chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No control at all; fell down by the bed; cannot stand; Cannot lift her arm; not able to think properly; feeling weak; Walk around with the help of walker , but cannot straighten up her knees; Walk around with the help of walker , but cannot straighten up her knees; tired easily; bad reaction; no muscle control; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (bad reaction), MUSCLE DISORDER (no muscle control), MUSCLE DISORDER (No control at all), FALL (fell down by the bed) and DYSSTASIA (cannot stand) in a 94-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.     Concomitant products included ATENOLOL for Blood pressure management, APIXABAN (ELIQUIS) for Clot blood, RIVASTIGMINE for Sinus infection, HYDROCHLOROTHIAZIDE, BENAZEPRIL, POTASSIUM CHLORIDE and GABAPENTIN for an unknown indication.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION COMPLICATION (bad reaction), MUSCLE DISORDER (no muscle control), FALL (fell down by the bed), DYSSTASIA (cannot stand), LIMB DISCOMFORT (Cannot lift her arm), THINKING ABNORMAL (not able to think properly), ASTHENIA (feeling weak), WALKING AID USER (Walk around with the help of walker , but cannot straighten up her knees), KNEE DEFORMITY (Walk around with the help of walker , but cannot straighten up her knees) and FATIGUE (tired easily). On an unknown date, the patient experienced MUSCLE DISORDER (No control at all). At the time of the report, VACCINATION COMPLICATION (bad reaction), MUSCLE DISORDER (no muscle control), MUSCLE DISORDER (No control at all), FALL (fell down by the bed), DYSSTASIA (cannot stand), LIMB DISCOMFORT (Cannot lift her arm), THINKING ABNORMAL (not able to think properly), ASTHENIA (feeling weak), WALKING AID USER (Walk around with the help of walker , but cannot straighten up her knees) and FATIGUE (tired easily) outcome was unknown and KNEE DEFORMITY (Walk around with the help of walker , but cannot straighten up her knees) had not resolved.            No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Large, very red rash around the injection site. The rash is about the size of the palm of my hand and is raised and swollen above the skin. It is hot and painful to touch. It does not itch yet.  This reaction occurred with my first dose as well but the rash was much smaller. It was also painful at first but the pain went away after a few days and then it began to itch. It looked and felt like an insect bite so I thought I had hives as a result of an allergic reaction to the band aid from the shot.   I did not use a latex band aid with the second shot.
Full body red raised scattered rash, from hear to toes, slight cough, clear runny nose and watery eyes.
Next day 11/18/22 mom took him to ER. Eye lids reddish, swollen, itchy. Per ER doctor's report mom had given Claritin and he was improving. No other symptoms. He had L eye lid dermatitis on 11/17/22 which mom stated that he gets in winter. He had also vomited once on the way to clinic 11/17/22.
Patient received 5th dose of Pfizer COVID vaccine by error. Clinic was not notified until patient called clinic this morning stating he looked at his COVID vaccine card and noticed he received his 5th dose at our clinic yesterday (6/29/22).
This is a spontaneous report from a contactable pharmacist communicated to a Pfizer colleague. A 72-years-old male patient of an unspecified ethnicity started to receive PREVNAR 13, via an unspecified route of administration on 30Oct2015 at single dose in arm and high dose influenza vaccine, via an unspecified route of administration on 30Oct2015 in arm. The patient medical history and concomitant medications were not reported. Approximately a week later patient reported bleeding at injection site, and injection site reaction described as a lump the size of a goose egg, reporter thinks it was 06Nov2015, but was unsure. The patient was admitted 2 weeks later to the hospital. He suffered a vagal nerve response and 'weird heart things'. Vagal response did not start on date of injection. The patient stated his heart stopped 4 times in the ambulance. He was still in the hospital. The outcome of 'weird heart things' and injection site reaction described as a lump the size of a goose egg was not recovered. The outcome of vagal nerve response, bleeding at injection site, and heart stopped was unknown.
Large circular arm rash appearing  8 days after injection, near injection site.  Slightly raised, red, warm, non-painful. Still has not resolved but barely spreading.   Also had acid reflux while this was developing which I never experience.
Kinrix given to a 2-year-old; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 17-FEB-2023, the patient received Kinrix. On 17-FEB-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix given to a 2-year-old). The outcome of the inappropriate age at vaccine administration was not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 03-MAR-2023 The registered nurse called and inquired that would this DTaP-IPV count towards the patient's immunization. The reporter wanted to know how to proceed with series. The nurse reported that 2 year old patient was inadvertently administered a Kinrix dose. The reporter unable to provide any additional patient or vaccine details. The reporter did not consent to follow up. Additional Supportive Information: 2 years old patient received Kinrix, which led to inappropriate age at vaccine administration.
101 FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced 101 fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 101 fever was not reported. This report was non-serious.
This spontaneous report was received from other health professional (licensed practical nurse) and refers to an unspecified number of patients of unknown demographics. There were no information on patient medical history, concurrent condition, drug allergies or reaction. On an unknown date, unspecified number of patients were vaccinated with improperly stored VARIVAX (incorrect product storage) (lot # N014369, expiry date:09-MAY-2019) (dose, frequency not provided) for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT) which was stored properly (lot number and expiration were unknown by reporter). No adverse effects were reported. The vaccine VARIVAX was stored at -14 degree Celsius(C) to -10 degree C (-13.7 degree C) for 14 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information available. This case has been linked with 1710USA014684 as same reporter link.; Sender's Comments: US-009507513-1710USA014684:
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25 Jan 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25 Jan 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25 Jan 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25 Jan 2022) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2022 at 6:33 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Jan-2022 at 6:33 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25 Jan 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25 Jan 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25 Jan 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 25 Jan 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Vaccine administration time 18:33:16. No treatment medications were reported.
Left arm muscular pain persists, especially at night, left deltoid muscle, months later, I went to my doctor, X-ray was done. I am still having intermittent left deltoid muscular pain.
Is pregnant: Yes, Last menstrual date: 03Jun2021, Delivery date: 11Mar2022; Left hand/ arm numbness and tingling/Beginning to radiate to feel slightly numb on left side neck as well.; Left hand/ arm numbness and tingling; This is a spontaneous report received from contactable Other HCP. The reporter is the patient.  A 37 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 14:30 (Lot number: FF8839) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic gastritis" (unspecified if ongoing); "Penicillin" (unspecified if ongoing), notes: known allergies :Ibuprofen & penicillin; "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Date of last menstrual period: 03Jun2021. The patient was 20 weeks pregnant at the time of exposure to bnt162b2. The patient was 20 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 11Mar2022. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; PRENATAL DHA; VITAMIN D3. Past drug history included: Ibuprofen, reaction(s): "Allergy", notes: known allergies :Ibuprofen & penicillin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2589, Location of injection: Arm Left), administration date: 01Oct2021, when the patient was 37 years old, for Covid-19 Immunization. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Is pregnant: Yes, Last menstrual date: 03Jun2021, Delivery date: 11Mar2022"; HYPOAESTHESIA (non-serious) with onset 24Oct2021 12:00, outcome "not recovered", described as "Left hand/ arm numbness and tingling/Beginning to radiate to feel slightly numb on left side neck as well."; PARAESTHESIA (non-serious) with onset 24Oct2021 12:00, outcome "not recovered", described as "Left hand/ arm numbness and tingling". It was unknown if therapeutic measures were taken as a result of hypoaesthesia, paraesthesia.  Additional information:The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid 19. Device Date as 24Oct2021.
Patient was to be administered Pfizer COVID-19 vaccination for pediatric patients second dose. According to the technician, during administration to the left arm the patient moved away from the needle and only received a partial dose of the 0.2mL dose. Approximately 0.06mL of the vaccine was left in the original syringe and some of the vaccine dripped down his arm. According to CDC guidance, as an unknown amount was administered, with parent approval, a repeated 0.2mL dose was administered by the pharmacist in the right arm.
This case was reported by a consumer via another manufacturer (Merck) and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with Hepatitis B vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, the subject received unspecified dose of ENGERIX B (unknown) and experienced not responding to therapy. The subject's mother reported that her son was found not to have immunity to hepatitis B despite receiving the vaccine. No further information was provided.
A patient received her booster dose at 4 months instead of five. She had had Pfizer as her primary series and received Moderna as the booster dose. The patient has been informed of the situation and knows to contact us if there are any problems. Patient did not report any side affects when she left observation.
Initial report received from a healthcare professional on 06 August 2013. A 34-year-old female patient, whose medical history and concomitant medications were not reported, had received first dose of ADACEL vaccine, batch number: U4646AA (route and anatomical site of administration were not reported) on 05 August 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 28 December 2012 and the estimated date of delivery was 08 October 2013. The patient's health during pregnancy, specific risk factors (e.g.: alcohol, tobacco or recreational drugs) was reported as "N/A". Laboratory investigations and treatment for infertility were not reported. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none.
Numbness on neck, face and arm on side on injection; This spontaneous case was reported by a consumer and describes the occurrence of   in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Initial information received on 03-Jul-2018 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves patient who was vaccinated with an expired dose of 0.5 ml PENTACEL lot number: C5384AA, expiry date: 30-Jun-2018 via intramuscular in right thigh on 03-Jul-2018. On 03-Jul-2018, the patient concomitantly received a dose of suspect MMR not produced by Sanofi Pasteur lot number not reported. The patient's medical history were not reported. It was an actual medication error due to expired vaccine used. It was unknown whether any adverse events occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
The next day after the vaccine I got really dizzy, felt faintish and  developed SOB and felt as if my heart was racing so I went to the ER where various test were performed but nothing was seen and was released after some time. A few days later the same thing happened again but the dizziness wasn't associated but this time I was hyperventilating so I went back to the same ER and various test were performed again.  But this time my Potassium was low but nothing else was seen and was released again after some time. A few days later I saw my PCP who changed some meds dealing with my hernia. Omeprazole was changed to Pantoprazole because my PCP felt the vaccine could have possibly activated my hernia. This did help but not it has limited me from now taking in large portions of meals. I have to monitor my stomach and can no longer drink any sodas.  I feel a little off still to date but all other symptoms has subsided so far at this moment.
Light fever; Slight chills; A spontaneous report was received from a consumer concerning a 43-year-old, female patient, who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced slight fever and light chills.  The patient had no current condition or medical history. Products known to have been used by the patient, within two weeks prior to the event included unspecified vitamins.   On 04JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) for prophylaxis of COVID-19 infection.   On 04-JAN-2021, one-hour post vaccination the patient experienced light fever and chills.  On 03-FEB-2021, the patient received her second dose of vaccine mRNA -1273 (Lot number: 029L20A) for prophylaxis of COVID-19 infection. It was reported that the second dose was perfect with no adverse events.  At the time of the report, the patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events slight fever and light chills was considered as recovered.; Reporter'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.
Patient received 12 month vaccines that included an extra Hep A and PREVNAR. Child was not supposed receive them and did not receive a DTAP/IPV. Will come back to receive it. No S/S or adverse reactions present.
Pt reported red rash at injection site & under L arm is swollen - edema extends to L breast area.  Non painful - no discharge or drainage.
This is a spontaneous report received from contactable patient (case identifier: 4308546#9265-2013929268). A 51-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 51, on Apr 19, 2021, single dose, for COVID-19 immunisation. Medical history included multiple sclerosis (ongoing). The patient's concomitant medications not reported. The patient had fatigue (very tired), and nausea (a little nauseous), onset Apr 19, 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Following vaccination, patient experienced extreme fatigue and tiredness starting 2 days after vaccine. A couple days later, tiny pinpoint sized dark red spots appeared on torso, arms, upper legs, chest. Some spots itchy, not all. Lesions took about a week to clear up.
01/12/22 presents to EC ED for "nausea, vomiting and diarrhea". PMHx of "SLE, kidney transplant 2019"
Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium
Right arm where shot was administered turned red & swollen on entire upper arm. Pain shooting in arm, flu like symptoms - a slight fever - tremendous headache - feeling tired. Upper arm hurt all the time for 4 days. Redness disappeared after 6 days, upper arm was itchy too.
Sore arm, itchy arm, headache, sneezing, runny nose, fatigue. Started approximately two hours after administration.
Pt said she had soreness, redness and itching at injection site.  The red area was about a 3 inch circle.
while in car, pt exp poss sz activity-rapid back, forth movement of head; no crying, no BM, no extraocular movements occurred once the day of vax & again 9 days later-no fever detected;
my arm sore as hell; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case US2022AMR153687).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR153687   Additional Information: GSK receipt date: 23-OCT- 2022 Reporters comment: This case was reported by the patient via interactive digital media. The patient stated he/she did not know but the 2 Shingrix shots made his/her arm sore as hell for a good 24 hours. Additional Supportive Information: Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR153687:Same reporter
p/vax redness, edema & sl tenderness was noted to lt upper arm;ice was not applied to site;an increase in redness & tenderness was noted on 11/3/99;pt not having full range of motion to lt arm d/t pain;dx cellulitis;given Dicloxacillin;
Had the Moderna vaccine on January 21,2021 @9:15am, the next day started having  light tea colored urine in the morning and in the afternoon-amber colored urine. That night 11:00pm started urinating red colored urine which lasted until after 11:00pm of January 22,2021. On January 23,2021 in the morning-back to normal yellow urine. Reported this information  to my nephrologist on January 23, 2021 @7:37am.  Dr. responded via MyChart message: Ordered some lab work and recommend to report this information to CDC.