. She felt feverish and was sweating last night (3/28/19) but the feeling is better today.
Not sure how much dose the patient got; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was not sure how much of the dose the patient got (Incorrect dose administered).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 13 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (LOT 011L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 13 Jan 2021, a healthcare professional was unsure of exactly how much of the vaccine the patient received as the luer-lock came off of the syringe during administration.  The reporter wanted to know what the next step was in order to make sure the patient was protected.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.    The event, not sure how much dose the patient got, was considered resolved on 13 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown age and gender who experienced a non-serious unexpected event of Incorrect dose administered during their first injection of mRNA-1273.
Severe Sore Throat, Shortness of Breath, Productive Cough, Right Side Chest pain, hoarseness, lethargy, malaise.
Pt. was given a tetanus injection on 5/25/10 and on 5/30/10 pt went to hospital for hives around injection site; Mom is giving cortisone cream and over the counter BENADRYL.