chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client called on 5/21/03 to report redness and raised area approximately size of silver dollar in yellow fever injection site area - soreness and warm to touch. Noticed symptoms when he woke up in morning of 5/20/03. Recommended Benadryl cream to area for itching and Tylenol or Ibuprofen for soreness. 5/22 follow up call to pt. He states swelling is decreasing in size.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with, 1 DF GARDASIL. Other suspect therapies included RECOMBIVAX HB and VAQTA. No concomitant medications were reported. On an unknown date the patient experienced incorrect storage of drug. No treatment information was reported. The outcome of incorrect storage of drug is unknown. Incorrect storage of drug is not related to VAQTA, RECOMBIVAX HB and GARDASIL. (Additional information has been requested. / Additional information is not expected.)
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2022) Positive, notes: COVID 19 Treatment; (28Oct2022) Positive, notes: Rebound of Covid symptoms on 28 including positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound of covid symptoms on 28Oct2022 including positive test outcome was not recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
rash-15 macular papular lesions on trunk & scalp started on 25FEB98;
This literature marketed report has been received from the authors of a published literature article,  and refers to a 13-year-old patient of unknown gender. The patient's concurrent condition included Coronin1A, reported as inherited immunodeficiency and cutaneous granuloma. The patient's medical history and concomitant medications were not reported. On an unknown date at age of 3 years and 5.7 years, the patient was vaccinated with M-M-R II (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient developed immunodeficiency-related vaccine-derived rubella virus (iVDRV). The patient had skin involvement that was described as initially psoriasiform or resembling pyoderma gangrenosum. The patient had chronic inflammation in skin and underlying bone. The rubella was detected by immunofluorescence or polymerase chain reaction (PCR) in skin. The Rubella capsid protein was detected and the iVDRV strain with multiple non-overlapping mutations was identified in the skin biopsy by sequencing viral genomes. The patient's CD3 count was 464 cells/uL, CD4 count was 224 cells/uL, CD19 count was 24 cells/uL and natural killer (NK) cell count was 144 cells/uL. The authors assessed CD3 and CD4 count as low, and NK count as normal. The patient received antimicrobial treatment with cotrimoxazole, azithromycin, fluconazole, amoxicillin (+) clavulanic acid, ciprofloxacin; immune modulatory treatment with topical steroids and intravenous immunoglobulin (IVIG). There was no improvement after these treatments. Surgical excision was performed, but with local recurrence. Nitazoxanide was used for 4 months largely as salvage therapy in this extremely ill patient but with no improvement. At the time of this report, the outcome of the rubella was unknown and the patient was alive. The authors considered the iVDRV to be related to M-M-R II. Upon internal review, the iVDRV was determined to be medically significant as the patient was treated with immunoglobulin therapy. This is one of seven reports derived from the same literature article (linked marrs# 1902USA004783, 1902USA004784, 1902USA004785, 1902USA004786, 1902USA003143, 1902USA004788). Sender's Comments: US-009507513-1902USA003143:
About thirteen (13) hours after the second Moderna vaccine shot, I began bleeding profusely from my nose, developed painful headaches  along the left side of my head, with feelings of intense pressure throughout my head, my blood pressure and heart rate were very high, and have remained high since. I get continuous nose bleeds several days per week. I've been prescribed blood pressure medication. Let it be noted, three days prior to the second dose I had a full body physical, and my blood pressure was normal. I've never suffered from high blood pressure before
Erythema L arm. Pt given ibuprofen Rx and advised to ice area.
On my Left arm, approximately 3 inches below where the shot was given, a very red, swollen & hot area. The area was approximately 3 inches by 3 inches. It was very hot to the touch. I used an infrared thermometer & just that spot was 101 degrees Fahrenheit. I did not have a fever.
Pt had a large 8cm diameter local reaction to immunization with reported systemic fever and large red, raised annular reaction at injection site.
Complained of head twitching in right temporal area beginning on 5/30/2000. Also complained of insomnia and being very hot for 2 weeks post vax.
He said he had both shots and every booster except the most recent booster, in Oct he caught Covid; He said he had both shots and every booster except the most recent booster, in Oct he caught Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID. The reporter is the patient.  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (2023) and all described as "He said he had both shots and every booster except the most recent booster, in Oct he caught Covid".  Clinical course details: The caller said he has been looking all over the place and his doctor hasn't returned his call. He said he had both shots and every booster except the most recent booster, about the time he was going too early and in Oct2023 he caught Covid and he was over covid now. He said he was just trying to get somebody a straight answer if how long he should wait after he had covid recently to get the most recent booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Info has been received from a male physician who on 10/24/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, he developed local induration, tenderness, significant headache, myalgias and arthralgias. The physician sought unspecified medical attention. He was not hospitalized and was treated with methylprednisolone (MEDROL). No further info is available.
Fever of 101; Achy body; Nauseated; Sore at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Moderna (she had side effects with Moderna -Covid vaccine before ever getting her first dose of Shingrix.) and Shingrix vaccine (1st dose on an unknown date).   On 14th October 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 14th October 2021, less than a day after receiving Shingrix, the patient experienced injection site pain. On 15th October 2021, the patient experienced fever, general body pain and nausea. The patient was treated with excedrin (nos) (Excedrin). On an unknown date, the outcome of the injection site pain, fever, general body pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, general body pain and nausea to be related to Shingrix.   Additional details were reported as follows: This case was reported by the patient for herself. The patient received shingrix vaccine and last night her left arm was sore at injection site. The patient also stated that this morning she woke up achy, nauseated and had a fever of 101degree fahrenheit, she added. The patient also mentioned taken Excedrin for her symptoms. The patient asked how long do side effects last. The patient also mentioned that had side effects with Moderna -Covid vaccine before ever getting her first dose of Shingrix. Encouraged the patient to report Adverse event to Moderna, even though it was given months ago. The reporter consented for follow-up.
metallic taste; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed but manufacturer unknown), for COVID-19 Immunization. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "metallic taste"; NAUSEA (non-serious), outcome "unknown".  Additional information: Agent stated they have a 80 year old patient who took the Pfizer COVID 19 booster dose and is experiencing metallic taste and nausea. Per agent, caller wants to know why she is "still having COVID after taking the booster dose". (After providing this information, call went silent and agent was unable to hear the rest of the call, call disconnected due to technical issue)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 43-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th November 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comment: The expired Havrix was administered to the patient. No adverse reactions were reported. The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up via email. Additional Supportive Information: The expired Havrix was administered to the patient, which led to expired vaccine used.
After the vaccine I was nausea and vomiting had migraines for three days. I had flu like symptoms and experience fatigue.
upset stomach; diarrhea; temperature to 101.7; I was tired and sleepy; I was tired and sleepy; fever; This is a spontaneous report from a contactable physician (patient). A 64-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), second dose on 07Jan2021 07:00 (lot number: EJ1685) via an unspecified route of administration in the left arm at a single dose for covid-19 immunization. Medical history included diabetes mellitus (DM), coronary artery disease (CAD), hypertension (HTN), HLD, glaucoma, retinal tears and overweight. Concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) via an unspecified route of administration in the left arm, first dose on 31Dec2021. The patient previously received first dose of bnt162b2 on 18Dec2020 16:45 (lot number: EL3248) for covid-19 immunization. On 08Jan2021 07:00, the patient experienced upset stomach, diarrhea, temperature to 101.7, tired and sleepy and fever. The patient received Pepto-Bismol and Azithromycin as treatment for the events. The patient did not have covid prior vaccination and had not tested positive for covid post vaccination. Events fever ad temperature to 101.7 recovered on 09Jan2021; event diarrhea recovered on 11Jan2021; all other events resolved with sequel.
MENACTRA given in right deltoid. Arm was red & hot. It covered from 1" below elbow up to neck (At the time public health nurse saw it). Mother said it had been slightly worse but couldn't describe how. Saw PA at Drs office & put on steroid for 6 days. Had also been taking BENADRYL.
sore in the site for at day; explosive diarrea, liquid; Fatigue; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot number and Expiry date were not reported) via an unspecified route of administration on 09Feb2021 at single dose for covid-19 immunisation. Medical history included gastrobypass in 2004, after that I have to be and take care of not grease in my food cause I got as secondary diarrea. The patient's concomitant medications were not reported. The patient experienced sore in the site for at day, diarrhea and fatigue. Customer verbatim: The first vaccine fine small sore in the site for at day, after one day the pm I was very fatigue. second dossis since I got the vaccine even with a band diet everyday worse today in one hour it is the worse, explosive diarrea, liquid, patient cannot hold it. Patient had accidents and have to wear diapers please. Yesterday the only bad thing it was holiday and patient had a small coffee size but full of Nutella, It was for information. Was this an effect for us gastric bypass. Please be aware. The outcome of the events was unknown.  Information about lot/ batch number has been requested.
Pt reports tongue irritation of roughness 2 weeks post vaccination. Pt also reported painful swollen lymph nodes in the axillary region on the left side one week post vaccination. subsided two days later. Pt had PCR COVID test. Negative result. Pt advised to take Benadryl prior to next administration on 2/2/21
Rash near the site of injection, Dr. had stated that the reason for this reaction is indefinite that it was anthrax vaccine.
Numbness and pain started in legs, moved to both arms, then numbness and loss of grip in left hand.
This is a very pleasant 74-year-old female with history of squamous cell lung carcinoma, on chemotherapy, followed by Dr., anxiety, hypertension, hypothyroidism, chronic GERD, chronic diastolic heart failure, immunocompromise, atrial fibrillation, on chronic anticoagulation, recent hospitalization and treatment for UTI, patient presented to the emergency department on 08/18/2021 due to worsening shortness of breath, increased oxygen demands at home and chest congestion.  In the emergency department, patient requires 4 L O2 via nasal cannula, she was tested for COVID-19 infection and was found to be positive.  Tested positive 8/18/2021 This is a pleasant 93-year-old female with hypertension, chronic GERD, diabetes, advanced age, chronic kidney disease, nursing home resident, patient was diagnosed with COVID-19 infection 2 days ago at the nursing facility, she was brought into the emergency department today due to worsening hypoxia and hypothermia.  Patient initially required non-rebreather mask in the emergency department, and high-flow oxygen via nasal cannula, however she continued to have hypoxia therefore currently she is requiring CPAP treatment.  Patient currently reports mild improvement of her shortness of breath with CPAP therapy, she denies any chest pain, she has nonproductive cough.  She has Bair Hugger in place and her temperature is improving, she is alert and oriented x3.  She has DNR code status but she is agreeable for noninvasive mechanical ventilation.  Nothing seems to improve or worsen her symptoms.  She denies any nausea, vomiting, sweats, headache or syncope.  She received 1 L IV fluid bolus per emergency department, blood cultures obtained and received empiric antibiotics.   She is currently hemodynamically stable and normotensive.
Narrative:  Patient was fully vaccinated with 1st dose of Moderna vaccine on 12/17/2021 followed by second dose of Moderna on 3/17/2021. He did not receive a booster. He tested positive on 12/21 and was admitted due to reports of weakness x 1 week, cough, and mild hypoxia. He was treated with remdesivir and dexamethasone while admitted. He completed 3 days of these treatments while inpatient until he was discharged on 12/24.
increased need for oxygen; difficulty breathing; A spontaneous report was received from a consumer concerning a 85 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events needing additional oxygen (PT: Hypoxia) and difficulty breathing (PT: Dyspnoea).  The patient's medical history was not provided. No relevant concomitant medications were reported.     On 30 Jan 21, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for the COVID-19 infection prophylaxis.   On an unknown date, the patient experienced increase difficulty breathing and increased need for oxygen. Treatment included oxygen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, needing additional oxygen and difficulty breathing, were unknown/not reported.; Reporter's Comments: This case concerns an 85-year-old female who experienced a serious unexpected event of HYPOXIA along with a nonserious unexpected event of DYSPNOEA.  The events occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient received COVID-19 vaccination (Moderna) at 12:04pm. He sat at the table for observation period ?stood up and turned, stated he was feeling nauseated, took a step forward and then fainted forward onto a different table. Staff responded and lowered him backward onto the floor. Vitals assessed ?BP 100/62, P 72, O2 SAT 98% on room air. Ice pack applied to forehead; patient sweaty but responding, stated hands tingled but no other complaint. Breathing regular, not labored. Admits he had a similar reaction to a vaccination about 3 years ago ?does not recall type of vaccine but agreed not life threatening reaction. Denied having any allergies that he is aware of. Admits he did not eat recently. Patient stated he did not hit his face when he fell onto the table, denied physical injury. Assisted to sit up while on floor for a while, then to stand and sit back onto a chair. Given bottle of water and granola bar. Orthostatic blood pressure checked at 12:25pm ?sitting blood pressure was 110/72 and standing 108/62. Patient stated feeling well; had him wait out a 30-minute observation period rather than 15-minute period. Walked out of building with staff and his sister; encouraged sister to drive them home, and for him to eat.
mom states pt felt warm, not hot & began having a rash on rt thigh only 24hr p/vax;no other s/s;pt active, good appetite, no distress;afeb in clinic;
Two hours after injection experienced buzzing, vibrating, electrical pressure in bladder and urinary tract. Within four hours had severe UTI symptoms. Painful, burning and frequent urination with no relief.  Pressure and cramping.  Treated with D-Mannose over the counter which gave some relief for one day. Symptoms returned. Doctor tested my urine for infection. No signs of infection. Clean urine. Symptoms have remained every day and night. Prognosis is possible IC (Interstitial Cystitis)
Diarrhea & stomach ache; mom was told to mix milk & baking soda w/1st capsule; remaining capsules w/jello & had no rxn;
Started itching on way home. Redness has reach approximately 5 inch area (5/20/15). Swelling has reached approximately 8 inch area (5/20/15). MD advised to ice/ibuprofen, will go see MD if worsening. Follow up call 5/26/15-symptoms almost completely subsided.
A physician reported the occurrence of injection site cellulitis in an 18 month old female who received Infanrix. The subject's medical history, concurrent conditions, and concurrent medication were not provided. The subject had no adverse experiences following receipt of prior immunizations. On an unspecified date, the subject received an injection of Infanrix. On 5/9/02, post immunization, the subject experienced cellulitis at the injection site. Treatment included antibiotics NOS. According to the reporting physician, the immunization series was discontinued and the subject will not receive her next injection until age five. The event was reported to have improved as of 5/19/02. Information received from the reporter on 10/7/02, indicated that the event was serious for unspecified reasons and possibly related to Infanrix immunization.
A red rash has been gradually going down her arm since the night of the vaccine. The right arm is also swollen.
Approx 24 hours after shot, skin started to itch around hairline. Approx 48 hours after shot (on waking up in the morning) noted hives starting on torso front. By evening, full front torso covered, some up neck, and inside elbows. Took benadryl. Next morning (72 hours after shot) hives starting to fade.
The night I received the vaccine, I started to feel very tired. I also had chills, aches, and a headache. I didn't sleep well. I had a 99.9-degree temperature. When I woke up the next morning, my fever was 101.4-degrees. I took some TYLENOL to bring down the fever. The chills were gone, but I still had aches and a headache. A couple of hours later, I took my temperature again. My temperature had dropped to 100.4-degrees. Three hours later, I took my temperature again. It was 99.3-degrees. I still had the body aches, but I didn't feel as tired. When I woke up from a nap, my temperature was 98.3-degrees. I felt much better. I was still a little achy, but the headache was gone. That evening, my temperature was exactly 98.6-degrees. Saturday and Sunday, I had a sore arm and a slight headache that was intermittent. On Monday, I felt fine until about 09:00PM. I had a sore throat and stuffy nose. On Tuesday morning. I had a sore throat, a scratchy cough, and a runny nose. I did not have a fever. I took a COVID-19 test that morning, and it was positive. I called my doctor. That afternoon, I had a telehealth visit. Since I'm considered high risk, she prescribed PAXLOVID. I started it that evening. Yesterday morning, my head was stuffed up and my voice was hoarse. After I showered, I felt a lot better. I still had a slight cough and a runny nose. Last night, my cough got worse. Today, I feel pretty good, but I still have a slight cough and runny nose. I still don't have a fever.