chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states that, starting the day after receiving the shot, for a day and a half she experienced severe fatigue and confusion and "couldn't count out my pills or function". Says the effects lasted a day and a half. Denies pain or any other adverse effects. Received the influenza vaccine (Fluad) on the same day. Related these events to us on 10/18 when she stopped by our pharmacy.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    Concomitant medications were not reported.  It was reported that patient was administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults. No AEs were reported.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  Treatment medications were not reported.
pt recvd vax;had unconsolable crying for 4 hrs;red swollen leg & fever 102; PAR consulted ped who advised no more pertussis for pt;apap & cold compresses given;
Persistent chronic headache, which started 2 weeks, post vax, lasted 7 months, and still persists!! Numbness in head and on face, pain in neck and swollen on left side. Treated with several medications. Symptoms persist. Had chronic diarrhea and became hyperthyroid.
local reaction consisting of warmth to the touch, redness at injection site. clinic instructed to take benadryl and ice to area. suspected allergic reaction
16 year-old-patient inadvertently received the Moderna Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old-patient inadvertently received the Moderna Vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.) and Product administered to patient of inappropriate age.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old-patient inadvertently received the Moderna Vaccine). On 08-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old-patient inadvertently received the Moderna Vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Accepted VAERS ICSR as Follow-Up, likely NNI, there was no new info in the SD
Acute transverse myelitis, optical neuropathy - loss of vision (impairment), demyelinating disorder (CNS) severe, myelopathy. Per follow up report-Neurological symptoms that has been ongoing for the past three years as of 10-31-05.  Patient didn't have this conditon before the shot was given.
breakthrough infection with COVID after having received Moderna vaccinations; This spontaneous case was reported by an other health care professional and describes the occurrence of BREAKTHROUGH COVID-19 (breakthrough infection with COVID after having received Moderna vaccinations) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAKTHROUGH COVID-19 (breakthrough infection with COVID after having received Moderna vaccinations). At the time of the report, BREAKTHROUGH COVID-19 (breakthrough infection with COVID after having received Moderna vaccinations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: (Positive) Positive.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.  HCP states that a staff member at her facility tested positive for COVID within the last couple of weeks after having received previous Moderna COVID-19 vaccinations. She wanted to inquire on behalf of this staff member, how soon can they receive the new Moderna COVID-19 bivalent booster after testing positive for COVID. HCP requests for information to be sent via email.  Company Comment: This is a spontaneous case, concerning a patient of an unknown gender and age, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19, in an unknown date, in the context of the administration of a dose of the MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) in an unknown scheme of administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case, concerning a patient of an unknown gender and age, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19, in an unknown date, in the context of the administration of a dose of the MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) in an unknown scheme of administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Headache, fever, malaise, cough, congestion started 11/2, worsened daily. OTC meds. Rx PHENERGAN/CODIEINE, TYLENOL, IBUPROFEN on 11/6/09.
contracted COVID-19; contracted COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "contracted COVID-19".  Clinical course: The patient contracted COVID-19 in Feb2023 after having been vaccinated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This 98 year old female was admitted from medical center this date to this facility due to dehydration and deconditioning.  Pt has ribs 6 and 7 Fx on left side with pleural effusion.
by 9am on 6/26/21 a little over 1/2 a day from time of Moderna Shot #2 I had minor fatigue and a very slight headache, but my arm at injection site hurt about a 5 out of 10 on a pain scale with zero being no pain. I took 2 Tylenol gel caps  about 10am, then again about 8pm that day, then on Sunday about 9am and the headache was gone.  I was lucky and was functional both days following the second shot with only the very minor reaction.  Today, Monday, 6/28/21, I would never know I had the shot, the arm and the headache and fatigue are gone.
As soon as I was injected I felt a burning sensation that went from the site up into my neck. Day 2, 7am I woke with a temperature of 102 degrees, Throughout the day I had fever, chills and arm injection site to neck continued to be painful, arm swollen and warm to touch with a lump about the size of a walnut, and lethargic. Day 3-4 symptoms continued same as day 2 with temperature decreasing to 100 degrees. Day 5 fever gone. Day 5 through today the injection site continues to be somewhat painful with some heat in the arm and lump has decreased to dime size. Called and spoke with doctors office this morning. Advised to treat with wet warm compress and Ibuprofen for discomfort. Call is worsen.
Information has been received from a Registered Nurse concerning a male patient who on 27-JAN-2011 was vaccinated intramuscularly in the arm with the first dose of PNEUMOVAX 23 (lot #667995/1150Z expiration date: 04-MAR-2012). Subsequently the patient experienced soreness at the injected arm. No treatment needed to be given. At the time of the report patient had recovered. It was unspecified if patient sought medical attention. By nurse's request, a lot check has been initiated. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
An immediate burning sensation at the vaccination site as the vaccine was being injected. The burning sensation spread from the injection site upward to my  neck all the way to my right ear. The burning sensation then started from my injection site down to my elbow. The burning sensation stopped after a few minutes, then I felt silently nauseous and lightheaded.   After waiting 15 minutes I felt fine enough to go home. However, the pain and stiffness in my neck was ongoing throughout the following day and night and was only slightly relieved with 500mg doses of Tylenol every 4-5 hours.  On a couple of occasions the day of and the day following the vaccination I did feel fleeting chest pain, but not enough pain or intensity to warrant a trip to the doctor. This morning (4-11/21) the aching sensation in my neck and arm (primarily neck) have lessened, but still present.
In March 2000, the patient experienced a bad case of chickenpox. Soon after, the patient experienced osteomyelitis. Medical attention was sought.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 63-year-old female patient who received SHINGRIX (batch number G72ZD, expiry date 24th November 2020) for prophylaxis. The patient's past medical history included rheumatoid arthritis.  On 5th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th February 2019, less than a day after receiving SHINGRIX, the patient experienced feeling unwell, injection site pain, upset stomach and weakness. On 14th February 2019, the patient experienced shingles and blister. In February 2019, the patient experienced pain. On an unknown date, the outcome of the shingles, feeling unwell, injection site pain, upset stomach, weakness, pain and blister were unknown. It was unknown if the reporter considered the shingles, feeling unwell, injection site pain, upset stomach, weakness, pain and blister to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. On the day of vaccination, the patient felt a little sick, complained of soreness at the injection site, upset stomach and weakness. Less than a month after receiving SHINGRIX, the symptoms started to get worse and she began to experience a lot of pain. Nine days after receiving SHINGRIX, the patient broke out in blisters. The next day, the patient was diagnosed by her physician. The shingles was on the right side of her body.
Information has been received from a pharmacist concerning a 49 year old male with a history of five episodes of Shingles who on 25-JUL-2008, was vaccinated with ZOSTAVAX (Oka/Merck) (lot# 659672/0294X) SQ into his left arm. Concomitant therapy included other unspecified medications. On 25-JUL-2008, the patient told the pharmacist he had burning in the left arm. Additional information has been requested.
Daily erratic,spontaneous heart palpitations varying in strength and length of episode duration. 11/30/2016 Ambulance transport to hospital ER with symptoms of elevated, pounding, erratic heart rate with pressure across chest. BP in transit 200/90.
No additional AE/ PQC reported atthis time.; temperature excursion/ vaccines have been administered to patients; This spontaneous report was received from a nurse and refers to a 4-month-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-MAR-2021, the vaccine experienced the temperature excursion of 9 degrees Celsius for 30 minutes.  On 18-MAR-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1742460 has been verified to be a valid lot number, expiration date was reported as 16-NOV-2021 (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Data logger was involved. There were no previous excursions reported.; Sender's Comments:  US-009507513-2105USA007003: US-009507513-2105USA006817:
Dizziness, lightheadedness  B/P 70/50.  Pt was transferred to Hospital for further evaluation.
Coughing in September 2 or so - she was having a deeper cough (then usual and more often) with clear phlegm and Urgent Care. They gave her antibiotics (Amoxicillin 500 mg) -  and Benzoate - 100 mg. It seemed to help. The cough is still kind of there but it's at a lesser degree (not as often and not as deep).   Sept 1st or so - I noticed she had developed a growth on the back of her head. She probably had it sometime in August. She still needs to be determined as to what it is. She has had this three years ago - and at that time we took her took to the doctor for it. They burned it off.  It was called Saboric Keratosis (three years ago). I am assuming that this is what it is again. We had an over the phone doctor's appt due to COVID - but it's still not determined. She is to go in on October 11 to get the doctor to look at it closer to see what it is and what kind of treatment to receive.  Note: August 26, 2021 she received her TDAP vaccine.
large quantity deep vein thrombosis:  R leg extending to mid-IVC, pulmonary emboli, and LLE DVT
patient reported flu like symptoms that started the next day after getting the shingrix shot. He was bedridden also like his wife (they both got the 2nd shingrix dose together on 9/29/2020) and could not function. he felt tired, worn out but his symptoms were less harsher then his wife. she had it worst. He feels better now and can do errands, but gets easily tired afterwards.
Initial report received from healthcare professional on 21 March 2014. A 6-year-old male patient whose medical history and concomitant medication were not reported, had received intramuscular dose of FLUZONE (lot number UH900AD, expiration date was not reported) in to the deltoid right on 07 November 2013 and had cellulitis like area at injection site, injection site red, injection site itchy on 09 November 2013 and had cellulitis like area at injection site, injection site red, injection site itchy on 09 November 2013 and given ABT script. The event of cellulitis like area was reoccurred on 05 December 2013. It was also reported that on 13 January 2013, 06 February 2013, 26 February 2013, 13 March 2013. Mother reported injection site got red and itchy and resolved in 12-18 hours. The laboratory details and corrective treatment were not reported. The outcome of the event was not resolved at the time of report. List of documents held by sender: none  Follow-up information received from healthcare professional on 24 June 2014. The patient received fourth dose of FLUZONE and received previous 3 doses of influenza vaccine. The patient had no cellulitis like area at injection site. On 09 November 2013, the patient experienced golf ball size swelling and redness and injection site was itchy. The patient did not receive any other vaccinations within 4 weeks priors to vaccination and had no illness at the time of vaccination.  The patient has no known drug allergies; Ventricular Septal Defect (VSD) and patent foramen ovale were resolved on 30 September 2013. It was reported that, the patient did not experience any adverse event to prior vaccination.
received tenivac instead of boostrix with no reported adverse event; Initial information received on 25-Apr-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 28 years old female patient who received diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] instead of boostrix with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection lot number not reported via unknown route in unknown administration site (dose, frequency, strength and expiration date: not provided) for immunization.  On an unknown date the patient received tenivac instead of boostrix with no reported adverse event (wrong product administered) (latency- same day) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
pt called c/o pain in knees & waists;started 2 days ago-states has not had problems w/arthritis in past;Is hard for pt to walk d/t severe pain in knees; has call into MD
Tinnitus, Vertigo, light headed with both shots; Tinnitus, Vertigo, light headed with both shots; Tinnitus, Vertigo, light headed with both shots; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Aug2021 16:00 (Lot number: FC3184) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Psoriasis" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: HUMIRA. Past drug history included: Humira, reaction(s): "known allergies: Humira". The following information was reported: DIZZINESS (non-serious), VERTIGO (non-serious), TINNITUS (non-serious) all with onset 24Aug2021 14:00, outcome "not recovered" and all described as "Tinnitus, Vertigo, light headed with both shots". The event "tinnitus, vertigo, light headed with both shots", "tinnitus, vertigo, light headed with both shots" and "tinnitus, vertigo, light headed with both shots" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, vertigo, tinnitus.Doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible. No further information is expected.
09Feb91 pt vax w/ MMR;  11Feb91 devel fever 103F, irritability, cheilitis.  After 5 days swollen lips appeared more irritated + tx w/ amoxicillin.
deltoid area became red, tender & swollen (site of inject) spread down arm-spontaneous drainage; sterile abcess;
2:50 H1N1 vaccine administered by RN.  Noted prior to giving injection some redness on neck (patches not raised) injection site clear at time of injection.  2:55 talking with pt.  Noted face and ears red and flushed.  Looked at injection site very red with redness trailing down arms, back, and chest.  BP 106/70, P 88, R 22.  No c/o itching or raised areas.  3:00 school nurse called mom to get permission to administer Benadryl.  3:09 Benadryl 12.5mg fast melt tab given.  3:19 red rash lightened in color.  Face and ears less flushed.  Redness on back, neck, and arms improved.  No c/o itching, breath sounds clear.  Remained alert and oriented the whole time.  3:30 RN walked child to school classroom to collect books.  Walked child to car where father was picking up child.  Explained child's situation (reaction to injection) and that Benadryl was given.  Explained that child never c/o itching, just redness noted by nurse.  Told him redness has decreased significantly.  If child c/o SOB take to ER.  Released to father.
pt said there was leakage of a liquid from the injection site .. she noticed that around 30 minutes after receiving the shot .
Within 24 hours developed hives at the right deltoid injection site that spread up to the right side of his neck. The rash was itchy. He took Benadryl and the rash was gone in 24 hours. Four days later the rash started again at the injection site and spread up to the right side of neck. It then spread to the back of his neck. All the rash cleared in 24 hours after the use of Benadryl except for the back of neck. Then 4 weeks later he developed a eczema type rash on the sides of his neck, torso and is no spreading down the arms. He was seen by his MD who believes this is related to the vaccine and recommends he not get the flu shot. The associate has gotten flu shots for the past 25 years without a problem. This year he received Fluzone and in previous years he has received Afluria without issue.
Patient developed spreading redness at injection site. She went to PCP clinic and was prescribed doxycycline 100mg twice daily x 10 days.