chrisvoncsefalvay/vaers-outcomes huggingface dataset:
STARTED WITH FEVER, SORE THROAT AND MUSCLE ACHES. THEN DEVELOPED SWELLING OF LIPS AND ARM. GIVEN BENADRYL BUT SWELLING INCREASED AND INCLUDED THE THROAT. TAKEN TO ER WHERE ONE DOSE OF ORAL STEROIDS GIVEN. ALREADY IMPROVING FROM PREVIOUS DOSE OF BENADRLYL. INSTRUCTED TO CONTINUE BENADRYL FOR 2 MORE DAYS. IF BENADRYL DOESN'T HELP WILL CONTINUE STEROIDS.
pt recvd HIB/MMR & devel a lump (size of golf ball) @ HIB site & irritability which consisted of loud crying on evening following vax; treated w/ice packs & APAP; next day, pt walking, but site tender to the touch, swollen & bruised;
Reports feeling depressed; Feels a little "out of it"; Could not sleep for a couple of days; Light chills which became stronger that night; Low grade fever (100-101F),102F fever; Severe knee pain; Neck aches that felt like her "neck was going to break if she moved it".; Did not eat much for 2 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (Neck aches that felt like her "neck was going to break if she moved it".), DECREASED APPETITE (Did not eat much for 2 days), DEPRESSION (Reports feeling depressed), MALAISE (Feels a little "out of it") and INSOMNIA (Could not sleep for a couple of days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression. Concomitant products included METOPROLOL for Heart rate.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced NECK PAIN (Neck aches that felt like her "neck was going to break if she moved it".) and PYREXIA (Low grade fever (100-101F),102F fever). 16-Mar-2021, the patient experienced DECREASED APPETITE (Did not eat much for 2 days), INSOMNIA (Could not sleep for a couple of days), CHILLS (Light chills which became stronger that night) and ARTHRALGIA (Severe knee pain). On 19-Mar-2021, the patient experienced DEPRESSION (Reports feeling depressed) and MALAISE (Feels a little "out of it"). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever and Pain, at an unspecified dose and frequency; HYDROCORTISONE at an unspecified dose and frequency and CALAMINE, DIPHENHYDRAMINE HYDROCHLORIDE (CALADRYL [CALAMINE;DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 17-Mar-2021, NECK PAIN (Neck aches that felt like her "neck was going to break if she moved it".) and ARTHRALGIA (Severe knee pain) had resolved. On 18-Mar-2021, DECREASED APPETITE (Did not eat much for 2 days), INSOMNIA (Could not sleep for a couple of days) and PYREXIA (Low grade fever (100-101F),102F fever) had resolved. At the time of the report, DEPRESSION (Reports feeling depressed), MALAISE (Feels a little "out of it") and CHILLS (Light chills which became stronger that night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 122/73 (Inconclusive) BP at 122/73. On 16-Mar-2021, Body temperature: 100 (High) low grade fever (100-101F) and 102 (High) 102 F. On 16-Mar-2021, Heart rate: 85-10 (Inconclusive) Resting heart rate is now85-90 BPM.         Concomitant medication include unknown antidepressant.  Treatment medications include Advil, Hydrocortisone cream, Caladryl (calamine lotion)   This case was linked to MOD-2021-051947 (Patient Link).
vaccine given 9:30am 3/5/20 at pediatrics, 7 am on 3/6/20 patient woke up with a 102 degree fever. fever remained 102 throughout the day. 3/7/20 he woke up with a fever still at 102. at around 7:30 am he vomited.  he threw up again one more time that day as well as having diarrhea several times throughout the day. 3/8/20 fever up to 103.5 and still has diarrhea. also, vomited one in the morning. took patient to the urgent care at 2:15pm for evaluation where they concluded he was having a vaccine reaction.
developed red spots at the site of her COVID-19 vaccine injection; developed red spots at the site of her Cosentyx (secukinumab) injection; red spots were painful; red spots were painful; red spots were itchy; red spots were itchy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; secukinumab (COSENTYX) (Batch/Lot number: unknown). Relevant medical history included: "Ankylosing spondylitis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 09Oct2021, outcome "unknown", described as "developed red spots at the site of her COVID-19 vaccine injection"; INJECTION SITE ERYTHEMA (non-serious) with onset 09Oct2021, outcome "unknown", described as "developed red spots at the site of her Cosentyx (secukinumab) injection"; VACCINATION SITE PAIN (non-serious), INJECTION SITE PAIN (non-serious) all with onset 09Oct2021, outcome "unknown" and all described as "red spots were painful"; VACCINATION SITE PRURITUS (non-serious), INJECTION SITE PRURITUS (non-serious) all with onset 09Oct2021, outcome "unknown" and all described as "red spots were itchy". The action taken for secukinumab was unknown.  Additional information: The causal relationship between the events injection site warmth, injection site erythema, injection site pruritus, injection site induration, injection site pain, and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. Injection site reaction which the patient describes as redness, hardness, a little bit itchy but not too bad, and warm to touch / red spots lasted about 4 days and were painful and itchy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Given 6 month vaccines including Pediarix, Prevnar, oral Rotavirus, and ACT-Hib.  4 hours later she was lethargic, was felt to be hot to touch, was seen approximately 8 hours later and was very sleepy and irritable.  Improved by morning, all symptoms resolved in a few days
Stomach ache, nausea, moderate arm pain, 102 degree F, urticaria on chest.
Patient is a previously healthy 13 month old boy who presented with respiratory failure, then developed ARDS and multiorgan dysfunction on VA ECMO, requiring vasoactive support and CRRT. Subsequently found to have multiple disseminated viral infections, including HSV, adenovirus, and low level positive CMV and EBV. Suspected immunodeficiency, workup pending. In setting of recent MMR and varicella vaccinations, critical illness, and suspected immunodeficiency, workup for disseminated vaccine strain measles sent at CDC. Positive for vaccine-strain measles from nasopharynx and urine.  Patient initially presented with an otitis media on 1/30 and then re-presented with stridor and rapid respiratory failure. Evidence of epiglottic inflammation with "white dots" noted during intubation and cervical & retropharyngeal lymphadenitis. He had a respiratory PCR positive for adenovirus and RSV and serum positive for adenovirus, though not remarkably high level. EBV PCR in serum also low-level positive but serology from OSH suggestive of past infection. I&D of L neck lymphadenitis performed; cultures from lymph node I&D are negative. CT with evidence of developing retropharyngeal phlegmon.  Subsequently developed knee lesion which was positive for HSV, HSV PCR from serum shows disseminated HSV at high viral levels. EBV and CMV positive at low levels, also HHV6 positive, likely represent reactivation in setting of severe illness. Based on multiple viral infections, immunology team involved and on DDX are immunodeficiencies such as TLR defects. HLH/MAS was considered and he met some criteria for this; was on anakinra and received intermittent steroid dosing. BAL cytology from 2/14 showed multinucleated giant cells. ETT quantitative RSV level pending. When measles results from NP/urine returned on 2/21, started on oral ribavirin (while pursuing IV ribavirin), high dose vitamin A, and redosed IVIG. HSV level continuing to fall. Unclear of contribution of measles vaccine strain to respiratory presentation; felt to be unclear whether represented prolonged shedding versus true pneumonia/pneumonitis.  Further testing at CDC pending including measles IgM and measles PCR on deep respiratory sample.
8-10mins p/vax pt was up in the clerical office became dizzy fell & hit head on printer & then fell backwards & hit head on floor;nurse called to office pt conscious,crying,skin warm & dry,pupils reactive,moving all extremities,no resp
Burning and then numbness during needle injection, followed by ongoing numbness after injection of needle.  No prior adverse effects from vaccine injections.
Achy; Muscles hurt; Joints hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), MYALGIA (Muscles hurt) and ARTHRALGIA (Joints hurt) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2020, the patient experienced PAIN (Achy), MYALGIA (Muscles hurt) and ARTHRALGIA (Joints hurt). At the time of the report, PAIN (Achy), MYALGIA (Muscles hurt) and ARTHRALGIA (Joints hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-043100.
Information has been received from a physician concerning a 15 year old female patient with obesity and no drug reaction or allergies who in 2009 (approximately September), was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL. There was no concomitant medication. Six-eight weeks ago (approximately October 2009), the patient developed idiopathic pancreatitis one month after her second vaccination. The patient sought unspecified medical attention. The physician suggested that the patient continue with the series, but the consumer's parent decided to discontinue it. The patient had been hospitalized three times for this adverse event. At the time of the report, the patient was recovering. Additional information has been requested.
LOSS OF APPETITE; GROGGY; FATIGUE; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and  expiry: 21-JUN-2021) dose was not reported, administered on 02-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced groggy. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, headache, nausea, loss of appetite, and groggy. This report was non-serious.
Lump Opposite Arm; Large raised lump in legs; Orthopedic nerve pain; Burning pain in all over of body; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lump Opposite Arm), PERIPHERAL SWELLING (Large raised lump in legs), NEURALGIA (Orthopedic nerve pain) and PAIN (Burning pain in all over of body) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced MASS (Lump Opposite Arm), PERIPHERAL SWELLING (Large raised lump in legs), NEURALGIA (Orthopedic nerve pain) and PAIN (Burning pain in all over of body). At the time of the report, MASS (Lump Opposite Arm), PERIPHERAL SWELLING (Large raised lump in legs), NEURALGIA (Orthopedic nerve pain) and PAIN (Burning pain in all over of body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Dizziness that is continuing, fatigue, arm soreness, swelling of lymph nodes
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (07-09-2020: pregnancy end date. Live, full term birth.).   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 02-Dec-2020 and the estimated date of delivery was 24-Sep-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy.  On 27-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Pregnancy test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided. Action taken with mRNA-1273  in response to events was not applicable.
Patient experienced altered mental status within hours of the vaccination - could not write sentences or comprehend what he was reading; symptoms lasted for four days; confirmed lacunar stroke on MRI
Two hours after the second dose of the vaccine my daughter developed a sore throat. The next day she felt better but her throat still hurt. On the fifth day she complained  that she felt like she couldn't breathe so I took her to the ER. She was diagnosed with an Allergic reaction because her throat was swollen and she was prescribed some Prednisone. They gave her Benadryl and Steroids. It has been nine days and it seems to be a little better but her throat still hurts and she is very tired.
NOT CERTAIN THIS IS A SIDE EFFECT: a couple MONTHS after the shots child started having swelling, redness, itching ,heat and cold in hands and feet. Circulatory issue had never presented itself prior.  Breakthrough covid case in december 2021 and toes went white and blue during viral infection.  More frequent swelling, redness, discoloration in hands and feet without change sin temperature, medication or lifestyle (other than anxiety over the issues themselves)
flu like symptoms, headache, fever of 102-104 currently 102; Patient feeling "80% to 90%  better". No longer has fever, this morning temp at 98.6F*. Still has minor headache but took pain reliever to relieve pain. Recommended to follow up with primary provider if symptoms worsen.
Pregnancy EDD 5/22. Approximately 21 weeks at time of vaccination. Had flu-like symptoms that started approximately 12 hours after vaccine. I felt weak, achy and tired. Symptoms resolved around 36 hours after vaccine.
This was a seasonal flu shot. It was a dark yellow brown color. Maybe 5cc or less
The afternoon of receiving vax, pt developed an injection site reaction characterized by swelling and redness. He was treated with applications of warm compresses and Tylenol. This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune-23, lot 469-132. Follow-up info recvd from MD on 6/25/01 indicated that the pt recovered.
8/9/21 went into SVT 190s, went to ER self converted. Did a whole PE work up, CT,Xray chest,cardiologist referral   (vagal maneuver) started Metropolol 12.5 mg 2x a day, 8/12/21 went into SVT 190s while driving, went to ER self converted, chest Xray and cardiologist referral.
LEFT DELTOID INJECTION SITE REDDENED AREA--APPROX 4" IN DIAMETER, HARD TO TOUCH, INCREASED PAIN WITH ANY MOVEMENT AND TOUCH.
Had immunization on 3/28/06, elevated fever T-102 and had febrile seizure 4/7/06; sent home and restarted seizuring and admitted to hospital for 4 days. Sepsis was ruled out.
Pt was excessively sleepy the day after vaccine with significant (R) thigh redness, swelling and itching.
Patient experienced immobility of the arm where vaccine was injected. The site of injection was tender, sore and red. Symptom lasted for over (1) week - pt went to walk in clinic to seek medical advice - was given antibiotics just in case of abscess.
No additional AE reported; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W019628, expiration date: 19-DEC-2023, albumin status has been verified as recombinant human albumin (rHA), administered intramuscularly in right thigh for prophylaxis (strength and dose was not provided). The vaccine had undergone temperature excursion (product storage error). No additional adverse event (AE) reported.; Sender's Comments:  US-009507513-2303USA002114:
Report 2001027603-1 describes decreased T cells in a male approx 50 years of age who received hepatitis B recombinant (Engerix-B). Medical history, concurrent conditions, and concurrent medications were not specified. "Four years ago", the pt received his 2nd injection of Engerix-B. Subsequently, "four years ago", the pt experienced skin changes, psoriasis, and decreased T-cells. As of 11/20/2001, the outcome of the events was unknown.
This spontaneous report as received from a medical assistant also reported as healthcare worker refers to an unspecified group of patients of unknown demographics. Patients' medical histories were not provided. In approximately 2014, the patients were vaccinated with doses of RECOMBIVAX HB (dose, frequently, route of administration and lot # were not reported) which were exposed to an unsupported temperature excursion since 02-NOV-2014. Concomitant medication was not reported. The reporting medical assistant was not aware of any adverse effects. Product quality compliant (PQC) was not involved. This is several reports received from the same reporter. Additional information has been requested.
Covid monitoring documentation. PT admitted 10/22/21 documented to have positive covid. PT received Moderna 2/26/21 Lot 022M20A for dose 1. Dose 2 was Moderna given on 3/26/21 Lot 007B21A. PT expired on 11/5/21 due to acute respiratory failure secondary to COVID19 pneumonia and bilateral PE according to death summary.
Initial pain, tenderness  and discomfort at injection site after a couple of minutes. Within  24 hours after injection body aches and flu like symptoms. After 48 hours intermittent dizziness and lightheaded has continued to the present day.
Initial misuse report received on 09 December 2013 from a health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of PENTACEL (lot number, route and site of vaccination was not reported) on an unspecified date which was potentially unstable and was advised to repeat the dose. List of documents held by sender: none.
Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PFIZER8731) via an unspecified route of administration in the right arm on 11Apr2021 at 16:45 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. 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. On 12Apr2021 at 08:00, the patient experienced dizziness. No therapeutic measures were taken as a result of the adverse event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizziness was resolving at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Patient given Pneumovax 2 in left deltoid as ordered. Patient c/o HA approximately 1 hour later with left arm pain, tenderness, swelling, redness at site of left deltoid. Patient returned to clinic next am; left increase arm deltoid area, with heat, tight, induration erythematous tender area approximately 6 inches, width entire diameter of deltoid.
I started to have a lot of soreness at the injection sight so I took a Tylenol and went to bed. I woke up around 12:30 with chills and aches and I took another Tylenol and laid back down. I woke up again at about 1:30 with severe vomitting every 15- 20 minutes that lasted until about 9:00am. That Wednesday I had severe chills, headache, and aches.
Lymph Node on my  right side by my coller bone had swollen went to PCP, PCP sent me to have a ultra sound done, then a CT scan , then got sent  to a oncologist, that referred me to a surgeon which I see on 01/18/2021 to get a biopsy/remove it and send it off to pathology all happened in one week,
This spontaneous report as received from a nurse refers to unspecified patients of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that it is possible that VAQTA (dose strength, route, was not reported) dose was administered to the patients on an unspecified date after a cumulative temperature excursion of 123 hrs at 10C. No adverse effect reported. The outcome of the events reported is unknown. No product quality complaint was involved. Nurse also informed that with multiple excursion for three different sites with the vaccine reported. Nurse requested letter of evaluation data by e-mailed to her. It was also reported that adverse event was filed as one site may have administered product involved in cumulative excursion. No product quality complaint. 10C was sum or total 122.5 hours VAQTA no, product was received January 2014. 9C for total 31 hours VAQTA yes. This case is linked to the cases 1405USA005087, 1405USA005086, 1405USA005088 via same reporter link. Additional information is not expected.