chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered 1ml of the Moderna Covid19 vaccine instead of just 0.5ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (administered 1ml of the Moderna Covid19 vaccine instead of just 0.5ml) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Mar-2021 at 10:30 AM, the patient experienced ACCIDENTAL OVERDOSE (administered 1ml of the Moderna Covid19 vaccine instead of just 0.5ml). On 06-Mar-2021 at 10:30 AM, ACCIDENTAL OVERDOSE (administered 1ml of the Moderna Covid19 vaccine instead of just 0.5ml) 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 information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-035775 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-035775:
Approximately 6 months post vax, the pt complained of pain in her left elbow. She was seen by an orthopedist who diagnosed her with tendonitis and prescribed unspecified anti-inflammatory medicine and exercises. Per the pt, the orthopedist "did not relate the complaint to Lymerix". The pt experienced joint warmth as well. Six months later, in 3/00, the right elbow became painful. At that time, the pt did not seek treatment. In 2/01, the pt complained of right knee pain and was seen by the physician. The pt stated that MRI of right knee confirmed arthritis under knee cap and torn cartilage". Per the pt, the bilateral elbow pain has not resolved as well as the knee pain. As of 3/13/01, the outcome of the events is ongoing.
Dizziness, feeling hot inside and out but no fever, sweating,I felt weak after 1 hr  I have Rashes on and off 2 times on my first day. I have Head ache for a couple of days. I took tylenol for a couple of days. I slept  and feel better.
pt recvd vax & devel white dots on trunk area;thought it would go away, cont on VIVOTIF & completed all 4 capsules; on leg got two white dots w/red around that & then pink around the red; burning sensation; nausea, stomach cramps, dizzy & d
rash and redness and it is every where on her. It started just on her arms but now it is all over; rash and redness and it is every where on her. It started just on her arms but now it is all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72-year-old female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown (booster), single (Lot number: HG4633) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: I take medicine for diabetes; "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, manufacturer: Johnson & Johnson), for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, manufacturer: Moderna), for COVID-19 immunisation; Comirnaty (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: RASH (medically significant), ERYTHEMA (medically significant), outcome "unknown" and all described as "rash and redness and it is every where on her. It started just on her arms but now it is all over". The patient underwent the following laboratory tests and procedures: Weight: about 200 pounds. Therapeutic measures were taken as a result of rash, erythema.  Additional information: The patient asked about what they are calling Covid arm. She have been reading about it online and she got this Pfizer Vaccine last Friday and she have this Covid arm that looks like rash but it was everywhere from her neck down to her knees and it started out with just her arm and then her forearms and then next day on her neck and then on chest, stomach and in her legs it just kept adding and she was just wondering. Patient discovered it after administration of the Pfizer COVID-19 vaccine "covid arm" and looked it up online. She had rash and redness and it was every where on her. It started just on her arms but now it is all over. She was wondering if that was unusual and would like to know what recommendation of something topical to put on it or med she can take by mouth. She used Benadryl but did not know if there was something better to use. She mentioned what more importantly is at what point does this become a concern. She wanted to know if it was something unusual and how does she know when it gets to the point that she needs to go have somebody look at it. Patient took Benadryl as treatment.  She stated she only took 2 tablets, she did not take any medication before, she took Benadryl afterwards.
Local topical reaction,  Some redness that is fading, pain.  Icing and ibuprofen as needed for pain. Resolution without further treatment.
Immediately after injection patient had severe vasovagal episode for 45 seconds. He appeared unconscious and then became responsive. Did not show signs of being post-ictal, transferred to the Emergency Department. Observation only, discharged from the Emergency Department.
Pneumonia; A spontaneous report (United States) was received from a consumer concerning about a 70 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia.  The patient's medical history included smoking.  Concomitant medications were not reported.  On 04 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A) via intramuscular for prophylaxis of COVID-19 infection.   On 28 Feb 2021 the patient had pneumonia and she hospitalized for that. But the reporter states that pneumonia was not related to the vaccine, but it might be due to cold temperatures and the patient smokes too.  Laboratory tests was not reported.  Treatment information was unknown.  All the events occurred after first dose of vaccination.  Action taken with mRNA-1273 in response to the events are unknown.  The outcomes of all the events remain unknown.; Reporter's Comments: The events were consistent with increased risk of infections associated in pandemic set up confounded by elderly age of patient. Company assessed the events to be unlikely related to company product.
AT SIX MONTHS, MY SON HAS GOT SHOTS THAT MADE HIM BREATH WEIRD. HE STARTED WHEEZING REALLY BAD TO A POINT THAT THE DOCTOR PRESCRIBED ASTHMA MEDICINE ALBUTEROL. THE ONLY WAY FOR HIM TO BREATH BETTER IS IF WE GIVE HIM THE ALBUTEROL.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I woke up at night and my heart was racing. I woke up from a dead sleep, I was not short of breath and no chest pain. I just feel my heart racing. I was observed for a 4 hours and discharged the next morning.. My blood Pressure was 158/96. I had had Covid-19 tested positive on 12/29/2021. I had the second dose, and I did not experience the same symptoms.
blood clots; Colored urine for 2-3 days; few tiny red spots on the lower arm that was injected/ red dots; mild heartburn for 8 days; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOMA (blood clots), CHROMATURIA (Colored urine for 2-3 days), DYSPEPSIA (mild heartburn for 8 days) and VACCINATION SITE ERYTHEMA (few tiny red spots on the lower arm that was injected/ red dots) 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 HAEMATOMA (blood clots), CHROMATURIA (Colored urine for 2-3 days), DYSPEPSIA (mild heartburn for 8 days) and VACCINATION SITE ERYTHEMA (few tiny red spots on the lower arm that was injected/ red dots). At the time of the report, HAEMATOMA (blood clots), CHROMATURIA (Colored urine for 2-3 days), DYSPEPSIA (mild heartburn for 8 days) and VACCINATION SITE ERYTHEMA (few tiny red spots on the lower arm that was injected/ red dots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Patient was very anxious prior to vaccine. Patient came tremoring and anxiety Water was provided Discharged to home
HEADACHE; BACK PAIN; RIB PAIN/THE LEFT SIDE OF THE RIBS UNDER THE ARM; SEVERE BODY PAIN; ITCHY RED SPOTS ON LEGS/SPOTS ON BOTH LEGS, UPPER LEG, LOWER PART ANKLE, AND ONE ON THE FEET, SMALL LIKE A DIME; BLOOD SUGAR FASTING RESULTS WAS 450 MG/D; This spontaneous report received from a patient concerned a 65 years male. The patient's weight was 175 pounds, and height was 68 inches. The patient's concurrent conditions included diabetes, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  Patient reported that, received the COVID-19 vaccine on 11-MAR-2021on the left arm. Patient's main reason for calling was the severe body pain on the right back and the left side of the ribs under the arm. Patient was taking Tylenol 500 mg 2 tablets in the morning for the past weeks to ease the pain, which was not normal for him, living on tablet for a couple of week. The pain on the ribs, come on hard, and it might stay like 10-15 mins then it cools off. Patient mentioned that he had headache too and had red spots on his legs that started out to be itchy. Patient had spots on both legs, upper leg 3, lower part ankle 2, and one on the feet, small like a dime. Lastly, patient said that his blood sugar fasting results is 450 mg/dL and that was not normal for him (his normal is 110/180-200mg/dL). However, Patient's blood pressure is under control.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood sugar fasting results was 450 mg/d, and had not recovered from headache, back pain, itchy red spots on legs/spots on both legs, upper leg, lower part ankle, and one on the feet, small like a dime, rib pain/the left side of the ribs under the arm, and severe body pain. This report was serious (Other Medically Important Condition). .; Sender's Comments: . 20210438296- Covid-19 vaccine ad26.cov2-blood sugar fasting results was 450 mg/d. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
This spontaneous report as received from a pharmacist refers to a patient of unknown age. Medical history and current conditions were not reported.On an unknown date, the patient was vaccinated with ZOSTAVAX (404) VIAL 19400 PFU, via unknown route for unknown indication. Concomitant medications were not reported. IT was reported that patient received a dose of (Oka/Merck) VARIVAX, and then was prescribed a dose of ZOSTAVAX by the healthcare provider. The patient received this first dose of ZOSTAVAX two years ago, and this patient received another dose of ZOSTAVAX two years later. The dates of those doses of ZOSTAVAX were unspecified, and she did not specify whether or not this patient was experiencing any adverse effects. The anonymous pharmacist disconnected without taking the service request number. No product quality complaint was not reported. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L051123, expiration date 13-OCT-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 52.8 degrees Fahrenheit for 1 hour and 15 minutes. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 16 hrs after receiving 2nd dose of Gardasil, patient experienced flu-like symptoms of chills, muscle/ joint aches, headache, nausea. Four days later, still has lethargy, malaise and muscle spasms in arm.
Pain level 8 down to fingers for hours, swelling, redness, fever, itching, unable to lift arm 2 days, third day swelling from elbow up and feeling like there is lump in my arm, some soreness, 4th day, today still swelling and upper arm turning yellow.  The injection site never was a problem,  but from shoulder to elbow was very painful and could not move some of the time.  I have had these shots before, the flu shot every year, always a little sore, but this side effect.  It was the week end, did not go to the doctor.  Advil and ice packs and being still.
Nausea and vomiting, onset 3 days after dose and lasting 48 hours.
consumer reports 20mins p/child's vax 11OCT93 pt exp high fever & cried 2hrs;rx w/APAP/ADvil/warm baths;@18mos unable to walk or talk;re-challenged w/HBOC 29JUN94, staring episode noted;no sz dx developmentally delayed;
This case was reported by a physician via a sales representative and described the occurrence of swelling in a subject of unspecified age and gender who was vaccinated with INFANRIX, GlaxoSmithKline. On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced severe swelling. At the time of reporting the outcome of the event was unspecified. The physician considered the event was probably related to vaccination with INFANRIX. This event occurred in four different subjects. The reporter indicated that they narrowed the events down to the same lot number for all cases. The lot number was not provided at the time of reporting. Case A0722975A serves as the master case. The other case numbers are A0722979A, A0722980A, A0722981A. Follow-up information was received on 25 April 2008, via sales representative who reported an additional event of fever. It was stated the physician saw in increased incidence of excessive swelling with INFANRIX. At the time of this report, the physician considered the fever probably related to vaccination with INFANRIX. Follow-up information was received on 01 May 2008, via physician, who reported limb swelling in a 2-year-old subject. The physician believed there was a problem with this particular lot of INFANRIX.
Within 15 min. after vaccine pt. reports tingling in upper arm (L), dizziness & headache at the top of her head BP 128/76 - pt. took 2 MOTRIN and felt headache relief within 5 min.
Around Jan 30.2022, I got a sore enlarged nodule on my right index finger that was sore and tender to the touch. It proceeded to get more tender and more painful for the next 2 weeks to the point it got so painful I was keeping it covered with a Band-Aid I went to urgent care on Jan 13, and they gave me antibiotics, I took the full course as directed and, but it did not get better, but it had spread to my pink finger and my right index finger. I went back to urgent care 02.19 as it was not getting better after the medicine, the new doctor I saw thought it was something auto immune she ordered blood work and sent me to a dermatologist, on 02.25 they did a punch biopsy and returned on 03.04 for the removal of stiches. The results came back with a lot of possibility's and had no real result. I then had to go to urgent care 4 times before I could see dermo ago. 03.14 I went to the ER because all of my fingers were swelling. I saw a vascular doctor who determined it was no vasculitis. When I left the ER, they gave me prednisone and that did make me feel completely better. On 03.16 I saw the doctor; she ordered more blood work and ordered an ultrasound and she stated I had primary Raynaud's syndrome without gain green. I had a follow up visit today and all the blood tests came back negative, my scans were normal. She stated that it may be caused by the booster.
patient received BEXSERO on 07/22/22 and TRUMENBA on 7/20/22; This case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 22nd July 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 20th July 2022, the patient received TRUMENBA. On 20th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   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: 28-Jul-2022. Reporter's Comment: The reporter was a GSK field rep who stated she had an AE to report. The reporter was confused and thought this AE was already filed. It was not so she was filled now.  The patient received Bexsero on right deltoid at HCP office and received Trumenba (no injection site available). The reporter stated both of those 2 vaccines were not interchangeable. The reporter stated the wrong vaccine was administered, the second dose was supposed to be Bexsero as well. The reporter consented to follow up. Additional Supportive Information: The patient was vaccinated with Bexsero and Trumenba, which led to interchange of vaccine products.
Headache; fever (102.5ºF); shivers. Subsided around 5 pm that evening.
Booster; COVID-19 VACCINE taken by ENDOCERVICAL; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 80-years-old female patient received third dose of bnt162b2 (BNT162B2, Batch/Lot number: unknown) as DOSE 3 (booster), SINGLE for covid-19 immunization. Relevant medical history included: "Eyeglasses wearer" (ongoing). Concomitant medication(s) included: ELIQUIS taken for cerebrovascular accident prophylaxis, start date: 2018; CRESTOR; ZETIA; VERAPAMIL; OMEPRAZOLE. Past drug history included: Coumadin, start date: 2011, for AFIB, reaction(s): "Abnormal clotting factor"; Pradaxa, stop date: 2018, for AFIB, reaction(s): "Upset stomach". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization, reaction(s): "COVID-19 VACCINE taken by unknown route of administration", "COVID-19 VACCINE taken by unknown route of administration". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "COVID-19 VACCINE taken by ENDOCERVICAL". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow up (15Nov2021): The following information was received from BMS: The query was: Xml provided Suspect drug of "COVID-19 VACCINE" with route "ENDOCERVICAL", it seemed the route not usual and may be error. Please confirm if the route of "COVID-19 VACCINE" was correct, since it will determine split case validity. The response was: The route of administration of Suspect medication COVID-19 VACCINE should be unknown (previously entered as endocervical in error).
Patient age 7 y.o. received dose of Pfizer Covid-19 (12+) vaccine. No adverse reactions noted or reported by patient or parents to date.
Redness in face, throwing up, tinnitus, fever... pt reports had to start taking antivirals.
History of anxiety, clammy, dizziness, syncope. BPs 142/92 (pulse 97), 134/88 (pulse 123).
High temp - 103.3F, dizziness, vomiting, weakness, ten hrs of symptoms.
This spontaneous report was received from a physician and refers to a female patient of unknown age. Concurrent conditions, medical history, historical and concomitant medications were not reported. The reporting physician informed that on 21-JUL-2015, 22-SEP2015 and 09-FEB-2016, the patient was vaccinated with the first, second and third doses respectively, of GARDASIL 9 Injection, for prophylaxis (strength, dose, route and anatomical location were not reported). The lot numbers and expiration dates of the first and second doses were not reported, while the lot number of the third dose was L045711, and the expiration date was 08-MAY-2017. The physician stated that the doses may had been improperly stored, but the temperatures of storage, time frames and previous temperature excursions were unknown at the time of this report. No adverse events were reported.
pt recvd vax 4OCT95 & next day called reporting redness, low grade temp, entire upper arm-sore, felt shaky & soreness 2wks;redness subsided w/in 4 days;problems resolved completely by 20OCT95
Pericarditis; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The pharmacist had an ICU patient that received the COVID vaccine dose 2. On day 3 after the vaccine, the patient was admitted to ICU with pericarditis. It was not a confirmed diagnosis. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.; Sender's Comments: The information provided is limited and doesnot allow a full medical assessment.  Considering a temporal relationship, a possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of pericarditis cannot be fully excluded.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.