chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills for 2 hours non-stop, fever of 102, injection site pain, redness about the size of a golf ball around the injection site, tiredness, headache, muscle pain, joint pain, dizziness.
Four hours after dose pat had joint pain all over. That night 10/12/2018 pat had fever and flu like symptoms which she took TYLENOL for. Flu symptoms and fever lasted a day and half into 10/14/18. Pat then had rash develop on 10/20/18 on legs. Pat went to hospital and diagnosed with vasculitis. She had history of vasculitis but it was in remission for years. Was given 21 days of prednisone and pat will follow up with specialist next.
I developed allergy like symptoms like postnasal drip onto my vocal cord. I thought that it was allergies, so I started to take a very the counter medication. I developed Laryngitis. After about 3 weeks, I went to the urgent care. I had no voice. This has happened in the past but It normally would resolve itself with less talking. My throat was so painful that I thought I had strep but was negative. The doctor found an inner ear infection and gave a prescription for AUGMENTIN for 7 days. I started to take the medication a week ago and I felt really bad all week long. I am finally starting to feel better. I was not coughing as much yesterday. He told me that the Laryngitis was viral. I do feel like I have recovered from my symptoms.
she was administering a shot to a patient when more than half the dose leaked out, and some leaked onto her pants with no reported adverse event; Initial information received on 12-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to case 2022SA378582(CLUSTER).  This case involves a 31 years old female who while administering a shot of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] to a patient more than half the dose leaked out, and some leaked onto her pants with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 10-Sep-2022, while administering suspect INFLUENZA QUADRIVAL A-B VACCINE pre filled syringe at an unknown dose (lot UT7680KA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for immunization to the patient more than half the dose leaked out, and some leaked onto her pants with no reported adverse event (accidental exposure to product) (latency: same day).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
he got 2 moderna doses back to back within 5-10 minutes of each other.; pain in arm; Fever; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL OVERDOSE (he got 2 moderna doses back to back within 5-10 minutes of each other.), PAIN IN EXTREMITY (pain in arm) and PYREXIA (Fever) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 25-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Feb-2021 at 4:05 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 25-Feb-2021, the patient experienced ACCIDENTAL OVERDOSE (he got 2 moderna doses back to back within 5-10 minutes of each other.), PAIN IN EXTREMITY (pain in arm) and PYREXIA (Fever). The patient was treated with NAPROXEN SODIUM (ALEVE) for Fever, at a dose of 2 dosage form. On 25-Feb-2021, ACCIDENTAL OVERDOSE (he got 2 moderna doses back to back within 5-10 minutes of each other.) had resolved. On 26-Feb-2021, PAIN IN EXTREMITY (pain in arm) and PYREXIA (Fever) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included unspecified blood pressure medication.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Follow up received and events added Fever and Pain in arm
Area of erythemia, swelling, scratchy throat, the day following injection. Remembers the same as far as swelling and tenderness on 10-18. Pt advised to use ice pack on area and use Benadryl.
Fever; chills; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever) and CHILLS (chills) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (chills). At the time of the report, PYREXIA (Fever) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. Concomitant and treatment information not provided.
onset 11SEP97 fever, swollen glands lt neck, joint aches elbows, knees, h/a duration 3 days;15SEP h/a & fever gone-no joint pain;
CDC stated that there might be a possible increase reaction at injection site. PCP stated there was no concern.
Dizziness, nausea, sudden deafness in right ear. Prolonged vertigo symptoms from 7/30/21 to present (9/1/21). Diagnosed with labyrthitis by ENT.  Daily lightheadedness/dizziness with no relief.
Headache, Myalgia, Arthralgia, Fever, Rash & NauseaVomiting Narrative: required to remain out of work and still having arm soreness.
vial was first punctured on 30-Jun-2022 10:00 am and administered on 01-Jul-2022 09:50 am; patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature) and PRODUCT STORAGE ERROR (vial was first punctured on 30-Jun-2022 10:00 am and administered on 01-Jul-2022 09:50 am) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2022 at 9:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2022 at 9:50 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was first punctured on 30-Jun-2022 10:00 am and administered on 01-Jul-2022 09:50 am). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received dose from a Moderna vial that had been punctured for more than 12 hours and 24 hours at ambient room temperature) and PRODUCT STORAGE ERROR (vial was first punctured on 30-Jun-2022 10:00 am and administered on 01-Jul-2022 09:50 am) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that patient was administered with second Booster.  It was unknown when vial was initially stored in the refrigerator. The vial was first punctured at 30-Jun-2022 at 10 AM and the vaccine was administered on 01-Jul-2022 at 9.50 AM.  The vial was stored post puncture in room temperature in the Pyxis machine.  The vial did not undergo any temperature excursion.  For roughly 24 hours vial was exposed to room temperature range.  Treatment information was not provided.
This spontaneous report as received from a pharmacist refers to a 63 year old female patient with lupus and diabetes mellitus. There was none of the drug reactions or allergies reported. On 24-JUL-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # L012476, exp. date: 10-JUL-2016) 0.65 ml injection, subcutaneously in the left arm. Concomitant therapies included ENBREL. On 24-JUL-2015, the patient developed an injection site reaction 15 minutes after ZOSTAVAX administration. The injection site area became pink and the affected area was the size of a dime. The patient reported to the pharmacist that during the past two days the injection site reaction has become red and looked like "a burn". The affected area had also increased in size (the specific size was unspecified). No treatment was given for the adverse events. None of the lab diagnostics studies were performed. The outcome of the patient's events was reported as not recovered/not resolved. The relatedness between vaccination with ZOSTAVAX and the patient's events was not reported. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 24 year old female who on unspecified dates was vaccinated with the first and second doses of GARDASIL by IM. After receiving the vaccines, the patient experienced headache, fatigue and tiredness. The patient's symptoms resolved after sleeping for about 4 hours. Additional information has been requested.
MOTHER TOOK PATIENT TO THE EMERGENCY ROOM THE DAY AFTER RECEIVING HIS VACCINES (12/11/2020) SHE REPORTED THAT THE EVENING AFTER HIS IMMUNIZATIONS HE HAD DEVELOPED A RASH ON HIS LOWER LEGS, RIGHT LOWER LEG, THEN LEFT LOWER LEG. HE WAS FUSSY, INCONSOLABLE. HE WAS NURSING LESS FREQUENTLY AND HAS LESS WET DIAPERS.
SWEATY, NAUSEA, DIZZY, EYES GLAZED OVER, NOT TRACKING RIGHT, STARTED MORNING AFTER SHOT
The patient had severe neck and muscle pain.  Due to the pain caused the patient to vomit.  The patient was seen at the emergency room 24 hours later where he was given penicillin and pain medications due to severe head pain.  The back pain has subsided as of 10/5/20.  The patient has received a doctors note never to receive any meningitis shot again.
feeling cold; shaking; Pain entire body; nausea; increase in heart rate; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 18th June 2019, less than a day after receiving Shingrix, the patient experienced feeling cold, tremor, general body pain, nausea and heart rate increased. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the feeling cold, tremor, general body pain, nausea and heart rate increased were not recovered/not resolved.   It was unknown if the reporter considered the feeling cold, tremor, general body pain, nausea and heart rate increased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix the day before reporting and developed the following symptoms feeling cold, shaking, pain entire body, nausea, and increase in heart rate.  The patient went to see her physician for the symptoms at the time of reporting and her physician performed an Electrocardiography which was normal.  The reporter consented to follow up. Emergency room visit was required.
28MAY98 soreness @ inj site;29MAY98 redness & heat 6cm diameter;31MAY98 inc redness;1JUN98 inc redness & itching 18cm diameter;
Received vaccine on 2/3, On 2/5 developed pain in upper back and bilat axillae soft tissue. Feels like painful muscles. No rash. Started to feel better after 10 days. Advil PRN only treatment remedy tried.
swelling, erythema of L shoulder spreading to back, painful, appears consistent with cellulitis
Myalgia & Arthralgia Narrative: Reports recieved #2 dose covid vacc on 1/26/21, noticed 1 neck pain in occipital area at base of skull and in 1 posterior neck the past 3 weeks, since 2/18/21. Has h/o parotidectomy, has also noticed some tenderness mild swelling over 1 postauricular and 1 occipital lymph node. Has appt with pmd today, plans to have c spine xray
pt began napping (unusual for pt) & was cranky p/the shot 3AUG93; 5AUG93 pt has a red, splotchy rash (diffuse); mom to contact MD for eval;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 4:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 4:15 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 71.76   Concomitant medications were not provided.  On 12-Jan-2021 Excursion time was reported at 8 am and 9 am with temperature as 34 and 34 degrees Fahrenheit respectively , total doses given for the day was 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 12-Jan-2021. 3 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Wheezing, shortness of breath, fever, warm body but felt chills, extreme body aches especially in neck, low back and knees, dizziness.
Severe chills followed by vertigo presyncope and fainting.  Could not stand.  Fell when I fainted and landed very hard.  It is now 1 p.m. and I am just now able to sit up in a chair.  Last night, hands and feet were blocks of ice, couldn't stand to take temp.  Barely able to get to bathroom, rocketed off walls and furniture.  Extreme weakness in legs.
Approx. 25 minutes after the second Moderna vaccine I developed facial numbness. This lasted all say the day of the shot, and since the shot the numbness comes and goes. The numbness does not keep me from moving my face or cause a change in my face.
Vaccination was successful.  Immediately afterwards I engaged the needle guard.  The guard did not cover the tip of the needle and I jabbed my thumb.
Patient received the vaccine 10/16/19. She woke up on the 17th with redness and swelling to her left arm. She has placed ice packs and taken Benadryl. Today 10/18/2019- the redness and swelling, and heat have increased. Continuing ice packs/medication
Following initial vaccination given at work around 11:45 am I started feeling weak and lethargic.. almost as of electricity was running through my entire body.  At approximately 3pm I began to feel and increased pain sensation run down my left arm down to my hand. At approximately 5pm, I began to feel my whole left side of face with prickly tingling sensation. I called my administrator close to 6pm.. as symptoms began to worsen and whole left side of face became numb along with numbness tingling sensation running down my left arm down to hand. I was instructed to go to ER. As I was driving to ER from work, I began to feel my lips become more numb and felt as if my throat was swelling up and getting tight finding it difficult to breathe. I was given a steroid injection at ER and monitored. I had to stay home for close to 4 days following ER visit, and continued with numbness to left side of my face. The symptoms persisted along with fever chills, flu like symptoms and still till this day have occasional numbness to left side of face.
A report was received from a health professional on 11/13/2001, concerning a 69 year old male, who experienced an injection site reaction, 3 - 4 days after receiving the Fluviron vaccine on 11/06/2001. On 11/09/2001, the patient experienced severe pain at the injection site, approximately 3 - 4 days after receiving the Fluvirin vaccine in the deltoid portion of his left arm. There were no signs of infection of inflammation including redness and tenderness at the injection site. The patient had received previous influenza vaccinations (brand unspecified) without incidence. The patient did not receive any treatment for the pain. At time of report, the pain had continued for 3 days but was improving. The reporter has assessed the relationship of the study medication to the event as probable.
Pt. received injection on Monday, July 9 presented at pharmacy July 11 with a swollen, red hot arm. We advised BENADRYL and TYLENOL, and contacted M.D. He will not receive second shot.
Pt vaccinated with MMR/TINE TEST 1 min later fainted sustained minor abrasions of face as result of syncope awoke spontaneously in 20 seconds after fainting.
16 month-old here with mother for follow-up on ear infection. Had completed antibiotics x 10 days and no issues at this time.  (+) MMR, varicella - given on 4/19/2023 4 days ago, had fever x 2 days and then on third day, had erythematous rash that started on the face and spread to the trunk and extremities. (+) cough and congestion.
Information has been received from a female patient who in 2001 was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included influenza virus vaccine (unspecified). The patient developed a rash at the injection site of the right upper arm immediately after the vaccination of PNEUMOVAX 23. She also developed a rash at the injection site of the left upper arm immediately after the vaccination of "influenza virus vaccine" (manufacturer unknown) on the same day. There were no labs and diagnostic tests performed. The patient sought unspecified medical attention. At the time of the report, the patient had recovered. Additional information has been requested.
pt reports arm ache p/MMR shot; no lump @ site when lifted arm; site hurt off & on; no swelling occurs 1wk; c/o weakness when hurts;
Erythema/induration at the site of injections. No tenderness. S/s start within 24 hours of receiving the vaccinations. Tx: symptom care/cool compresses prn.
Patient is a 79 y.o. male patient of MD with history of pulmonary embolism, stroke, traumatic brain injury, aspiration risk presented with COVID-19 infection     Acute hypoxic respiratory failure Viral sepsis due to Covid-19 Virus infection Date of onset of symptoms: 10/18/2022 Symptoms present on admission: Fever, cough, weakness Date of covid positive test: 10/20/2022 Vaccination status: vaccinated. Patient is unsure if had booster Imaging: Chest x-ray shows left basilar atelectasis/scarring  Oxygen requirements on admission: 2 L Current oxygen requirements: room air Medical therapy: Remdesivir and Steroids (10 days total of therapy) Consultants following: None Anticipated special isolation end date: 10/28/22 CRP 40, ESR 18 SIRS (+) Albuterol, Tessalon Perles, Robitussin PRN IS Home O2 eval today. Does not qualify for home oxygen Discharge on Decadron x7 more days, and Tessalon Perles PRN  History of pulmonary embolism Continue Apixaban   Traumatic brain injury At baseline able to walk with help of walker Continue Baclofen 10mg TID PRN, Donepezil 5mg, Lexapro 20mg, Remeron 7.5mg HS Continue aspiration precautions PT/OT/CM consulted. 2-3 days per week of therapy. HHC at discharge   Obesity BMI 30.9 Recommend lifestyle changes
Approximately 5 minutes after receiving her vaccine patient reported to healthcare staff her lips were tingling and tongue was starting to swell.  She was directly monitored by nursing staff and treated with 50mg of oral benadryl.  She did not present with any other serious or worsening symptoms and returned to her baseline about 15 minutes after treatment of benadryl.  The event lasted approximately a half hour and she resumed her normal activities within 45 minutes of the vaccine.
Patient given pediatric dose Hep B of 0.5 ml. Needed full adult dose of 1.0 ml. Patient notified and will receive second pediatric Hep B dose of 0.5ml on 7/29/2020
8/20 pt had low grade fever 100.5. Treated with Tylenol. Mom called RN 8/22 & informed it was most likely MMRV side effect. 8/23 red patch formed with fever 103, went to ER given Keflex, Red patch grew 8/24 Urgent Care & her Tx with clindamycin, red spot better fever gone
it is aching; her feet and hands are aching; she doesn't feel good; she is tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (it is aching), PAIN IN EXTREMITY (her feet and hands are aching), FEELING ABNORMAL (she doesn't feel good) and FATIGUE (she is tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (it is aching), PAIN IN EXTREMITY (her feet and hands are aching), FEELING ABNORMAL (she doesn't feel good) and FATIGUE (she is tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (it is aching), PAIN IN EXTREMITY (her feet and hands are aching), FEELING ABNORMAL (she doesn't feel good) and FATIGUE (she is tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the vaccine on 01Mar2021 and today 02Mar2021 it is aching, she was tired, her feet and hands were aching, she doesn't feel good, she took 4 Tylenol. No more information was provided