chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose received in parts 0.05ml and then 0.45 ml; This spontaneous case was reported by a health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Dose received in parts 0.05ml and then 0.45 ml) in a 21-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Dose received in parts 0.05ml and then 0.45 ml). At the time of the report, INCORRECT DOSE ADMINISTERED (Dose received in parts 0.05ml and then 0.45 ml) outcome was unknown.        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.   No treatment medication was informed by reporter.
HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
Confusion, dizziness and lethargy. Extremely difficult to properly wake up after a long sleep, nighttime incontinence. Nausea, vomiting, headache and neckache, backache.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 05-SEP-2002, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml, intramuscularly, with a reported lot # M0011840 with expiration date 01-FEB-2018 (anatomical route of vaccination was not provided). The patient's concomitant medications were not reported. The office manager stated, that the vaccine temperature excursion had a time frame of 72 hours at 34 F. Data logger was involved. However, no side effects were noted. GARDASIL 9 was not involved on a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received Pfizer COVID vaccine on 7/17/21 and 8/7/21. Patient tested positive for COVID on 1/28/22. On 2/3/22, patient admitted to our inpatient med/surg unit with acute hypoxic respiratory failure secondary to COVID19 and acute asthma exacerbation. As of today (2/4/22), patient is still admitted in the med/surg unit.
Passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) in a male patient of an unknown age 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) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The patient's wife reported that the patient passed away a few weeks after taking the Moderna vaccine.  Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable  Company comment Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
bottom lip swelled up; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the right arm on 30Mar2021 at 10:00 (at the age of 82-year-old), dose number unknown, single for COVID-19 immunisation. Medical history included lupus syndrome. The patient's concomitant medications were not reported. The patient had no allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 03Apr2021 at 09:00, the patient's bottom lip swelled up. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with prednisone, cortisone for the event. The patient had not been tested for COVID-19 since vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
20-30 mins p/vax pt fainted-hit forehead over eye-followed by vomiting taken to ER by paramedic;
Rumbling sound in right ear. I previously/currently have sensitive ears. Have to keep water out of them, use cotton in them during cold weather. Was already slight ringing, But the vaccine made it worse, And it hasn't gotten better. This also happened on my 2nd shot, which was Pfizer.
Received two vaccines at target pharm on 8/30/17 came into office on 8/3/17 w/pain in arm, feeling shaky and dizzy.
Given first HPV on 10/2/07 left arm IM. As pt being given 2nd varicella, passed out. Did report some burning at site of HPV. Recurrent syncopal episode later same day and persistent eyelid hand swelling after IV fluids x 48 hours. Low grade temp (99) 48 hours after imm. Anxiety and hyperventilation first 72 hours. Onset of menstrual period 10/3/07.
PATIENT RECEIVED VACCINE AND BEGAN FEELING ILL AS HE LEFT THE STORE. STATES HE BEGAN FEELING LIKE HE WAS GONNA FAINT, STARTED SWEATING, AND BECAME DIFFICULT TO BREATHE. ALSO STATES HE HAD TINGLING IN ARMS AND SORENESS AT INJECTION SITE. PATIENT SAT DOWN BUT HAD TO LAY DOWN AND BEGAN FEELING BETTER. EMS WAS CALLED TO STORE AND THEY TOOK OVER SITUATION.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. In 2014 (reported as in this last year; exact date unspecified), an unspecified number of patients were revaccinated with the second dose of PNEUMOVAX 23 (batch/lot#, dose and route were not reported), because the physician believed the serotypes for PNEUMOVAX 23 had changed. No adverse symptoms were reported. Additional information has been requested.
positive antigen test; positive antigen test; 102.4 fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6205), in right arm, on 30Mar2021 as dose 2, single (Lot number: EP7533), in right arm and on 30Sep2021 as dose 3 (booster), single (Lot number: 301558A) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Minor asthma" (unspecified if ongoing); "minor lung disease" (unspecified if ongoing). Concomitant medication(s) included: FISH OIL; TUMS 500 CALCIUM; CENTRUM A TO ZINC. Past drug history included: Known allergies: allergic to midol, reaction(s): "Known allergies: Allergic to midol". The following information was reported: PYREXIA (non-serious) with onset 25Apr2022, outcome "not recovered", described as "102.4 fever"; VACCINATION FAILURE (medically significant) with onset 26Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 26Apr2022, outcome "not recovered" and all described as "positive antigen test". The patient underwent the following laboratory tests and procedures: Body temperature: (25Apr2022) 102.4, notes: symptom start up to 102.4 fever; SARS-CoV-2 test: (26Apr2022) Positive, notes: positive antigen test- began paxlovid that night never missed a dose for 5 days, symptoms cleared in a couple days; (01May2022) Positive, notes: retest antigen still positive; (05May2022) Negative, notes: retest antigen NEGATIVE; (09May2022) Positive, notes: retest for ultracaution and test very positive. Minimal to no symptoms. Therapeutic measures were taken as a result of covid-19. Therapeutic measures were not taken as a result of pyrexia. Clinical Course: It was reported that 25Apr2022 symptom start up to 102.4 fever plus. 26Apr2022 positive antigen test- began paxlovid that night patient  never missed a dose for 5 days, symptoms cleared in a couple days.01May2022 retest antigen still positive, continue isol. 05May2022 retest antigen NEGATIVE. Discontinu isol. 06May2022 visit fiance finally after 12 days 07May2022 fiance becomes sick 09May2022 fiance still sick, patient retested for ultracaution and test very positive. Minimal to no symptoms Which is the reason for this report. Either reinfection from 07May2022 fiance visit or paxlovid rebound.
Lymph node swelling in the left supraclavicular area with both injections. The swelling started the second day after injection and remained swollen for 2+ weeks. Confirmed with Ultrasound after 1st injection. Follow-up Ultrasound scheduled for May.
Initial information received from another manufacturer (service request number 1-5424891248) on 13 August 2012. The information was originally provided to the other manufacturer from a pharmacist. A patient with (unknown demographics) (unknown gender) with no reported medical history and concomitant medications received FLUZONE and PNEUMOVAX 23 injection (batch number, route, site of administration, dose, dose number were not reported) on an unknown date. It was reported that the patient developed rash after possibly receiving FLUZONE. Details of lab tests and treatment were not reported. The outcome of the events was not reported. Documents held by sender: none.
had vaccine 12/30.  About 1/1 had ill feeling, very tired, soreness in joints, extreme pain in arm/ legs. did not have breathing problem.  pain and limited range motion lasted until 1/7/21. I called health clinic and they told me to call cdc number on vaccination card.  That number sent me to reporting center, no help.  Called family physician, they said they knew nothing about vaccine.  Since i wasn?t having breathing problem i just dealt with pain and took Tylenlol couple times each day.  Took second dose vaccine 1/20/21.
Vaccine was administered in the Deltoid region, she called a week ago and spoke with my colleague and he suggested icing, taking tylenol and let us know in few days, she visited the pharmacy now (10/22/20) and informed that she started having pain at the ELBOW (not Shoulder) area, she said she started having the pain approximately a week or so after the vaccine.
Chill, Overall body ache, Temperature of 103 F for 24 hours.  Increased fluid intake
pt recv vax & noticed this AM 2inch in diameter swelling, reddened rt deltoid area, warm to touch;advised cold compresses if it gets worse to take to MD;
Patient received COVID-19 vaccine at approximately 6:30pm 4/23/21. After waiting 15 minutes in the observation area, patient tried to stand up and lost consciousness. Patient hit his head on the floor. EMS was called, but patient refused treatment or transportation to the hospital. EMS advised patient he may have a mild concussion and he should follow up with a medical professional.
This case was reported by a pharmacist and described the occurrence of expired vaccine used in a patient who received ENGERIX B (batch number unknown, expiry date 24th January 2015). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: Pharmacist was not sure but she thinks that an expired dose of the vaccine was administered. She did not have any patient information. The only information she has was the expiry date: 1/24/15.
Information has been received from al licensed practical nurse concerning a 17 year old female with no pertinent medical history, who on 02-JAN-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. The nurse reported that the patient received the vaccination via the subcutaneous route and on 02-JAN-2007, developed in injection site reaction. The reaction was described as being that of a swollen and bruised injections site on the patients shoulder. Unspecified medical attention was sought. The patient subsequently recovered on 03-JAN-2007.
DEMYELINATING CNS PROCESS; INFECTIOUS ACUTE DISSEMINATE ENCEPHALOMYELITIS.
This literature case was forwarded by Novartis with the reference number: PHHY2013US017448. An initial report was received on 18.FEB.2013 and concerns a previously healthy 33-year-old male patient, who on an unspecified date received typhoid vaccine (manufacturer and batch number: not reported). On the same day, the patient also received inactivated hepatitis A and yellow fever vaccination (manufacturer and batch number: not reported).
Nauseous for 30 minutes after vaccine, then reported itchy eyes that felt "tight" and stated she had this same reaction with latex allergy.  Usually takes Benadryl for it.  Treated by NP with po Zofran and po Benadryl
Information has been received from an office manager in charge of vaccine storage referring to a child (reported as vaccine for children (VFC)) of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 25-OCT-2018, the patient was vaccinated with improperly stored GARDASIL 9 (lot # 1586749 and expiration date 31-FEB-2021; route, strength, dose and frequency were not reported) for prophylaxis after the second temperature excursion which occurred on 24-OCT-2018. No patients received the improperly stored GARDASIL 9 between the first excursion and the second one. No adverse effects were reported. The vaccine was exposed to temperature below 32 Fahrenheit (-13.46 Fahrenheit) for 16 minutes. The previous excursion was 47 Fahrenheit to 77 Fahrenheit (47.6 Fahrenheit) for 15 hours. The call was because of a data logger.
PATIENT EXPERIENCED HIVES ON TORSO, ARMS AND LEGS; CHILLS
Pt here for update imms for school. No record at the time. I entered in the dates that were given from previous provider. Status stated he was due for DtaP, IPV, MMR and VAR. Mother advised of imms needed and signed consent. Imms were given. VIS given to mother. She then states that the chicken pox shot that he was given at age 12m gave him "shingles" per last provider. I advised the patients Dr. of this new info. I then advised the mother to watch for fever, SOB, rash, lumps, redness and any blister like lesions. If symptoms develop to bring him to ER or call for appt here if not to severe. Mother agreed. Before he left I did check his breathing and pulse both of which were totally normal. I did notice a dime size lump in the area which the injection was given. I advised mom to give him some Benadryl when she gets him home and put some ice on that area. She agreed to that as well. Pt discharged without any further problems.
Several days after 1st and 2nd dose, small filaments emerged from palms and fingers, much like splinters. Clear to white in colour. Minuscule to several millimetres in length and super fine. Spouse was vaccinated at same time and had same adverse event. Kept area clean and filaments emerged and fell out. Filaments stopped appearing in just under one week and self-resolved.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 27-SEP-2016, the patient was vaccinated with an improperly stored dose of VAQTA lot # M009377, expiration date: 17-JUN-2017, (Strength was not reported), 0.5 ml, intramuscular. The administered dose of VAQTA underwent temperature excursion at 32 Fahrenheit degrees, for 13 hours and 30 minutes. No previous temperature excursions were reported. The temperature excursion was not detected by a data logger. Patient's concomitant medication was not reported. No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
patient experience dizziness and slight shortness of breath. NO anaphylaxis.  pt was taken to hospital by ems.
A day after getting the first shot of the Pfizer vaccine - shot received 8/6/2021, I developed ringing in my ears. It is persistent. It's been over a week and it's enough to cause issues for me when trying to sleep. The Physician says there is nothing that they can do for it According to the doctor, I just have to wait until it clears. She believes that it will clear up in time as the ringing was not caused by sound damage but rather as a result of receiving the Covid 19 vaccine.,
Patient with history of dementia and diabetes. She was brought in by EMS to the ED on 12/6/22 after she had an unwitnessed fall at her memory care facility. She additionally reported pain to her neck, midline upper back, and right upper leg, along with nausea and vomiting. While in the ED she was found to be experiencing generalized weakness, requiring 2 heavy assists for ambulation. She also tested positive for COVID-19 by PCR in the ED. Ultimately, she was admitted 12/6/22 - 12/12/22 for generalized weakness, nausea/diarrhea/emesis from COVID-19, possible bacterial pneumonia, among other discharge diagnoses. She has received the COVID primary vaccine series and two boosters.
sore throat; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's mother) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 02Apr2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient scheduled for the 2nd dose on 23Apr2021 (exactly 21 days apart). The patient currently has a sore throat that started a couple hours ago (Apr2021). She was asking if her daughter can proceed with the 2nd dose scheduled tomorrow. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I RECEIVED BOOSTER 10/8/21 HEART MONITER WAS ON. AT 5 AM AWOKE TO PALPITATIONS . MONITOR SHOWED  i WAS IN A-FIB.. LASTED TIL ABOUT 130PM
After the 1st set of vaccines, DTAP, IPV, Hib at 5 months of age, pt developed fever up to 102F, shortness of breath, limp and erythema extending for about 30" from knees. Pt admitted to ICU for observation of fever. No other episodes. Work-up neg except for anemia. After 2nd set of vaccines DTAP, PIV, Hib, another episode of shortness of breath; fever up to 101F; no LOC.
1/25/21 0800 Fever 101.5, nausea, joint pain, HA. Rash appeared at injection, circular around 50 cm in length. Red, hot and itchy. 1/27/21 1600-1700 rash increased in size to 195 cm. Red, hot and itchy. Other symptoms resolved by 1900. Oral and cream Benadryl OTC taken and administed had no effect on rash
My daughter pt. has heart palpitations and fast heartbeat at times, her pressure can go from 100 to 40 or below very quickly and she feels nauseous and lightheaded. Dr. did EKG was good but is still experiencing these affects frequently and she doesn?t feel good at all, then she?s fine for a while and it comes back again.
Fainted, lost control of bladder, describe sensation of severe pain and arm where shot given, lightheadedness and ringing in ears.
Patient received incorrect vaccination. Patient received KINRIX, but is not old enough for this vaccine. Should have received PENTACEL vaccination.
Headaches and migraines lasted for 2 weeks after second Pfizer Covid vaccine shot. Also kaleidoscope vision which I have never experienced before (happened 4 times within the 2 week period). Now 7 months later, still have kaleidoscope vision about twice a month.
Vivotif was expired on November 30th and the patient started his course on December 1st and completed the course correctly; Spontaneous report received on 10DEC2020.  A pharmacist reported regarding a male consumer where "Vivotif was expired on November 30th and the patient started his course on December 1st and completed the course correctly" (PT: Expired product administered). He was receiving Vivotif for immunisation. On 01DEC2020, the consumer started his course of Vivtoif, which had been expired on 30NOV2020. It was reported that the consumer completed his course correctly. Action taken with Vivotif with respect to reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer started Vivotif course after the expiration date and completed the course correctly (expired product administered). Further information of the event is limited. The causality of expired product administered is not applicable with Vivotif due to the nature of the event.; Sender's Comments: It was reported that a consumer started Vivotif course after the expiration date and completed the course correctly (expired product administered). Further information of the event is limited. The causality of expired product administered is not applicable with Vivotif due to the nature of the event.
Resident tested positive for covid and passed away 2 weeks later  Received Moderna Vaccine in jan and feb of 2021 and then received Moderna booster 11/15/2021
hives on upper Left arm (injection site Left Delt.)- Benadryl 50mg given IM at this time
Swollen lymph nodes and pain in armpit.; Swollen lymph nodes and pain in armpit. Swelling under skin on the left hand side of chest  It feels like jello under my skin. Its visible to the naked eye and can feel it when walk and move. On the right side can see my ribs and on the left they are not visible due to this swelling; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0161) via an unspecified route of administration in the left arm on 22Apr2021 at 15:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW7533) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, the patient experienced swollen lymph nodes and pain in his armpit. The day after the injection (23Apr2021), he noticed swelling under his skin on the left-hand side of chest. It felt like jello under his skin where it was visible to the naked eye and felt it when walked and moved. On the right side, his ribs were seen and on the left they were not visible due to that swelling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of the events. The clinical outcome of the events swollen lymph nodes and pain in armpit and swelling under skin on the left-hand side of chest was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.