chrisvoncsefalvay/vaers-outcomes huggingface dataset:
threw up; cannot read without dizzy spells; 102.1F FEVER; he has been feeling nauseous; The headache started around his frontal lobe but now it is the side and the back of his head; severe body aches; FATIGUE; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (cannot read without dizzy spells), VOMITING (threw up), PAIN (severe body aches), FATIGUE (FATIGUE) and HEADACHE (The headache started around his frontal lobe but now it is the side and the back of his head) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (severe body aches) and FATIGUE (FATIGUE). On 11-Feb-2021, the patient experienced HEADACHE (The headache started around his frontal lobe but now it is the side and the back of his head). On 13-Feb-2021, the patient experienced DIZZINESS (cannot read without dizzy spells), PYREXIA (102.1F FEVER) and NAUSEA (he has been feeling nauseous). On 14-Feb-2021, the patient experienced VOMITING (threw up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (cannot read without dizzy spells), VOMITING (threw up), PAIN (severe body aches), FATIGUE (FATIGUE), HEADACHE (The headache started around his frontal lobe but now it is the side and the back of his head), PYREXIA (102.1F FEVER) and NAUSEA (he has been feeling nauseous) outcome was unknown.        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.
Patient here for immunizations. Patient requested #2 MMR & #2 varicella. The #2 MMR planted in L Sq Arm. The varicella was inadvertently chosen with a Proquad SQ RA. Pt notified. No signs or symptoms pf adverse reactions at this time. Conversation occurred with interpreter.
This spontaneous report was received from a registered nurse and refers to a 15 month old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 11-OCT-2016. On 13-DEC-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M023931 with expiration date of 09-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA013888:
None.  Child received 2nd dose of Menactra.  Had first Menactra in 2007.
Nurse had popped a vial of Moderna Covid-19 yesterday on 13 Apr 2022 and doses were administered from the vial greater than 12 hours later; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse had popped a vial of Moderna Covid-19 yesterday on 13 Apr 2022 and doses were administered from the vial greater than 12 hours later) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J212A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022 at 2:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022 at 2:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse had popped a vial of Moderna Covid-19 yesterday on 13 Apr 2022 and doses were administered from the vial greater than 12 hours later). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse had popped a vial of Moderna Covid-19 yesterday on 13 Apr 2022 and doses were administered from the vial greater than 12 hours later) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date the vial was initially stored in the refrigerator was on  04 Apr 2022. The vial was first punctured on 13 Apr 2022 at 8.53 AM and the vial was stored in refrigerated post puncture. The vial did not undergo any temperature excursions.Total amount of time the vial was exposed to room temperature range was less than 15 minutes. It was reported that the patient received first booster dose Moderna Covid-19 vaccine 12 hours after the vial had first been used. No adverse reactions known of to the primary series of the Moderna Covid-19 vaccine. Patient did not complain of any other adverse reactions. No treatment information was reported.   This case was linked to MOD-2022-540183, MOD-2022-540269, MOD-2022-540268 (Patient Link).
57 y/o female with past medical history of Asthma who presents with palpitations post vaccination administration. Patient states that this is her second dose in the two-dose series. Patient denies previous reaction with first dose. Patient states that received todays vaccination to the R arm. Patient states that she was nervous prior to receiving todays injection and that she suffers from anxiety (undiagnosed). Patient also states that she takes Albuterol daily and Montelukast. This NP explained to patient that Albuterol is a rescue medication and not a controller, that she is taking the medication incorrectly. I advised the patient to follow up with her primary physician to discuss a controller such as Pulmicort instead of using a rescue drug as maintenance. NP, CNO and Paramedics at patient side. Patient with noted peripheral edema. Patient initial vitals showed tachycardia and hypertension. Patient initial vitals (153/88 BP, 127 HR, 98% RA, Resp 16 and EKG Sinus Tachy). Patient states that her palpitations come and go. Patient denies sore throat, difficulty swallowing, chest pain or difficulty breathing. Patient monitored for 30 mins with no improvement of symptoms (Patient remained Hypertensive (171/88, 172/87, 174/94) and Tachycardia (105-127) and it was determined to call Fire Rescue. Fire Rescue assessed patient and advised to seek further medical attention but patient refuses. Patient signed AMA with rescue and patient was provided with the AshBritt Logistics and IEM Health AMA form, patient signed and ambulated off site without difficulty.
Pt states after 2 months arm continues to feel painful and weak in left arm. One full month of documented pain.
I begin experiencing symptoms of Covid 03/10/2023 sore throat elevated body temperature, no fever runny nose mild congestion and chills.
Per patient, he started to experience fever, rash at injection site, and some muscular/joint pain on the right lower side at midnight of 01/14/2023.  Today is the 3rd day. All symptoms are subsiding except for residual muscular and joint pain. Patient notified his PCP and is instructed to take Tylenol 650mg today. As it today, patient hasn't taken any medication to alleviate the symptoms.
Vaccine was received by clinic on sept 15th 2021, then left out at room temp for 5 days before being put in the fridge and then used for administration. Manufacturer states it can only be left out for up to 20 minutes. Effects unkown.
VACCINATION ADMINISTRATION ERROR OCCURED-NO ADVERSE EVENT.  Pfizer Bivalent Booster vaccine 12yr+ was given to 6yr. Office setting unaware of seperate vial for ages of 5-11yr new approval bivalent booster.
Covid 19 antigen: Positive; Covid 19 antigen: Positive; Alopecia areata; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Dec2021 10:00 (Lot number: FJ1620) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing); "low testosterone" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "Covid 19 antigen: Positive"; ALOPECIA AREATA (non-serious) with onset 14Dec2021 18:00, outcome "not recovered", described as "Alopecia areata". The event "alopecia areata" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of alopecia areata.  Clinical course: The Alopecia areata was treated with products that are supposed. The patient did not receive any other vaccine in four weeks and not having Covid prior vaccination. He tested Covid post vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness cannot be ruled out.
Within hours of immunization she noted aching in the area with generalized sweats and chills. Over the next several hours developed general myalgias and malaise. She noted erythema over the arm the next day about 4cm distal to the injection site in a circumferential pattern but is unsure if it was there immediately. Felt "out of breath like if you are very active." No throat swelling.
Within a few hours, patient developed a fever and was walking less steadily than usual. The next morning, we discovered chicken pox on his right thigh, bum, and penis. It was spreading all over his trunk EXCEPT at the injection site, with the fever still present. Over the following 24 hours, his chicken pox continued to spread up to his arms, hands, and face, and down to his calves and feet.
Mild flu symptoms for a day; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   The reporter considered the influenza-like symptoms to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. With the Flu vaccine the patient normally had mild flu symptoms for a day. The case had been linked with US2021AMR016766 for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR016766:Same reporter.
Patient experienced a black out for a few seconds approx 5 minutes after Covid vaccine administered while seated and talking on phone with friend.  Patients friend called us to check on her and she was conscious but very nauseous. She seemed unable to calm down but was breathing  fine and no signs of hive/allergy. Called 911 and EMT gave patient an exam of BP, HR and breathing and said she was fine. Offered patient water and soda and she left approx 30 minutes later with friend to drive her home.
4/14-vaccine. Stiff neck, sore left base of skull, beginning w/in 1 hour.  Painful arm barely lift-able by 9 PM, largely resolved w/ 48 hrs. 4/16, AM awoke w/intense pain in buttock and down leg to knee when trying to walk or crawl. Right and left low back pains. 2 days in bed with ice, Tylenol, CBD balm, diclofenac.  By 4/18, able to shuffle. Right buttock soreness. 4/19 cautious walking. Burning in right buttock, off and on. 4/19-Very sore base of skull both sides, stiff and sore right jaw, ear fullness, numb teeth, headache.  Anxiety treated w/ herbs, Tylenol for pains, herbal balm for pain.
Patient had a dizzy spell and fell to ground from sitting position.  Patient skinned open a nickle sized cut on  right side of face. No other symptoms were reported. Patient continued to sit down for another 15 minutes under observation and left site afterwards. Patient refused medical treatment via ambulance. After sitting for the  additional 15 minutes, patient reported no other symptoms.
sharp pain in my rib cage; flank pain; fever of 100.9; chills; muscle aches; This case was reported by a consumer via call center representative and described the occurrence of rib pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of musculoskeletal chest pain (received 1st dose on 12th May 2020, refer case US2020147948).   On 13th July 2020, the patient received the 2nd dose of Shingrix. On 14th July 2020, 1 days after receiving Shingrix, the patient experienced fever. In July 2020, the patient experienced chills and muscle pain. On an unknown date, the patient experienced rib pain and flank pain. The patient was treated with paracetamol (Tylenol Extra Strength). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rib pain, chills, muscle pain and flank pain were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the rib pain, fever, chills, muscle pain and flank pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The patient received Shingrix in the right arm and had this sharp pain in my rib cage inside the right flank.  The patient reported that the pain was always on the right side for both doses. The patient had a fever of 100.9 that started the next day following the injection and went up to 101.9 and it lasted 4 to 5 hours.  The patient took Tylenol Extra Strength for the fever and reported having chills and general muscle ache. The reporter consented to follow up. The patient got the injections at his pharmacy and they had this information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020147948:same reporter
no adverse effects. Patient was accidentally given the pediatric dose instead of the adult dose of Hep B
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly-stored dose (at 6 Fahrenheit (F) for 4 hours, because of data logger) of ZOSTAVAX, lot # L032184, expiry date 25-NOV-2016, one dose, (route of administration and frequency not reported). Previous temperature excursions was reported as 7 F for 5 hours. No adverse event (adverse symptoms) was reported. The outcome of events was unknown. Reporter inquired about vaccine stability following a temperature excursion. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Horrible pain and a numb arm about 4 hrs after shot. could not lift arm without screaming for 4 days. It is now 12 days later and still have pain, not as bad, and 60-65% mobility in left arm. The shot was administered close to shoulder and I think I hit a nerve. Bad neck pain also.
pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm). At the time of the report, PAIN IN EXTREMITY (pain in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
patient was administered a act-hib that was expired on 13August2023 no adverse event; Initial information was received on 06-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age of patient was administered hib (prp/t) vaccine [ACT-HIB] that was expired on 13august2023 no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect hib (prp/t) vaccine (Powder and solvent for solution for injection) (lot UJ756AA, strength was unknown, expiry date : 13-Aug-2023) via unknown route in unknown administration site for prophylactic vaccination(Immunization).  On an unknown date the patient was administered a act-hib that was expired on 13august2023 no adverse event (expired product administered) (latency: same day).  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event patient was administered a act-hib that was expired on 13august2023 no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported in a literature article and described the occurrence of ischemic optic neuropathy in a 51-year-old female subject who was vaccinated with INFLUENZA (manufacturer unspecified). This case corresponds to case 2 in literature article. In October 1994, the subject received an unspecified dose of INFLUENZA (unspecified) (administration site and route unknown, batch number not provided). 1 day after vaccination with INFLUENZA (unspecified), the subject experienced fever, chills and myalgia. After 3 weeks, the events were resolved. 4 weeks later, the subject had ear pain, headache and blurry vision first in her right eye then in her left eye. Examination revealed acuities of 25/50 on right eye and 20/25 on left eye with an inferonasal visual field defect on right eye and a supernasal defect on left eye. Both optic discs were edematous, worse segmentally superiorly on right eye and inferiorly on left eye. This case was assessed as medically serious by GSK. The subject was treated with methylprednisolone. Despite this, her vision progressively worsened over several weeks to count-fingers right eye and 20/100 on left eye. Fluorescein angiography showed late optic disc staining consistent with disc edema. Her visual function was unchanged at 2 months and bilateral optic disc atrophy had developed. At the time of reporting the events were unresolved. The final diagnosis was bilateral anterior ischemic optic neuropathy rather than demyelinative optic neuritis due to the close temporal relationship to influenza vaccination and the bilateral involvement. According the authors, it might be an immune complex -mediated vasculopathy. This presumptive mechanism might also account for the systemic symptoms experienced by the subject prior to visual loss. Summary of the literature article: Optic neuritis is an occasional complication of vaccination. Visual loss can be unilateral or bilateral and most subject recover substantially without treatment. The presumptive mechanism is an immune-mediated demyelinating injury of the optic nerve. The authors report 2 subjects who had permanent visual loss following influenza vaccination. Their pattern of visual loss, segmental optic disc changes and failure of visual recovery were atypical for demyelinating optic neuritis and reminiscent of a primary ischemic injury to the optic nerve. The authors speculate that an immune complex-mediated vasculopathy following vaccination can cause anterior ischemic optic neuropathy. Clinicians should be aware of this entity because of the less favorable prognosis for visual recovery in these cases.
A 21 month old, male patient experienced severe (entire right thigh) swelling after he received DAPTACEL (lot number unknown) in the right thigh on 09 January 2003. It was unknown if any other vaccines were administered on the same day. The reporter did not have any other information and was not sure if a VAERS form was filled at that time. Follow-up information received on 05 March 2007 from a health care professional. The patient additionally had received a left thigh, intramuscular injection of a varicella vaccine on 09 January 2003. The trade name, manufacturer name, and lot number of that vaccine was not provided. The DAPTACELl that was given on 09 January 2003 was reported as being the fifth dose the patient had received, and it was administered intramuscularly. The adverse event of severe entire right thigh swelling began on 09 January 2003. The time of onset was not provided. The recovery status of the patient is still unknown. Reportedly, the patient had an adverse event of swelling after he received his "fourth dose" of DAPTACEL at age "2". This event is reported in case number 2007-00671.
Patient feel down ( passed out ?) probably hit her head on the wall. Looked like she had a seizure, but lasted 30 seconds (?) then she was aware. Complained of being cold, but hot to the touch. Did not feel well. EMT was called.
On 2/20/2021 at approximately 6:30 PM, I felt a tingling and numbness in my left fore arm. I attempted to lift my left fore arm by bending it at the elbow, but could not. After trying to lift my arm a couple of times with no success, I picked up my left arm with my right hand. Cupping my left elbow in my right hand, I began to move my left fore arm back and forth until the tingling and numbness subsided. A little while later (15-30 minutes) I tried to remove a baseball cap that I was wearing. I was not able to accurately reach the bill of my cap. It appeared that I was uncoordinated, lacked control of motor skill in my left hand.  About 30 minutes later the motor skills appeared to return. Later that night, approximately 9:30 - 10:00 PM, while trying to type on the keyboard of my laptop computer, I noticed that I couldn't hit all the keys effectively with my left hand unless I made a conscious effort to hit the correct key. I went to bed shortly there after.  The next morning when I woke (Sunday 2/21/21), I tried the computer key board again.  At this time, I did not have any of the issues of hitting the correct keys that I experienced the previous night.   I was out of town visiting relatives during this time.  I returned home on the afternoon of Monday 2/22/2012. At this time, approximately 4:00 PM, I called my primary care physician and relayed the symptoms to her.  She informed me that I needed to go to the emergency room at our local hospital as soon as possible for treatment observation.