chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling, Pins and needles feeling down arm. Continued for 2 weeks before patient reported symptoms to pharmacy.
Amost 1 year after second dose of covid 19 vaccine, I was exposed and on 11/20/21 i tested positive for covid 19. on day 1-3 i had severe fatigue muscle aches, fever and mild congestion. on days 4-10 i flucuated with fatigue and sinus drainage in additon to contunual mild non productive cough
Patient administered moderna covid vaccine while temperature excursion was ongoing(possible temperature excursion); Patient administered moderna covid vaccine while temperature excursion was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing(possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of DEC 2021, JAN 2022, and FEB 2022. Reporter said that they are filling out a temperature excursion assessment with the State at this time and she was calling in to report the same to Moderna.  Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing. It was reported that no adverse reactions were reported by any patients. No treatment medication were reported.
Custodial parent stated after Hep A vaccine on 9-14-07, taken to ER on 9/15/07 for blotchy rash.  Eyes looked like pink eye.  ER gave script for prednisone & eye drops.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: gave pt zyrtec 10mg to take at home, and advised trial of ibuprofen. pt will try and if no relief, will report to her dr
I received my Pfizer Bivalent on 09/22/2022. My COVID-19 symptoms started on 11/20/2022 in the morning around 08:00AM. I thought I was coming down with a cold. I did a home COVID-19 test which was positive, later that night I went to the clinic to confirm that I had COVID-19 infection. They prescribed with with cough medication and nausea medication. They also advised me to wait for 5 days till I fully recover. As of today 12/27/2022 I am still recovering.
Pt recvd 1st dose of Engerix-B vax 14JAN92 & 19JAN92 pt exp rash over entire body; no tx was given;
swollen red face, hot red ears, patches of red on stomach and back. Reaction subsided slowly after the consumption of allergy medication.
pt recv vax & hr later same day devel erythema & non pitting edema inner aspect of lt elbow & fore arm;required heating pad use & NSAIDS:
15 minutes after vaccine were given, infant became lethargic and developed areas of blotchiness around head. BP 100/60, pulse 160. Pulse oximeter-95%. Lower extremities "blotchy". Benadryl 0.5ml. No respiratory difficulties. Observed for 1 hour blotchy areas subsided. Discharged to home mother given status post vaccine.
Morning after receiving my first time high dose flu vaccine, I awoke w/fever, severe muscle aches, upset stomach, diarrhea, fatigue.  Over the course of Saturday, 9/25 , rash began to develop on face and neck.  Symptoms improved by Sunday, but rash continued to intensify.  Went to my NP PCP on Monday, 9/27.  She ran tests as noted below.  Took photos of rash.  Prescribed medrol dosepak.  Today is day #2 of oral steroids, and rash slowly improving.
No adverse effects; a patient received a dose of VARIVAX following a temperature excursion; This spontaneous report was received from an office manager regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On 16-JUN-2019, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX)  batch/lot # N034553, expiration date: 05-DEC-2019 (dose, unit and route of administration were not reported) following a temperature excursion (product storage error) for prophylaxis. There were no previous temperatures excursion. The vaccine was exposed at the temperature from 15 Fahrenheit degrees to 46 Fahrenheit degrees for 30 days. Data digital logger was involved. No adverse effects were reported.
bottom of her back is hurting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (bottom of her back is hurting) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013721A, 027L20A and 031L20A) for COVID-19 vaccination.    Co-suspect product included non-company product PNEUMOCOCCAL VACCINE for an unknown indication.    Concurrent medical conditions included Epilepsy.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient received dose of PNEUMOCOCCAL VACCINE (unknown route) 1 dosage form. In November 2021, the patient experienced BACK PAIN (bottom of her back is hurting). The patient was treated with IBUPROFEN for Low back pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (bottom of her back is hurting) outcome was unknown.            Concomitant medications of the patient include seizure medications.  On 16-Nov-2021, the patient used heating pad as treatment.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 22-OCT-2009, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, he was treated at a physician office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
3 by 3 inches redness on left arm; tenderness on left arm; left arm warm to the touch; "COVID arm"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (3 by 3 inches redness on left arm), VACCINATION SITE PAIN (tenderness on left arm), VACCINATION SITE WARMTH (left arm warm to the touch) and VACCINATION SITE REACTION ("COVID arm") in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Melanoma (Melanoma scar she has 2 inches below the injection site). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (SLEEPING [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (3 by 3 inches redness on left arm), VACCINATION SITE PAIN (tenderness on left arm), VACCINATION SITE WARMTH (left arm warm to the touch) and VACCINATION SITE REACTION ("COVID arm"). At the time of the report, VACCINATION SITE ERYTHEMA (3 by 3 inches redness on left arm), VACCINATION SITE PAIN (tenderness on left arm), VACCINATION SITE WARMTH (left arm warm to the touch) and VACCINATION SITE REACTION ("COVID arm") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Usual flu like symptoms after 24 hours. However when that was done by left arm became swollen and red with an itchy rash. However not at the injection site itself. Very painful and hot to the touch. This happened at 48 hours. Using aloe vera and cortiszone 10 for relief
Patient received Pfizer COVID primary series dose instead of bivalent booster. Will return in 2 months for correct vaccine.
Headache; Flu symptoms; aches and pain; Rash very bad on upper left arm; Temperature; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included RSV VACCINE PROT. SUBUNIT PREF 2V (ABRYSVO) for prophylaxis.   On an unknown date, the patient received Shingles vaccine (left arm) and ABRYSVO (left arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced headache (Verbatim: Headache), flu symptoms (Verbatim: Flu symptoms), pain (Verbatim: aches and pain), rash (Verbatim: Rash very bad on upper left arm) and fever (Verbatim: Temperature). The outcome of the headache, flu symptoms, pain, rash and fever were resolving.   It was unknown if the reporter considered the headache, flu symptoms, pain, rash and fever to be related to Shingles vaccine.     It was unknown if the company considered the headache, flu symptoms, pain, rash and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-OCT-2023 The patient reported he/she got the shingles and ABRYSVO (RSV VACCINE PROT. SUBUNIT PREF 2V) vaccine on same arm. The patient had temperature, flu symptoms, aches and pain, headache and rash. Rash on upper left which was very bad. The patient stated it took a week to feel better. The pharmacist had to write a report. The patient never reacted before for a vaccinations. It was unknown if the reporter considered the headache, flu symptoms, pain, rash and body temperature to be related to ABRYSVO (RSV VACCINE PROT. SUBUNIT PREF 2V) vaccine.    The follow-up could not be possible as no contact details were available.
Patient reports she received varicella vaccination in right upper arm 6-19-15 (AM). By 9:30 PM on 6-19-15, pt c/o pains on left side (legs and arms), followed by flu-like symptoms (aching over entire body). Pt was seen at urgent care facility on 6-20-15 and was given injection of PHENERGAN and blood work done. Awoke on 6-21-15 with redness at injection site approx 90 x 90 mm. Swelling and slight vesicular area approx 20-30 mm. Pt reports this is first varicella vaccination. Has appt on 6/23/15 with primary MD.
diarrhea; vomited; low grade fever (around 100 degrees F); This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VOMITING (vomited) and PYREXIA (low grade fever (around 100 degrees F)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID-19 in Dec/2020 and was hospitalized until February. She had some blood clots during the COVID-19 hospitalization. She still had a cough and used oxygen.) in December 2020. Concurrent medical conditions included Cough.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Apr-2021, the patient experienced DIARRHOEA (diarrhea), VOMITING (vomited) and PYREXIA (low grade fever (around 100 degrees F)). On 18-Apr-2021, DIARRHOEA (diarrhea), VOMITING (vomited) and PYREXIA (low grade fever (around 100 degrees F)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 100 degrees f (High) 100 degrees F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. The patient drank water and juice.   This case was linked to MOD-2021-142683 (Patient Link).
CONTINUAL INTENSE TINNITUS; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: abstains from alcohol, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 21-SEP-2021) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced continual intense tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from continual intense tinnitus. This report was non-serious.
Patient received 2nd COVID vaccine 5/24/21 therefore was fully vaccinated.  Patient presented to testing clinic with symptoms of cough and tested positive for COVID-19 on 8/26/21.
Experienced violent shaking, not just shivers, violent teeth shattering shaking for 3 hours. Woke up the next day feeling exhausted and sick to my stomach. By 10:30 I was fine.
Left here after her shot and went to the pharmacy. Reports to ARNP-C that she started feeling "bad" at that time. Then her arm is now swollen and warm to touch. Got up in the middle of the night and had a syncope episode. ARNP-C called us and is treating with fluids for hypo-tension today. She has not been not been hospitalized at this time. Flu vaccine was not given.
Patient was diagnosed with COVID-19 infection after being at a Wedding this past Friday, 9/10, developed symptoms of SOB, fatigue, cough on 09/13 and was diagnosed with COVID-19 positive on 09/14 and again positive at our facility 09/21/2021. Patient progressively worsened with SOB and cough and called EMS and was found to be hypoxic with O2 sat at 88% requiring 4L O2 NC to maintain mid 90's O2 sat. Arrived to ER and was found to have possible Right lower lobe pneumonia secondary to COVID-19 infection, hypoxia at 88% requiring 2L NC and was admitted to the hospital for IV Remdesivir and dexamethasone therapy.
Excruciating pain; Muscle weakness; Excruciating pain started on her neck; Excruciating pain in back/excruciating pain in multiple spots in her back; Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers; It is so bad she can barely move; Excruciating pain in shoulder; Muscle pain/muscle burning; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Excruciating pain), MUSCULAR WEAKNESS (Muscle weakness), NECK PAIN (Excruciating pain started on her neck), BACK PAIN (Excruciating pain in back/excruciating pain in multiple spots in her back) and PAIN IN EXTREMITY (Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers) in a 28-year-old female patient 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 Hypertension (High blood pressure), Genital tract inflammation (GTI) and Pain. Concomitant products included LABETALOL for Hypertension.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN (Excruciating pain), MUSCULAR WEAKNESS (Muscle weakness), NECK PAIN (Excruciating pain started on her neck), BACK PAIN (Excruciating pain in back/excruciating pain in multiple spots in her back), PAIN IN EXTREMITY (Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers), MOBILITY DECREASED (It is so bad she can barely move), ARTHRALGIA (Excruciating pain in shoulder) and MYALGIA (Muscle pain/muscle burning). At the time of the report, PAIN (Excruciating pain), MUSCULAR WEAKNESS (Muscle weakness), NECK PAIN (Excruciating pain started on her neck), BACK PAIN (Excruciating pain in back/excruciating pain in multiple spots in her back), PAIN IN EXTREMITY (Excruciating pain in legs/excruciating pain in hands/excruciating pain in fingers), MOBILITY DECREASED (It is so bad she can barely move), ARTHRALGIA (Excruciating pain in shoulder) and MYALGIA (Muscle pain/muscle burning) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included patient was on antibiotic for GTI and on medication for the pain.  It was stated that since the following Monday 16-Aug-2021 or Tuesday 17-Aug-2021 (patient did not remember which day) she has been experiencing excruciating pain, muscle pain and burning and weakness, starting on her neck, shoulder, then her back (multiple spots in her back), legs, hands and fingers. On a scale from 1 to 10 (where 10 was the worst pain a person could feel) she would describe her pain as a 12. It was so bad she could barely move and it was not getting any better.
Pt came back after 1 month of vaccination complaining of sore arm at injection site.
second dose was administered 53 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered 53 days after the first dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027132A and 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D2, VITAMIN D3, MULTIVITAMIN [VITAMINS NOS] and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered 53 days after the first dose). On 08-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered 53 days after the first dose) had resolved. Not Provided          Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
(R) arm erythema, edema & pain within 12 hrs after vaccine, followed by fever to 101.5 & chills lasting 3 days. Improvement of arm redness & swelling after 4 days without treatment.
Sore left arm near site the first 72 hours which I expected . Since then it feels like nerve pain extend above and below the site.
~4 days after vaccination, he developed fever, chills, headache, fatigue, focal L anterior cervical chain lymphadenopathy, sore throat with unilateral left tonsillitis (found to be HSV2+ on PCR swab), and unilateral chin rash (found to be HSV2+ on PCR swab). He was seen 11/15 was treated with Keflex and mupirocin for impetigo and pharyngitis. He returned to clinic 11/19 for no improvement in facial rash on this regimen. Doxy was briefly added to his regimen for potential MRSA coverage. HSV PCR swabs were performed of L exudative tonsilitis and facial rash, which both returned HSV2+. He was subsequently started on Valtrex and doxy was stopped. No known history of HSV or prior lesions suggestive of HSV.
A serious report of transverse myelitis has been received from a study investigator concerning a 28-month-old male participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment or accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history included single seizure and possibly tremors. No concomitant medications were reported. On 10-Sep-2009, the subject received FLUMIST, 0.25 ml per nostril. He received a total of one dose of FLUMIST before onset of the event given on 10-Sep-2009. On 19-Oct-2009, the subject awoke with inability to grip and was complaining of arm pain. From 19-Oct-2009 to 21-Oct-2009, the subject had pediatric and neurologist visits. On 21-Oct-2009, he was hospitalized for transverse myelitis. Nuclear magnetic resonance imaging (MRI) was done and showed swelling of the cervical cord with mild mass effect. His vital signs were following: blood pressure of 89/56 mmHg, pulse of 112, and body temperature of 96.7. On 23-Oct-2009, the subject was discharged from the hospital. His treatment medications included steroids. On 24-Oct-2009, he visited a neurologist. His parents reported that he seemed fine on 23-Oct-2009 till he jumped up and down, and then he looked shocked and stopped walking well. On 24-Oct-2009, the subject was admitted to the hospital again for transverse myelitis. He started on IVIG daily for four days and continued steroid medications. A repeat MRI was done which demonstrated marked improvement of his spinal transverse myelitis with no brain involvement. The subject eventually was walking around without any signs of discomfort and was noted to have appropriate leg strength. He was discharged from the hospital in good condition on 27-Oct-2009. On 10-Nov-2009, his follow-up examination indicated that bilateral hands are still weak but have improved greatly. Forearms (for the most part) have recovered. The subject has been right handed previously. However, his left part was more involved than the right part. The outcome of the event was ongoing. The investigator assessed the causality for the event for transverse myelitis to FLUMIST as remote. The severity of the event was moderate. The alternative etiology was natural causes. The sponsor assessed the causality for the event of transverse myelitis as not related to FLUMIST.
scratchy throat, throat clearing Given sips of cold water, 4 inhalations of albuterol inhaler via a spacer and observation. Symptoms resolved in 40 minutes. Patient observed for 50 minutes
Arm was very swollen, huge lump & very itchy & red. Swelling is going down, lump is still visible now.
Approximately 1 hour after vaccine pt developed flushing, swelling & rash around shot site. 1 hive was visualized on lower part of deltoid away from shot site. Pt took 25 mg Benadryl. BP was initially elevated during observation period (175/107) however decreased over the course of an hour to 155/94.