chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The following was reported by the patient on 3/23/2021: On 3/13/2021 at 9:10AM, the patient suffered a seizure, she was calm after 5 minutes. At 2:25PM, there was a second episode of seizure. The husband decided to take her to the hospital ER. When they were in the ER, at around 5:50PM, she suffered another seizure and the doctor decided to admit her to the ICU. She stayed in the ICU and was discharged on 3/15/2021. Since then, she was fine already.
ovary pain; an inconsistent cycle; stress; endometrioma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jun2021 (Lot number: EW0221) at the age of 31 years as dose 2, single and administered in arm left, administration date 29Apr2021 (Lot number: EY4825) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: other medical history: migraine. Concomitant medication(s) included: ZINC; VIT C. The following information was reported: ADNEXA UTERI PAIN (non-serious) with onset 2021, outcome "recovered" (Oct2021), described as "ovary pain"; MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "recovered" (Oct2021), described as "an inconsistent cycle"; STRESS (non-serious) with onset 2021, outcome "recovered" (Oct2021), described as "stress"; ENDOMETRIOSIS (non-serious) with onset 2021, outcome "recovered" (Oct2021), described as "endometrioma". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of adnexa uteri pain, menstrual disorder, stress, endometriosis.  Additional Information: Patient did not experience covid prior to vaccination. Patient received supplements only (zinc, vit c, vit b, prenatal, et). After the first 2 shots, patient experienced ovary pain and an inconsistent cycle. Patient attributed that to stress and maybe a normal reaction to the vaccine at first, but after 2 or so months, the pain and inconsistent cycles persisted so her doctor gave her an ultrasound where they discovered an endometrioma. Patient took some supplements (serrapeptase, DIM, NAC) and did acupuncture and 3 months later, the follow up ultrasound showed that the endometrioma was no longer there. This was end of October. Patient didn't feel anymore discomfort and had a regular cycle in November and December until the booster.  No follow-up attempts are possible. No further information is expected.
I received my flu vaccine shot from a pharmacist on 10/17/2013 at pharmacy.  She gave the shot in my left arm and I looked away.  She put the bandaid up over the shoulder joint.  Two hours later I started experiencing intense pain and inability to move my left arm.  It is now 10/29/2013 and I only have partial use of my left arm and I still am experiencing this pain.
This spontaneous report as received from a registered nurse refers to an approximately 359 days (reported as 6 days before 1 year old) male patient. The patient pertinent medical history was not reported. On 02-FEB-1999 the patient was vaccinated with M-M-R II and VARIVAX (Merck), which was 6 days before the patient turned 1 year old. No adverse effect was reported. No product quality complaint (PQC) was reported for M-M-R II and VARIVAX. This is one of the two reports received from the same reporter. Additional information has been requested.
Swelling around eyes noted 15 mins after vaccinations when arrived home - no trouble breathing. Mom called ambulance - seen in ER about 30 mins after vaccines, no interventions needed sent home on BENADRYL and prednisolone.
Generalized blanching erythematous mac-pap rash and tactile high fever.
pt recvd vax & devel oozing of sanguinous fluid, edema, 2.5-3 cm size wheal, area of induration & redness @ the inject site; ice was applied; sx were resolved by 8OCT93
Pt received vaccine that is recommended for 18 years and older and is only 16 years at time of injection
The patient developed severe low back, hip and buttock pain with some sciatica starting 3 weeks after vaccination. Pain persisted despite several epidural injections. This lasted for about a month after which the pain stopped but the patient developed bilateral sensory and motor neuropathy of her upper and lower extremities.
Burning in the glutes; Cant get out of bed; Back pain; Mild diarrhea; Tiredness and fatigue; Joint pains; Headache; Delayed her 2nd dose due to back pain after first dose; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning in the glutes), ASTHENIA (Cant get out of bed), BACK PAIN (Back pain), DIARRHOEA (Mild diarrhea) and INTENTIONAL PRODUCT USE ISSUE (Delayed her 2nd dose due to back pain after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. UNKNOWN and 029A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     There was no medical history provided.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced BURNING SENSATION (Burning in the glutes), ASTHENIA (Cant get out of bed), BACK PAIN (Back pain), DIARRHOEA (Mild diarrhea), FATIGUE (Tiredness and fatigue), ARTHRALGIA (Joint pains) and HEADACHE (Headache). In March 2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Delayed her 2nd dose due to back pain after first dose). At the time of the report, BURNING SENSATION (Burning in the glutes), ASTHENIA (Cant get out of bed), BACK PAIN (Back pain), DIARRHOEA (Mild diarrhea), INTENTIONAL PRODUCT USE ISSUE (Delayed her 2nd dose due to back pain after first dose), FATIGUE (Tiredness and fatigue), ARTHRALGIA (Joint pains) and HEADACHE (Headache) outcome was unknown. Not Provided          No concomitant medicines reported. No treatment medicines reported.   This case was linked to MOD-2021-221345 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up received on 07-05-2021 and there is No new information
prothrombin time - INR  was  1.7 and  1.8; Had redness at the injection site; Felt awful; Hot and cold sweats; Loose stools; Exessive fatique; This is a spontaneous report from a contactable consumer.  A 36-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), dose 2nd intramuscular, administered in Arm Left on 11Mar2021 as single dose for covid-19 immunisation.  Medical history included Antiphospolipid disorder from 2018 and ongoing. Concomitant medication(s) included warfarin taken for antiphospolipid from 2018 and ongoing, lamotrigine taken for mood disorder from 2020 and ongoing, topiramate taken for migraine from 2020 and ongoing, hydroxyzine taken for sleep from 2020 and ongoing. Family medical history not relevant to Adverse event. The patient had redness at the injection site, felt awful, hot and cold sweats, loose stools and excessive fatigue on 12mar2021, prothrombin time - inr was 1.7 and 1.8 on 17Mar2021. The patient underwent lab tests and procedures which included prothrombin time: 1.7 on 17Mar2021, prothrombin time: 1.8 on 25Mar2021, Norm :Low :2.0, Norm High:3.0. Patient did not receive any treatment for the event redness at the injection site, felt awful, hot and cold sweats, loose stools and excessive fatigue. Event reported as non-serious. The outcome of the event redness at the injection site, felt awful, hot and cold sweats, loose stools and excessive fatigue was recovered on 13Mar2021, and unknown for prothrombin time - inr was 1.7 and 1.8.  No follow-up attempts are needed. No further information is expected
Went to the ER with severe dizziness, light-headedness, and dry mouth.
This case was reported by a lawyer and described the occurrence of anemia in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix unknown. At an unspecified time after vaccination with Lymerix, the subject experienced pain and swelling in her joints, fatigue, anemia, possible neurological injuries, possible autoimmune disease, and decreased activities of daily life. At the time of reporting the outcome of the events were was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Patient called the pharmacy on 9/18/2020 stating they had received a flu shot on 9/15/2020 and their arm was still sore from it. Upon further questioning  the patient stated they had a rash from the site of the injection down to their elbow. It had started the next morning after the shot on 9/17/2020.
10/8/13 fever with cough 10/11/13 doctor appt (fever, chill, loss of appetite, cough, runny nose/congestion, sore throat, postnasal drip), sent home told return if worsens 10/14/13 doctor appt (fever/chills, not sleeping well, runny nose/congestion, ear pain, daytime cough, nighttime cough disturbing sleep, pain with palpitation on sinuses) prescribed Aumentin antibiotic, increase fluids 10/28/13 doctor appt (Not hearing well out of one ear, ear pain, runny nose/congestion, daytime cough, nighttime cough disturbing sleep) prescribed Omnicef antibiotic, just finished Aumentin, increase fluids 11/5/13 doctor appt (whining/crankiness, runny  nose/nasal congestion, sore throat, post nasal drip, change in hearing, nighttime cough disturbing sleep, over one month of symptoms)  prescribed Zithromax antibiotic, increase fluid 11/7/13 ENT appt (chronic ear infection and hearing loss, tinnitus, irritability, lethargy) suggested tube placement 11/20/13 ENT surgery (Myringotomy with insertion of ventilating tube) 12/19/13 ENT appt (symptoms improved)
Anaphylaxis with shortness of breathe, throat swelling, tongue swelling, lip numbness, eye protruding.  Documented as anaphylaxis and recommendation to never get vaccination again per Hospital.
pt recv vax & devel a mild case of varicella w/a handful of pox blistering @ surface;pt seen by MD who dx chickenpox;
incorrect dosing schedule; This case was reported by a consumer via call center representative and described the occurrence of non-hodgkin's lymphoma in a 17-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced non-hodgkin's lymphoma (serious criteria GSK medically significant). Shingrix was discontinued. On an unknown date, the outcome of the non-hodgkin's lymphoma was unknown.   It was unknown if the reporter considered the non-hodgkin's lymphoma to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Wife reported that her husband received the first dose of Shingrix about a year ago and then he was diagnosed with the 4th occurrence of Non-Hodgkins Lymphyoma for the 4th time in 17 years and his physician suggested that he not receive the second dose of Shingrix because of the concern that the chemo could render the vaccine ineffective. The reporter consented to follow up.
Sleepy; Grandchildren who are below 18 years of age received moderna vaccine; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Grandchildren who are below 18 years of age received moderna vaccine) and FATIGUE (Tired) in a  patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Grandchildren who are below 18 years of age received moderna vaccine) and FATIGUE (Tired). At the time of the report, SOMNOLENCE (Sleepy), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Grandchildren who are below 18 years of age received moderna vaccine) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant mediations were not reported.  Treatment information was not reported.  Grand children are  below 18 years of age.   This case was linked to MOD-2022-533771, MOD-2022-533772 (Patient Link).
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFS-Luer-Lok" which had a lot number of L001312 and expiration date on 24-FEB-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the GARDASIL 9 vaccine had two temperature excursions; one of 24 hours and other one of 32 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius) and the highest recorded temperature was 48 F (8.888888889 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
The patient did not experience any adverse events other than sore arm, but the vaccine was administered a week early.
CEREBRAL PALSY; GUILLAIN-BARRE SYNDROME; This spontaneous report received from a consumer via media through a company representative concerned a male of unspecified age, race and ethnicity. 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, and batch number were not reported) 1 total, dose and start therapy date were not reported administered for prophylactic vaccination. The dose number in series was 1. 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 patient experienced cerebral palsy and Guillain-Barre Syndrome (GBS). The consumer stated that " I met a man who is now got GBS, another sudden cerebral palsy, after the Janssen. I want Sinovac even more now". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cerebral palsy and Guillain-Barre Syndrome syndrome was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20211222475.  It was determined that Manufacturer Case Number 20211222475 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20211223649.; Sender's Comments: V0: 20211223649-covid-19 vaccine ad26.cov2.s-cerebral palsy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211223649-covid-19 vaccine ad26.cov2.s-Guillain-Barre Syndrome. This event(s) is labeled per Agency and is therefore considered potentially related.
On the morning of 11May2921 I blew my nose and looked like a piece of dried blood was on the tissue, and nose feels dried out; On the morning of 11May2921 I blew my nose and looked like a piece of dried blood was on the tissue, and nose feels dried out; On 08May2021 at 2000 hrs. started smelling a diesel fuel odor; aeration in sinus canal as I was sitting or laying down (was at hotel); This is a spontaneous report from a contactable consumer (Patient reported for herself that).   A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0179), via unspecified route of administration in right arm on 06May2021: 17:30 as DOSE 2, SINGLE for COVID-19 immunization (Age at vaccination:55-Year-old). Medical history included PE, Sarcoidosis. Patient concomitant medications were not reported. Patient had no known allergies. The patient previously received BNT162b2 (COMIRNATY, Batch/Lot Number: EW0150) via an unspecified route of administration in left arm 14Apr2021:01.30 PM, as DOSE 1, SINGLE for COVID-19 immunization and experienced had slight headache on 14Apr2021 about 1hour after lasting about 4 hours and soreness in left arm on 15Apr2021.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and had received dietary supplements within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 08May2021: 08:00 PM Patient started smelling a diesel fuel odor and have aeration in sinus canal as he was sitting or laying down. On 09May2021, when he move or do any activity it will go away. This event does not interfere with other odors, he can smell and taste food, and other odors. On the morning of 11May2021, he blew his nose and looked like a piece of dried blood was on the tissue, and nose felt dried out. Sinus canal still felt aerated. Patient did not receive any treatment. The outcome of the events were Not recovered  No follow-up attempts are required. No further information is expected
Full body hives starting on the ninth day post-booster shot hives were red and itchy, and changed location frequently. hives are worse at nightime went to urgent care on third day of symptoms and was given a steroid shot, as well as 6 days worth of prednisone and a prescription for hydroxyzine. hives never fully went away, and redness and itchiness continued. I used cortizone cream and benadryl as needed, which did not help the symptoms either
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II, lot # K002527, expiration date 18-FEB-2016 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as there was no consent to contact any physician.
headache/ headachy; muscle aches; sore throat; sore arm; I felt worse; fever of 99.8; just felt overall very sick - flulike; just felt overall very sick - flulike; remaining very fatigued and slightly headachy; This is a spontaneous report from a contactable nurse (patient). This 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL8982; dose 2) intramuscularly on 26Jan2021 at 13:00 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included prolactinoma and osteoporosis. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior of the vaccine. The patient did not have COVID-19 prior to vaccination. Concomitant medications included vitamin D3 and bromocriptine (PARLODEL) from unknown dates for unknown indications. The patient had no known allergies. The patient previously received BNT162B2 (dose 1; lot number EL0142; left arm) on 05Jan2021 at 13:00. The patient felt fine until 26Jan2021 at 22:00- bedtime. She woke up during the night with a headache, muscle aches, sore throat, and sore arm. She tried to sleep it off but when she awoke at 07:00 she felt worse and had a fever of 99.8 and felt overall very sick- flulike. The patient was treated with ibuprofen. The patient started feeling better by about 14:00 "the next day" (unspecified) although she remained very fatigued and slightly "headachy." The clinical outcomes of headache, muscle aches, sore throat, sore arm, fever, flulike symptoms, and fatigue were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Within 36 hrs of receiving vaccines, the baby began crying inconsolably and passed bloody bowel movements. Symptoms lasted <24 hrs.
Dose was administered at 0805, patient passed out at 0810. Patient reported that he had worked all night and hadn't eaten for a while. He also said he has passed out from blood draws before.
Information has been received from a consumer concerning her approximately 12 month old son with allergic reaction to antibiotics who in 2001 was vaccinated with MMR II. Within a week of receiving the vaccine the patient experienced mild fever and then he started having seizures. Since then, the patient had been having seizures and he was taking medications for it. In 2004 the patient was diagnosed of epilepsy. The patient had ECG and other unspecified tests performed. On 21-JAN-2009 the patient experienced seizures again and was hospitalized for 1 night for observation. It was also reported the patient would experience leg cramps sometime that  makes him have difficulty walking. At the time of reporting, the patient had not yet recovered from epilepsy. Upon internal review, seizures was considered to be an other important medical event. Additional information has been requested.
On day after receiving 2nd Covid vaccine, experienced chills, congestion, diarrhea and pain of right arm.,  Unable to work.  Seen by Concentra provider on 2/26/21.  On 3/1/21, still feeling ill, unable to come to work.
Information has been received from a pharmacist concerning a 73 year old white retired female in a nursing home with mitral valve prolapse and a history of a left total knee replacement who on 06/26/03 in the evening, also reported as 06/26/03 in the AM or 06/27/03 in the morning was vaccinated ID in the left forearm with a first 0.1mL dose of pneumococcal vaccine 23 polyvalent. The reporter indicated that "they thought it was mantoux". Concomitant medications included "tape", "IVP dye", azithromycine (Zithromax), PCN, Codeine, mercury, iodine, ranitidine hydrochloride (Zantac), sucralfate (Carafate), and levofloxacine (Levaquin). Areas of the arm have swelling and redness. No further information was provided. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that the reporter confirmed that there was no "confusion" regarding the appearance or name of the product, and the error did not result from any confusion as to the proper dosing of the product. It was noted that the medication error resulted from a procedural error in their office. The nurse intended to vaccinate the pt with pneumococcal vaccine 23 polyvalent, but inadvertently used the "mantoux" administration procedures (0.1mL liquid injected ID).  Additional follow up information indicated that on 06/27/03 in the AM the pt developed redness and irritation around the injection site. No other symptoms were noted. The pt stated that she had some itching at times. No relevant diagnostic tests or lab data were reported.  The pt was reported as recovered on 06/29/03.  No further information is expected.
MD reported a number of pts experienced soreness & irritation @ inject site & irritability the day following vax W/Haemophilus B conjugate vax. No further details were provided.