chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed acute anxiety, tachycardia, hypertension ~ 48 hrs after vaccine (4/26/18). Was admitted overnight at Hospital due to uncertain origin of hypertension. Resolved, & was discharged. On 4/29, was noted to "not be herself," & became more agitated & less communicative over the course of the day. Was re-admitted to Hospital that evening for acute mental status changes. Was minimally responsive/catatonic for about 48-72 hrs. Extensive w/u ruled out infectious, toxic, metabolic causes. MRI showed mild acute L optic neuritis (Pt had no visual changes), but was otherwise normal. Was treated with high-dose steroids for possible acute encephalomyelitis, & began to improve. Was also discovered during her second admission that immediately prior to the first onset of anxiety & tachycardia on 4/26, patient had disclosed to her teacher a past episode of sexual assault - an event that had occurred about 5 years earlier. Final discharge diagnosis was acute catatonia secondary to trauma, and L optic neuritis of uncertain etiology. Multidisciplinary team unable to determine if the two were somehow related to each other, related to vaccine, or unrelated. Since no visual symptoms, neuro-ophthalmologist was unclear if MRI findings were clinically significant or not. As of today, patient continues to improve, but is not 100% back to her normal self yet. She will have a follow-up MRI & euro-ophthalmology visit within the next few weeks.
No adverse effect; patient received second dose in VARIVAX series that was improperly stored; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent condition and medical history were unknown. The patient's concomitant medication included steril diluent. On an unknown date, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection (frequency, route of administration, lot # and expiry date unspecified) for prophylaxis. On 09-SEP-2019, the patient received second dose of varicella virus vaccine live (oka/merck)(VARIVAX) series (of lot # R020650 with expiry date 18-JUL-2020) that was improperly stored(product storage error). Sterile diluent was properly stored. On an unknown date in April 2019, the vaccine was exposed to 7.7 Fahrenheit (F) for 30 minutes. Previous temperature excursion was at 6 F to 14 F for 188 minutes. Data logger was involved. No adverse effects reported (no adverse event). The outcomes of the events were unknown.
Rash (itchy), red and swollen, left arm (vaccine site) covering most of upper arm.  I have self-treated with topical cortisone ointment and antihistamine (fexofenadine HCI). Rash persists unchanged at day 5 (2/5/2021).
Tenderness in deltoid region of right arm that will not go away. Started about 2 months after second injection. I take anti-inflams for it and linament. Ice it afterwards. It will dissipate, but if I use my arm to lift or do yardwork, it comes back.
Patient was given expired vaccine. Vaccine expired 9/11/2023. Clinically, patient is doing well with no symptoms or adverse reactions.
SORE SHOULDER FOR ABOUT A WEEK; This spontaneous report received from a patient concerned a male of unspecified age. 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) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 08-MAR-2021, the patient experienced sore shoulder for about a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore shoulder for about a week on 15-MAR-2021. This report was non-serious.
Chills; Increased Heart rate; body aches; headache; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills), HEART RATE INCREASED (Increased Heart rate), PAIN (body aches) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), HEART RATE INCREASED (Increased Heart rate), PAIN (body aches) and HEADACHE (headache). At the time of the report, CHILLS (Chills), HEART RATE INCREASED (Increased Heart rate), PAIN (body aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Vomiting. He anxiety with symptom vomiting.  Heart rate decreased as relax sat in lobby away from people and felt better went home
Pulmonary Failure, Tremors, Chills, Regurgitation, Confusion, Fever, Myaglia, Passed out
Headache, Fever, CoughWheeze, CHILLS Narrative:   Other Relevant History:
Adacel that expired 6 days earlier was administered to a patient in error/ No AE; Initial information received on 17-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves male patient of an unknown age who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number not reported, expiry date- 05-04-2019 via intramuscular route in unknown administration site on 11-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used. Adacel was given to patient 6 days after expiration date.  No Adverse Event reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Pericarditis presenting one week after shot was taken; patient was hospitalized x3 and failed first line therapy with aspirin and colchicine. Was then titrated up to using aspirin, colchicine, prednisone before feeling any relief. Thereafter, was discharged on a long term taper of all the medications. Yet to follow up with outpatient cardiologists.
6-7 AM woke up red area left leg size of lemon, 3 pm called to be seen. 4:15 - size of cantaloupe.
I had no history of miscarriage, my baby was developing strong and healthy at the 7 1/2 week scan my baby was perfect everything was fine... until I received the second dose. once the second dose was given I was fine for a week then I heavily bled. went to the hospital in which they said my baby passed. I'm linking it to me receiving the vaccine same with everyone I talk to says its from the vaccine since i took every single precaution as an expecting mother to make sure my baby would be healthy. July 19th is the date I found ou t of the miscarriage.
Initial and follow-up information has been received from a registered pharmacist concerning a 55 year old male patient who on 15-DEC-2008 was vaccinated with a dose of PNEUMOVAX (lot # 661529/0858X).  Within 24 hours of vaccination, the patient developed swelling and warmth down at the injection site.  The patient sought unspecific medical attention from a physician.  This is one of three reports received from the same source.  Additional information has been requested.
Information has been received via Sanofi Pasteur from an investigator concerning a 12 month old female with a history of viral tonsillitis on 10-MAR-2007, congenital hip deformity, otitis media and bronchiolitis who entered a study. It was reported that the patient received three doses of study vaccine Pentacel, with the last dose prior to the event on 18-SEP-2006 (Lot# Y0890). On 01-MAR-2007 the patient was vaccinated with a first 0.5 ml subcutaneous dose of ProQuad. Concomitant vaccines administered on the same day included a fourth intramuscular dose in the right thigh of Prevnar and a first intramuscular dose in the right thigh of Vaqta. On 10-MAR-2007 the patient presented to the physician's office with a three-day history of fever, a bright red oropharynx, tonsils size two with mild exudate, and tachycardia. No rashes were noted and a rapid strep test was negative. The patient was diagnosed with viral tonsillitis and treatment included pain medication and hydration. On 23-MAR-2007 the patient experienced several episodes of falling down and bumping her head, and one episode of vomiting. She was noted to have poor balance and could not walk unassisted. The patient was seen in the emergency department and was admitted to the hospital early in the morning on 24-MAR-2007. The patient was noted to be afebrile, and no significant neurologic impairment was found. A CT scan of the head, MRI, and lumbar puncture were all normal. The patient was diagnosed with post-viral cerebellar ataxia, and remained hospitalized until 25-MAR-2007. The patient was considered recovered on 27-MAR-2007, and continued in the trial. The event of post-viral ataxia was reported by the investigator as unrelated to the study vaccine, and related to ProQuad. Other manufacturer numbers included: 2007-02018 and 160-25045.
LVN attempted to administer the vaccine on the client's right deltoid. LVN noted the needle bent and did not penetrate the client's skin. LVN the needle away from the client. The plunger was not activated and no medication was administered in or on the skin of the client. Client received COVID vaccine Pfizer Lot#FL3209 on the left arm at 3:10PM. The client did not report any symptoms during the 15 minute observation period. With Interpreter translating between languages, RN educated client on possible adverse reactions and when to seek medical care. The client voiced understanding of this education. The client left the vaccination site unassisted with a steady gait.
Guillain-Barre Syndrome. The hospital discharge summary received on 12/15/03 states apnea/respiratory failure.
Information has been received from a certified medical assistant concerning a 30 year old female patient with polycystic ovary disease and no drug reactions or allergies who in the past could have been vaccinated with a dose of MMR II (Lot number not provided). The healthcare worker reported that the patient had a negative antibody titer for rubella. At the time of the report the patient's outcome was unknown. The patient sought medical attention by an office visit. Additional information has been requested.
1 day after vaccination described severe radicular neuropathic pain in left leg. Has improved but not resolved
Patient received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine past the beyond used by date).    This case included information of patient 11 out of 190 reported patients.  No concomitant product reported by reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 190 patient received a vaccine past the beyond use date from 9 different lot number vials.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
LITTLE ACHY; HEADACHE; ARM HURTS A LOT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.   No concomitant medications were reported. On an unspecified date, the subject experienced little achy, headache, and arm hurts a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, arm hurts a lot and little achy was not reported. This report was non-serious.
Narrative: doses of prednisone to treat bells palsy may have masked reaction to second dose of COVID vaccine
Inappropriate Route of Vaccination; Patient experienced fussiness; Vomit after the injection; This case was reported by a other health professional via call center representative and described the occurrence of irritability in a 2-month-old male patient who received Rota (Rotarix) (batch number KZ97P, expiry date 22nd September 2020) for prophylaxis.   On 26th September 2019, the patient received Rotarix (intramuscular). In September 2019, less than a week after receiving Rotarix, the patient experienced irritability and vomiting. On 26th September 2019, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the irritability, vomiting and inappropriate route of vaccination were unknown.   It was unknown if the reporter considered the irritability and vomiting to be related to Rotarix.  Additional details were received as follows: The vaccine was given in the right thigh on September 26, 2019. A male patient was given Rotarix via the intramuscular route, which led to inappropriate route of vaccination. The patient experienced fussiness and did vomit after the injection. The reporter consented to follow up.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 25-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because their facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. It was also reported that no adverse reactions were reported by patient.  No treatment information was provided.   This case was linked to MOD-2022-501575 (Patient Link).
Very tender, sore shoulder.  "fever chills".  Very tired.  Bad headache.  Friday night, Saturday and Saturday night.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: EFFEXOR; REXULTI; LISINOPRIL (other medication in 2weeks). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) High; SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid from 26Sep2022 to 30Sep2022.  Clinical course: It was reported as they were double vaccinated and boosted with all Pfizer products.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Felt fine on 1/4, day of vaccine except for sore arm and neck pain in the night. 1/6, perorbital edema bilat and jaw swelling, red rash over face except for forehead and itchy.   Benadry 25 mg taken on 1/6 and 1/7.  Sx resolved by morning on 1/9
blood clot in his left leg and diagnosed with a DVT; leg was hurting; leg was purple; feeling crappy; This spontaneous case was reported by a patient and describes the occurrence of DEEP VEIN THROMBOSIS (blood clot in his left leg and diagnosed with a DVT) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced FEELING ABNORMAL (feeling crappy). On 22-Jun-2021, the patient experienced DEEP VEIN THROMBOSIS (blood clot in his left leg and diagnosed with a DVT) (seriousness criterion medically significant), PAIN IN EXTREMITY (leg was hurting) and SKIN DISCOLOURATION (leg was purple). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. At the time of the report, DEEP VEIN THROMBOSIS (blood clot in his left leg and diagnosed with a DVT), FEELING ABNORMAL (feeling crappy), PAIN IN EXTREMITY (leg was hurting) and SKIN DISCOLOURATION (leg was purple) outcome was unknown.            The patient had reported on the evening of 21 June 2021 to be feeling crappy. The next day, on  22 June 2021, the patient had reported that his leg was hurting and was purple, so he went to the doctor, who found out he had a blood clot in his left leg, and the patient was diagnosed with a DVT. The patient reported being put on a blood thinner Eliquis to treat the blood clot. No concomitant medication was provided by the reporter.  Based on current available information and the temporal association between produce use and the start date of the events cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between produce use and the start date of the events cannot be excluded.
Almost 12 hours after the second shot was received (no side effects from the 1st shot), at about 8:30 PM I started to feel some mild achiness in my body accompanied by fatigue. As a result I felt the need to go to bed early at about 9:30 PM. At about midnight I woke up with severe chills and intense body aches. I didnt get much sleep but the chills went away before 6:00 AM. The achiness remained but not as intense. I then had a migraine with a lost of appetite and more fatigue most of the day on February 10. Around 4:00 PM on the 10th all the symptoms suddenly started to leave and I began to feel normal.
No additional AEs or PQC reported.; Caller reported expired PROQUAD administered.; Dose: 0.5 ml IM; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, concomitant medications, pertinent medical history or drug reactions/allergies was not provided.  On 18-APR-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin, rHA) (PROQUAD) dose of 0.5 mL, lot number: T032148 was confirmed to be valid, expiration date: 20-MAR-2022, administered intramuscularly (anatomical location was not reported) for prophylaxis (expired product administered, incorrect route of product administration). The vaccine was reconstituted with sterile diluent (STERILE DILUENT), dose of 0.5 mL, lot number: U008044, expiration date: 06-JUL-2023. No additional information was provided. No additional adverse events (AEs) or product quality complaints (PQC) reported (no adverse event).
Date of immunization 3/6/07.  PM of 3/6 felt beginning of pain - on 3/9 patient noted itching, redness and felt warm.  Signs and symptoms same next 2 days.  Today, 3/12 redness decreasing.  Still itchy but not as much.