chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE/PQC reported; improperly stored and administered VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were not reported.  On 21-JUL-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection 0.5 mL (two dose series) as prophylaxis (lot # W032507 and expiration date was 11-OCT-2024; strength, route of administration, and frequency were unknown) (product storage error), the single patient involved had not reported any symptoms related to this adverse event. No additional adverse event (AE) reported (no adverse event).
double vision with sustained lateral gaze noted on 10/1/21 as isolated incident. noted again in January 2022. evaluated by optometry 1/2022 and referred to ophthalmology where diagnosis of ocular myasthenia gravis was made. treatment was started with mestinon 90 mg tabs take 2 tabs tid prn. By March of 2022 I was having daily symptoms.  subsequently seen by neurology in June 2022 who ordered testing and confirmed diagnosis.
Patient explained that later that day after the vaccination had trouble breathing and had pain everywhere. Went to hospital to be treated.
1/2 hr after receiving immunization, pt started having hives, rash, coughing and severe itching. Benadryl given and symptoms went away within 2 hrs. Medical treatment was recommended.
1125-EE received vaccine; 1135-EE reported numbness in their hand post vaccine.  1140-EE given a snack and water. 1145-EE reported resolution of symptoms 1200-EE departs vaccine clinic with complete resolution of symptoms
Information has been received from a woman at a physician's office concerning a 7 year old female who was vaccinated with a dose of Varivax. Subsequently, the patient developed chickenpox. It was reported that she recovered on an unspecified date. Additional information has been requested.
Tested positive on Shingles; Pain in her sciatica/shooting pain that she initially thought was sciatica; Sore arm; Chills; Fever; Shooting pain; nerve pain; I also had a little bit of infection; I was suffering from Sciatica because my right hip and leg was sore; I was suffering from Sciatica because my right hip and leg was sore; This is a spontaneous report from a Pfizer-sponsored program  a contactable consumer (Patient). A 59-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK9231), via an unspecified route of administration on 27Jan2021 as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified, The patient experienced tested positive on shingles (herpes zoster) , pain in her sciatica/shooting pain that she initially thought was sciatica (sciatica) , sore arm (pain in extremity), chills (chills), fever (pyrexia), shooting pain (pain), nerve pain (neuralgia) , i also had a little bit of infection (infection), i was suffering from sciatica because my right hip and leg was sore (arthralgia), i was suffering from sciatica because my right hip and leg was sore (pain in extremity). The patient had experienced pain in her sciatica and tested positive on Shingles after receiving the 1st dose. Dates for The lesions they never really went anywhere, they sort of popped-up and then they dried out within about 3 to 4 days so they never blistered they never opened up. because my right hip and leg was sore. Saturday after getting shot I ended up finding out I had Shingles because I broke out. I went to the emergency room so they put me on Valtrex and they put me on Keflex because it looks like I also had a little bit of infection so I just finished up those medicines and I am due to have my second Covid shot next Wednesday and wondering since I had shingles since I had shingles, should I postponed that second shot or is it safe for me to get it. The outcome of the events was unknown.
90 minutes post vax (left deltoid IM), left wrist and hand swollen, warm, with bright erythema. Mother iced hand and gave Benadryl. Slight pain, ? dull. symptoms lasted approximately 18 hours.
This spontaneous report was received from a Certified Medical Assistant (C.M.A.) concerning a 1 year old male patient. No concurrent conditions or medical history were reported. On 03-AUG-2015, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (Lot # L003218 date: 30-APR-2016), 0.65 ml in the "right thigh" instead of receiving PROQUAD (Merck). No adverse effects reported at this time. Additional information is not expected as the reporter did not wish further contact.
About 4 hours after vaccine I felt exhausted and a little light headed. I went to bed early and the next day I woke up with extreme body aches and a fever. That last until Thursday.  I then started feeling better still exhausted but then that late afternoon 3pm, I got stomach cramps and began vomiting.  That lasted on and off thru Friday. Then I just felt nauseous.  Still today which is 4 days later still nauseous and vomiting on and off.
a 2-year-old son of a couple died after being vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown).  A 2-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "a 2-year-old son of a couple died after being vaccinated". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: a 2-year-old son of a couple died after being vaccinated
Pfizer-BioNTech COVID-19 Vaccine EUA Swollen eyes 24 hours after vaccination.  Diagnosed with conjunctivitis 4 days after vaccination.  RX TobraDex ST - 1 drop each eye 4 times daily until 4/15/21 or until systoms are gone. Was given a  RX
Pt. here with 2 children, all receiving their COVID shots. Pt. accidentally received a peds (.2ml) Pfizer dose in l-arm. Director of vaccine clinic notified and recommended still giving adult dose (.3ml). Pt. ok with decision and given Pfizer adult dose in r-arm.
Information has been received from a physician concerning a 8 year old female who on 08/01/1995 was vaccinated with Varivax. On approximately 03/15/02, the patient developed chickenpox. The patient sought unspecified medical attention. Additional information has been requested.
Headache, difficulty breathing (tightness of chest), uncontrolled shaking, feeling extremely chilled (couldn't get hands or feet warm, had to use heating pad), woke up wet from sweating. Called primary care physician and he will keep in touch and monitor symptoms; he suggested going to ER if symptoms persist or get worse.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Additional Details: Pt mother stated pt was nauseous and then that he was passing out. RN ran over to check on pt as pt eye rolled back and pt limbs fell limp. Pt moved to the floor by RN, rolled to the side by RN. Pt regained consciousness almost immediately and was laid on his back with feet elevated. Pt stated he felt fine, did not recall exactly what happened. Pt helped up into chair, given water and crackers. Pt stated he felt fine, observed by medical personnel for 30 min and pt was able to ambulate off site.
Achy, exhaustion, loss of continence very loose soft stools ... sudden emergency to bathroom still present headaches, loss of balance
Tuesday- received shots. Wednesday- rash presented w/heat and soreness at injection site. Thursday- heat and soreness the same rash spreading.
chills; Fever; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced CHILLS (chills) and PYREXIA (Fever). At the time of the report, CHILLS (chills) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: non significant followup
Beginning about 16hours after the shot (the next morning) my stomach began to bother me a little, within half an hour or so I began to feel a little tingle from the top left arm (shot area) down to my stomach including my sternum area.  It got progressively worse. By about hour 17 I was beginning to get cold sweats and stomach bothering me more. By hour 18 I was cold, sweating, nauseous, vomiting, hard tight pain in stomach /and sternum/chest.  Stomach / chest pain persisted badly for about 30- 45 minutes then began to subside.  By hour 19 most of the sever pain subsided.  for the rest of the day (@and still 25 hours later) I still have a lingering miserable stomach and slight headache.  I slept most of the afternoon without any medication.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, drug reactions or allergies and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot number M025565, expiration date 06-NOV-2017, (dose was not reported) for prophylaxis (incorrect product storage). There was no concomitant medication reported. No adverse effects were reported. This is one of two reports from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1610USA009463: MERCK 1610USA006200:Mfr number.
Intractable projectile vomiting x 12 hours Fever for 36 hours
02/02/22 presents to Birth Center Triage for "PROM, labor". PMHx of " positive for COVID-19 on 1/25"
shivers; tired; belly pain; diarrhea; pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th April 2019, the patient received the 1st dose of Shingrix. On 10th April 2019, 3 hrs 30 min after receiving Shingrix, the patient experienced pain in arm. On 11th April 2019, the patient experienced shivers, tiredness, abdominal pain and diarrhea. On 12th April 2019, the outcome of the shivers was recovered/resolved. On an unknown date, the outcome of the pain in arm, tiredness, abdominal pain and diarrhea were unknown.   It was unknown if the reporter considered the pain in arm, shivers, tiredness, abdominal pain and diarrhea to be related to Shingrix.  Additional details were provided as follows: On Wednesday at 1:30 pm, the patient received Shingrix and at 5:00 pm experienced pain in arm. On Thursday, the patient experienced Shivers till noon of the day of reporting. Since Thursday afternoon, the patient was very tired and had belly pain. On the day of reporting, the patient experienced diarrhea. The reporter asked how long would these side effects last. The patient was very energetic person and could not stand this tired and other side effects. The patient would like to know if it likely to get side effects from the 2nd dose also.
This spontaneous report was received from a pharmacist concerning to a 63 year old female patient. Information regarding the patient's medical history or concurrent conditions was not provided. On 06-JUL-2015, the patient was vaccinated with ZOSTAVAX subcutaneous injection, lot # L008357 with expiration date of: 11-JUN-2016, 0.65 ml, subcutaneous. Concomitant therapy was not reported. On 09-JUL-2015, the patient developed a rash on an unspecified area of the body, following the administration of ZOSTAVAX. Then, on 13-JUL-2015, the patient was seen by an unspecified physician who diagnosed her with shingles and prescribed her treatment with: amoxicillin 500mg 3 times daily for 7 days, Prednisone (manufacturer unknown) 60 mg for 3 days, 40 mg for 3 days, and 20mg for 3 days; acyclovir tablets 1gm 3 times daily for 1 week, and Miconazole 0.1% cream 2 times daily. At the time of this report, the outcome of herpes zoster was unknown. Additional information has been requested.
A nurse working in the vaccine clinic administered a 2nd dose of Janssen vaccine to a patient who had already received a Janssen vaccine.  This was identified after the patient had already received the 2nd dose.
8 days p/immun pt had fever of 105.6 & generalized sz of 1 1/2 hr duration.
Fever, welts, dizziness. Nausea and swelling of arm. Welts got larger as time passed and arm swelling and pain got worse.
vaccine only serves half despite having the two doses, it gave me covid; vaccine only serves half despite having the two doses, it gave me covid; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (Patient) reported that a patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACUBE, Solution for injection), dose 2 and dose 1, both via an unspecified route of administration on an unspecified date (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported vaccine only served half despite having the two doses, it gave covid and patient was screwed at home. The outcome of events was unknown.   Information about lot/batch has been requested.
This female subject was enrolled in a study. On 16 August 2010 and 18 October 2010, she received the 1st and 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), Wyeth's PREVENAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 17 January 2011, she received 3rd dose of HIBERIX, PEDIARIX and PREVENAR 13. On 09 December 2011, she received a booster of HIBERIX and a dose of INFANRIX. On 17 December 2011, 14 months after the 2nd dose of ROTARIX, 11 months after the 3rd dose of PEDIARIX, 11 months after the 3rd dose of PREVNAR 13, eight days after the 4th dose of HIBERIX, eight days after the 1st dose of INFANRIX, this 18-month-old subject developed traumatic head injury : cephalohematoma and traumatic subdural hemorrhage. The subject was hospitalised. The events resolved on 30 December 2011. The investigator considered that there was no reasonable possibility that the cephalohematoma and traumatic subdural hemorrhage may have been caused by ROTARIX, PEDIARIX, PREVNAR 13, HIBERIX and INFANRIX and that the events were possibly due to accidental fall. Investigator Comments : 20Dec2011-CT Head WO Contrast: Findings: Nonenhanced axial images obtained from skull base to vertex. CSF spaces and ventrioles remain normal without evidence of hydrocephalus. A tiny extra-axial hyperdense collection bordering the left temporal frontal lobe best noted on images 10-20/56 has a maximum diameter of 1.5mm. Allowing for slice thickness differences on comparison exam, finding has not significantly changed and compatible with a tiny extra-axial hematoma. Reidentified is the moderate sire left frontal temporal cephalohematoma. No calvarial fracture is appreciated. There is no evidence for new interval finding. Impression: Stable left temporal frontal extra-axial tiny hematoma, probably subdural. No calvarial fracture identified. A moderate left frontal temporal cephalohematoma is unchanged. No new interval finding. 18 month old brought to clinic for evaluation for enlarging lump to head. Pt was being carried by older sibling and fell approximately 3 feet onto concrete driveway 2 days prior. No loss of consciousness, cried immediately, no emesis/crankiness, with normal activity and appetite. Lump to left side of scalp noted to be increasing in size and softer. Medical findings: 9-10 cm left parietal cephalohematoma, tender to palpation: child alert/oriented, moving all extremities. DTRs 2+. Admitted to hospital for observation and neurosurgery consult 12/19/2011. CT scan confirmed left temporal frontal subdural hematoma. No skull fracture, no edema, no mass effect. Discharged 12/20/2011 asymptomatic. January 31, 2012 (First Follow Up) 01/10/2012 spoke with mom, reports hematoma all resolved 12/30/2011 when saw neurosurgery for follow up appointment.
Recurrence of Covid symptoms and confirmed positive test; 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 72-year-old male patient received BNT162b2 (BNT162B2), on 15Jul2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm 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 included: "Wheat amkwrgy" (unspecified if ongoing), notes: Known allergies: Wheat amkwrgy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 02Sep2022, outcome "recovering", described as "Recurrence of Covid symptoms and confirmed positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Recurrence of Covid symptoms and confirmed positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown if therapeutic measures were taken as a result of disease recurrence. Patient was treated with paxlovid from 24Aug2022 to 29Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Both of my feet became very numb from about mid-foot thru all toes, shortly after the first Moderna Covid vaccine shot. The symptoms started to get slightly better just before receiving the second Moderna shot, but then came roaring back worse than ever after the second shot. My feet are still completely numb almost 5 weeks after receiving the second dose of the vaccine.
PT C/O  FAST HEART BEAT AND NAUSEA. PT HAS A Hx OF HTN AND COMPLETED HER BP MEDICATIONS THIS MORNING. PT ADMITTED FEELING BABY PRESSURE ON HER CHEST.  PT'S PCP WAS CONTACTED TO R/O HEART DISEASE. PT ABANDONED F/U CARE AND PCP WAS NOT ABLE TO VERIFY CURRENT MEDICATIONS. VS @ 9:58 BP 151/77 HR 73 SpO2 99%  REPEAT BP 168/74  HR 73  ON EXAMINATION: NORMAL HR AND RHYTHM, NO RADIATING PAIN, OR SIGNS OF SEVERE DISTRESS.  BREATHING NORMAL WITHOUT USE OF ACCESSORY MUSCLES.   PT INSTRUCTED TO BREATH SLOWLY, VOMIT IF NEEDED,  AND PROVIDED WITH FLUIDS. PT WAS STABLE TO WALK TO THE BATHROOM AND  STATED THAT HER SYMPTOMS IMPROVED. PT STABLE AT D/C WITH HER DAUGHTER DRIVING. NAUSEA NOT COMPLETELY RESOLVED.
Pt says he had dizziness, mumbled/slurred speech, droopy face on left side, pt says he dropped his coffee
About 6 hours after vaccination, patient felt immense headache, muscle pain and weakness, chills, sleepiness, lack of appetite to eat and slight nausea. This phenomenon lasted for about 48 hours.
11/5 Tired, blister near injection site burst; 11/6 emesis x2, headache, rash at injection site; 11/7 increased size rash (4.5x7cm erythema/induration on exterior surface left upper arm)-no streaking.
I had my booster on 11/9/2021 and had headache and fever for a couple of days afterward. Then on 11/15/2021 it started to get worse. The headache turned into a migraine, and I started having joint, muscle and nerve pain along with cramping and sciatica pain. It got to where I could barely move without being in pain, and I could barely drive. The pain never did ease up. All my joints are inflamed and above a 10 on a pain scale. Until this happened, I didn't menstruate for 10 months, then all of a sudden started having heavy discharge. It's not blood, like a regular period would be, it's like a light pink and brownish color with yellow mixed in sometimes. The clinic told me it sounded like my uterine line was shedding. But I haven't been able to confirm anything. I started to have IBS problems as well. I started to have acid reflux and was barely able to stomach anything. I decided to try intermittent fasting to help reset my digestion. I've occasionally tried this in the past and I've always felt like it helped me. This time I did it for almost a month and gradually started bringing soft bland food into my diet. Still working through migraines and sciatica and having joint pain, it's like having "charley horses" in different parts of my body daily. My doctor advised me to have an MRI, but I don't have the money or anyone to take me as I still can't safely drive very well.
no appetite; looked and felt sick; nauseous; tired/fatigue; chills; felt groggy/slept; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (felt groggy/slept), DECREASED APPETITE (no appetite), ILLNESS (looked and felt sick), NAUSEA (nauseous) and FATIGUE (tired/fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A, 039A21A and 065S21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (felt groggy/slept). On 07-May-2021, the patient experienced NAUSEA (nauseous), FATIGUE (tired/fatigue) and CHILLS (chills). On an unknown date, the patient experienced DECREASED APPETITE (no appetite) and ILLNESS (looked and felt sick). At the time of the report, SOMNOLENCE (felt groggy/slept), DECREASED APPETITE (no appetite), ILLNESS (looked and felt sick), NAUSEA (nauseous), FATIGUE (tired/fatigue) and CHILLS (chills) outcome was unknown.            The patient received the first vaccine in her left arm shoulder deltoid muscle. The patient had no adverse reactions to her first Moderna COVID-19 vaccine.   Concomitant medication of the patient was not reported.  The patient received the second vaccine in her left arm shoulder deltoid muscle.    No treatment information was provided by the reporter.  The patient received the booster dose in her left arm shoulder deltoid. The patient had no adverse reactions after her booster Moderna COVID-19 vaccine.