chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cardiac disorder" (unspecified if ongoing), notes: Caller also stated she has APS and is a cardiac patient too.; "APS" (unspecified if ongoing), notes: Caller also stated she has APS and is a cardiac patient too. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Unknown), for COVID-19 immunization, reaction(s): "Nausea", "vomiting"; Bnt162b2 (DOSE 2, SINGLE, Lot number: Unknown), for COVID-19 immunization, reaction(s): "Nausea", "vomiting". The following information was reported: NAUSEA (non-serious), outcome "recovered"; VOMITING (non-serious), outcome "recovered".  Additional information: Patient mentioned she was vaccinated with the primary series and two boosters, all from Pfizer. She mentioned she got a reaction a couple of times, with nausea and vomiting all night, until 7:30 am. She mentioned she was concerned about getting the Omicron vaccine and that she was allergic to something vaccine. Caller asked if in stoppers or syringes might have latex. Caller also mentioned she just recently received a Flu shot and asked how long she should wait to get the new Omicron vaccine. Caller also mentioned there were new two variants that had come out so that was totally absurd, because the virus was constantly mutating, and that people were still getting COVID and Omicron, so it did not prevent anything. Caller expressed her main concern was if she should talk it or not because she was afraid of getting the reaction and to be up all night. She also mentioned her Doctors did not know how to treat or prevent the side effects from these vaccines. She asked if the Pfizer Product get into the valves of the heart. Caller also mentioned her last booster was in Jul2022 and asked when she could receive the bivalent vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient has only received one dose of the Moderna monovalent vaccine a fact which was missed by the pharmacy staff. This caused the patient to receive the Bivalent booster when in fact she should've received the Monovalent vaccine. Upon realization of the mistake the error was reported to the district manager for pharmacy and after reviewing the protocol we offered the patient the option to receive to proper vaccination to complete her series. At the time she declined to return into the store and stated that she may at a later point with the stipulation that she must return prior to the 1st of the year due to the monovalent vaccine being fazed out.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 02-FEB-2018 (also reported as 08-FEB-2018), the patient was vaccinated with improperly stored dose of ROTATEQ 1 DF (lot # M035456, expiry date: 01-MAY-2018) orally for prophylaxis. No adverse effects reported. The vaccine had undergone a temperature of 1.2 degree Celsius to 1.9 degree Celsius for a duration of 816 hours from 11-JAN-2018 to 14-FEB-2018. No previous temperature excursions reported. There was a digital data logger involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1803USA002218.
Caller stated he got second Moderna vaccine on Friday and on Sunday he felt a "ping" on top of his head. It happened twice on Sunday, three times yesterday, today, three times already. RN asked if he took anything like Advil or TyTylenol. He stated it is not a headache. He stated it only lasts seconds. He stated otherwise he is feeling fine, and is not sick. He denies any other symptoms.
Two weeks after receiving the 2nd COVID Moderna booster shot, I developed rashes concentrated on my upper back, and some on both underarms, arm fold and waistline. Antihistamine and anti-itch lotion help temporarily. The rashes come and go. Today, April 28,, I'm still experiencing this condition.
Patients husband called office on February 3rd wanted to let us know his wife was in the hospital and my not be out to get her 2nd Moderna COVID-19 vaccine on Monday February 8th. I talked with the husband briefly about why his wife was hospitalized. He reported she got sick 2 days after getting her first COVID-19 vaccine. He states she had pneumonia, had a urinary tract infection and had to have a heart catherization with stent placement. We moved her second vaccine appointment to February 17th. The spouse came in on February 8th for his 2nd dose. He told me the doctors did not believe his wife's hospitalization was related to the first COVID vaccine and he said the doctor's told him that she needed her 2nd dose.
LACK OF EFFECT/ NO EVIDENT OF THE PATIENT  HAVING HAD THE JANSSEN COVID-19  VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 55 year old male. Initial information was processed along with additional information received from a department on 04-OCT-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and Expiry: Unknown) dose was not reported,1 total, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in SEP-2021, the patient went to the doctor for routine blood work and was told that there was no evidence of the Janssen Covid-19 vaccine in his system (Lack of effect/ no evident of the patient having had the Janssen Covid-19 vaccine administered). The doctor specify that he should receive another vaccine, possibly Pfizer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lack of effect/ no evident of the patient having had the Janssen covid-19 vaccine administered was not reported. This report was serious (Other Medically Important Condition). This report was associated with a REGULATORY AUTHORITY: 90000195676.; Sender's Comments: V0:20211004100-covid-19 vaccine ad26.cov2.s-lack of effect/ no evident of the patient having had the Janssen covid-19 vaccine administered. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 13Oct2021 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient didn't taken other medication in 2weeks. Patient didn't have any known allergies. Paxlovid was taken as treatment for covid-19. Treatment started from 19Jun2022 to 24Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a registered nurse and refers to a 28-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date when she was a child, the patient was vaccinated with an unspecified number of doses of M-M-R II reconstituted with sterile diluent and VARIVAX (for all dose, route of administration, lot# and expiration date were not reported) as pediatric immunizations. On 17-JAN-2018, the patient had negative titres for rubeola and varicella. There was no additional adverse events/reactions reported. The reporter inquired whether or not M-M-R II and VARIVAX could be given on the same day. The outcome of the events was reported as not recovered. The relatedness between the events and suspect therapies were not reported.
Pt returned in 90 min and stated that he felt his throat was swelling, but did not have a trouble breathing. Advised to seek medical attention, but pt declined & went home. Took BENADRYL. Claims that the problem is gone.
2 months after the second vaccine (4/7/21) I developed  a cough, wheezing, headache, slight runny nose. Went to the doctor on 4/27- still wheezing/coughing. prescribed inhalers, nasal spray. back to doctor on 4/29- still wheezing, started prednisone and continued inhalers. saw pulmonology on 5/24- still wheezing. started new inhaler, new nasal spray, higher dose of prednisone. now feeling better, not wheezing as much but continue to have headaches
After initial dose patient waited 15 minutes. Redness, itching and small hives occurred to bilateral upper arms
focal seizure; This spontaneous case was reported by a pharmacist and describes the occurrence of PARTIAL SEIZURES (focal seizure) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARTIAL SEIZURES (focal seizure) (seriousness criterion medically significant). At the time of the report, PARTIAL SEIZURES (focal seizure) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  The patient recovered from the event of focal seizure after one week of receiving the first dose.  Company Comment: This is a spontaneous case concerning an elderly patient (unknown age and gender) with no reported medical history, who experienced the unexpected, serious (medically significant) event of Partial seizures (reported as focal seizure), which occurred on unknown date after receiving the first dose of mRNA-1273 vaccine and had resolved after a week. Clinical course, diagnostic tests and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-542549, MOD-2022-542594 (Patient Link).; Sender's Comments: This is a spontaneous case concerning an elderly patient (unknown age and gender) with no reported medical history, who experienced the unexpected, serious (medically significant) event of Partial seizures (reported as focal seizure), which occurred on unknown date after receiving the first dose of mRNA-1273 vaccine and had resolved after a week. Clinical course, diagnostic tests and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Client states on 06/16/2011 she began to have a constant charley horse cramping symptom with extreme pain from shoulder area of upper left back to left fingertips x 24 hours each day from 06/16/2011 through present 7/8/2011.
GI illness nausea/vomiting started 10/3/14. Continued for 24 hrs. On 10/4/14 visiual disturbances and gait issues and headache. To ER, dx viral illness continued with symptoms Oct 4 and OCt 5. To clinic Monday the 6th. Concerned possible brain tumor, to another medical center and had MRI and CT done. Transferred to another facility, lumbar puncture and labs done ro meninigis and enterovirus. Ataxia and dipolpia continued 2 doses Immunoglobulin given.
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Vaccine Saturday evening. Noticed ball of left foot feeling numb Sunday morning. Numbness spread throughout left leg during the day.  Some aching but mostly numbness in the subsequent days. No loss of function. Left arm went numb Wednesday. Right foot and right hand developed some tingling/numbness Wednesday night/Thursday morning  (today). Right leg has progressively gotten more numb today (Thursday). Vaginal spotting started Tuesday 3/9, only 1.5 weeks into my current cycle and current pack of birth control pills (highly unusual).
Patient received her first dose of the Moderna COVID-19 Vaccine on 1/20/21 at 1531 and subsequently had complaints of closing airway (patient felt her posterior oropharynx closing up), noted stridor and hives over her torso.  Of note: patient has a known history allergic reactions to foods/drugs (including anaphylaxis). Patient brought her personal epi pens with her to the vaccine clinic and self-administered an epinephrine 0.3mg dose. Nursing staff in the clinic then gave her a Benadryl 25mg and an additional epi 0.3mg dose given no improvement in symptoms after first dose. CODE BLUE activated via security officer nearby. Volunteer staff member obtained wheel chair from main lobby to transport patient to the ED at 1548. In the ED, patient was given x1 dose Solu-Medrol IV 125 mg and later cetirizine IV 10mg. Per the ED note, no airway edema, wheezing, or strider noted and patient was reported to be doing well after medications. Patient remained in the ED for observation and was discharged at 2211.
Information has been received from a physician concerning an 82 year old female who "about 2 months ago", in approximately February 2008, was vaccinated with zoster vaccine live (Oka/Merck). There was no illness reported at the time of vaccination. On 24-APR-2008, the patient developed facial pain. Over the next few days, the patient developed shingles on her eyelid and the side of her face and sought medical treatment at the physician's office. No laboratory/diagnostic tests were performed. She was being treated with Neurontin and Percocet. As of 29-APR-200, the patient was recovering from shingles on her eyelid and the side of her face. Additional information has been requested.
This spontaneous report as received from a 73 years old female patient regarding herself. The patient's medical history included chicken pox during childhood. Drug reactions or allergies were none. On 08-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route were not reported). Concomitant medications were none. On 08-DEC-2012, the patient had an adverse reaction with ZOSTAVAX. The patient reported that a cold sore formed on her lip, around the sore there were pus filled papules and the consumer reported that it could be chicken pox. Laboratory diagnostic test were not performed. The patient sought no medical attention and no treatment was provided. All the reported events were not recovered. Additional information has been requested.
SWELLING OF THROAT, FAST HEARTBEAT, WEAKNESS, FATIGUE. BEGAN 4 HOURS AFTER SHOT.
35 yo M w/PMH of asthma, allergies, w/acute onset of lower chest/epigastric pain, nausea, cough, and feeling flushed within 30 minutes of Pfizer dose #1. T: 98.3 F, BP: 139/105, HR : 89, Ox 98% RA. CO is well appearing, not diaphoretic, w/clear lungs and normal heart sounds. No rash.  PO Benadryl given at 13:07 PM d/t cough and CO observed until 13:24 w/resolution of chest discomfort and throat irritation. Tolerating sips of water.  ER precautions discussed.
6 hrs after vax; "start of head cold"; sore injection area. Fever 103 x 2 days, nausea throughout, skin "hurt" shooting pain from arm to chest to spine, muscle ache, dizzy; 3 day bilateral hip/leg nerve pain. DR rx'd by phone: Flumadine x2d
Headache injsite pain X2 days, H/A lethargy, myalgia X7 days Narrative:  Other Relevant History:
5/15/14 pt got Tdap. On drive home (+) burning pain to neck, low grade fever, swelling to (L) shoulder, deltoid and arm, shooting pains, body aches, numb and tingling.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. There was no information about the patients current conditions, concomitant medications and medical histories reported. On an unknown dates between 02-FEB-2016 and 02-APR-2016, the patients were vaccinated with an improperly stored doses of PNEUMOVAX 23 (lot# L033707 with expiration date 18-MAY-2017; lot# L038522 with expiration date 11-AUG-2017; dose, anatomical location and route of administration were not reported). It was also reported that an improperly stored sterile diluent (lot# L015432, expiration date 24-JAN-2018; lot# reported as K023007 with expiration date 24-SEP-2017, lot# L017417 with expiration date 02-FEB-2018 and lot# L03221, expiration date was not reported; dose and route of administration were not reported) was used. No adverse events were reported. Temperature was 49.3 Fahrenheit degrees (F) for 48 hours, 31.2 F for 16 hours and 16.5 F for 2400 hours. There was no previous temperature excursion and no data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot# L018351, expiry date 11-AUG-2017 and lot# L024993, expiry date 17-OCT-2017; exact dose and route of administration were not reported). There were no concomitant therapies reported. The medical assistant stated that the doses of the vaccine were exposed to a temperature excursion for a cumulative time of 2.5 hours (2 hours 27 minutes) at a temperature of -0.1 degrees Celsius. There was no previous temperature excursion involved. No adverse effect was reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
the patient did not experience any symptoms; a patient, who is 12 months old was inadvertently administered one dose of GARDASIL 9; This spontaneous report as received from a nurse refers to a 12 month old patient of unknown gender. No information regarding the patent's medical history, concurrent conditions and concomitant medications was provided.   On 23-JAN-2020, the 12- month- old patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R032768, expiration date: 31-AUG-2021, 1 dosage form, intramuscularly for prophylaxis. The patient did not experience any symptoms.
Developed a 5cm x 6cm warm, erythematous patch corresponding with the injection site on day 8/9 post vaccine
Pain in the injection site began about 3 hours after the dose was given. This worsened throughout the night and caused me to be awake in pain most of the evening. The pain in the injection site arm continued for 2 days.  I experienced a stiff neck the day of the shot. This went away by the 2nd day. Then, 5 days after receiving the shot I began to experience pain in my underarm, like I had been bruised inside my armpit, of the same arm that received the shot. This pain in my armpit lasted for 4 days.
Resident was inoculated on 04/09.  According to family  members, he began to feel unwell that evening, cold sweats, high fever,  dehydration.  According to family members, he refused to get medical  attention.  After not hearing from him for a few days, family members  called for a wellfare check on 04/12 at which time he was found  deceased.
He was nervous before shot, then relieved that it didn't hurt much. After being told to wait 15 minutes, he wanted to go grab a drink and was walking by coolers when he passed out.
BREAKTHROUGH HOSPITALIZATION Hospital notes state that she began to feel poorly the night of Thanksgiving with nausea, vomiting, cough and shortness of breath.  She thinks she was exposed to Covid by her grandson.  She had a positive home covid test on 11/28/21 then retested at pharmacy and was positive.  She received monoclonal antibody infusion on 12/1/21 which improved her cough and shortness of breath, but presented to the ER on 12/5/21 with persistent nausea and vomiting and was admitted for hyponatrimia and resolving Covid pneumonia.  She received 2 doses of Moderna on 3/4/21 and 4/1/21, then a 3rd dose on 8/30/21 due to immunosuppressant therapy for her heart transplant.
Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M007764 with expiration date 30-JAN-2018 or lot# reported as K010215 with expiration date 05-MAY-2017, dose and route were unknown). The vaccine had been stored under the temperature of -0.6 Celsius degree for 361 hours and 35 minutes. Digital data logger was involved. It was unknown if there was previous temperature excursion. No adverse effects were reported. Lot number K010215 is an invalid lot number for GARDASIL 9. This is one of several reports received from the same reporter. Additional information has been requested.
DISCRETE ITCHY PAPULES EACH LASTING ABOUT 1 WEEK INVOLVING FACE, NECK, ARMS, AND TRUNK BEGINNING DAY AFTER RECEIVING VACCINE.