chrisvoncsefalvay/vaers-outcomes huggingface dataset:
History is indicative of recurrence of ocular myasthenia gravis. Uncertain whether he is having swallowing issue and fatigue as part of this. Symptoms began 2-3 weeks following his second Moderna Covid 19 vaccination.
Vaccinated 3/18 same day itching. 3/19 swelling redness, pain, tenderness, ROM limited.
This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions, drug and allergy history were not provided. It was reported that on 17-FEB-2017, 20-MAR-2017, 22-MAR-2017, 28-MAR-2017, 15-MAY-2017, 18-JUL-2017 and 24-AUG-2017, the patients were vaccinated with an unspecified number of improperly stored doses of M-M-R II lot # M000768, expiration date 05-JAN-2018 (dose, frequency and administration route were not reported), for prophylaxis. Concomitant therapies included the sterile diluent used for reconstitution, which did not undergo a temperature excursion. The data logger registered a temperature of 47° Fahrenheit (F) to 77°F (-3.10) for 17 hours 15 minutes. There were not previous temperature excursion. No adverse effects were reported.
Client became pale and stated he felt faint.  Client dazed and was unresponsive to voice X 2 for approx. 5 sec.  Client stated ears ringing.  911 called.
Reported by client less than 15 minutes after administration.  Client left before observation time expired.  Client called saying she felt throat was swelling.  Denied any problem breathing.  Advised to go to nearest ER.
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  It was not known on which arm the patient received her first and second dose and the patient reported no adverse reactions after the first or second doses.   The facility received the vaccine in October 2021. The reporter reported that when the lot number of Moderna COVID-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on website the expiration date was found as August 14, 2021. The reporter also reported that she had a screenshot of the lot number 010A21A, entered into the lot number expiration date check program that showed the expiration date as October 14, 2022.  Date the vial was initially stored in the refrigerator was not provided and the vial did not undergo any temperature excursions.  The patient received the booster dose in her left arm shoulder deltoid muscle. Also, after the booster dose, no other adverse reactions were reported by the patient.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2022: Product Quality Complaint number was added. On 11-Mar-2022: Additional reporter was added.
asked mom child's name and DOB , she was on the phone and gave me wrong child's info
Sore Arm; Vomited; Rash (Macular pupura); rash/rash return/on buttocks rash that looks like she went through a briar patch; Upset stomach; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), PURPURA (Rash (Macular pupura)), RASH (rash/rash return/on buttocks rash that looks like she went through a briar patch), PAIN (Sore Arm) and VOMITING (Vomited) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical history was reported by the reporter.  Concurrent medical conditions included Penicillin allergy. Concomitant products included OMEPRAZOLE for Cholesterol, SIMVASTATIN for GERD, ASA, CALCIUM, COLECALCIFEROL (VIT D [COLECALCIFEROL]), ASCORBIC ACID (VIT C) and FISH OIL for an unknown indication.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 27-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach). On 20-Apr-2021, the patient experienced RASH (rash/rash return/on buttocks rash that looks like she went through a briar patch). On 27-Apr-2021, the patient experienced PURPURA (Rash (Macular pupura)). On an unknown date, the patient experienced PAIN (Sore Arm) and VOMITING (Vomited). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), PURPURA (Rash (Macular pupura)), RASH (rash/rash return/on buttocks rash that looks like she went through a briar patch), PAIN (Sore Arm) and VOMITING (Vomited) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes Primary Care Physician Visit (twice), Dermatologist Visit.   This case was linked to MOD-2021-091737 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up received on 1-jun-2021 had Updated events and outcome of the events updated from unknown- recovered/resolved. Concomitants medications included.
Patient presented to ED for DVTs, currently being treated with warfarin and heparin bridge. Patient remains in the hospital at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 08-NOV-2012 13:47, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Swelling Rt deltoid area 5 1/2 inches in length with redness 2 1/2". C/o pain and soreness esp. to touch. Low grade fever 6/28 PM with chills. 3-4 mm raised area at injection site.
Patient describes severe pain in the shoulder and has difficulty moving in the arm, mostly occurring at night when going to sleep/laying down.
Patient reports getting cold sores in her mouth and by her nose. These happened the day after getting her first dose of the Pfizer covid vaccine. However, she dose have these episodes happen occasionally, typically when she has a cold/sinus issues. Most sores have resolved by the time of her second dose on 3/18/21. The main symptom was pain. With this information, it does not appear to be vaccine related, but more of an occasional happening for the patient. the patient did note this was the first time this happened after getting a vaccine
Patient reported to office staff where he was vaccinated that he noticed a knot, redness, and heat to injection site on 4/2/21. He is not a regular patient of the health center and he was instructed by staff on duty to contact his PCP or go to Urgent Care for treatment. I have attempted to reach the patient by phone multiple times but have been unable to reach him and have not had a return call. It is unknown if he has actually been examined by a doctor or other health care professional as in question #21.
Information has been received from a physician concerning a female patient who was vaccinated with the first dose of GARDASIL vaccine. After receiving her first dose she experienced swollen lips. At the time of the report, on an unknown date the patient recovered from swollen lips. The physician did not provide any details of the case. The patient sought medical attention, not specified. No further information is available.
This spontaneous report as received from a  other health professional (registered nurse) refers to a unspecified number of patients of unknown age. Current conditions and medical history was not reported. Since 05-NOV-2014, patients were administered with GARDASIL (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On 05-NOV-2014, GARDASIL was exposed to temperatures (9 degree for 6 hours) out of the recommended range and administered to unspecified patients. It was reported that the nurse was not aware of any adverse effects. At the time of this report, the excursion has not ended. It was reported to nurse that as per stability assessment data, GARDASIL would not be adversely affected by this specific temperature excursion. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was 29 years-of-age and a G1P0 at 30 weeks 1 days gestation with an estimated delivery date of 12/24/21 who went into preterm labor on 10/16/21 and delivered - prematurely, at 30 weeks 4 days gestation.  Baby boy's birth weight was 312 grams (50th percentile for his gestational age).  Additionally, patient developed post-partum gestational hypertension and required IV magnesium sulfate as well as PO labetalol.
Arm pain after vaccine administration that has persisted to present time.  Patient administered ibuprofen and ice to reduce swelling, which relieved pain, but pain resumed when IBU and ice were withdrawn.
Immediately after the shot she experienced a cold arm. She was shaky and couldn't hardly walk. Her temperature dropped to at or below 70F (according to the pt). Pt experienced chest tightness as well.
Patient received booster dose of  Moderna vaccine from an expired vial which had been kept in refrigerator. Vial expired on 2/3/22 and dose given on 2/9/22.
Red lumps and rash on all limbs and chest, spread to back, buttocks  within 3 days. After second day, skin on hands, palms and fingers started to  turn crusty and peel and crack. ENTIRE hands front and back were ruff, peeling and cracked, sore and bleeding. This condition still remains at this writing.
Patient arrived for her first dose appointment for the Pfizer vaccine. After receiving the vaccine, the vaccinator found on that the patient record matched with a patient who had previously received 1 dose of the Moderna vaccine on May 10th.   The patient insisted that the vaccine she received today was her first vaccine and that she had been struggling over the last four months to combat an identify theft incident involving her bank accounts, vehicles, and other accounts tied to the contents of her wallet.  Patient was grateful to have received the vaccine and had no adverse reactions to the vaccine. Patient was observed for 15 minutes after her vaccination and left the location without incident. Patient was advised to call 311 to attempt to reconcile and correct her vaccination record.
Left elbow cellulitis within 48 hours of vaccine  Seen PCP, diagnosed with cellulitis as an adverse reaction to the vaccine and put on antibiotics (Keflex 4Xday for 10 days)
About 2 days after the vaccination (02/13/2021) she had facial numbness that has lasted for 6 weeks.  She has only recovered about 75% of her facial function/numbness.  He Doctor diagnosed her with Bells Palsy.  Her eyelid and eyebrow on one side of her face still are not functioning fully still.
Immunization administered subcutaneously left arm on 06/24/2005.  On 07/17/2005 patient developed pain at injection site and varicelliform rash on Torso and abdomen.
inappropriate schedule of vaccine; They may be giving Kinrix as the next dose of Dtap/IPV; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 5-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (DTAP), POLIOMYELITIS VACCINE INACTIVATED (IPV), HEPATITIS B VACCINE and MMR (MEASLES/MUMPS/RUBELLA).   On an unknown date, the patient did not receive Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: inappropriate schedule of vaccine) and circumstance or information capable of leading to medication error (Verbatim: They may be giving Kinrix as the next dose of Dtap/IPV). The outcome of the inappropriate schedule of vaccine administered and circumstance or information capable of leading to medication error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-AUG-2023 The clinic reported they had a 5 year old patient who had never received any vaccines. They might be giving Kinrix as the next dose of Dtap/IPV as the first doses she got were two separate vaccines, and they would like to combine them, which led to inappropriate schedule of vaccine administered and circumstance or information capable of leading to medication error. vaccine specialist stated it might be as the patient was off schedule already the patient got a dose of Dtap, IPV, Hep-B and MMR, all separately today (reporting day) at their clinic, none were GSK vaccines. The vaccine administration facility was the same as primary reporter for non GSK products. The reporter consented to follow up.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 28th August 2018, the patient received the 1st dose of SHINGRIX. On 28th August 2018, 6 hrs after receiving SHINGRIX, the patient experienced pain in arm, chills, headache and fatigue. On an unknown date, the outcome of the pain in arm, chills, headache and fatigue were recovered/resolved. It was unknown if the reporter considered the pain in arm, chills, headache and fatigue to be related to SHINGRIX. Additional details were reported as follows: About 6 to 7 hours later, the patient experienced events which resolved within 48 hours. This case has been linked with US2018178313, reported by same reporter.
My vaccine was listed as "2023 monovalent Covid-19 Booster targeting the XBB 1.5 strain of COVID-19". I don't have other info about which vaccine I received.  I have received all recommended COvid vaccines, including 2 initial doses, one booster in Nov 2022 and this booster yesterday  I was vaccinated on 10/8 at 2:30pm.  That night, approx 10pm I was very fatigued.  By midnight I had significant aches and chills and took tylenol for that.  I use tylenol normally for pain and do not have issues with it.  The following day, (today) my aches were still present, but not as severe as overnight.  I took a second dose (2 tablets ) of tylenol.  By noon, my eyelid had swollen noticably, but not so much that I couldn't open it.  I had the same reaction to my last Covid Booster in Nov 2022 which was Pfizer.   In November, I had continued swelling for a couple of days.  I presume the eyelid edema will self resolve again.
Shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "Shaking".  Additional Information: Reporter stated, "I had my Pfizer/BioNTech COVID vaccine yesterday at 17:00 o'clock at (Pharmacy name Withheld) in (City name Withheld), (State name Withheld) and when I got the vaccine, the pharmacist whose name was '(name Withheld)' told me that he had just gotten his and he had some severe shaking for a while after he got the vaccine and it does not show up as a side effect of the vaccine but he just wanted to warn me of that. Well, I am glad he did because tonight at 19:00 o'clock I started shaking, my hands were shaking so bad, I could not even hold anything, my arms were shaking and my body started shaking but not my legs so I got in bed and covered up and laid in bed and was shaking for probably 40 minutes may be 45 minutes and then it finally stopped. So, I was so grateful to the pharmacist for warning me about that otherwise I would have no idea what was happening to me and then I googled side effects and this particular side effect does not show up anywhere. So, I do not know if you have heard of this before or I just thought I should report it."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309706 same reporter/drug/event, different patient.;
Patient injected with 5ml of anthrax vaccine.  10x normal dose (.05ml).  Patient experiencing significant pain at injection site.  Continuing to monitor.
really sick/ she felt sick; fever; metallic taste; felt not good; her whole body hurts / muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick/ she felt sick), PYREXIA (fever), MYALGIA (her whole body hurts / muscle pain), DYSGEUSIA (metallic taste) and FEELING ABNORMAL (felt not good) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Migraine, seasonal allergies. Medication: Zoloft for anxiety, Ajovy for migraine. Caller got COVID-19 on 01FEB2023 with mild to moderate symptoms and it was prolonged.  Concurrent medical conditions included Migraine, Seasonal allergy and Anxiety. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety, FREMANEZUMAB (AJOVY [FREMANEZUMAB]) for Migraine.   On 09-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2023, the patient experienced MYALGIA (her whole body hurts / muscle pain). On an unknown date, the patient experienced ILLNESS (really sick/ she felt sick), PYREXIA (fever), DYSGEUSIA (metallic taste) and FEELING ABNORMAL (felt not good). At the time of the report, ILLNESS (really sick/ she felt sick), PYREXIA (fever), DYSGEUSIA (metallic taste) and FEELING ABNORMAL (felt not good) outcome was unknown and MYALGIA (her whole body hurts / muscle pain) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient got fist vaccine and did not experienced any symptoms.  For 2nd dose, the patient got really sick, whole body hurts, fever and felt not good for like 5 days.  The concomitant medication was not reported.  No treatment was given.   This case was linked to MOD-2023-714780 (Patient Link).
Vaccine stored under refrigeration beyond 30 days. Moderna Case ID CEA-2628: lot number 056M21A maintained the activity necessary to protect against the SARSCoV-2 (COVID-19) virus at time of administration. Did not contact patient per no action required.
This initial spontaneous case, was received on 17-Oct-2017, from other health professional, concerning a 04-year-old male child. The patient had no medical history or concomitant medications. On 17-Oct-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XT33908, expiry date: 30-Jun-2018), instead of FLUZONE. The error was noticed later when the lot number did not match in the patient chart. It was reported that, no adverse event occurred after the administration of the vaccine. The reporter assessed the event as non-serious. Follow up received on 24-Oct-2017: It was reported that, no adverse event occurred after the administration of the vaccine. Non-significant case correction received on 24-Oct-2017: The case comment was corrected. Significant case correction was received with IRD 17-Oct-2017: The events 'wrong vaccine administered' and 'no adverse event' were deleted. Significant case correction was received with IRD 24-Oct-2017: The suspect product was changed from AFLURIA QUADRIVALENT to AFLURIA (TIV) based on the batch number. Narrative was amended accordingly.
Covid arm - very large.  Started 3/3/2021 (8th day).  Over 8 inches, extreme pain, swelling, itching, burning, heat, blistering.  Contacted Dr. on 3/5 - prescribed a strong topical steroid cream which has helped.   Most symptoms much improved, but area involved continues to slightly expand around arm.
PAIN, SWELLING, REDNESS, AND HEAT AT SITE OF INJECTION (WITHIN HOURS, PERSISTED ~7 DAYS) SYSTEMIC HISTAMINE REACTION WITH INTENSE ITCHING (WITHIN 12 HOURS, LASTED A DAY) LOCALIZED RASHES ON LEG W/ITCHING BUT NO PAIN, SAME SIDE AS INJECTION (WITHIN A DAY, PERSISTED FOR ~7 DAYS BEFORE NEW LESIONS STOPPED SHOWING UP; LESIONS HAVE NOT YET HEALED NINE DAYS POST INJECTION)
Information has been received on 02-NOV-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 27-APR-2015 at a clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 15-APR-2016, the patient was treated at a dermatology physician office for a blistering vesicular outbreak, which was diagnosed as a severe case of herpes zoster, also known as shingles, on the forehead. The patient was referred to ophthalmologist specialists to address the shingles spreading near her eyes. The patient has been prescribed VALTREX for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, 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, pain and suffering, and other damages. Upon internal review, shingles spreading near her eyes was considered to be medically significant. Additional information has been requested.
A lump was found on my left breast in February 2023 (6x5x4mm). The only reason I got the breast MRI was because I was found to have the Braca1 gene found after I had my colonoscopy. At this time, I am not having a biopsy. I will be having a mastectomy soon.
it was rpt pt recv 1dose varivax & same day mmrII 5/4/98 & on 5/6 pt devel a macular rash dime sz on forehead & spread to face, forehead, back & stomach