chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients aged 12 received their first dose of Moderna by mistake; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patients aged 12 received their first dose of Moderna by mistake) in a 12-year-old patient of an unknown 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patients aged 12 received their first dose of Moderna by mistake). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patients aged 12 received their first dose of Moderna by mistake) had resolved.        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.   Concomitant product use was unknown by the reporter. Treatment information was not provided.
This patient possible received the adult vaccine in a 0.2ml dose (20mcg) which is double the dose indicated. There were no adverse events, patient tolerated fine
Patient came for consultation, states had chills on the evening of 11/27 and awoke with fever of 101.1 on 11/28. Took ibuprofen and fever did not return. She presented with 3 red spots, flush with skin, below the injection site (the injection site was clearly seen with dark red dot) each the size of a dime. I recommended watchful waiting, that I would contact her 11/29.  Spoke with patient today, states she is feeling better with no fever or chill but the red spots have enlarged and are now slightly raised.  I recommended cold compress to reduce inflammation, counseled on symptoms of shingles to contact MD and us.
The pressure like midsternal pain started on 1/28/2021 around 10:00, I was standing. It came on and went away throughout the day. I woke up on 1/29/2021 and about 11:00 I started having the same pain again. I am more tired today. I have problems with acid reflux in the past usually after eating too much or during my menstrual cycle. I have been seen in hospital recently prior to covid vaccine and my heart is very great. I don't smoke or drink alcohol, no illicit drugs. I took Prevacid, it didn't help. The pain comes and goes with no aggravating or relieving factor.
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a 28-month-old female. Neither the patient's past medical history nor the concomitant medications were reported. The FLUMIST expired on 09-Jan-2011. The patient received the expired FLUMIST on 10-Jan-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 11-Mar-2011: Reporter confirmed that there was no late occurrence of adverse events.
Information has been received from a registered nurse concerning a 9 year old female who on 13-JUL-1999 was vaccinated with a dose of Varivax. On 05-MAY-2006 the patient developed a breakthrough case of varicella. It was reported that the patient had less than 50 lesions on her trunk. The patient received no treatment and she was not hospitalized. No further information was available. There was no product quality complaint involved. Additional information has been requested. The patient's siblings (WAES # 0608USA06083 and 0608USA06084) had similar experiences following vaccination with Varivax.
Pt was administered 0.3 ml of Pfizer adult Bivalent instead of 0.2 ml of pediatric 5-11 Pfizer vaccine
EPILEPSY, UNSPECIFIED 5/17/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/24/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION EPILEPSY, UNSPECIFIED 5/17/2022 URETHRA INJURY, INIT RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/24/2022 URETHRA INJURY, INIT EPILEPSY, UNSPECIFIED 5/17/2022 ANEMIA RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/24/2022 ANEMIA EPILEPSY, UNSPECIFIED 5/17/2022 ANASARCA RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/24/2022 ANASARCA EPILEPSY, UNSPECIFIED 5/17/2022 HYPOTHYROIDISM RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/24/2022 HYPOTHYROIDISM EPILEPSY, UNSPECIFIED 5/17/2022 ANEMIA RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/24/2022 ANEMIA EPILEPSY, UNSPECIFIED 5/17/2022 ANEMIA RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/24/2022 ANEMIA EPILEPSY, UNSPECIFIED 5/17/2022 ADENOMATOUS POLYP, COLON RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/24/2022 ADENOMATOUS POLYP, COLON EPILEPSY, UNSPECIFIED 5/17/2022 ADENOMATOUS POLYP, COLON RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/24/2022 ADENOMATOUS POLYP, COLON EPILEPSY, UNSPECIFIED 5/17/2022 ANEMIA RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/24/2022 ANEMIA
cellulitis; A spontaneous report was received from a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed cellulitis.  The patient's medical history was not reported.  Concomitant medications were not reported.  On an unspecified date, the patient received his first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  The patient reported that a few days after receiving the vaccine, he developed cellulitis. His physician prescribed antibiotics.   Laboratory details were not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, cellulitis, was reported as resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
dropping my k+ landed me in the hospital; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in May2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization.  The following information was reported: BLOOD POTASSIUM DECREASED (hospitalization), outcome "unknown", described as "dropping my k+ landed me in the hospital"; VOMITING (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood potassium: dropping my k+; other test: negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
DIED 36 HOURS AFTER BOOSTER; This spontaneous report received from a consumer via social media through company representative concerned a 54 year old of unspecified sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (dose number in series 1), (suspension for injection, route of admin, and batch number: Unknown, expiry: unknown) dose was not reported, 01 in total administered for prophylactic vaccination.  No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, route of admin, and batch number: Unknown, expiry: unknown) dose was not reported, 1 in total administered on unspecified date (therapy start date and therapy end date were not provided) 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.  The reporter stated that his friend died 36 hours after booster (dose number in series 2). The cause of death was not reported. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211256303-covid-19 vaccine ad26.cov2.s -died 36 hours after booster. 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).; Reported Cause(s) of Death: DEATH
Pt experienced neurogenic syncope. Pt also experienced epistaxis lasting 15-20 mins but may last as long as one hour. Dizziness and syncope 3-4 times per week, pain on right lateral head preceding syncope occurring 5 time in 2 weeks.
Nausea, body aches, headache, malaise and swollen lymph nodes under arm and down side (same as side of shot).  Tylenol, ibuprofen and Benadryl.  Lasted 48 hours.
My Mom suffered a series of debilitating strokes in the early morning hours of 04/09/2021 after receiving the second dose of the Moderna vaccine on 04/08/2021.
syncopal episode after Gardasil injection. Awakened in seconds after feet elevated. c/o lightheadedness. Given crackers and soda and monitored x 1 hr. BP 108/72. Left with parent and walked out on own and started felt fine. Client was very nervous before vaccination.
Saturday all day my arm hurt. Sunday I woke up with no arm pain. Then after eating lunch I had diarrhea consistently and increased. Woke up in the middle of the night with more diarrhea and cold sweats. Temp 93.4.  Sugar 112 in the middle of the night. I feel completely like trash, feel sick all over.  Stomach hurts and lots of gas and diarrhea consistently.
difficulty lifting arm; Severe headache; Fatigue; Sore joints; Sore arm at the injection; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (difficulty lifting arm), VACCINATION SITE PAIN (Sore arm at the injection), HEADACHE (Severe headache), FATIGUE (Fatigue) and ARTHRALGIA (Sore joints) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021 at 3:00 PM, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection). On 06-Jan-2021, the patient experienced LIMB DISCOMFORT (difficulty lifting arm), HEADACHE (Severe headache), FATIGUE (Fatigue) and ARTHRALGIA (Sore joints). At the time of the report, LIMB DISCOMFORT (difficulty lifting arm), VACCINATION SITE PAIN (Sore arm at the injection), HEADACHE (Severe headache), FATIGUE (Fatigue) and ARTHRALGIA (Sore joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medication included Paracetamol.  Company comment: 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.; 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's mother handed the technician her own ID to register for a walk-in covid shot for her son. The prescription was put through for the mother instead of the 15 year old son. The pharmacist checked MIIC for the mother and verified the shot. The technician gave the immunization without verifying DOB or who the VAR was filled out for. The tech realized the mistake when filling out the CDC vaccine card. The patient had received Pfizer in the past and was expecting a second shot of Pfizer. Instead, he received one dose of Pfizer and one dose of moderna. The patient was counseled to watch for any side effects. The patients primary care doctor was contacted an a report was filed at the store level.
Vaccine leaked out between the Luer Lok and barrel of syringe during administration so patient did not receive full dose.  The pharmacist contacted the clinical to advise but received a response the following day and therefore patient needs to be re-vaccinated in 4 weeks to make up dose.
Arm soreness from 1/25/21 to 1/30/21 then from 1/30/21 arm redness and swelling and pain in right under arm lymph node.
~ 90 h after vaccine developed diffuse E-M minor rash w R wrist, L knee swelling. Pt. did not improve on Zyrtec, and Orapred (prednisolone) given 15mg daily. Pt had a quick improvement and these were discontinued after 4d
Tachycardia - onset 1/4 9pm lasting - present  HR range from 90-105 Chest tightness - intermittent over last 12 hours
Had very painful aches in arm at site of injection lasting for 3 days; also had hives on her right knee and back of neck lasting for 3 days. Took 1 extra tramadol for the pain.
Significant menorrhagia, severe daily/constant headaches with vision disturbance (migraine), chest pains at sternum, heart palpitation, insomnia, excessive hair loss. Symptoms significantly impair/interfere with daily life. Symptoms continue @ >4 months. NO symptoms ever experienced prior to vaccine.
Initial report received from a healthcare professional on 21 June 2013. A 20-year old female patient had received an intramuscular dose 1 of ADACEL (batch number: U4612AA and site of administration was not reported) on 21 June 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 01 November 2012. The estimated date of delivery was 08 August 2013. The patient's health during pregnancy, risk factors, concomitant medications, treatment for infertility and medical history were not reported. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none.
My left foot became swollen; I had blood clots in my left lower leg and also in my groin.
Sore muscle at first then nasaua, vomiting, diarrhea and extreme exchaustion. Elevated temperature for about 12 hours then normalized.
Patient has swelling to right thigh where MRM and Varicella were administered on 2/5/16. Patient was seen 2/9/16, swelling was reported as 3cm at the longest diameter. No fevers, no illness. Pain noted to site on administration date.
Initial case was received from a healthcare professional, who was also the patient, on 11 February 2013, with follow-up information on 12 February 2013. A 60-year-old female patient received an injection of TYPHIM Vi, Sanofi Pasteur SA, lot number unknown, (route, site, side and dose in series not reported) and an injection of Hepatitis A vaccine, other manufacturer, (lot number, route, site, side and dose in series not reported) on 09 January 2013 at work place in preparation (prep) for travel. The patient traveled on 16 January 2013. On Saturday, 19 January 2013, ten days post vaccination; the patient noticed she could not "place right foot correctly when walking" but thought she was tired from the trip. Then on 20 January 2013, reported as in the morning "am" Sunday, she could not feel left side from naval to toes and was limping. On Monday, she sought medical treatment and saw a neurologist; the followed up with neurologist. The patient had no past medical history and no known allergies. She had received no other vaccinations within four weeks of vaccinations and had no illness at time of vaccination. On unspecified dates, a magnetic resonance imaging (MRI) showed lesion on T3-T4; and unspecified other numerous tests were performed. The neurologist diagnosed the patient with transverse myelitis post vaccination and treated her with high doses of steroids. At time of report the patient still had a limp, was using a cane, and had not returned to work. She was continuing follow-up treatment and had appointment with neurologist on 14 February 2013. The patient's outcome was reported as not recovered. Documents held by sender: None.
swelling and soreness and red at injection site, hot to touch at injection site,  low grade head ache, itchy next day redness was gone, not as much swelling/soreness and not as much heat. low grade head ache, still itchy next day just a little soreness, no swelling, headache gone
One hour after vaccine I experienced pain at injection site, chills, a little nausea, and muscle aches and pains. It lasted for three days.
Vx administered after a temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect product storage in a 59-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 29th November 2021, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.  Additional details were reported as follows: The patient received a dose of Boostrix where the vaccine suffered previous temperature excursion, which led to Product storage error. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR257611:Same reporter
Pt received 1 yo vaccines instead of 5 yo vaccines. No adverse reaction noted.
sore left arm; experienced body aches; felt fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm), FATIGUE (felt fatigued) and MYALGIA (experienced body aches) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore left arm) and MYALGIA (experienced body aches). In February 2021, the patient experienced FATIGUE (felt fatigued). At the time of the report, VACCINATION SITE PAIN (sore left arm), FATIGUE (felt fatigued) and MYALGIA (experienced body aches) outcome was unknown.            Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. Patient had a sore left arm, felt fatigued, and experienced body aches.   This case was linked to MOD-2021-375119 (Patient Link).
Covid vaccine was given without being diluted with 0.9% Sodium Chloride first.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Concurrent conditions, medical history, historical or concomitant drugs or vaccines were not reported. The nurse reported that on 10-JAN-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 Injection, lot # M043424, expiration date 06-JUN-2018, for prophylaxis (strength, dose, dose number, route and anatomical location were not reported). The nurse informed that the dose was exposed to a temperature from 47 F to 77 F, for 15 minutes, and there was no previous temperature excursion. No adverse effects were reported. This call was made because of a digital data logger.
Felt awful like they had the flu; Felt awful like they had the flu; This is a spontaneous report from a contactable consumer through a Pfizer-sponsored program. This consumer reported similar events for three patients. This is the second of the three reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy dates unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had felt awful like having the flu. The outcome of the events, 'felt awful like having the flu', was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082187 same reporter/product/event, different patient
This spontaneous report as received from the medical assistants and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in the temperature above 46F but below 77F for 3 hours) doses of ROTATEQ (orally, lot # M016238, expiration date 07-DEC-2017; dose was not reported) for prophylaxis. No adverse effects and no previous excursion were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA003256: US-009507513-1702USA004697.
This case was reported by a healthcare professional and described the occurrence of shoulder pain in a 40-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history included asthma and graves' disease. Concurrent medications included ALBUTEROL, CALCIUM and multivitamin. On 14 April 2009 the subject received 1st dose of BOOSTRIX (unknown route, left arm). On 17 April 2009, 3 days after vaccination with BOOSTRIX, the subject experienced pain in left shoulder that radiated down to her neck and elbow. The subject was treated with prednisone and KEFLEX and warm compresses to arm. Blood work was drawn and an ultrasound of the left deltoid shoulder area was performed. The subject had follow-up scheduled five days from the time of reporting. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. Follow up received from healthcare professional on 11 May 2009: The subject's medical history included seasonal affective disorder. It was reported that she had not received BOOSTRIX previously. The onset date of the events was changed to 19 April 2009, 5 days after vaccination with BOOSTRIX. The subject was also treated with IBUPROFEN. It was reported that complete blood count, sedimentation rate and basic metabolic profile were done on 17 April 2009. All were reported as "high norm", and basic metabolic profile was also reported as "low norm". At the time of reporting the events were improved on an unspecified date. The healthcare professional considered the events were clinically significant (or requiring intervention). The healthcare professional considered the events were related to vaccination with BOOSTRIX.
Mother noted the child looked dazed and rolled his eyes few minutes after the shots.  He did not cry after the shots (however he usually does not cry that much after shots). He slept off right away in the car. Not shown to a Dr. the symptoms reported to me next visit on 06-20-2013 - 9 days after the apparent adverse reaction. She also reports other seizure like event- choking noise rhythmic that happened a few times after that day.
I have felt more pain on the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 12Mar2021 (Lot number: EN6204) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "unknown", described as "I have felt more pain on the first dose".  No follow-up attempts are possible. No further information is expected.
I began having symptoms of peripheral neuropathy in my feet and hands.  It has been confirmed by the doctor that I now have peripheral  neuropathy.