chrisvoncsefalvay/vaers-outcomes huggingface dataset:
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times), ACCIDENTAL UNDERDOSE (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times), ACCIDENTAL UNDERDOSE (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times), ACCIDENTAL UNDERDOSE (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-375352.
generalized itching, constriction of throat, difficulty breathing developed almost immediately after injection. Patient was given IM epinephrine, IM Benadryl in the clinic, was transported to ED via EMS within approx. 30 minutes of symptom onset, evaluated at ED, was given IV dexamethasone, lactated ringers, and metoclopramide. Patient was given outpatient prescription for prednisone and epinephrine. Was discharged from ED approx. 5 hours after injection.
4 inch by 2 inch red, hot, itchy rash area lasting 4 days.  Sinus congestion.
Pt lives with daughter who is COVID positive and he was tested and positive also.  He has been having cognitive decline and falling.
Patient received vaccinations without incident.  However, she returned to clinic several hours later complaining of feeling dizzy and lightheaded.  She also reports that her she'd feel cold one moment and then hot another.  Patient did not eat anything all day.   Blood sugar was 83.  Pulse: 83, Blood pressure: 102/70, Resp Rate: 18, Temp: 97.9.  She was diaphoretic and pale when she first returned.  Otherwise, physical exam was unremarkable.   She stayed with us for ~45 min.  Was given graham crackers and water.  After sitting and eating, her coloring appeared more at baseline.  She reported feeling better.  Family was called and notified.  She left clinic for home with instructions to monitor closely.
At about 5:30 PM patient's throat starting feeling like it had a lump in it which made it hard to swallow.  About 10 minutes later started feeling nauseous and began vomiting.  That was followed by shaking and feeling very cold and a headache.  Vomited several times until patient's stomach was empty and then continued to feel nauseous. Did not have a fever but was shaking from feeling cold.  The nausea and vomiting subsided around 11:00 PM.  The feeling of tightness in throat also stopped at the same time as the nausea.
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot  number FD0809. The Public Health District, per guidance from the Department of  Health (DH), Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the  dose of vaccine that you received is valid.
neighbors son passed out; has dizzy spells; vomiting; This is a spontaneous report from a non-contactable consumer. A potential AE has been reported. A male patient (neighbor's son) of unknown age received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), unknown dose via an unspecified route of administration on unknown date at dose number unknown, single for COVID-19 immunization. No medical history and concomitant medications were reported. The Caller and her husband got Pfizer Covid vaccines in Jan2021. They haven't had any problems, until about 2 months ago. Her husband started having headaches and he was dizzy. He has had an MRI, EEG, wore a heart monitor, and a carotid artery check and they can't find anything wrong. It was reported that, reporter neighbors had similar side effects, neighbor's son passed out and has dizzy spells, and neighbors boyfriend has passed out several times and vomits. The outcome of events was unknown.  Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100956276 Same reporter and drug,  different patients
48 hrs after injection, from just above right knee to right foot, bright pink manifestation in skin leading to skin peeling within 15 minutes and blistering within 30 minutes; looked like burn.  continuing large up to 3" x 3"  blistering through 48 hours and beyond.  MD described as consistent with chemical or scalding burn both of which are out of the realm of possible causes. No fever, no severe pain. No history of bullous pemphigoid.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema, injection site pain and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient could be 49 or 50 years old. The health care professional reported that the patient might have received a SHINGRIX subcutaneously instead of intramuscular, which led to Intramuscular formulation administered by other route. The patient also experienced a 2 to 3 inch red area with soreness at the injection site site. The reporter consented to follow up.
Information has been received from a physician concerning an 11 year old female who was vaccinated with GARDASIL. It was reported that the patient passed out 'almost immediately" after receiving the vaccine. No lot number was provided. The patient sought unspecified medical attention. The patient had her blood pressure measured. It was reported that the "patient was fine". Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007. In follow-up it was reported by the registered nurse concerning an 11 year old, female, with no illness a the time of the vaccination and no pre-existing allergies, birth defects, or medical conditions, who on 16-APR-2007 at 10:00 a.m., was vaccinated in the left deltoid muscle with the first dose of GARDASIL, (Lot # 657005/0314U). It was reported tht immediately after receiving the immunization the patient had a syncopal episode. The patient's mother and the nurse caught the patient before she hit the ground. The patient was pale and diaphoratic, blood pressure was 84/57 mmHg. The patient was put in the Trendelenburg position. The patient's blood pressure rose to 96/54 mmHg. The patient walked out after 10 minutes. It was reported that the patient recovered on 16-APR-2007. Additional information has been requested.
Patient received vaccine on 10/20/12, then a few days later (she is not sure of exact amount of time that passed) she started developing pneumonia-like symptoms. She went to her doctor & received an inhaler & antibiotics.
Patient is not immunocompromised and therefore not eligible for a 2nd booster per the current recommended guidelines. No adverse event reported.
patient was hospitalized 4/8-4/12.     **date of 2nd vaccine was 3/3/2021
Patient passed out after TYPHIM administration. Patient did not fall, Rph. caught patient before she fell. Patient was conscious and responsive. Called 911 but patient left before they got here.
Atrial Flutter - High Blood Pressure - Shortness of Breathe  (two visits to ER )
Mother called in am of day following vaccinations (6/23) to report that child had "slight fever, headache, sore arm." RN advised her to give him ibuprofen and monitor if condition worsened. Mother called back later in day to report that he no longer had a fever or sore arm, but that he "had a severe headache" and was "not able to get up and was continually crying." Mother was then advised to take him to Urgent Care/ER. Telephone follow-up was done with mother the next day (6/24), and she reported that she did take him to ER, and they checked him out. Says she was told it was "probably a vaccine reaction since he got several shots." Says that he had no more problems, and had completely recovered.
Ocular (red eyes) and eye pain of 24-48 hours duration. Local site redness, induration, pain and soreness, 24-48 hours.
Fever, rash, not eating for 2 days, feeling low-sick for days, the 1st injection of Twinrix was sick within 24 hours. The 2nd injection was sick for weeks and doctor refused to treat these symptoms, which the manufacturer states if you have them see your physician that was ignored. RE: Information only on the negligence of the deliberately ignoring the manufacturer's warning on Twinrix label, of adverse reactions. Dear Sir or ma'am: This is the problem. Twinrix for hepatitis C clearly states that if you have the symptoms that are printed on their label adverse reaction to Twinrix, see your doctor soon. That don't work here. I was low-sick and nicely ask for treatment from the induced medication based on a non-liver test (no liver biopsy) and the test has not been approved nor cleared by the Food and Drug Administration and when I complained, I was put in Administrative Segregation for 50 days with no treatment because I demanded treatment for this induced sickness, the reaction from Twinrix. I know or feel I know that your company receives millions of complaints from people looking to lawsuits from manufacturers because of a medical discomfort, however, I am filing a civil action not on the manufacturer but the (place I'm at) doctor's for negligence by these reject doctors who can't get a job in the free world because their skills are below normal or no hospital wants them because of lawsuit malpractice suits,
Arm swelling (more than injection site reaction), itching, Pt came to ED to have it looked at by doctor.
after injection. patient had reddness and swelling that was not at the site of injection. reddness was to the left arm 4 inches from injection site
Seizure on 4/15/21, 1-2 minutes, post-ictal for a few hours prior to return to baseline. No prior history of seizures.
Hearing go out and tinnitus in one ear intermittently for 2 weeks; Hearing go out and tinnitus in one ear intermittently for 2 weeks; Muscle jerking in arm, stomach, and one toe; Headache; This is a spontaneous report from a contactable other health care professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8731), via an unspecified route of administration in the left arm on 10Apr2021 at 00:00 (at the age of 41-years-old), 1st dose, single, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at hospital. On 11Apr2021 at 13:00, the patient experienced hearing went out, tinnitus in one ear intermittently for two weeks; muscle jerking in arm, stomach, and in one toe and headache. The patient underwent lab tests and procedures which included nasal swab COVID-SARS PCR test: negative on 21Apr2021. The events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovered on an unspecified date.
Third dose last Wednesday on 18Aug2021; sore throat; Third dose last Wednesday on 18Aug2021; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer Sponsored.   This female patient (age unknown) received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unknown route, on 18Aug2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient stated that she received her third dose last Wednesday on 18Aug2021 and has a sore throat. The patient had an appointment to get swabbed for COVID and wanted to know if this will affect the result of the COVID test because her Pharmacist explained that she may test positive because she just had the booster. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
Patient was administered an extra dose of the Pfizer 5-11 monovalent COVID-19 vaccine instead of the intended Pfizer 5-11 Bivalent Booster COVID-19 vaccine on 12/4/22 at 12:34pm.   I called and informed patient's mother on 12/5/22 and she reported that patient is doing well except for some expected post-vaccination symptoms.
ACHY; FEELING TIRED/FATIGUE; This spontaneous report received from a patient concerned a 75 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced achy. On 15-JUN-2021, the subject experienced feeling tired/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tired/fatigue, and achy. This report was non-serious.
This spontaneous report has been received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients was vaccinated with LIQUID PEDVAXHIB (strength, dose, dose number, route and lot # not reported) which was improperly stored. The temperature excursion for LIQUID PEDVAXHIB was supported with in-house stability data. It was reported that there had been two episodes of temperature excursion, after the second excursion, doses of improperly stored vaccines were administered to patients. No adverse symptoms reported. This is one of the several reports received from the same reporter. Additional information has been requested.
17 year old patient presented to clinic with parent to receive first covid vaccine, patient received Moderna instead of Phizer. Parent was informed and no additional signs and symptoms reported per parent.
Redness, swelling, tenderness around the site of injection. Patient reports Tmax 100 F x 2. She was seen and treated on 08/28/2015.
pushed the plunger through and half of the vaccine went in and the needle separated from the product with no adverse event; Initial information received on 16-Sep-2022 regarding an unsolicited valid non-serious case received  via pharmacist. Agency number: 01282920  This case involves a patient of unknown demographics to whom Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] was administered with pushed the plunger through and half of the vaccine went in and the needle separated from the product with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect Fluzone High-Dose Quadrivalent half dose at (formulation, strength, lot number, route, administration site) for prophylactic vaccination as the plunger was pushed through and half of the vaccine went in and the needle separated from the product with no adverse event (incorrect dose administered) (unknown latency).  It was reported that "the caller stated as one of the employees was giving the patient the FLUZONE HIGH-DOSE, he pushed the plunger through, and half of the vaccine went in, and the needle separated from the product while the other half didn't get administered. The reported inquired should they re-administer, or would half the dose suffice? Pharmacist states it was a PFS and the employee didn't have the needle tight on the syringe."    Action taken: Not applicable.  At time of reporting, the outcome was Unknown.    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 the 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.
On mar 18 late afternoon i started with a burning in my neck and the pain kept getting worse then it went to my head and my head started killing me. I tried to eat cuz i thought i might be hungry, i was also very confused and i ended up passing out at the food place at the table, i never ate i woke up cuz i had to puke them i ran outside and threw up a total of 4 different times from that point on for the next 3 days i couldn?t keep my eyes open i was beyond tired i had no control my eyes would close and i would fall asleep for hours at a time. It?s day March 20 and I?m still exhausted tired trying to fight the fatigue.
Localized swelling and erythema started 24 hours post injection. Not painful not pruritic, neurovascular function normal.
patient felt nauseous, so when he stood up to go the restroom, he took a few steps and then fainted.
6-11-09 approx 2 pm ZOSTAVAX given approx 1:30 am. Pt experienced rapid pulse of 80-93; BP 146/84, went down to normal after 2 hours, reported 6-24-09.
About 48 hours after receiving the vaccination, my son was in his high chair eating lunch.  I asked him a question and noticed he had a blank stare on his face.  I thought maybe he had zoned out or something so I said his name; he did not respond.  I said it a few more times with increasing urgency with no response.  I frantically removed him front the high char while saying his name.  He was limp, motionless, eyes open with no expression - totally unresponsive.  It was like the life went out of him.  It was awful.  I was in full panic about to call EMS when he came back.  He was a little out of it but close to normal pretty quickly.  I didn't know if fainting or something like that could happen after vaccination, so I called the pediatric office.  They said it was not connected to the vaccine,.  I was certain it was the vaccine based on his daily routines and usual behavior but appreciated their time.  They said I didn't need to do anything, bring him in, etc and to call them if it happened again.  And to call EMS if he went unresponsive again and didn't come back.  Thankfully, there was not another incident.  He has not had Pentacel since.
The morning after receiving vaccine I worked out lifting weights and jumping rope.  After about a half hour I suddenly stopped sweating became very chilled (shivering), weak, very nauseous, felt rapid heart rate.
Pt reported badly bruised arm that swelled and was black. Pt also on blood thinner, so told that she may experience worse bruising. Pt requested report filed.
pt recv vax & immed p/vax pt felt light headed & passed out;pt laid down & light headedness resolved;pt is a paramedic for the fire dept;
Had shot at 10:30 am flemy cough, hoarseness, fast heat beat. Cough came about 2 hrs after shot - 12:30 pm then hoarseness and then my voice was gone completely about 2:30. Went to ER arrived 4 pm - symptoms cleared up at 5 pm. Called RN and couldn't leave ER before being seen
Dizziness, shaking in extremities approximately 2 hours after inoculation. 25mg Benadryl given orally 2.5 hours after inoculation.
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored VAQTA lot # n005274 with expiry date: 03-APR-2018 (dosing details, anatomical location, route were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32F to 35F (35F) for 4 minutes; 32F to 35F (34.7F) for 11 minutes and 32F to 35F (35F) for 4 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1708USA011663: US-009507513-1708USA011662:
I had a non stop cough, really tired, and headache. I already had a chronic cough and COVID-19 made it way worse. I tested positive for COVID-19 at home on 08/29/2022. I called my doctor through telehealth the same day and she prescribed me symbicort and to take mucinex. It has been 2 months and I still have the cough.
Mixed Series. First dose Moderna. 2nd dose Pfiizer. Pt did not have vaccine card avaiable. Pt asked upon admission  which vaccine for 2nd dose. She stated Pfizer. Pt asked again by this writer. Pt reported Pfizer. Pfizer admin to left deltoid. Well tolerated. Upon chart review. revealed pt rcvd first dose Moderna. Pt contacted. States no adverse effects. Explained CDC protocol for mixed series. Pt able to repeat back teaching. Pt later reports she realized she stated the wrong vaccine for 2nd dose.
RT with evidence of blistering edema and discoloration 12cm by 14cm.
Left arm pain on injection site the second date after booster shot. the pain disappeared on third date However,  Developed Groin and thigh pain on left side on Dec 22, then a days later, developed rash on the lower back and left thigh. It is confirmed as shingles by doctor on Dec 30th.
On the 3rd night after the vaccine, I was sleeping and started feeling numbness in one arm. It slowly moved to both arms and legs.   4 weeks after, I am having numbness in my toes. It comes and goes. I am not sure if it is related or not.
Fever, diffuse rash over entire body, measles like, started on trunk, spread to face then extremities. Symptoms started 10 days post vax. Treatment Tylenol for fever.
Case number PHEH2014US018094 is an initial spontaneous report from the pharmacist received on 08 Sep 2014. This report refers to a 21-year-old male patient. He was vaccinated with 0.5 ml of MENVEO (batch number: M11077) intramuscularly on 18 Aug 2014. It was reported that the patient accidentally received an expired MENVEO vaccine. No adverse event reported following this medication error (expired vaccine used).