chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my 5th dose of Moderna Bivalent on 11/07/2022. My adverse event started on 01/18/2023 at 05:00PM in the evening. I was walking out I noticed my foot was heavy. I felt my toes were numb. I had balance issue. I also noticed on my left hand it was numb. I went to the urgent care at 06:00PM. I had a CT scan and MRI on that day. It was normal. The doctor said it was a possible TIA. He wanted me to follow up the next day for a neuro exam. She wanted me to see a neurologist but she hasn't set up an appointment yet. I have a doctor's appointment on 02/15/2023. If  I have any balance issue they said to call 911.
Lower intestinal distress; Painful lower intestinal distress; Copious vomiting; Nausea with eating; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 at 13:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included lamotrigine (LAMICTAL), quetiapine fumarate (SEROQUEL) and meclozine hydrochloride (MECLIZINE), all taken for unspecified indications from unknown dates. The patient previously took keflex and codeine and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 18:00, the patient experienced very painful lower intestinal distress, vomiting for 3-4 hours and continued nausea with eating causing more pain for the next 2 full days. On 13Apr2021, the patient experienced less pain but still had gut unease. The clinical outcome of the events vomiting was resolved on 11Apr2021 and the outcome of nausea was resolved on13Apr2021, while that of painful lower intestinal distress was resolving at the time of this report.  No follow-up attempts are required; information about lot/ batch number cannot be obtained. No further information is expected.
Fever; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nausea". Additional information: Device Date: 14Jan2022 No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse practitioner, concerning to "couple of youngsters", who were vaccinated with the second dose of VARIVAX (Oka/Merck). The patients experienced itching and large swelling after the second dose of VARIVAX (Oka/Merck). The patients sought medical attention. There was no product quality complaint. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Follow-up information has been received from a Licensed Practical Nurse, concerning a 12 year old male patient, who was vaccinated with VARIVAX (Oka/Merck) (Lot # 660671/0430X). Subsequently, the patient experienced itching, large swelling and fever. The patient recovered from the itching and swelling. The outcome of fever was not reported. Further information is expected.
Lightheadedness leading to brief syncopal episode. Patient could not tolerate any other position than supine for 2 hours. Received 25mg BENADRYL PO and symptoms resolved.
lots of muscle soreness in her legs and arms, not feeling good at all; not feeling good at all; lymphnodes swelling on one side of her throat.; she is really tired; headache / head hurts really bad; nausea; feels like a touch of the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "allergic to seafood" (unspecified if ongoing); "allergic to iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Benadryl, reaction(s): "she is allergic to benadryl".  The following information was reported: MYALGIA (non-serious) with onset 26Mar2021, outcome "unknown", described as "lots of muscle soreness in her legs and arms, not feeling good at all"; MALAISE (non-serious) with onset 26Mar2021, outcome "unknown", described as "not feeling good at all"; LYMPHADENOPATHY (non-serious) with onset 26Mar2021, outcome "unknown", described as "lymphnodes swelling on one side of her throat."; FATIGUE (non-serious) with onset 26Mar2021, outcome "unknown", described as "she is really tired"; HEADACHE (non-serious) with onset 26Mar2021, outcome "unknown", described as "headache / head hurts really bad"; NAUSEA (non-serious) with onset 26Mar2021, outcome "unknown", described as "nausea"; INFLUENZA (non-serious) with onset 26Mar2021, outcome "unknown", described as "feels like a touch of the flu". Therapeutic measures were taken as a result of myalgia, malaise, lymphadenopathy, fatigue, headache, nausea, influenza.  Additional information: The patient took two Tylenol but no ibuprofen. The patient wanted to know if this was normal or what she needed to do.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2 day history of progressive swallowing difficulty, speech changes, and  bil. numbness and tingling of hands and feet. Bulbar weakness due to Miller-Fischer Guillain-Barre variant likely due to flu shot. Received approx 12-01-05. Medical records state somnolance, decreased reflexes, tachycardia, anxiety, apnea. msv Information received from the annual follow up indicates patient has not recovered. As of November 06, patient is still on therapy for decreased grip strength and inablity to complete ADL's due to GUILLAIN-BARRE.
No additional adverse effects were reported in the patient; a expired dose of Proquad was administered to a patient; This spontaneous report was received from a certified medical assistant and was referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, or concomitant therapies were not reported.   On 24-JAN-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), lot # R020678, expiration date 15-JAN-2020, (strength, frequency, route, and anatomical location were not reported), for prophylaxis (Expirred vaccine used).   No additional adverse effects were reported in the patient.
Received her first dose of the Pfizer BioNTech COVID-19 vaccine on 13APR2021 and a week later reported persistent dizziness and vertigo.; Received her first dose of the Pfizer BioNTech COVID-19 vaccine on 13APR2021 and a week later reported persistent dizziness and vertigo.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 45 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious), VERTIGO (non-serious) all with onset Apr2021, outcome "unknown" and all described as "Received her first dose of the Pfizer BioNTech COVID-19 vaccine on 13APR2021 and a week later reported persistent dizziness and vertigo.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I've had 1 menstrual cycle between shot #1 and 2 and it was an abnormally painful period. Intense leg pain and cramps.  After shot #2 my arm was sore almost immediately. That evening I experienced severe pain all over my body, sweats, chills and I was twitching. That lasted for about 8 hours. The following day I was extremely tired, had skin sensitivity, aches in my joints especially of the arm which received the shot.
spotting; This spontaneous case was reported by a nurse and describes the occurrence of INTERMENSTRUAL BLEEDING (spotting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced INTERMENSTRUAL BLEEDING (spotting). At the time of the report, INTERMENSTRUAL BLEEDING (spotting) outcome was unknown. Not Provided      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.   No concomitant medications were reported.  Treatment information was not provided.  The reporter was unsure if the event was vaccine related or if the patient had an underlying condition.
Initial report received from a healthcare professional on 18 July 2013. A female patient (age at the time of event was not reported) had received a dose of MENACTRA (Lot number: U4412BA, route and site of vaccination: not reported) and also received GARDASIL (Merck), (Lot number: H020002, route and site of vaccination: not reported) on 10 July 2013. At the time of vaccination the patient had strep throat since 02 July 2013. The patient was allergic to amoxicillin. Concomitant medications cephalexin 500 mg (for 10 days) TID for strep which began on 02 July 2013. On 12 July 2013, 48 hours  after vaccination, the patient experienced vomiting, headache and fever. Laboratory tests and corrective treatment details were not reported. On an unspecified date, the patient had recovered from the events. Documents held by sender: none.
Mother noticed redness, edema to right thigh 12 hours after admin. of vaccine, pt complained of pain/discomfort to site. Tylenol/Benadryl prescribed by doctor during office visit.
This case was reported by a nurse and described a 38 year old male subject who had decreased response to vaccination with Engerix-B. The subject's medical history included non-smoker and non-drinker. On 03 February 2005, the subject received the third dose of Engerix-B (lot AHBVA077AB). On 28 November 2005, a hepatitis B surface antibody test revealed a titer "below five." The nurse considered the decreased therapeutic response to be related to vaccination with Engerix-B.
pt recv vax 19MAY97 1045AM;1200AM mom arrives w/child stating pt was trembling & had chills;MD was unavailable so seen by head RN;temp taken & recorded 100.9 instructed by RN to come back;cyanosis;sz;ear infect;MD states rxn to vax;
Daughter reported her father died the next day after receiving his flu shot.  She believes there could be a link. No other information given.
I started to feel fatigued, had a headache, chills, and then a fever. I had a 102 degree fever for 3 days. I had a runny nose, scratchy throat, and a deep productive cough for about 2 weeks. My fever started coming down after the 3rd day, but I still had a fever for up to about 10 days. Now I just have fatigue, brain fog, and really tired with a runny nose. I had a infusion for covid on 1/12/2022, but it wasn't the Monoclonal Antibody one. I was prescribed Omnicef.
Technician was given the vaccine that was dosed twice; This is a spontaneous report from Regulatory Authority.  A patient of unspecified age and gender received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  Pharmacy tech has concern with covid vaccine. Technician was given the vaccine that was dosed twice on an unspecified date. the event outcome was Unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Patient was given too high of a dose of covid vaccine.  He received 0.2mL of the 30 microgram dose (intended for ages 5-12) rather than the expected 0.2mL of the 3 microgram dose (for his age range).  Report was filed immediately after the event, so unknown if any adverse events happened.
Sore arm  Headache  Drowsiness  Upset stomach  Body aches
diffuse red spots 1wk p/vax 27FEB98;beginning @ diaper area & extending over trunk, T99;sl dec in appetite;otherwise well;dx transient rash;
Symptoms started soon after (same day) getting vaccine. C/O right arm pain from neck to hand and right breast pain including axilla.
In mid March, I was very physically active and had no physical limitations. I had no underlying conditions except for a slightly elevated homocysteine level diagnosed a year prior. I have never smoked in my life or has any prior lung issues. After the two doses I developed difficulty in breathing, shortness of breath in any minor activity, which began about two weeks after the second dose, and pains in my right side.
Chills, Nausea, sharp stabbing pain on right side of head. Earaches, muscle ache, sore neck, headache
vaccine 7/7/08 approx 3 pm. Reportedly child fus til 7/8/08 afternoon nap with mom. When mom awoke child unresponsive -> died 10/20/08-records received-COD Sudden unexpected infant death. Manner of death-undetermined.
racing heart  and high blood pressure lasted for a week. Diarrhea  and chills 6 hours. Nausea lasted 4 days. Headache lasted 4 days, severe back pain 1 week.  fatigue lasted a month.  Cough for a month. Menstrual period felt like I had another miscarriage- severe pain and heavy bleeding for 4 days.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 60-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), on 22Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 24Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "IBD" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "hypertension" (ongoing). Concomitant medication(s) included: AZATHIOPRINE oral; CITALOPRAM oral; IRBESARTAN oral. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jul2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive; (08Jul2022) Negative; (12Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and received Paxlovid orally.  Clinical information: The patient was treated with Paxlovid via oral from 02Jul2022 to 07Jul2022. Patient tested positive on 02Jul2022. After treatment, patient status was improved and tested negative 08Jul2022. He felt better then tested positive for COVID on 12Jul2022 with nasal congestion and headache only. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report, a causal association between reported events and suspect BNT162B2 cannot be excluded.
Patient is experiencing itchiness, lightheadedness, upset stomach, abdominal cramping 4 days after vaccination. Patient is seeking medical attention due to severity of discomfort.
RECEIVED T-DAP 4/1/09 AT BEGINNING OF 12 HOUR SHIFT (0700) AND HER SHIFT EXTENEDED UNTIL 0300 THE NEXT DAY.  ON THE NIGHT OF 4/3/09 SHE HAD A FEVER, CHILLS, AND NUMBNESS IN HER HANDS AND FEET.  FEVER RESOLVED WITH IBUPROFEN.  SYMPTOMS RESOLVED BY MORNING OF 4/4/09.
First dose of Moderna vaccine was administered to a 16-year-old male patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose of Moderna vaccine was administered to a 16-year-old male patient) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose of Moderna vaccine was administered to a 16-year-old male patient). On 27-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose of Moderna vaccine was administered to a 16-year-old male patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications were reported.  No treatment related information has been reported.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old male) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Forty-eight hours post vax, child complained of soreness in right upper arm. Mother noted onset of swelling 3cm x 4cm area, minimal redness and moderate tenderness. Ice applied, Motrin.
swelling, redness of thigh in 2 hours. continued for 3 days with central subcut. bruising , No fever.
Patient was given Varicella vaccine during 6 month well child visit. No adverse events occurred at that time. Physician researched possible adverse events in order to give parents information on what to look for in case of adverse event.
Information has been received from a medical assistant referring to an 18 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 03-OCT-2016 the patient was vaccinated with an "adult dose" of VAQTA (50 U/ml, lot # M022556, expiration date 26-MAY-2017, 1 ml, route unknown). No adverse effects reported. Additional information has been requested.
Patient's mother reported by phone that her daughter's right upper arm was hot and red. I received this report shortly before 5 p.m. on 02/17/2016. With another staffer, we called the patient's mother to assess her daughter. The daughter's behavior was normal and the child had no fever. I advised the mother to offer the child acetaminophen or ibuprofen before bedtime and that she take the child to the doctor if the redness and heat got worse overnight. At 9:15 a.m. on 02/18/16, through yet a third staffer, we called the client's mother for a report on the child. The child had no fever; slept well overnight; the extent of the redness was the same as the evening before; behavior was as usual; and "Motrin" had been given the previous evening. The injection site still "hurts a lot" and is "warm." I advised the mother, through the interpreter, to continue pain medication and to outline the extent of the redness to be able to monitor its progression. Another follow-up call at 4:20 PM 02/18/16 yielded the same information: child is behaving as normal; had "Motrin" during the day; slept well overnight; no fever; arm "hurts a lot"; no change in extent of redness.
Vaccine arm - tenderness, redness, swelling, hardened skin, medium sized circle, itchiness.
Patient given vaccine on day of discharge to swing bed facility and returned with altered mental status, hypoxemia, hypoglycemia and MRI ultimately revealed multiple strokes.
Approximately 3-5 minutes after receiving shot, I experienced rapid heartbeat, rapid deep breathing, light tingly and numbness on my lips and feet and mild stomach weakness. I was immediately attended by the fire rescue on site who took my heart pulse and blood pressure. After leaving the location I experienced two more episodes of the same symptoms within 1 hour of receiving the vaccine. After that I have been okay.  I would like to know if after having experienced these symptoms should I still receive the second dose.
This spontaneous report was received from a medical assistant (patient's mother) refers to 16 years old female patient. Pertinent medical history and concomitant medication were not reported. On an unknown date in October 2006, the patient was vaccinated with first dose of GARDASIL for prophylaxis, lot# 0668F, expiry date 21-NOV-2008 (strength, dose were unknown) in the office. After the first dose of GARDASIL the patient always felt tired. The patient also complained all the time that her legs ached. It was hard for her to get across campus because she felt very winded all the time. On an unknown date in November 2006, the patient was vaccinated with second dose of GARDASIL in her arm. After second vaccination, her arm would not stop bleeding and the reporter had to hold it until it stopped bleeding. The patient became very puffy, lethargic and on and off she'd have a sore throat. The patient had not received the third dose of GARDASIL. It was reported that, the patient experienced 104-105 fever at home and she kept going through ibuprofen. Her body was aching and she didn't know, her period too that would just be prolonged, she had a sore throat and some swollen lymph nodes. The physician thought it was tonsillitis, hence she was prescribed of amoxicillin. After two-week round of antibiotics, the patient came back because she hadn't gotten any better. She looked white as a ghost, very weak. The reporter had to almost carry her into the doctor's office. The patient was very pale, she looks anemic. The hemoglobin was 4. She had bruising on her legs and petechiae. The patient was hospitalized. On an unknown date in March 2007, the patient was diagnosed with leukemia. The patient received blood transfusion. The reporter stayed in the hospital for 10 months pretty much straight. They weren't allowed to leave because of her white blood cell count and her contacting other viruses. So, they were allowed to leave if her blood count was high enough. On an unknown date in October 2007, the patient experienced first coma and was supported with life support. On 03-JAN-2008, in the morning, the reporter was informed that, her daughter was having trouble breathing and experienced second coma. The patient's condition got deteriorated and they couldn't tell if there was any brain function. As of 03-JAN-2008, the patient had meningitis and sepsis. The patient died on 03-JAN-2008 due to deterioration of leukemia. It was unknown if the autopsy was performed. The outcome of leukemia was reported as fatal. The causality was not reported. The reporter considered the event leukemia as serious due to hospitalization and medically significant. Reported Cause(s) of Death: Leukemia deteriorated.