chrisvoncsefalvay/vaers-outcomes huggingface dataset:
given DT instead of Tenivac with no AE; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (caregiver of the patient).  This case involves a 10 years old female patient who was given DIPHTHERIA AND TETANUS TOXOIDS instead of DIPHTHERIA AND TETANUS TOXOIDS (Tenivac) (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.   The caller said that his daughter had cut her hand on a rusty nail last night and he took her to the ER for a tetanus shot. On 20-Dec-2020, the patient received a once dose of suspect DIPHTHERIA AND TETANUS TOXOIDS instead of DIPHTHERIA AND TETANUS TOXOIDS (Tenivac)(with unknown strength, formulation, dose, frequency and lot number; expiration date: 31-May-2022) via unknown route in unknown administration site.  It was a case of actual medication error due to wrong vaccine administered. (latency same day). He was very frustrated and upset. He wanted to know what side effects she might have.  At the time of report, no adverse event was reported.     There will be no information available on the batch number for this case.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
GRAY CAP PFIZER VACCINE DILUTED PRIOR TO ADMINISTRATION RESULTING IN PATIENT BEING UNDER DOSED
Got sick, with symptoms, tummy ache, 102.6 fever and cough for more than 2 days; Talking to doctor on 11/09/2009, not sure if its flu or swine flu -
HEART FUNCTION SLOWED TO ONLY 10 PERCENT; LARGE THROMBOSIS (BLOOD CLOT); PNEUMONIA IN BOTH LUNGS; HARDLY BREATHE; NO LONGER ABLE TO WORK; CONSTANT FLUID BUILD UP IN MY BODY WHICH CAUSES ME TO SWELL; This spontaneous report received from a patient via a company representative via social media concerned a male of unspecified age, race, and ethnic origin. The patient's height and weight were not reported. The patient's past medical history included: heart cath. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 13-MAY-2021 for prophylactic vaccination (dose number in series 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 15-MAY-2021, the patient experienced heart function slowed to only 10 percent, large thrombosis (blood clot), pneumonia in both lungs (double pneumonia), hardly breathing and no longer able to work, and was hospitalized (date unspecified). The patient reported as "Patient took the Johnson and Johnson Covid-19 Vaccine on 13-May-2021 and symptoms started after 2 days. He developed pneumonia in both lungs, and his heart function slowed to only 10 percent. This allowed for a very large thrombosis (blood clot) to form in his lower heart. The patient is constantly being monitored. His blood pressure will drop due to certain meds and his heart rate stays elevated mostly. Patient had a constant fluid build-up in the body which causes swelling. When too full, the patient can hardly breathe. This battle they tell will go on for up to a year before the patient will see much improvement with his heart function. The patient was currently in Hospital.They did a heart cath, want to verify and make sure that patient was on the best path for this moving forward. He still only has 10% of my heart working, so his battle is still long and difficult. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pneumonia in both lungs, heart function slowed to only 10 percent, large thrombosis (blood clot), hardly breathe, no longer able to work, and constant fluid build up in my body which causes me to swell. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20220100738-covid-19 vaccine ad26.cov2.s -pneumonia in both lungs, heart function slowed to only 10 percent, large thrombosis (blood clot), hardly breathe, constant fluid build-up in the body which causes me to swell and no longer able to work.. 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).
Sore throat runny nose and low grade fever 3/10 and 3/11 COVID POSITIVE 3/14/2021 -rapid COVID Positive  3/15/2021 -PCR COVID Positive 3/22/2021- PCR
Patient developed itchy rash/ hives 3 days after received the second Pfizer COVID vaccine.
right oblique is swollen like a lymph node; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SWELLING (right oblique is swollen like a lymph node) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SWELLING (right oblique is swollen like a lymph node). At the time of the report, MUSCLE SWELLING (right oblique is swollen like a lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided. treatment medication was not provided.
I was diagnosed with UTI.  They said there was small traces of blood in my urine. They gave me prescription to this.  It seem to clear up.  I had served pain on July 5th in my groin area.  It felt like I was passing a kidney stone.  I went to the ER. They did blood work.  They gave me a CT scan, that was fine.  They gave me pain medicine.  They did not know what is causing it.  I had a cystoscopy done, that can back negative.  They did another urine sample, negative on infection.  They gave me antibiotic just in case.  They thought that my prostate was inflammation.  They gave me medicine for that, and it seem to help.
Patient called the pharmacy and reported experiencing joint pain that feel like her joints were on fire. Pt stated that the symptoms started the morning after she received the covid19 vaccine on 6/6/23. She stated that the pain made walking difficult.
Later on that evening my back & neck felt sore I had headaches as well. As the days pass it got progressively worst by day 7 was worse & I decided to see a doctor. They said I had mild situs & prescribed me muscle relaxers. I did not fully recovered until 1 or 2 days before my second dose which was 1/27/2021
Vaccine was given subQ instead of IM/Injection way below deltoid; Intense burning; Reduced range of motion; Red; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was given subQ instead of IM/Injection way below deltoid), BURNING SENSATION (Intense burning), MOBILITY DECREASED (Reduced range of motion) and ERYTHEMA (Red) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 21-Jan-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was given subQ instead of IM/Injection way below deltoid), BURNING SENSATION (Intense burning), MOBILITY DECREASED (Reduced range of motion) and ERYTHEMA (Red). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) (oral) at an unspecified dose and frequency. On 21-Jan-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was given subQ instead of IM/Injection way below deltoid) had resolved. On 31-Jan-2021, BURNING SENSATION (Intense burning), MOBILITY DECREASED (Reduced range of motion) and ERYTHEMA (Red) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: This report refers to a case of Inappropriate route of vaccination for mRNA-1273, lot # 028L20A. Based on the current available information and temporal association between the use of the product and the start date of these adverse events, a causal relationship cannot be excluded.
soreness in the left arm; This is a spontaneous report from a contactable healthcare professional reporting for herself.   A 46-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730, expiry date 31Mar2021) via an unspecified route of administration in the left arm on 18Dec2020 right before 9:00 am for COVID-19 immunization. Medical history included migraine (she occasionally had migraines and treated it with ibuprofen). The patient's concomitant medication included ibuprofen for migraine. No other vaccine received within 4 weeks. The patient experienced soreness in the left arm on 18Dec2020. The event lasted for a day and a half and was resolved on 20Dec2020.   The reporter considered the event soreness in the left arm was related to the vaccine.
Flu-like muscle/body aches, headache starting about 6 hours after shot was administered and ending about 30 hours after the shot was administered
Person was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc.  Local DOH notified and Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement from the local DOH are to notify all of the recipients that received an incorrect dose and submit a VAERS report for each.
Sore arm decreased on own after 3-4 days, exhaustion continues until now, nausea/loss of appetite/occasional vomiting  and dizziness started started 4-5 days after shot and continues now
my hair has been falling out in handfuls; I have had horrible headaches; constipation; insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Nov2021 11:00 (Lot number: FJ1620) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Coeliac disease" (unspecified if ongoing), notes: other medical history: Celiac disease; "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; ZOLOFT; ALEVE. Past drug history included: Known allergies: gluten, reaction(s): "Drug allergy". The following information was reported: ALOPECIA (non-serious) with onset 01Dec2021 08:00, outcome "not recovered", described as "my hair has been falling out in handfuls"; HEADACHE (non-serious) with onset 01Dec2021 08:00, outcome "not recovered", described as "I have had horrible headaches"; CONSTIPATION (non-serious) with onset 01Dec2021 08:00, outcome "not recovered", described as "constipation"; INSOMNIA (non-serious) with onset 01Dec2021 08:00, outcome "not recovered", described as "insomnia". Therapeutic measures were not taken as a result of alopecia, headache, constipation, insomnia.  Additional Information: Serious was reported as no. Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. Since the vaccination, has the patient been tested for COVID-19 was reported as no.  No follow-up attempts are possible. No further information is expected.
2 days after vaccination she started have nerve pain from finger then move up to upper arm for 1 week then she started to have rash from palm and move up
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a patient via a company representative 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  (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced administration of expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210604819.
Received call from pt c/o rash buttocks - legs, arms - abd - called back to give pt. doctor's instructions daughter had called ambulance - speech garbled - face flushed pt almost passed out - was treated in ER - hypotension.
This case was considered medically important. Information regarding PREVENAR was received from a healthcare professional regarding a 11-month-old male patient who experienced pneumococcal bacteremia, drug ineffective. The patient received the third dose on an unspecified date. On an unspecified date, after having received 3 doses of PREVENAR, the patient experienced pneumococcal bacteremia. The reporter indicated it was unknown if the event "was caused by a vaccine or non-vaccine strain". The patient recovered on an unspecified date. No additional information was available at the time of this report.
I take birth control that doesn?t have a period and I have started spotting. Everyday since it began.
Vesicles developed within 24 hours at site and swelling and erythema from shoulder to elbow.
About 5 minutes after receiving vaccination case client reported he was having numbness and tingling sensation on tongue.  No shortness of breath.  BP 150/80  Pulse 88 continued to observe case, tingling sensation and numbness sensation was not resolving.  Reported was just not "feeling right"  Benadryl 50mg po given about approx 12:10 Case was instructed to call for transportation home from clinic and to be observed at home to continue monitoring.  Case stayed at clinic til approx 12:40 and departed with brother He reported he the numbness and tingling had subsided.  Case was also instructed to notify his Dr which he did while at clinic to notify of the reaction.  The office reported he would receive a call back yesterday.  Case was instructed by this nurse to call 911 if symptoms worsened.  Case had reported he also had bendaryl at home and for mild symptoms he could take again after 6:00 pm.  Spoke with case today.  He reported he had an appt yesterday at Drs office for 4:30, however he developed severe headache and nausea.  He was seen in ER.  reported his BP was WNL and he was instructed to take tylenol for headache. Symptoms resolved when he left hospital and he denied any headache, nausea, tingling or numbness today.  He was provided a note to return to work for today
High fever of 104.3 Heart Palpitations with chest pain, shaking/chills throughout body and splitting headache (not migraine). Heavy mentrual bleeding with clots for long periods of time
Information has been received from a registered nurse concerning an 18 week old white female infant with no known allergies or pertinent medical history who on 23-JUN-2008 was vaccinated orally in the AM with a second dose of ROTATEQ vaccine live (human-bovine) (lot # 660596/0211X). There was no illness at the time of vaccination or any adverse events following prior vaccination. Subsequently, on the same day of vaccination (in the PM) the patient had loose, watery stools that lasted 4-5 days. There were no lab studies performed. At the time of the report, the patient recovered on approximately 27-JUN-2008. Additional information is not expected.
I took my first covid vaccine dose on Feb. 8th 2021 and second dose on March 8th. At the time of my first shot, within the first 5 min I felt very weird, and I started having palpitations., the paramedic team hooked me up to see my heart rate and it was too elevated. I felt OK after 15 min, but since then my blood pressure keeps dropping.  And when I got my second dose, I felt the same within 5 min again, however I was OK. But when I came home I felt usual side effects chills, feverish, fatigue. At night around 2 am I woke up and tried to go to bathroom and I felt on the floor because I fainted. My bp was so low (60 -40) the machine was not able to recognize it easily. We called 911 they came and checked my heart rate and bp etc. BP was still low but the rest was OK.
10:55 vaccines administered - 11:00 Pt stated "I'm going to pass out. 11:01 pt out unresponsive, moved from chair to floor, elevated legs, B/P 68/40 pulse 48, EMS called, very pale. 11:05 BP: 98/62, repirations 26, responsive, alert, oriented, EMS arrived 11:18 B/P 104/78 11:30 left clinic via personal car with mother.
DEVELOPED INCREASED HYPERTENSION >20 POINTS HIGHER THAN NORMAL (185/115 ON  01.02.2021); GENERAL MALAISE, HEADACHE.  TREATMENT NONE AS OF THIS DATE; OUTCOME;  PENDING STILL ELEVATED BP AND HEADACHES
Patient received Moderna COVID vaccine on 4/23/21 Patient received Pfizer COVID vaccine on 5/4/21 AS of this reporting the reporter is not aware of adverse outcomes.
Patient fainted in the waiting area within 3 minutes of receiving her 2nd dose of the Pfizer/Biontech Covid vaccine.  According  to witness and mother, the patient fell to the ground from a seated position and was shaking.  It is unknow wether the patient lost consciousness.  Witnesses reported the patient may have hit her head when falling.  Patient was cold and clammy to touch.  911 was called and transported to hospital.
Became nauseous, got chills and fever. Soreness in arm (as expected)
17 year old patient received both doses of the Moderna covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received both doses of the Moderna covid-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received both doses of the Moderna covid-19 vaccine). On 15-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received both doses of the Moderna covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.    This case was linked to MOD-2021-354555 (Patient Link).
Subsequently post vax, the pt developed painful lymphadenopathy described as swelling under the left arm and axilla, and pain under the left arm. The pt was seen by the physician on 5/28/99 and she recovered.
Had MMR and Varicella on 7.18.07. Went to ER on 7-20-07 with febrile seizure with a fever of 105.
Dermatographia; hives and itching anywhere on body that is touched or scratched. Hives and itching last 30 minutes or so until no longer provoked.
This spontaneous report was received from a licensed nurse practitioner refers to an unspecified number of unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored ROTATEQ (lot #, expiry date was not reported). No adverse event was reported. The outcome of the events were not reported. This is  one of the several reports received from the same reporter. Additional information has been requested.
Woke up early in the morning with a fever of 99.5 (typically temperature is 97.7).  Was extremely fatigued, tired for the next 24 to 48 hours and temp peaked at 100.5.  Took tylenol and by afternoon of April 2nd temp had returned to normal.  Slept almost all day April 1 and much of day April 2nd, too weak to do anything.  On April 2nd developed "Covid arm", a rash spreading across upper arm (slightly itchy, red and hot to the touch).  Had headache down the back of left side of head.  By April 3 returned to normal, just a little tired.
Initial and follow up information has been received from a registered nurse concerning a female who was vaccinated with VARIVAX (Merck) (lot #, route and site of administration not reported).  Subsequently the patient developed cellulitis after getting the vaccine.  The outcome of the patient was unknown.  Follow up information has been received from a registered nurse concerning the 14 year old female student with no other relevant history who on 10-JAN-1998 was vaccinated with the first dose of VARIVAX (Merck) (lot #, route and site of administration not reported).  On 25-APR-2009, at 11:30 a.m., the patient was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot # 662448/1785X) into the left arm.  On 27-APR-2009 the patient presented to office with 13 X 13cm area at posterior upper arm, red, warm, tender, minimal induration.  There was no lymphangitis.  There was no illness at time of vaccination.  The patient and none of her siblings had no adverse event following prior vaccination.  No relevant diagnostic tests performed.  The patient was prescribed with clindamycin 300, three times a day for 10 days.  On 01-MAY-2009 the patient recovered.  Additional information is not expected.
Rash at/around site of injection occurring 7 days dafter shot - resolved after a week Menstrual spotting then period started 7 days after shot - which was mid cycle ( two weeks early)
Pt symptoms began 07/21/21 with coughing with thick white mucus, chest hurts due to coughing, fatigue, loss of appetite, other symptoms included dizziness, pre-existing conditions includes: sever diabetic, heart disease, vision/hearing impairment, and Pt chews tobacco, Pt was admitted to Medical Center 07/25/21 released 07/26/21 was advised to take 6 vitamins over-the-counter, on 07/27/21 Pt fell and broke his hip and was taken to the ER at  Medical Center and then transported to another Medical Center
never got second one; This case was reported by a other health professional via (Shingrix  interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked, should the patient restart over.