chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 27 year old female with a swelling reaction to procaine hydrochloride (Novocain) who on 30-AUG-2006 in the morning was vaccinated with a 0.5 mL SC first dose of Varivax (lot # 652630/0247F). Concomitant vaccination that day included a SC second dose of MMR II (lot # 649759/0383R), a first dose of Daptacel (lot # C2491AA) and a fifth dose of Engerix-B (lot # AHBUB258BA). There was no illness at the time of vaccination. On 08-SEP-2006 the patient developed more than 50 lesions and itching. It was reported that she developed a generalized chickenpox rash over her entire body, in hair and mouth. She had a fever, headache and abdominal pain. The patient went to the emergency room but was not admitted. Subsequently, the patient recovered. There was no product quality complaint involved. It was reported that prior to vaccination the patient had a varicella titer that was negative. Additional information is not expected.
Patient had acute Onset abdominal and flank pain.  Work up revealed kidney cancer, required surgery
Near-syncope with likely vagal reponse; placed in supine position, rested, resolved over approximately one hour.
Experience soreness @ injection site and under right arm pit, with soreness developing into pain, redness and swelling of right arm from shoulder to elbow.  Treatment with Benadryl and Tylenol without resolution of symptoms.  Advised to see private physician.
This spontaneous report as received from a nurse refers to an approximately 58 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. It was reported that the patient had no drug reactions or allergies. On 13-FEB-2018 the patient was vaccinated with VAQTA (lot # N031940, expiry date 23-NOV-2018) (dosing regimen and frequency unknown) for prophylaxis. On 13-FEB-2018 (later that day), the patient was "was itchy on torso, eyes and ears". The nurse also reported that the patient does not have a rash and "you can't see anything on the body" (not further clarification provided). It was reported that the patient was taking BENADRYL as treatment for the itchiness. The outcome of the events was reported as recovering. The relatedness of the events to the therapy with VAQTA was unknown. There was no product quality complaint reported.
This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates (reported as on unspecified dates or after 05-JUN-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # M046133, expiration date 26-SEP-2019 and lot # M047666, expiration date 24-OCT-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 32 to 35 degrees Fahrenheit for 8 hours. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA011726:
DTAP given x2 within 1 week. 4-28-10 5-7-10.
Patient was given the 6mos-4 yr COVID vaccine. It was meant to be given to his 4 year old brother in the room, but was instead administered to him by the medical assistant. No treatment was necessary.
Vaccine administration error.  It is suspected that a 1/2" needle syringe was used instead of 1" needle syringe.
She got her vaccine, her whole body broke out.  Her head hurt, her body aches, nauseous, spit up.  Her arm is burning and underneath her arm is swollen, like a boil under arm.  She is also itching all over.   She took Benadryl which did not improve her reaction.  Her head hurts badly.
I tested positive for COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I tested positive for COVID) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.  Concomitant products included NIRMATRELVIR, RITONAVIR (PAXLOVID) from 02-Jun-2023 to an unknown date for an unknown indication.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 31-May-2023, the patient experienced COVID-19 (I tested positive for COVID). At the time of the report, COVID-19 (I tested positive for COVID) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2023, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Patient was tested positive for COVID.  The patient did not experience any additional symptoms/events.  No treatment details were reported.
Approximately 6 hours after receiving immunization developed "horrible pain" under left arm radiating to left shoulder, nect, and back of head.  Pain increases with movement.  Saw primary physician one day after receiving vaccine who diagnosed neuralgia secondary to influenza immunization.
within 24 hours experienced paralysis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: PARALYSIS (hospitalization, medically significant), outcome "unknown", described as "within 24 hours experienced paralysis".  Clinical course: The caller received the Pfizer Covid vaccine and within 24 hours experienced paralysis. Her doctor prescribed her a hospital bed and she is wondering if it's possible to get monetary compensation.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had severe bloating and discomfort when laying on my stomach with nausea. I had something of a gas blockage that kept me from eating, as well. 4/6/2022 I went to my clinic and saw a doctor and was given a blood test and fecal test. All came back normal except for issue with my pancreas. I am still under testing and was given pantoprazole for the duration. Will be getting an ultrasound as soon as it clears my insurance.
Developed ITP platelet count 2. Admitted to hosp for IVIG. Received MMR 9/21/15. Developed fever same day with diarrhea lasted approximately 5 days. Then fever returned approximately 2 weeks after receiving MMR which persisted. Rash with few petechia developed and sent for blood.
At 9 PM on December 22 I became absolutely exhausted extreme fatigue I went to bed I was woken around 11 1115 something like that every part of my body hurt it hurt to move my fingers it hurt to move everything every joint hurt and if I did move I felt nauseous then I started to throw up I did that for half an hour or so it was if you need to know it was violent and then I got back into bed with a cool cloth on my head at about 4 AM I got back to sleep I woke up at 6 AM to my alarm for work and I felt absolutely fine except my arm was sore just like it is from any regular inoculation.
Information has been received from a physician concerning a 7 year old female who at one year of age, in 1999, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In December 2005, the patient experienced a mild case of chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Received vaccinations 6/8/2009, developed quarter-sized reaction at injection site. Progressed to about grapefruit sized reaction, took BENADRYL and  ADVIL. Rash vs hives since then to present rash seems improved with ZYRTEC nightly.
CHILD WAS GIVEN HIB AND PCV7 ON 3/24/09. PT HAS A HISTORY OF SEIZURES. PT WAS CLEARED TO GET IMMUNIZATIONS. CHILD'S MOM CALLED CLINIC THE NEXT DAY. WE WRE GOING TO SEE PT BUT CHILD TAKEN TO ER FOR SEIZURE.
Hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In April 2021, the patient experienced ALOPECIA (Hair loss). At the time of the report, ALOPECIA (Hair loss) had not resolved.            It was unknown if patient was enrolled in a COVID-19 vaccine trial. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-623564 (Patient Link).
Injection site itchiness in the arm at injection site; blush colored redness at injection site after scratching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itchiness in the arm at injection site) and VACCINATION SITE ERYTHEMA (blush colored redness at injection site after scratching) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchiness in the arm at injection site) and VACCINATION SITE ERYTHEMA (blush colored redness at injection site after scratching). At the time of the report, VACCINATION SITE PRURITUS (Injection site itchiness in the arm at injection site) and VACCINATION SITE ERYTHEMA (blush colored redness at injection site after scratching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Information has been received from a physician concerning a 15 month old male, with past medical history of 10 week premature birth/"delayed milestones" and constipation at the time of vaccination, who on 06/01/01 was vaccinated with a first dose of MMR II (lot 635598/1659J), administered SC, in the left arm. Immediately, at 11:50 AM on 06/01/01, the pt developed a "dime-sized" hive at the injection site. The pt was medicated with 1 teaspoon of Benadryl, at that time. At 12:00noon that same day, 2 hives were noted on his face. The pt was medicated with epinephrine (manuf unknown) and dexamethosone. By 12:30 PM, that same day, the hive on his arm was still present, but the "rash on his face was gone." It was reported that the pt recovered on 06/01/01. No further info is available.
Her face has been swollen her eyes actually; Her face has been swollen her eyes actually; This is a spontaneous report from a contactable consumer (parent).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: FC3183) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced her face has been swollen her eyes actually (non-serious) on an unspecified date with outcome of unknown.
This spontaneous report as received from a pharmacist via a company representative refers to a 60 year old male patient. No pertinent medical history or drug reactions/allergies were reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency and route of administration were not reported). No concomitant medications were reported. On an unknown date, one week after receiving ZOSTAVAX the patient experienced rash and was diagnosed with a mild case of shingles, by his unspecified physician. The outcome of a mild case of shingles was reported as recovered (date unknown). Relatedness between vaccination with ZOSTAVAX and the adverse event was unknown. Additional information has been requested.
Petechiae to arms, chest, abdomen, and back.   Fever of 104 on 1/11/21.  Elevated creatnine.  Admitted to Emergency room for dehydration and diagnosed with covid 19.     On 3/20/21 lost vision to left eye.   Saw the doctor and diagnosed with optic neuritis.  On 4/11/21 lost vision to right eye. Went to emergency room, at the local medical center emergency room and the doctor also diagnosed with optic neuritis.
Vaccination potentially administered below the deltoid muscle; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, vaccination potentially administered below the deltoid muscle.   The patient's medical history was not provided. No relevant concomitant medications were reported   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot #025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Dec 2020, a nurse administered the vaccine to the patient. Later, the nurse questioned whether it was given in the deltoid, or inadvertently administered slightly below the deltoid muscle. The patient reported no symptoms and no treatment was provided for the event.   Action taken with mRNA-1273 in response to the event was not reported.    The outcome of the event, vaccine potentially administered below the deltoid muscle, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Product administered at inappropriate site for mRNA-1273, Lot #025J20-2A.  There were no reported AEs associated with this case of Product administered at inappropriate site.
pt exp severe diarrhea w/flu vax last year; pt ate eggs 24 hrs following flu vax; pt has no h/o allergies to eggs;
Muscle aches, fatigue, low-grade fever all lasted about 24 hours. Headache and eye pain were severe and lasted 72 hours before subsiding. I?m still managing a headache but believe it may now be from allergies/stress.
Within 48 hours, patient developed a rash around neck and upper chest.  No shortness of breath or tongue selling.  Resolved after 1 week.  Used Benadryl to help with itch during the week.
Site: Itching at Injection Site-Mild, Systemic: Nausea-Mild, Additional Details: Patient wanted us to call 911 to check. Paramedics came and everything is normal. We gave pt ice on the injected arm and asked mom if she wanted us to give her daughter benadryl but refuse, instead just wait for the paramedic to come. Patients mom was advised to just observe daughter and call pediatrician. My observation was the patient was just nervous.
presents with a cough since 9:00 p.m. this evening.  He had a fever measured at 100.7 at home
Itchiness at injection site few days after injection and then on day 8 a large area of redness, hardness and warmth in the skin at the injection site.  No treatment.  Symptoms gone by day 10.
Case number PHEH2014US016991, is an initial spontaneous report received from a healthcare professional on 21 Aug 2014. This report refers to a 15 year old unknown gender patient. The reporter stated that, the patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M14044), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component and then administered a correct dose of Men A reconstituted with the Men C, Y, W-135 at dose of 0.5 ml on 20 Aug 2014. No adverse event was reported following this administration error.
dizziness; felt yucky; vomiting/threw up; extremely nauseation; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FEELING ABNORMAL (felt yucky), VOMITING (vomiting/threw up), NAUSEA (extremely nauseation) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diverticulitis and Acid reflux (esophageal). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), METRONIDAZOLE BENZOATE (METROZOLE [METRONIDAZOLE BENZOATE]) and LETROZOLE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (dizziness), FEELING ABNORMAL (felt yucky), VOMITING (vomiting/threw up), NAUSEA (extremely nauseation), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 16-Mar-2021, DIZZINESS (dizziness) outcome was unknown, VOMITING (vomiting/threw up) and HEADACHE (headache) had resolved. At the time of the report, FEELING ABNORMAL (felt yucky), NAUSEA (extremely nauseation) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
EMS brought pt to ED with increasing SOB;  O2 saturation in 70s%; was found on the floor in house by EMS; may have been there x 2days; placed on NRB; rhabdomyolysis; diarrhea; found to be positive for COVID; intubated in ED and central line placed for vasopressor treatment; Decadron; AHRF; multiorgan failure; transferred to ICU; suffered PEA arrest; code called; ROSC achieved; family transitioned pt to DNR and pt passed away in the hospital
This spontaneous report as received from a physician refers to a 12 month old male patient. On 30-DEC-2013 the patient received a dose of ZOSTAVAX in error, rather than the VARIVAX (Merck) that was indicated for him. The patient presented to the physician's practice today to be evaluated for a skin rash. On an unknown date, influenza skin test by skin swab was performed: it was determined to be influenza. The physician, a dermatologist, stated that the rash was not varicella. He did not have much information about the patient at because the patient was new to him. He did not know at which healthcare provider's office the child received ZOSTAVAX. The patient's outcome was reported as not recovered. The patient sought unspecified medical attention. The causal relationship was not provided. Additional information has been requested.
I had a sore arm the next day. I had a lot of health issues but not sure they are related to the vaccine.
A cluster of four cases of injection site swelling, heat and tenderness in addition to large nodule at injection site out of an unknown number of patients who received DECAVAC (lot number and route/site of administration unknown. Follow-up information received from a health care professional on 25 August 2008 provided patient identification. This case now includes information concerning a 62-Year-old female patient, with a history of allergy to DARVOCET N and history of cat bite to the left hand, who received an intramuscular injection of DECAVAC (lot number U2294DA, site of administration unknown) on 30 June 2008. It was initially reported that on an unspecified date in June 2008, the patient experienced injection site swelling, heat and tenderness in addition to a large nodule at injection site. Follow-up indicated that the patient also experienced injection site pain and was unable to raise her arm for a few days. The events did not require an emergency room or doctor visit. It was reported that the patient recovered; date of recovery not provided. The reporter of this case is the same as case 2008-02713. From the original cluster of four cases, two patients have been identified and two patients remain unidentified.
I was having a dry cough that would get worse in the evening. When I went to sleep, it finally got the point where it would be disrupting my sleep and keeping me from resting. When I went to the doctor, he prescribed a Z-pak and the inhaler. The Z-pak I took for 5 days and the inhaler I'm still taking. It has improved the cough condition to the present time. I was fatigued, extremely tired. Probably a combination of not sleeping at night and in general not feeling well.
Initial report was received from the Nurse on 17 Feb 2010: This patient (under four years of age) was vaccinated with 0.5 ml of FLUVIRIN (batch number 102138P1A), intramuscularly on 16 Feb 2010. The outcome of patient's condition was not reported.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 51-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 51, single dose, for COVID-19 immunisation. Medical history included vertigo, start date: 2019 (not ongoing), notes: had a bout of vertigo around 2019 that lasted weeks. The patient's concomitant medications not reported. The patient had pain in extremity (sore arm), onset 2021, with outcome of not recovered. No therapeutic measures taken as a result of pain in extremity. Additional information: The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
temperature excursion/VARIVAX administered doses; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On an unknown date, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002843 with expiration date of 23-JAN-2022, and lot # S032357 with expiration date of 14-OCT-2021, 0.5 milliliter (strength, dose, route, frequency and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature range between -14°C to -10°C, during a time frame of 38 hours and 30 minutes which was called by a data logger. No previous temperature excursions reported.