chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my son received a half dose for his first dose , the pharmacy gave his the 2nd half dose within 5-7 minutes; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (my son received a half dose for his first dose , the pharmacy gave his the 2nd half dose within 5-7 minutes) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2022, the patient experienced PRODUCT ADMINISTRATION ERROR (my son received a half dose for his first dose , the pharmacy gave his the 2nd half dose within 5-7 minutes). On 13-Jan-2022, PRODUCT ADMINISTRATION ERROR (my son received a half dose for his first dose , the pharmacy gave his the 2nd half dose within 5-7 minutes) had resolved.            Reporter states that her son has not reported any side effects from the two doses he received yesterday. Reporter did not have the lot number information available at this time but said will call back later to provide it.  Concomitant medications include none. Treatment information was not provided.
Tightness in throat. Felt like a lump in my throat when I tried to swallow. At about 4pm my eyes started getting very red and bloodshot. Scary looking. Took Benadryl. Improved in morning to pink eyes. Went to doctor.
Patient received extra dose of Prevnar20, per health department there should be no adverse reaction to patient.
Arm soreness, swollen lymph nodes reported after one week. MD recommended Ibuprofen - OTC
received injection at 13:04, went to observation area. reported brief dizzy spell at 13:20.  Drank water, BP right arm 184/101, BP left arm  166/90 at 13:25.  Patient reported only brief episode of dizziness and no further dizziness.  User reports they ate lunch 1.5 hours earlier.  BP 173/90 at 13:30.  User reports she feels fine and will recheck BP when she gets home and follow up with her PCP.  User waited 5 additional minutes before leaving with no further adverse effects.  Total time of observation post injection was 30 minutes.
Little tired; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 18:45 (Lot Number: EN6201) at the age of 71 years old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. The patient experienced little tired on 11Feb2021 12:00. No treatment received for the event. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the event was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Patient was given covid vaccine, and within 3 minutes, began to develop tachycardia. Patient was placed in chair to be assessed, vital signs done. HR was 160 to begin, dropping to 140, and 117 when being transported to ED for evaluation. Patient stated that she felt like her chest was on fire, and heart was going to beat out of chest. Rapid Response Team called, and team responded, bringing patient to ED for closer evaluation.  From the ER MD: 39 year old female patient who was a rapid response after receiving her Covid vaccination.  She began to have palpitations and was tachycardic.  She appeared to be very tremulous and anxious.  She has no known history of allergic reactions.  She denies recent illnesses including fevers and chills.  Patient felt short of breath.  She had an O2 sat of 100% on room air.  Lorazepam 1mg po x1 dose ordered and was administered.
mild soreness at site of injection; no redness or swelling; 24 hours later, (Sunday night) stiffness in finger joints while lying in bed. Gone by next morning (Monday). Lingering mild soreness and mild feeling of heat at injection site. Could not feel or see any external signs.
Sloughing to the skin on the left arm.; Skin hanging about 3-4 inches due to some sort of fluid; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVENAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient went for his appointment at 11:40am and then got the vaccine at 12:00pm. Denied getting any other vaccines the same day or 4 weeks prior. Mentioned having the influenza shot and then later clarified it was actually the pneumonia shot that he had a pretty bad reaction to one time. It was hard to explain, he had sloughing to the skin on the left arm. Under the left arm was hanging down about 3-4 inches. There was some fluid of some sort. Went to the clinic and they gave him something and it went away, and he was told not to get another one. The outcome of the event was recovered on an unspecified date.  Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. No further information is expected.
Lowest temperature was -17C degrees.  Total excursion time was for 63 hour and  45 minutes with no AE; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA288477, 2020SA288422 and 2020SA290005.  This case involves a 67 years old female patient who received a 0.7 ml dose of vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]  (lot: UJ450AA, expiry date: 30-Jun-2021), via unknown route in the left deloid, on 05-Oct-2020. Along with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], also IPV (VERO) [IPOL], TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM], HIB (PRP/T) VACCINE [ACT-HIB] and TUBERCULIN TEST [TUBERSOL] reached lowest temperature of -17 C degrees. Total excursion time was for 63 hour and 45 minutes (product storage error).  The patient's medical history, medical treatments, vaccinations, family history and concomitant medication were not provided.  It was an actual medication error due to the Product storage error temperature too low.   At the time of reporting, the patient had no adverse event.  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.
injection site was itchy, warm to touch, and turned black & blue approx. 2 days after; injection site was itchy, warm to touch, and turned black & blue approx. 2 days after; injection site was itchy, warm to touch, and turned black & blue approx. 2 days after; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Oct2023 at 04:45 as dose 1, single (Lot number: HF9298) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUCELVAX QUAD taken for immunisation, on 30Oct2023 as dose 1, single; FISH OIL; VITAMIN D NOS; COQ 10; TURMERIC [CURCUMA LONGA]. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE DISCOLOURATION (non-serious) all with onset 01Nov2023 at 07:00, outcome "recovering" and all described as "injection site was itchy, warm to touch, and turned black & blue approx. 2 days after". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site warmth, vaccination site discolouration.  Additional Information: Comirnaty dose was received as more than 3 doses. The patient did not experience COVID prior to vaccination and was not tested positive post vaccination. The patient has no allergies that she was aware of. Other medication in two weeks included multi vit. and simv
Onset of Seizures, Ear Infections & Respiratory Inflammation. EEG performed with no diagnosis or unknown reasons for seizures. Recurrent respiratory infections/inflammation. Antibiotics that would only clear problem momentarily.
pt recvd vax;  5 days after vax devel 2.5 x 4.0 cm urticarial, red, rash at site of HIB shot (lt thigh);
Patient reported she had Moderna vaccines on 2/12/21 and 3/12/21 but does not have her card for Lot numbers. She came to hospital for uncontrolled a fib, irregular heart rate, chest pain. CAT scan revealed multiple spiculated masses in right lung that were not known previously. Pt also found to have NSTEMI.
I had a baseball sized redness on my arm and my arm was swollen. I have been experiencing bouts of vertigo off and on. I had episodes of vertigo years ago but these were worse. The last episode was short lived but the worse episode lasted for about a month and a half. This was around the end of February-March but lasted until April. I did Epley maneuvers and was placed on Antivert. In November, I saw the ENT who performed the Epley maneuver and told me to continue to take the medicine. There are times that I can look up at a person I am talking to and it throws me to the floor. I put ice and heat on my arm. I was also sent to a heart doctor for the vertigo. I still feel foggy.
Body aches; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO153) via an unspecified route of administration in the left arm on 09Apr2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Apr2021 at 09:00, the patient experienced fever and chills, body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of fever, chills and body aches were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Varicella lesions - papular and vesicular pustular lesions on back, extremities.
I gained a great deal of weight during COVID. On June 13, during an extreme heat wave and being on my feet for a long period of time, I experienced severe swelling in my left foot and less so in my calf, which progressed until July 9th, and spread to my right lower leg to a lesser degree. I went to the ER to rue out a DVT. After Well's Criteria and an ultrasound, a DVT was ruled out. Swelling gradually receded slowly within the next two months. In September, I experienced severe pain and swelling in both hands, with significant numbness and tingling in all of my finger tips. It was my perception that the swelling went from my legs to my hands. After seeking medical attention and referral for ultrasounds by a vascular surgeon to r/o vascular insufficiency, it was determined that lymphedema was the diagnosis of exclusion. I have been going to PT for 4-5  treatments so far. The swelling has receded but the numbing and tingling persists. I am wearing compression gloves during the day as much as I can (my job requires that I wash my hands frequently between patients) and carpal tunnel splints during the night with the gloves underneath.
This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 65-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 30th April 2020) for prophylaxis. On 25th June 2018, the patient received the 1st dose of SHINGRIX(intramuscular). On 26th June 2018, 1 days after receiving SHINGRIX, the patient experienced hives, skin warm, pruritus and erythema. On an unknown date, the outcome of the hives, skin warm, pruritus and erythema were recovered/resolved. It was unknown if the reporter considered the hives, skin warm, pruritus and erythema to be related to SHINGRIX. Additional details were provided as follows: At 15:00, the patient received SHINGRIX in the right deltoid. The healthcare professional reported that, the patient developed hives, redness, warm feeling and itching around the waistline for about 3 hours the day after receiving the SHINGRIX.
MA was improperly giving the rotavirus monovalent vaccine and only giving the diluent of rotavirus vaccine instead of mixing the diluent with the vial of the rotavirus vaccine and administering that. The clinic was able to track back which patients this affected. Patients on this date may have gotten the diluent only or the proper vaccine based on counts of abnormal diluent and reconstitute vaccine vials. The mother of patient was notified 10/29/21. Provider discussed with patient family the patient should be vaccinated at 6 months visit.
patient received a dose of the vaccine from an expired vial;  This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose of the vaccine from an expired vial) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose of the vaccine from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a dose of the vaccine from an expired vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
sore throat, sl hoarse, t99.6; 4NOV92 230PM, t100 c/o being tired, coughing, sore throat; 7NOV started ATB @ 8PM; afebrile & feeling better 12NOV92; ATB finished 14NOV92;
Developed unilateral tinnitus in left ear; developed PVC's, developed macrocytic anemia
Red raised 2mm bumps appeared on (B) lower legs, forearms 9 days post vaccines. Day 10 the bumps appeared on chest, abdomen, thighs, feet, hands. Small amount on lower legs and forearms, moderate-severe on thighs. Very itchy. Applied rubbing alcohol to rash several times a rash. Resolved within 7-8 days. No other symptoms with rash.
bump on the injection spot; itchy on the injection spot; injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (bump on the injection spot), INJECTION SITE PRURITUS (itchy on the injection spot) and INJECTION SITE PAIN (injection site sore) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Nasal disorder.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE REACTION (bump on the injection spot), INJECTION SITE PRURITUS (itchy on the injection spot) and INJECTION SITE PAIN (injection site sore). At the time of the report, INJECTION SITE REACTION (bump on the injection spot), INJECTION SITE PRURITUS (itchy on the injection spot) and INJECTION SITE PAIN (injection site sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After three days of initial occurrence, the events they got better, then after 10 days the symptoms came back again.   Patient had a nostril problem for which she was taking unspecified anti fungal medication.   Patient used ice and anti itch cream to treat the symptoms.
12 YEAR OLD FEMALE RECEIVED A BIVALENT VACCINE AS A SECOND DOSE. PATIENT STAYED THE 15 MINUTES OBSERVATION PERIOD - NO SIDE EFFECTS WERE OBSERVED.
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 67-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
Swollen lymph nodes in left arm pit - started Monday am, 4th day after 1st shot.  No evidence to date in right arm.
A day or so after recovering from the expected flu-like soreness of the vaccine's 2nd dose, I was afflicted with full-body hives, originating on my extremities. After 24 hours, the hives had spread to roughly 70% of my body, and shifted constantly hour by hour to different sections of skin. Treatment was sought, and steroids prescribed (one shot, on-site, followed by a week of methylprednisolone tablets taken orally). Initial shot of steroids provided temporary alleviation, but side effects quickly returned until the oral regiment of steroids was started the next day. It took roughly 3 days to combat the worst of the hives.
Flu like symptoms, vomiting. Didn?t take any medication. Stayed in bed for a day . Loss of appetite
Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an eighteen months old female patient and it was reported that 18 months 20 days female child was given DAPTACEL along with her other vaccines that included PENTACEL, she received vaccines PENTACEL and DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis A Vaccine; MMR; PREVNAR 13; and Varicella Zoster Vaccine. On an unknown date, the patient received a 1st dose of 0.5 ml suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C524AA and expiry date: 18-Sep-2019) via intramuscular route in the right thigh. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (ACTHIB portion lot number: C5543AA and Dtap portion lot number: C540AA and expiry date: 08-Sep-2019) (dose, dose in series, route and site of administration was not reported). It was a case of actual medication error case due to inappropriate schedule of vaccine administered. No adverse event was reported. 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. List of documents held by sender: none.
some chest pain/fluttering, sharp stabbing headache on back of the head on the right side, throbbing headache