chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Loss of memory; Difficulty answering questions; Bronchitis; Major personality change; Flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AMNESIA (Loss of memory), MENTAL IMPAIRMENT (Difficulty answering questions), BRONCHITIS (Bronchitis) and PERSONALITY CHANGE (Major personality change) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced AMNESIA (Loss of memory) (seriousness criterion hospitalization), MENTAL IMPAIRMENT (Difficulty answering questions) (seriousness criteria hospitalization and medically significant), BRONCHITIS (Bronchitis) (seriousness criterion hospitalization) and PERSONALITY CHANGE (Major personality change) (seriousness criterion hospitalization). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). The patient was hospitalized on sometime in April 2021 due to AMNESIA, BRONCHITIS, MENTAL IMPAIRMENT and PERSONALITY CHANGE. At the time of the report, AMNESIA (Loss of memory), MENTAL IMPAIRMENT (Difficulty answering questions) and PERSONALITY CHANGE (Major personality change) had not resolved and BRONCHITIS (Bronchitis) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported. The patient received her first shot in early April 2021. She could not remember the exact date or lot number. Within a few minutes, the vaccination provider noticed that the patient had a major personality change, loss of memory, and difficulty answering questions. The patient was sent to the hospital because of this. While there, they informed her that she had bronchitis. The hospital sent her home and the patient was asked to monitor herself for three days. The patient's mental symptoms were reported as still ongoing. The patient also mentioned that she experienced two weeks of flu-like symptoms.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt states that when she woke up the next day after getting the vax she woke chills, sweats and body aches.  Temp was 101.4.  Pt states that her symptoms lasted 6 days.  Pt is feeling better today.
Information has been received regarding a case in litigation, from a lawyer, regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 14-OCT-2013, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the health provider. On unknown date, the patient experienced shingles (herpes zoster) and on 06-DEC-2016, the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (quality of life decreased and condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Started with aches and chills, progressed to being very hot and having a 99.5 fever, then had lingering headache. Arm was very very sore and painful. All symptoms disappeared next day.
great grandma called 320Pm reports fever of 102.5 ax;given APAP 3PM both arms sl swollen;pt c/o arms hurting & very whiny;great grandma states pt is playing better p/APAP;fill recheck temp 4PM & call RN back;425PM t102.5 ax, swollen
Information has been received from a health professional concerning an 8 year old male, with a history of asthma and allergic rhinitis, who on 7/16/1997 was vaccinated with a dose of varicella virus vaccine live. there was no illness at the time of vaccination and no adverse events following prior vaccination. On 12/15/2004 the patient presented in the office with a rash that was diagnosed by the doctor as chickenpox. There were no laboratory or diagnostic tests performed. Follow up information from a health professional indicated that on 12/15/2004 a physician examined the patient for a skin rash and diagnosed the patient with chickenpox. It was reported that the patient recovered approximately 2 weeks post onset, on approximately 12/28/2004. Additional information is not expected.
Partial loss of bladder control (sudden onset of inability to hold urine) and loss of feeling  in my feet.  Bladder control returned on 3/17,   Feeling in my feet returning on 3/17 but some residual at time of this report.
Healthy singleton pregnancy at 12 weeks gestation at time of vaccination.  Heart beat via ultrasound and genetic testing showed viable fetus. At routine prenatal appointment at 16 weeks, no heartbeat found. Estimated age of fetus 13.5-14 weeks,  approximately  two weeks after booster vaccination. No known cause for fetal death/ miscarriage (no known placental/ maternal or genetic causes). Patient had to experience D&E as a result of miscarriage.
Patient presented to free clinic with Right deltoid pain, swelling, reddness,induration, and itching. Patient treated with Benadryl,Hydrocortisone and Motrin
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: GABAPENTIN; REQUIP. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included product: COVID 19 Treatment, Brand: Paxlovid, from 28Sep2022 to 03Oct2022 as treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Waited 10 minutes after shot, on way out started to itch, sweaty, "feeling lightheaded" c/o chills.  Vitals monitored.  EMS already present on scene for clinic, transported to ER for further evaluation.
24 hours after vaccination chills and body aches very sore left arm. 3 days after vaccination rash on left arm and chest.
Received 2nd COVID vaccine dose. Started coughing and vomiting the following morning. Also has headache and sore throat.
Rash/hives, itching at injection site on evening after administration. Pt self-medicated with Benadryl.
Patient got immun. at 1:pm at 7:00pm c/o extreme soreness under same arm. Pneumonia vaccine was administered by 11:00pm c/o fever/chills, had trouble sleeping due to soreness. Feels better today but arm still extremely sore.
Patient, developed hives. The doctor has mention to me that that would be normal to get some hives but they are not some they are all over his body from head to toes. The arm were he got the hives is super swollen and very hot and the hives look like if he had chickenpox and shingles and the uniform hives that are super big. He has three different types of hives the ones on his head are very big and it feels very hard. Like if he had hit his head and he has a lot of them in the head. The ones on the legs and face look like chickenpox and the ones on his stomach are the uniform shaped ones and the shingle like are in the arms as well.
Immunocompromised patient received Pfizer as D1 and D2.  Received Moderna 0.5mL as AD on 11/20/2021 as indicated in this report.
Increased irritability, interrupted sleep patterns and waking up screaming for no apparent reason, nearly impossible to soothe/calm, 10+ day periods of constipation with few minuscule watery bowl movements, and foul/frequent gas.  Doctor brushed off concerns as side effects of reflux.  Also blamed newly developed behaviors as "colic".
pain at injection site; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  An adult male patient received meningococcal group b Rlp2086 (TRUMENBA), on 27Jul2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Meningococcal vaccine (PRIMARY IMMUNIZATION SERIES, MANUFACTURER UNKNOWN ), for immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Jul2023, outcome "recovering", described as "pain at injection site". It was unknown if therapeutic measures were taken as a result of vaccination site pain. Additional information: Physician shared personal experience with pain at injection site after receiving booster dose of meningococcal group b Rlp2086 last week on 27Jul2023.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
Nausea w/in 30 minutes of injection. Vomiting. Headache. Fatigue.
Narrative: COVID infection following COVID vaccine series 04/02, Pfizer, dose #2 06/22 COVID swab, result: not detected 09/17 COVID swab, result: detected 09/16 pt cc: cough, headache, loss of taste or smell, myalgias, nausea, rhinorrhea, dyspnea, sore throat exposure: wife 09/17 SARS-COV-2 Variant Sequencing result: pending 09/28 clinically resolved
03/09/2021...Sharp "prick" and then itch. (I did not scratch) 03/10/2021....Presistant itch (I did not scratch)  03/11/2021...Presistant itch plus area is light red about 3"x4" area  from side to slightly on the front of bicep
High fevers, swelling on lt arm, muscle pain, h/a, pain all bones, 15MAY- 18MAY can't move arm, hot flashes, chills started 3AM Fri to Mon 8PM;
Developed Bell's Palsy 8-28-06 9/12/06-note from 08/30/06-mom contacted office, daughter lost feeling in tongue earlier in day. Mom observed that face was drooping on one side when she speaks. advise nurse directed patient to ER-where patient was DX with Bell's palsy. RX with Prednisone. Visit on 9/1/06-symptoms remain with drooping of face to right side. Lyme lab work negative. Office visit 9/11/06-drooping remains on right side of face. R ear with redness and drying with oozing. Possible cellulitis of right auricle. RX with Duricef . Additional lab tests 8/28/06-Hct 36.2 repeat on 8/30/06 35.8, neutrophils 30, lymph 62, UA negative, Drug screen negative.  Will follow up with physician office in 2 weeks to check on status of symptoms related to Bell's Palsy.
temperature excursion; beyond the 30 days in the refrigerator on 24JAN2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion), PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023) 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)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023, 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 24-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion), PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion), PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) and PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023).    This case included information of patient 1 out of 4 patients reported.  Concomitant and treatment medications were not reported.  Pharmacist called to report a temperature excursion. Reporter stated that 4 adult patients received the Bivalent booster of Moderna COVID-19 vaccine beyond the 30 days in the refrigerator on 24-JAN-2023 with lot number AS7171B from intact cartons with vial size of 2.5ml. Vial was initially stored in the refrigerator 23-DEC-2023.   This case was linked to US-MODERNATX, INC.-MOD-2023-705192, US-MODERNATX, INC.-MOD-2023-705197, US-MODERNATX, INC.-MOD-2023-705202 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705192:Patient 2 US-MODERNATX, INC.-MOD-2023-705197:Patient 3 US-MODERNATX, INC.-MOD-2023-705202:Patient 4
pt revcvd vax 25JAN93 & on 11SEP93 pt dx w/URI & bacteremia; lab eval showed haemophilus influenzae type b; 20OCT93 pt was dx w/meningitis & bactermia; lab eval again showed haemophilus influenzae type b;
Subsequent to receiving one dose of varicella virus vaccine live the pt developed possible breakthrough chickenpox that consisted of approximately 15 lesions, 13 of which were scabbed over and other two look like watery bubbles.
Both my partner and I, who got our shots at the same time, are experiencing extreme waves of dizziness and light headedness. Last night, as I was walking out of my room, I was suddenly on the floor. I didn't lose consciousness, but it scared the heck out of me. Super disoriented, having a hard time keeping a thought in my head. And this comes and goes. Sometimes it's mild like the feeling of being on a boat, and other times, it's me clinging to the counter top for dear life. This is really scary.
Pt still complaining of arm soreness and loss of range of motion since shot was given. She has not sought treatment yet. I referred her to start at her primary care doctor so they could direct to appropriate specialist if needed.
Onset of symptoms occurred 48 hours post vaccine.  Symptoms were nausea and vomiting.  Spoke with patient today, 9/8/08.  Feels much better.  Able to tolerate solids and liquids.
Reddish purple; Big red welt in the injection site, seems to be getting bigger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Reddish purple) and VACCINATION SITE URTICARIA (Big red welt in the injection site, seems to be getting bigger) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.   Concurrent medical conditions included Thyroid disorder, Hypertension, Diabetes mellitus and Dyslipidemia. Concomitant products included RITUXIMAB (RITUXAN) for an unknown indication.  On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Reddish purple) and VACCINATION SITE URTICARIA (Big red welt in the injection site, seems to be getting bigger). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; Physical therapy (Ice therapy) for Vaccination site discolouration and Physical therapy (Ice therapy) for Vaccination site urticaria. At the time of the report, VACCINATION SITE DISCOLOURATION (Reddish purple) and VACCINATION SITE URTICARIA (Big red welt in the injection site, seems to be getting bigger) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  The concomitant medications included thyroid medicine, high blood pressure medicine, Diabetes medicines, and cholesterol medications.
Systemic: swelling around face/neck per patient-Mild, Systemic: Weakness-Mild, Additional Details: Pt states she started having swollen face/neck since 7/27/22 and saw a doctor for the adverse reaction. She was not prescribed anything or treated at doctor's office. She was told to wait for a couple of days and return to officec if not getting better. She came to pharmacy on 7/28/22 around 10 am to have us report this adverse reaction. She did not have severe swelling nor breathing difficulty, she appeared otherwise healthy. She insisted on filing the vaers to be followed up.
Redness, swelling and large, tight, fluid-filled vesicles developed at the injection site-- this began 59 hours after receiving the vaccine. One week after receiving the vaccine, the fluid-filled vesicles are still present.
Patient started to experience dizziness almost immediately after receiving immunization.  She did eventually experience syncope after being put into a reclining position.
hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional information was provided as follows: This case was reported by the consumer for his/her father. Age at the time of vaccination was not reported. The patient received Shingrix dose 4 weeks ago from date of reporting and few days later he broke out in hives all over his arms and face. The reporter mentioned that they know that hives is a rare side effects but few weeks seems extreme. The reporter inquired, whether it was normal or not.
On 03/09/2001 the patient developed chicken pox. The patient sought medical attention. Additional information has been requested. Per F/U 6/18/02: Info has been received from an RN concerning a 42 month old Asian male with an amoxicillin allergy who on 8/20/98 was vaccinated with the 1st dose of varicella vaccine (lot 625047/1574E) in the PM, SC in the left thigh. On 3/9/01, the pt developed chicken pox. The pt had "many vesicles with fluid on torso, face and arms". It was also reported that there were "some scabs noted". It was noted to be an apparent breakthrough of varicella. The pt sought unspecified medical attention. Additional info has been requested.
Customer after shot felt a flash a lightheadedness and some palpitations. Customer symptoms of lightheadedness subsided quickly. customer reported some panic and reported a first panic attack three days ago and was worried it would occur again. Customer was observed 20 minutes, ambulated without lightheadedness, HR wnl per radial check and  skin color was WNL Customer left feeling ok, still reporting some feeling of panic.
Patient wanted to receive a COVID vaccine (Pfizer first dose), however she received Tdap (Boostrix) instead by our staff pharmacist.  Patient currently has muscle ache and soreness on injection site.
Full body rash; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the right arm on 29May2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included birth control (MANUFACTURER UNKNOWN) from an unknown date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 08May2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. On 02Jun2021, the patient experienced full body rash. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 03Jun2021, the patient underwent SARS-COV-2 Test (Nasal Swab) and the result was Negative. The clinical outcome of the event full body rash was recovered with sequelae at the time of this report.   No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a 69 year old female pt with diabetes mellitis who on 3/8/99 was vaccinated with Hep B. On 3/10/99, the pt experienced an injection site reaction that consisted of a swollen warm to touch blotchy rash. Additional information has been requested.
Pt's arm is constantly sore, has limited mobility pt went to his Dr office pt wanted pain medication but Dr gave him gabapentin he is also using over the counter muscle rubs.