chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heavy breathing, feeling tired. Went home to bed. Next morning went to work and arm felt hot. After 9-hour shift went home, taking off shirt found left arm to be extremely swollen, hot and red. The red was appearing in her arm as if you poured something on it and it was running down unevenly - like streaking I assume. She then took Benadryl and it took approximately 4 days to resolve. Did not report to CPH, doctor, or anyone outside the home. Patient came in today with a friend to get his MCV4 and happened to mention the side effects to me. I then asked further questions, it had not been reported, so I am completing a VAERS today, 03/08/2012.
Shingles vaccine 2/2/2012, 3:20pm at the clinic. Left there 15mins later. Patient had to stop driving said he did not know the way home. I drove him back to the clinic, they did a CT, found nothing wrong with is brain no stroke. He had episodes of confusion, disoriented not making any since not known what he had to do. After the initial episode he lost a great deal of his memory there were no symptoms and no warnings. On 3/4/12 the clinic did an MRI on his head and found nothing that would cause these problems. On 4/23/12 the clinic did another CT and again found nothing wrong. On 9/27/12 another episode I took him to a hospital they ordered an EEG the findings were again nothing wrong. On 9/14/13 patient was having severe stabbing pain on the rt. side of his head down his neck. Pain was so bad he was yelling and his body stiffened in his recliner. I took him back to hospital emergency. The doctor ordered carotid ultrasound on both sides. Those were ok also. 10/7/13 patient had stabbing pains again, this time on his left lower side rib cage very painful. Lasted a short time. I have all the reports if you need to see them. All this started happening about 15mins. after that Shingles Vaccine was given to him. Because of this, he has not regained his memory, had his driving privileges taken from him, which lost him his job. This was a serious and detrimental event for him.
no additional adverse event; inadvertently administering a dose of PROQUAD by the intramuscular rather than subcutaneous route; This spontaneous report as received from a physician refers to a 4 year old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 16-JUN-2020, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S031705, expiration date: 06-APR-2021 (Albumin status: recombinant Human albumin (rHA))(strength and dosing schedule were not reported) intramuscular rather than subcutaneous route, for prophylaxis. No additional adverse event reported.
Received MENACTRA and FLAURIX (quad) on (L) arm 11/26/13. Presented to ER 11/29/13 with (L) axillary pain. No fever, rash, cellulitis. Treated with ibuprofen and discharged.
InfInformation  has been received from a nurse practitioner referring to a female patient over 55 years of age. Concurrent conditions and medical history of the patient were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot #,  expiry date, dose and route unspecified). Other suspect and concomitant therapies were not reported. On an unknown date, nine to ten days after the ZOSTAVAX vaccine was administered, the nurse practitioner explained that the patient returned to the office and was experiencing pain in the left leg "similar to shingles" (included as stated) but there was no rash. The pain extended from the knee to mid-thigh on the outside of the left leg. The outcome of the event was unknown. Additional information has been requested.
Lips are turning black after first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIP DISCOLOURATION (Lips are turning black after first dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP DISCOLOURATION (Lips are turning black after first dose). At the time of the report, LIP DISCOLOURATION (Lips are turning black after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  No treatment information provided.
the next day after his vaccine had a 102 degree fever; Got so sick; He got his along with the flu shot; He got his along with the flu shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; influenza vaccine (FLU) (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "the next day after his vaccine had a 102 degree fever"; ILLNESS (non-serious), outcome "unknown", described as "Got so sick"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "He got his along with the flu shot". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter stated that her son in law, the next day after his vaccine had a 102 degree fever. Stated that he got his along with the flu shot, and he got so sick. He lives in with her daughter. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional adverse events reported; A dose of an expired M-M-R II was administered; This spontaneous report was received from a nurse referring to an 18-month-old patient. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 28-MAY-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S014429 with an expiration date on 09-MAY-2021) at a dose of 0.5 milliliters (ml) for prophylaxis  (strength, anatomical location,  and route of administration were not reported).         On 28-MAY-2021, the patient was administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (expired product administered).    No additional adverse events were reported.  No temperature excursions were reported.
patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. HCP stated that she had 22 forms (from the CDC) about patients that were administered expired vaccines, she was asking if they should revaccinate those patients. Number of doses/vials: 22 The date of vial initially stored in the refrigerator was unknown. Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022.  The vial did not undergo any temperature excursions. In Apr-2022, patient received second booster dose which was expired on 27-Mar-2022. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received contains no new information. On 28-Apr-2022: Follow-up received included significant information wherein reporter, patient, suspect information updated.
Friday after the shot was good, just a sore arm. On Saturday I developed a fever of 101 and chills and was very tired. I felt a little better on Saturday night and Sunday morning after some Tylenol 500 mg. My fever would break then come back for a bit  By Sunday afternoon my back began to really hurt. I have some chronic back pain so didn't think too much of it just tried to massage it and stretch it out. However it just kept getting worse and the pain radiated into my chest around 9:00 PM Sunday night.  It continued to get worse until about midnight, and I  ultimately decided to go to the ER.  The tylenol helped reduce the pain by the time I got into the ER but I went in anyway because I was concerned about the intensity of the chest pain I'd had earlier.  I was tested for heart enzymes and they were slightly elevated, at .12.  On this result, I was admitted to the hospital on suspicion of having suffered a heart attack.  I was put on a heparin drip and my troponin levels were tested every 3 hours.  They continued to rise to a high of .67.  More testing was done, and the cardiology department concluded that I had not suffered a heart attack due to the low troponin levels but that instead I was dealing with heart inflammation.  Every doctor and nurse there commented that there had been other patients coming in with cardiac inflammation from vaccines as well.  Due to my family history of heart issues and my own existing risks, I was moved to the hospital where I was examined in the cath lab via angiogram.  This found no blockages in my arteries, further confirming the cardiology suspicion of cardiac inflammation, and I was given a diagnosis of pericarditis and prescribed colchicine to treat the inflammation.
This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that the VARIVAX subcutaneously, lot # R002507, expiration date 25-JAN-2022, indicated for prophylaxis (strength and dose were not provided), underwent multiple excursions since August 2018 and, on 16-OCT-2018 the vaccine VARIVAX was administered to one patient. The administered dose of the vaccine experienced a temperature excursion since August 2018 to 31-JAN-2019, the reported excursions were: 6 °Fahrenheit (F) to 14 °F (8.7F) for 15 minutes. 6 °F to 14 °F (8.7F) for 45 minutes. 15 °F to 46 °F (17.6F) for 2 hours. 15 °F to 146°F (19F) for 1 hour and 45 minutes. 6 °F to 14 °F (8.8F) for 15 minutes. 15 °F to 46 °F (20.5F) for 2 hours. 6 °F to 14 °F (12.8F) for 2 hour and 45 minutes. 6 °F to 14 °F (5.95F) for 15 minutes. 6 °F to 14 °F (8.8F). There was a digital data logger involved, and there was previous temperature excursion. No adverse effect was reported.
R facial droop, headache, dizziness and neck pain, started ? 2/27/2021
53-year-old male who received the Covid 19 vaccination today and  after 10 minutes developed dyspnea and pain in his left arm.  He denies rash or  swelling in his mouth, throat, lips.  He has a history of asthma. No hypoxemia. Anxiety
Case number PHEH2016US023385, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 31-year-old patient of an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into right arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
Information has been received from a physician concerning a female (age unknown), who on 25-SEP-2007 was vaccinated in the right arm with a first dose of Gardasil vaccine. Concomitant therapy included hormonal contraceptives (unspecified). On 08-OCT-2007, the patient developed pain in her right hand which turned into shooting pains in the right arm, and a swollen, dark red knot above her right wrist. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
small outbreak; my shoulder still hurts to the touch; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chronic pain (lived with chronic pain for 15 years).   On an unknown date, the patient received the 1st dose of Shingles vaccine. In August 2021, unknown after receiving Shingles vaccine, the patient experienced shingles and shoulder pain. On an unknown date, the outcome of the shingles was unknown and the outcome of the shoulder pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles and shoulder pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient stated that, having lived with chronic pain for 15 years and about 5 hours of the first Shingles shot, the patient's body felt like it filled with sand, laid in bed and almost cried because he/she felt zero pain, just a pleasant heavy feeling.  The patient said that, he/she could not wait for shot second shingles shot. The patient had another small outbreak a couple weeks ago from the time of reporting and his/her shoulder still hurts to the touch.
No additional AEs; HCP calling to report that one of her staff administered both PROQUAD and VARIVAX to 13 month old patient on 11/28/2022. No further information provided, no additional AEs, no PQCs.; This spontaneous report was received from a Physician and refers to a 13-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-NOV-2022, the patient was vaccinated with both varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, both administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Overdose). No additional Adverse events were reported.
Subsequent to receiving an unspecified dose of Lymerix the pt had a localized skin reaction to a tick bite at the bite site. The most recent information reports the outcome of the event as unknown.
patient being administered both IPOL and KINRIX and therefore received an extra polio dose,with no reported adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who was being administered both ipol and kinrix and therefore received an extra polio dose,with no reported adverse event while receiving vaccines KINRIX and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On 01-Aug-2022, the patient received a  dose of suspect IPV (VERO) (lot T1E871M and expiration date: 10-Oct-2022) at a dose of 0.5ml via intramuscular route in the right deltoid and suspect KINRIX not produced by Sanofi Pasteur lot number not reported at  a dose of 0.5ml via unknown route at unknown  administrative site for immunization.  On 01-Aug-2022 (latency: same day),  the patient being administered both ipol and kinrix and therefore received an extra polio dose,with no reported adverse event (extra dose administered).   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event .  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 guidelines. 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.
Patient is 12 years old on vaccination day and received a Pediatric dose of Pfizer COVID vaccine.
Pt states she started to feel lightheaded, SOB and dry throat within 1 hour of vaccine.
Swollen, warm to touch after 6 days. told to take benadryl and put call into MD.
1/9/21 at 1030pm began with chest pain, chills, sweats, fever 101, body aches, joint pain, headache, fatigue. Took tylenol and slept. Next morning, 1/10/21,w oke up at 10am, fever 102, continued with chills, sweats, body aches, joint pain, headache, fatigue and began with intermittent SOB. Took tylenol and slept most of the day and night. Next day, 1/11/21, temp 100.8, continued with chills, sweats, body aches, joint pain, headache, fatigue, intermittent SOB and chest pain. Continued to take tylenol and alternated with ibuprofen. Rested most of the day in bed. 1/12/21, no fever, intermittent SOB with activity, continue with headache and joint pain. 1/13/21 better today. Continue with intermittent SOB with activity and feel fatigue. No fever.
SOB, Placed emergently on BiPAP for increased work of breathing. Given Decadron.
A few minutes after vaccine was given patient reported having chest pressure, 5/10. He was evaluated, VSS and PE was unremarkable. Within a few minutes he reported having worse pain 6/10. The decision was made for patient to go to ED for further evaluation . He refused EMS transport and his brother took him to ED.
Patient reports extreme soreness later on the first day. Over the next few days..her arm was red with swelling across upper arm and slight warmness. By Friday, the redness had moved downward along with swelling and was still a little sore/sensitive. Patient says that it was subsiding as time went on though.
Lump in arm; Arm purple and blue; Lump turned itchy; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE MASS (Lump in arm), VACCINATION SITE BRUISING (Arm purple and blue) and VACCINATION SITE PRURITUS (Lump turned itchy) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump in arm), VACCINATION SITE BRUISING (Arm purple and blue) and VACCINATION SITE PRURITUS (Lump turned itchy). At the time of the report, VACCINATION SITE MASS (Lump in arm), VACCINATION SITE BRUISING (Arm purple and blue) and VACCINATION SITE PRURITUS (Lump turned itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.
She got her vaccine, had pain at the injection site that moved up her arm.  She was having chills.  She took a nap and when she woke up she could not lift her arm at all.  Had pain in the neck, wrist, arm.  She had pain/feelings in that arm.  She woke up sometime after midnight sitting up because she woke up and had a tingling sensation in her throat and felt as if her throat was going to close on her.  She did not go back to sleep fearing this.  She took 600 mg of Tylenol, as well as 600 mg today.  She has been better today, and thinks that she had the swelling and pain due to the way that the woman gave her the injection.   She has not notified her doctor.  She is not having any chills, and her arm is just sore right now, but able to use is otherwise.  When she lifts the arm it hurts, as well as shoulder/ball of her arm hurts.
Branch retinal artery occlusion (stroke) causing vision loss   Currently taking aspirin and Lipitor as prophylactic measure while continuing to undergo extensive testing
The patient is at the ER today 11/09/2020 4:00 PM. Patient claims on November 1, 2020 the third day after getting the immunizations he started feeling sick. He's at the ER today having severe muscle spasms at the stomach and back. There is a knot on the stomach that moves and it is causing him so much pain. They are doing test on him but couldn't find any and he has not taken any new medicine, On November 1st he also got chest congestion, his doctor prescribed him Zpack but didn't get better. No fever.
I experienced  a fever of 100.7 with it getting as high as 101, I have joint pains and body aches and pain at the injection site. Kinda the same as when I had Covid.  I was only sick one day.
received Fluarix expired dose; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2021, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 22nd September 2021, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received expired dose of Fluarix season 2020-2021, which led to expired vaccine used. The patient was revaccinated with correct Fluarix Tetra 2021-2022 season. The VARES report was filled by facility for the patient. The reporter confirmed that, there were 52 patients who received expired dose of vaccine and this is one of 52 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201400:Original Case : US2021201400 US-GLAXOSMITHKLINE-US2021AMR201274:same reporter