chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered an expired dose of Daptacel, had expired on 06 Jun 2022 with no reported adverse event; Initial information received on 26-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5 years old male patient who was administered an expired dose of daptacel, had expired on 06 jun 2022 with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine for Prophylactic vaccination.  On 26-Jul-2022 at 11:14, the patient received suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml (lot C5743AA, expiry date: 06-Jun-2022) via intramuscular route in left deltoid.  On 26-Jul-2022 the patient developed a non-serious patient was administered an expired dose of daptacel, had expired on 06-Jun-2022 with no reported adverse event (expired product administered) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken: Not applicable.  Outcome: Unknown for the event patient was administered an expired dose of daptacel, had expired on 06 jun 2022 with no reported 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 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.
Wheezing, rhinorrhea, sneezy, pruritis w/in min of receiving OPV/MMR;
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 06-JUN-2016, the patient was vaccinated with an expired dose of properly stored VAQTA lot/batch # reported as 1018498, expiration date 28-APR-2016 (dose and route of administration not reported). No adverse events reported. Additional information has been requested.
The site has been hard and warm to the touch since 3/13.  Today it started itching.  I feel it on my upper arm/deltoid area where I got the shot, around my arm and toward the front shoulder/chest area (all on the left).  I feel bumps that feel like bug bites, close to where the shot was administered.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 65-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 15-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250795, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805521 was crossed linked to original cases 201804863 due to same reporter.
Tingly fingertips on right hand beginning approximately 2 days after first shot, seems to have subsided after a few weeks.  Heart palpitations approximately 4 days after first shot; subsided after a few hours.
BREAK THROUGH PSORIASIS/PSORIASIS VULGARIS FLARE; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (BREAK THROUGH PSORIASIS/PSORIASIS VULGARIS FLARE) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 22-Feb-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PSORIASIS (BREAK THROUGH PSORIASIS/PSORIASIS VULGARIS FLARE). At the time of the report, PSORIASIS (BREAK THROUGH PSORIASIS/PSORIASIS VULGARIS FLARE) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a physician concerning a 16 year old female with acne, migraine, dysmenorrhea, mid cycle pain and oxycodone allergy (it was for a broken bone sustained in an athletic incident, much prior to receiving GARDASIL) who on 08-JUL-2009 was vaccinated IM with the first dose of GARDASIL (lot# 661954/1131X). Concomitant therapy included MENACTRA and minocycline. On 14-JUL-2009 the patient began to complain of neck pain and joint pain. Neck pain and joint pain happened twice in the week following the vaccination. On 17-JUL-2009, she went to her pediatrician, who noted that there was no joint swelling, redness, nor heat. On 10-AUG-2009, she went to a pediatric rheumatologist, who stopped the minocycline (for acne), and gave an anti-inflammatory for the neck pain and joint pain. Lab and diagnostic studies were normal. She recovered during the winter of 2009 (approximately December 2009). Neck pain and joint pain were considered to be other important medical events by the rheumatologist. Neck pain and joint pain were considered to be disabling since the patient couldn't go to school. No further information is available.
no adverse effects; Improperly stored administered doses; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On 21-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R034394, expiration date 27-NOV-2020; dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion from -14 to 10 degrees Celsius (C) for 15 hours. Data logger involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.  ; Sender's Comments:  US-009507513-1906USA000180:
feeling sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced MALAISE (feeling sick). At the time of the report, MALAISE (feeling sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant products reported
This spontaneous report was received from a licensed practical nurse and refers to a 9-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 23-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
Migraine headache; Had neck stiffness; This spontaneous case, initially received on 17-Sep-2018, reported by a physician, concerns a 63-year-old, adult male patient.   The patient had not received any concomitant medications.  On an unspecified date, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, anatomical location: deltoid, batch number: YF36505, route of administration: intramuscular, expiry date: not reported) for influenza prophylaxis.   On an unspecified date, 24 hours after vaccination, the patient experienced neck stiffness and migraine headache.  At the time of this report, the patient was almost back to normal, but was not quite yet (recovering).  The reporter assessed the case as non-serious.   Follow-up received from the physician on 26-Sep-2018: The patient's age 63 year was added in the patient tab. The event onset latency was changed from 2 days to 24 hours in the event tab. The outcome of the events was changed from recovered to recovering. The narrative and case comment were amended accordingly.; Reporter's Comments: A 63-year-old, male patient, experienced neck stiffness and migraine headache, 24 hours after vaccination with the suspect vaccine Afluria Quadrivalent. The company assessed the causality of the events as related due to plausible temporal relationship between events and suspect vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 at 15:00 as dose 1, single (Lot number: EL9269), in left arm, on 02Mar2021 at 13:00 as dose 2, single (Lot number: EL9269), in right arm and on 09Oct2021 at 15:00 as dose 3 (booster), single (Lot number: 30130BA) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre Diabetic" (unspecified if ongoing), notes: Pre Diabetic. Concomitant medication(s) included: METFORMIN, start date: 14Oct2021, stop date: 30Jun2022. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) negative, notes: Rebound after negative results; (2022) Positive, notes: Positive again 4 days later. Therapeutic measures were taken as a result of vaccination failure, covid-19.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-OCT-2017 the patient was vaccinated with 2nd dose of VAQTA 25/0.5 intramuscularly for prophylaxis 5 days too early (inappropriate schedule of drug administration). No adverse effects reported.
HEADACHE (MIGRAINE TYPE) AND SEVERE NAUSEA.  SYMPTOMS CONTINUING TO PRESENT (10/20/14 8:00pm).  Have been taking migraine (fioricete and relpax) and Mylanta.  Sleeping quite a bit which helps to calm my stomach.  Received the high dose vaccine by injection.
Pt exp fever of 104, redness & swelling @ inject site w/in 24 hrs p/immun; Resolved w/in 24 hrs w/no residual sequelae;
Patient was given Moderna Bivalent Booster 0.25mcg and was to be given 0.5mcg.  Wrong dose given.
About two weeks after receiving second dose, started having issues with vision (not able to focus,  words are blurry, can?t see up close). Vision issues have not improved.  Also,  around same time, intermittently throughout day would get lump in throat that made it hard to swallow and restricted breathing. Felt like swollen thyroid.  This symptom has reduced in severity, but still present.
Patient reported pain and swelling at injection site.  Exam revealed erythema (approx 3 cm in diameter) warm to touch and tender to palpation.  No fever.  Dx = cellulitis; Rx = Keflex 500 mg QID x 10 days.
This spontaneous report as received from a registered nurse refers to a 11 month old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 22-APR-2004, 5 days before the patient's first birthday, they were vaccinated with their first dose of M-M-R II (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Menstruated in Apr and May even though past menopause for more than 2 years; Extreme muscle soreness; weakness in legs (thigh muscles, calves, hips, knees, feet and bottom of feet); Headaches; swollen glands in neck and armpits; This is a spontaneous report from a contactable consumer (patient). This 49-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN8208) via an unspecified route of administration on 16Mar2021 (at the age of 49-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure, and allergies to sulfa drugs, latex, and shellfish. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included metoprolol succinate (TOPROL XL), olmesartan medoxomil (BENICAR), and escitalopram oxalate (LEXAPRO) from unknown dates for unknown indications. The day after the first shot (17Mar2021) the patient experienced extreme muscle soreness and weakness in legs (thigh muscles, calves, hips, knees, feet, and bottom of feet). The patient menstruated in April and May even though she was past menopause for more than two years. She also had headaches and swollen glands in neck and armpits. The events were reported as non-serious. The patient was not hospitalized for the events. The patient visited a doctor or other healthcare professional office/clinic visit as a result of the events. The patient received treatment with paracetamol (TYLENOL) and rest. The outcomes of extreme muscle soreness, weakness, menstruated, headaches, and swollen glands were not recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021582799 same patient, different event, different dose of vaccine
No adverse affects reported; a dose of PROQUAD was administer to a 31 year old patient; Information has been received from a medical assistant referring to a 31 years old patient of unknown gender. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.    On 30-MAY-2019, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (recombinant Human albumin) (lot # R003294, expiration date 31-JUL-2019; strength, dose detail, route were not provided) for prophylaxis (inappropriate age at vaccine administration). No adverse effects was reported.
System HAD A GLITCH. DIDNT SHOW THE VACCINE.  Patient mom did not show child's shot record.  The mom gave me a letter from the school nurse asking that patient be vaccinated.  Shot was not in Immunization System Database.
cough; congestion; adema both legs and feet.; This is a spontaneous report from a non-contactable consumer. A 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: GL3246 and expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 04Mar2021 18:00 (age at vaccination 83-years-old) as unknown, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient has not taken any other vaccine with in four vaccines. On 07Mar2021 06:00 PM, patient experienced Cough, congestion, adema both legs and feet. No treatment taken for AE. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information about patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications was reported. On 26-OCT-2017, the patient was vaccinated with two separate pediatric doses of VAQTA for prophylaxis (strength, lot # and expiration date were not reported). No adverse effects reported. This is one of 2 reports received from the same reporter. Sender's Comments: US-009507513-1711USA009694.
Tinnitus, started on left ear and progressed to right Year a couple days later. Last night it got louder.  Dr prescribed Medrol dose pack, which I took and finished this past Friday, but no improvement so far.
Information has been received from a registered nurse concerning a 7 year old male with no medical history or allergies who on 19-JUN-2000 was vaccinated SC on right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 635205/0073K). Concomitant therapy on same day included a SQ first dose on left thigh of measles virus vaccine live (enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 632456/0173K). At the time of vaccination, the patient was suffering from bronchitis. On 23-MAY-2007, the patient developed rash and increased body temperature. No medical attention was sought and no diagnostic laboratory tests were undertaken. No further information is available. This is one of several reports received from the same source.
SEVERE NEUROLOGICAL SYMPTOMS; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe neurological symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe neurological symptoms was not reported. This report was non-serious.
0000 hrs SAT 30 July 07 (admitted to hospital). Symptoms: vaccine area spread, red line going to under arms, all of infected areas on right arm was swollen, red and bumpy. Pain in right shoulder. Infected area was itchy and felt like it was burning pain under arm and by right breast. 8/17/07 Received hospital medical records which reveal patient experienced redness, swelling, streaking & pain of right upper arm, a pimple & recent cough.  Admitted 6/30-7/2/07 for cellulitis/abscess.  Tx w/IV antibiotics w/good response. D/C to home on continued oral antibiotics. FINAL DX: Vaccinia vs superinfection; adenopathy in healthy military patient  s/p smallpox vaccine.
9 y.o. child here today for dT and PPSV 23 per Dr. script.  Please see attached prescription under attached clinical documents. Father states child was at pulmonologist recently and was told child is allergic to multiple environmental factors. Father given VIS for both vaccines. Child given dT IM in (L) deltoid and PPSV 23 IM in (R) deltoid. Child was crying while receiving vaccines but tolerated well. Child left with father on own accord. Father returned to clinic stating that when child got in car and placed seatbelt on he had seizure like activity, body was contorted and child was unresponsive. Father brought returned inside clinic with child, available nurses on staff took child vitals - BP: 110/75, P:100, T:97.7, R:19. Child was diaphoretic when he returned to clinic and was responsive to commands. ARNP called to clinic to exam child. ARNP determined child needs to go to ER for further evaluation and he also spoke to child's pediatrician after father called him. VAERS report completed.
Pt developed left arm pain, shooting pain down the left arm and up in the the shoulder/ neck. Severe pain and did to to urgent care for pain management on 1/16/21. 1/17/21, did develop a rash and is consistent with shingles.
Itching at injection site; Feeling "achy"; This is a spontaneous report from a contactable other healthcare professional. A 55 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 22Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reports no missed doses. Prior to start of therapy thyroid nodules. After start confirmed diagnosis of hashimoto disease with increased thyroid nodules. Received both coronavirus vaccines: 22Jan2021 and 10Feb2021 with itching at injection site, feeling "achy" which resolved with aspirin. Unsure if feeling achy from vaccine or significant change in weather. Leg cramps resolved after prescription of coq10 supplement with a statin for cholesterol.  Therapeutic measures were taken as a result of this with Xeljanz XR 11mg daily oral route for Rheumatoid Arthritis taken From 01Oct2020 to current.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Right after 1st dose, i started having right big toe pain that continued to spread to all toes in both feet.  After 2nd dose pain became very bad and has since spread up to my knees.
BODY ACHES, CHILLS, AND VIRAL RASH OVER ABDOMEN/BACK/FOREARMS
Headache, Sedation, Myalgia, Arthralgia, NauseaVomiting,  Chills, Pain/Redness/Swelling/Itching @ injection site
My hair started falling out with the first dose of the vaccine and started to come out in clumps and falling out more with the second vaccine. You barely had to pull my hair for it to come out. If I washed my hair, it would come out in clumps, If I combed my hair when it was wet the comb would be entangled with hair. This has never happened to me before with other vaccines I have received. I also developed a fever that lasted for about two days. During the fever, I had horrible pain in my joints. Almost to the point where movement cause jolts of pain in my joints. I visited my endocrinologist and he prescribed me the following: Rogaine- use once a day as directed.  Spironolactone 25mg - once by mouth twice a day morning and evening  Diclofenac 500mg  one tablet by mouth twice a day for joint pain  My hair did not stop falling out until about 6 to 8 weeks after the vaccine.  The joint paint subsided in about 3 weeks.   The other side effect that I have experienced is I no longer have a period. I used to get my period very consistently. I did not get a period in November, December, or January. I have taken 6 at home pregnancy tests ( 2 each month spaced a week or two apart). All of the tests are negative.