chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid arm/slight soreness in the arm; really really badly itching; it had a harder look; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Covid arm/slight soreness in the arm), PRURITUS (really really badly itching) and ILL-DEFINED DISORDER (it had a harder look) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Covid arm/slight soreness in the arm), PRURITUS (really really badly itching) and ILL-DEFINED DISORDER (it had a harder look). At the time of the report, PAIN IN EXTREMITY (Covid arm/slight soreness in the arm), PRURITUS (really really badly itching) and ILL-DEFINED DISORDER (it had a harder look) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   This case was linked to MOD-2021-037201 (Patient Link).
Unusual shortness of breath and rapid heart rate when sitting or laying down.  Seems to come out of nowhere and didn?t have these conditions before.
This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. Patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-SEP-2018, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 for prophylaxis (lot # N001007, expiration date 19-SEP-2018, dosage and route of administration were not reported). No adverse effects were reported.
WITHIN 15 MINUTES, PATIENT EXPERIENCED SWELLING/NUMBNESS TO LIPS, FEELS SWELLING IN THROAT, SHORTNESS OF BREATH
Headache @ 2:00 PM for the rest of the day. Nausea & stomach ache for 36 hours after flu shot.
Rash, redness, swelling, warmth, and edema presenting 2 days after PREVNAR-13 injection that worsened over 4 days (affected area extended). Cold compresses used for treatment. Patient refused antibiotics for possible cellulitis. Reaction resolved within 1 week of the injection.
Pt recvd 3rd dose of Hep B vax intradermally instead of intramuscularly; Subsequently, the pt developed a local rxn;
received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was defrosted in 30Aug2021 and was administered on 01Oct2021.  Reporter stated that patient was fine. No concomitant medication were provided. No treatment information were provided.   This case was linked to MOD-2021-358921, MOD-2021-358773 (Patient Link).
Expired vaccine administered to 6 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 6 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 6 patients). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 6 patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.
Rash, facial swelling.  Pt was given Benadryl, Solu-Medrol and pepcid via IV.  Pt was given a prescription for Zyrtec, benadryl and a medrol dose pack.
A few minutes after receiving the vaccine, the patient complained of feeling hot, flushed, and faint.  She then wanted to lie down on the floor.  I called an ambulance, as she refused to let me take her blood pressure.  When the EMTs arrived, she was sitting up and feeling notably better.  She and her mother declined going to the hospital.
After-hours RN completed telephone assessment of 6 yo child reportedly refusing to stand on Right leg approximately 24 hours after receiving 1st dose of Pfizer vaccine. Mother reported child without known injuries, no obvious deformities, swelling, redness or localized areas of pain along Right leg. Mother states child has "very high tolerance for pain" but limping to the point he almost falls, wants to be carried by his mother, and if put down to walk, will instead go on all-fours and crawl.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 73-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fall (collapse due to stress and infection and was on respirator). Concurrent medical conditions included rotator cuff tear and carpal tunnel syndrome (causes numbness in hands and fingers). On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than 3 months after receiving SHINGRIX, the patient experienced fatigue, disorientation, feeling abnormal and influenza-like symptoms. On an unknown date, the outcome of the fatigue, disorientation and feeling abnormal were recovered/resolved and the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the fatigue, disorientation, feeling abnormal and influenza-like symptoms to be related to SHINGRIX. Additional information was reported as follows: After vaccination with SHINGRIX the patient felt what she called mild flu like symptoms of fatigue, feeling out of sorts and slight disorientation. The events experienced by the patient were mostly resolved. This case was linked with case US2018GSK170183 (2nd dose), reported by the same reporter for the same patient.
This spontaneous report was received from a certified medical assistant who administers vaccines concerning a patient of unknown age and gender. On 09-NOV-2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. On 05-SEP-2012, the patient was vaccinated with the second dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. On 13-NOV-2012, the patient was vaccinated with the third dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA277871, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  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 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.
Injection site raised after 8 days, itchy, red. Redness and itching spread to larger area of arm 9 days after injection.
BODY ACHES; FELT EXTREMELY TIRED OR FATIGUE; FELT NAUSEOUS; HEADACHE; SORENESS IN ARM; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included: acid reflux, and insomnia, and concurrent conditions included: migraines, cholesterol, thyroid, occasional alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies, no drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced soreness in arm. On 25-AUG-2021, the patient experienced felt nauseous. On 25-AUG-2021, the patient experienced headache. Treatment medications included: ibuprofen. On 26-AUG-2021, the patient experienced body aches. On 26-AUG-2021, the patient experienced felt extremely tired or fatigue. The action taken with covid-19 vaccine was not applicable. The patient recovered from soreness in arm, felt nauseous, and headache on AUG-2021, and had not recovered from body aches, and felt extremely tired or fatigue. This report was non-serious.
This spontaneous report as received from a physician via company representative refers to a 97 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number not provided) (route: injection). The patient experienced vomiting after receiving ZOSTAVAX. The outcome of vomiting was unknown. The patient saw the doctor for seeking medical attention. Additional information is not expected.
On day of vac developed dizziness, n/v, abd pain started about 15-20 min post vac & continued at home along w/ chills, felt hot/cold (no thermometer to take temp), diarrhea w/ cramping. Some diarrhea w/ cramping next day.
Patient is new to office as of 4/7/2022.  He states that every since he received both hs pfizer covid vaccine last year, he has had issues with his left shoulder.  He did not seek medical care until now.  He states he immediately started with left shoulder/deltoid pain with the first vaccine.  He continue to soreness to area for months which led to progressive limitation with ROM of the left shoulder.  He has not dealt with it until now since he is getting worse.  He has limited left shoulder abduction.  X-ray from 4/7/2022 suggests frozen shoulder.  Encouraged to do home exercises everyday.  He does not want PT.  MRI is also planned.
I had chest pains and chills and a little fever. Had shortness of breath with right lung pain or towards center of chest.
Vaccine site is hot to touch; Warm to touch; Arm is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccine site is hot to touch), SKIN WARM (Warm to touch) and VACCINATION SITE PAIN (Arm is red) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Vaccine site is hot to touch), SKIN WARM (Warm to touch) and VACCINATION SITE PAIN (Arm is red). At the time of the report, VACCINATION SITE WARMTH (Vaccine site is hot to touch), SKIN WARM (Warm to touch) and VACCINATION SITE PAIN (Arm is red) outcome was unknown.            No relevant concomitant medications reported. No treatment medications reported.
This spontaneous report as received from a consumer refers to her 54 year old husband. In October 2013, the patient was vaccinated with a dose of PNEUMOVAX23 lot # J007060, expiration date 28-AUG-2014 (dose, frequency and route were not provided). Other suspect therapies included Td, absorbed (manufacturer unknown) (dose, frequency, route, lot # and expiration date were not provided). The wife of the patient reported that her husband was at death's door with illness that occurred after receiving PNEUMOVAX23. The reporter stated that, at an unspecified time after receiving PNEUMOVAX23 and Td, absorbed (manufacturer unknown), the patient began to feel ill, spiking a fever, finding it "painful to breath" and experiencing extreme rib pain and discomfort. As the patient's discomfort increased, he visited the emergency room of a hospital, "due to the seriousness of his condition." Computerized axial tomography (CAT) scan "ruled out" cancer and a blood clot. On 16-NOV-2013, the patient was diagnosed with pneumonia and a collapsed lung and was admitted, according to his wife, who mentioned being "told" that her husband had a "dent" X-ray. The patient remained hospitalized at the time of the report, where he was being treated with both oral and intravenous antibiotics. The outcome of pneumonia and collapsed lung was reported as not recovered/not resolved. Additional information has been requested.
just a little draggish; This is a spontaneous report from a contactable consumer or other non hcp.A 74-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0162, Expiration Date: 31Jul2021) via an unspecified route of administration on 20Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient is not related to study or programme.On an unspecified date, the patient experienced just a little draggish. The outcome of events was unknown.  No follow up attempts possible. No further information is expected.
About two weeks after vaccine, I started to have respiratory symptoms. After two months of suffering from them, I figured out it's more like gastric reflux, GERD. Wheezing, coughing. Lots of mucous and fluid and some burning in my belly. I did a video visit with my respiratory doctor (an independent physician) in May, not sure of date. He did not believe it was respiratory. I recently saw him again on June 21 and he confirmed that it wasn't respiratory. A nutritionist and acupuncture doctor has helped me the most. I did see my primary care doctor today and she confirmed that I'm doing better. The nutritional changes I've made have helped me the most. I am about 85% better.
Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant therapies. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot number M031650 with expiration date of 16-MAR-2018 orally (strenght, dosage schedule and anatomical location were not provided) for prophylaxis.The administered doses were exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes (digital data logger) without any previous temperature excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA009504: US-009507513-1701USA008111:
I went to my doctor and found a soplo in my heart. Iam pending to get an Eco heart on jan25, 2022 to make sure every thing is ok.  I need to confirm if a third shot will be recommended. The doctor said that the soplo is very  small but need the Eco to make sure every thing is ok.
This case was reported by a newspaper reporter to a manufacturer employee and described the occurrence of hepatitis in a 2 year old female patient who received hepatitis A vaccine inactivated. This report has not been confirmed by a health care professional. On an unspecified date, the patient received the first dose of Havrix (lot VHA745C9). At an unspecified time following the administration of Havrix, on an unspecified date, the patient reportedly developed general hepatitis. The reporter stated that the hepatitis was some form of hepatitis other than hepatitis A. The child was said not to be enrolled in daycare and no other family members had contracted hepatitis. The patient was hospitalized and a liver transplantation was required. No further information was provided. Comment: Due to the severity of this event, the manufacturer has elected to submit this report as an expedited report. On 22Sep04 a manufacturer employee was contacted by a reporter. I asked the employee that if she had any further contact with the reporter, the reporter should be encouraged to ask the pt's mother or pt's physician to contact the company. On 03Oct04, Manufacturer sent a letter to the reporter via email (the only address we could obtain) asking that the reporter either give us her own mailing address or the pt's mailing address. The email explained that we would like to obtain written authorization from the mother to contact the child's physician and listed our Customer Response Center phone number for the mother or physician to call directly. If ther is no response to this email, a second email will be sent on 03Nov04. Any additional details we received will, of course, be forwarded to the agency as soon as possible. Follow up states no response to requests for additional information. Missing data from GlaxoSmithKline (October 1, 2004 to October 21, 2004). Reporter was newspaper journalist no follow-up available.
Yeast infection; This spontaneous case was reported by a consumer and describes the occurrence of FUNGAL INFECTION (Yeast infection) in a patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced FUNGAL INFECTION (Yeast infection). At the time of the report, FUNGAL INFECTION (Yeast infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Aching intermittent Left-sided CP x 2-3 hours, started while sitting today, radiates to Lt shoulder, deep breath makes worse; J&J COVAX yesterday.23 yo m presents with chest pain that radiates to lt shoulder, chills last night. J&J COVAX yesterday
Moderna bivalent was administered to the patient in her left arm.  When the needle was removed the vaccine leaked from the insertion site.  The amount that did not absorb was not measurable.  Another does was not provided.  No adverse reaction - no signs or symptoms exhibited.
Right shoulder pain started promptly after she received flu vaccine. She thought the placement seemed "abnormally high". Right after that, she started having R shoulder pain, tender to palpation at site and mild decrease in range of motion cross body abduction and overhead movements. Evaluated by MD 11/21/19 and referred to ortho for evaluation and possible steroid injection.
Mild headache, mild nausea, minimal soreness at injection site and fuzzy sound in ears for just a little over a day.
Multiple episodes of tachycardia (60+ since 2/28/2021) with accompanying symptoms of flushing labored breathing and triggering of bowels.
12/31/2020 Pfizer Covid vaccine Lot # EL 0140 01/21/2021 Pfizer Covid vaccine Lot # EJ1686 03/29/2021 became ill 3/31/2021 tested Covid positive with PCR test 04/9/2021 returned to work
5 hours after HIB & PREVNAR had hours of inconsolable screaming, jerking that mom thought was seizure. Went to ER - thought to be screaming & upset no seizure.
After vaccination and doing 20 wall push ups, I went to bathroom and noticed red flushing of face and chest. I then took 2 Tylenol. I notified Nurse Practitioner who had me go to separate room for monitoring and questioning. My blood pressure had risen to 144/70?. SaO2 97% and HR 82. In 5 min., it was down to 120/70 (normal for me). Then after walking in another 5 min. it was back up to 138/?. The flushing was lessening and I left in@ 30 min. to go grocery shoppping and home. I home I took 2 Benadryl and went to bed early. I awoke with just the sore left shoulder and better throughout day.
5 hr p/vax pt exp chills, t99;that afternoon pt exp numbness of fingers rt hand;numbness to elbow;the next day exp numbness of rt knee & hips;2 days post vax pt exp numbness & tingling in jaw;muscle weakness;CVA;dx GBS;drag leg when walk
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 23-DEC-2016, the patient was vaccinated with a expired dose of VAQTA, lot number L034381, expiration date 21-DEC-2016, (dose number, route and anatomical location were not reported), for prophylaxis. No adverse effects were reported. No product quality complain was involved. No other suspect or concomitant therapies were reported. This is one of several reports from the same reporter. Additional information is not expected because consent for follow up was not given. Sender's Comments: US-009507513-1701USA009559: US-009507513-1701USA001773.
Patient experienced rash on lower arm (opposite arm from vaccinated arm) a couple hours post vaccination.