chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 038K20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021 at 6:27 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Feb-2021 at 5:10 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-Jan-2022 at 11:22 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-Jan-2022 at 11:22 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On 24-Jan-2022 at 11:22 AM, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient allergies information is not known. It is unknown that the patient was diagnosed or tested positive for COVID-19.  Concomitant medications were not reported. Treatment medications were not reported.  The adverse event start date was reported as 11:22 AM. On 21-DEC-2021 the vial was initially stored in refrigerator.The vials did not undergo temperature excursions.It was stated that no adverse events were associated with this event. The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2022: Information regarding event was added. On 03-Feb-2022: Follow up received includes: Patient details, suspect product details and event start time updated.
petechial rash, new onset ecchymosis assoc w/thrombocytopenia;dx ITP
Information has been received from a pharmacist concerning a 1 year old pt who was vaccinated with varicella virus vaccine live and the MMR vaccine for treatment of prophylaxis (dose not reported). Five days, post vax, the pt developed a fever and a rash. After 10 day of the fever and rash, the pt was hospitalized. The pt had axillary lymphadenopathy, cracked red lips and the high fever and rash remained. The pt was dx'd with Kawasaki's Syndrome and was treated with IV immune globulin (IVIG). Additional information has been requested.
Major motor seizure; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SEIZURE (Major motor seizure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (Major motor seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (Major motor seizure) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Telephone call fr. pt. 48 hrs after vaccination arm swelled, 72 hrs after had diarrhoea, nausea myalgia, arthralgias, headache and malaise.  Swelling has gone down but arm still sore.  Night sweats, joint hurts, finger hurts, night sweat.
Nausea - started on the morning of Day 8 and has not resolved yet. Constant daily mild nausea, starts the second I wake up, it is not related to what I eat or when I eat. It is present all the time.
Pt felt lightheaded after vaccine administration. Pt laid down, vitals stable. Pt stated she started her monthly menses this AM and had a migraine prior to vaccine. Pt states nausea and vomiting is normal with her menses.
pt recv vax & devel vomiting, rash, t104.0; no further details were provided;
first day 3/31/21 - sore right arm second day 4/1/21 - sore right arm, beginning at 3:30 am fever of 100.1, chills, headache and subsiding 9:00pm
Breakthrough COVID-19 infection in fully vaccinated patient. Positive date 09/15/2021.
Generalized allergic rash, small maculo papules on trunk, face limbs 24 hours after vaccination. Prescribed Benadryl but still has rash .
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 17-year-old female patient who received ENGERIX B (batch number 3G535, expiry date 24th January 2021) for prophylaxis. On 7th November 2018, the patient received ENGERIX B 1 ml. On 7th November 2018, unknown after receiving ENGERIX B, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown. Additional details were provided as follows: The patient's date of birth was unknown. The batch number of ENGERIX-B was unknown. A 17 year old patient inadvertently received 1 ml dose of ENGERIX-B, which led to accidental overdose and adult product administered to child. The reporter provided consent to follow up. Follow up information were received from other health professional on 13th December 2018: The reporter spoke to patient's mother. The patient's demographic details were updated. The batch number for suspect vaccine has been updated. The patient received 1st dose of ENGERIX-B at birth. On 7th November 2018, the patient received the 2nd dose of ENGERIX B by intramuscularly, which led to lengthening of vaccination schedule. In 2018, less than a year after receiving ENGERIX B the patient experienced pain in arm. The outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to ENGERIX B. This was medication error associated with adverse event. The VAERS details were updated.
Patient had large red area around vaccine site right thigh (10 cm) day one without fluctuance, it did seem to itch him. He then had high fever on day 2 after vaccine, we called in po keflex.  day three fever persisted to 104, went to er, work up negative for bacterial infection told to go home on nsaid and tylenol alternating.  day 5 fever 103-104 without treatment, responded well to treatment, day 6 defervesce some but got rash consistent with measles mild case.
Same night of vaccine, sore arm, fever lasted 2-3 days. 2 weeks later a rash appeared and it lasted 4-5 days.
After otherwise very mild reaction to the vaccination, on the morning of day 4, I suddenly had an extreme IBS-C type event equivalent to a food poisoning. Because I am gluten intolerant, I have 3 medications I can escalate through to manage such a gastric spasmotic event. I required all 3 medications, and strongly considered going to the ER as the cramping and abdominal pain was so extreme, came on so suddenly (was definitely NOT a gluten exposure and did not present like one) and did not respond immediately to treatment.  without my medication for the gluten intolerance, it would absolutely have been an ER visit - it nearly was even with simethicone, loperamide, then bentyl.
About 24 hours of fever, headache, chills, mild fatigue. Several days of right underarm pain and discomfort (assuming Lymph Node), which is just starting to fade away, but not entirely gone yet.
For about 48 hours I felt out of it--lethargic, chilled, lack of appetite, slight headache, drainage down back of throat. Last symptom still exists.
Sore arm at 10:30.  Fatigue and nausea at 2:30 PM.  Chills and 102 degree fever starting at 3:30 PM.  101.4 degrees at present - 6:45 PM.
Headache, Angioedema, UrticariaPruritus, NauseaVomiting, fatigue, chills, swollen lymph nodes Narrative:
pain at injection site; joint ache; 101 temperature; This is a spontaneous report from a non-contactable consumer (Patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via unspecified route of administration on an unspecified date as an unknown, single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 05Feb2021, patient reported pain at injection site, and then in next 24 hours he was reported joint aches and pain at injection site to touch. Upon follow up he reported that, patient previously reported below now has a 101 temperature (date unspecified). The patient underwent lab tests and procedures which included body temperature of 101 on an unspecified date. Outcome of all the event were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Ate lunch after two or three hours of receiving 2nd vaccine, but within one or two hours after lunch, suddenly felt hungry and craved food.
Pt does not have any adverse symptoms, required to report if Bivalent was due but not give.
2 days after receiving the first dose, I had a sore throat for the following 7 days. 2 days after receiving the first dose, I had a headache that last 2 1/2 days.
fainted and collapsed for few seconds; husband mentions she was wide awake as ghost and unconscious at the same time; dizzy; fainted and collapsed for few seconds; disoriented; weak; intense chills; felt overwhelmingly nauseous; went to bed with throbbing injection site pain; stiff and sore arm; A spontaneous report was received from a consumer concerning a 49-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stiff and sore arm (musculoskeletal stiffness), went to bed with throbbing injection site pain (vaccination site pain), nauseous (nausea), disoriented, dizzy and weak (asthenia), then fainted (loss of consciousness) and collapsed (fall)for few seconds, and having intense chills (chills).   The patient's medical history, was not provided. No Concomitant medications were reported . On 11 Mar 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 003A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 11 Mar 2021, the patient felt stiff and sore arm, went to bed with throbbing injection site pain,.  On 12 mar 2021, she had awakened around 1 AM and experienced overwhelmingly nauseous, disoriented, dizzy and weak. She then fainted, collapsed for few seconds, during that that time her husband mentioned that she was wide awake as ghost and unconscious at the same time.  The patient also mentioned that she had intense chills.  She also reported that she had no history of fainting and or reactions from  any vaccine in the past.   Treatment for the events included Ibuprofen.Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the  events, experienced stiff and sore arm (musculoskeletal stiffness), went to bed with throbbing injection site pain (vaccination site pain), nauseous (nausea), disoriented, dizzy and weak (asthenia), then fainted (loss of consciousness) and collapsed (fall)for few seconds, and having intense chills (chills). were reported as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Hive like rash on upper forearm. Shoulder and lower arm feel sore. Uncomfortable to raise shoulder.
Vaccines given on 11/11/02, 2 seizures on 11/12/02. (Pt with underlying seizure disorder, dev delay, already on Tegretol). No fever with seizures. First seizure lasted ~ 10 minutes, nanny called 911 and paramedics came but sz self resolved. Second sz in my office, lasted less than 1 minute. Also with ~ 3 inch area of swelling and induration and tenderness L lateral thigh. Tx: Tylenol/Motrin/ice continue Tegretol.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was received from 13Jun2022 to 17Jun2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a pharmacist refers to a 71 year old male patient without drug reactions and allergies. On 28-OCT-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous, lot # reported as K003603, expiration date reported as 20-MAR-2015 (strength was not reported). On 30-OCT-2014 the patient experienced redness and itching at the injection site. He saw his pharmacist on unknown date and di not receive any treatment of the adverse events. There were not laboratory diagnostics studies performed. The outcome of the events was unknown. Additional information has been requested.
Inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ). On 15-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported.  Treatment information was not provided. Second dose administered 21 days after the first dose to patient.
Pt vaccinated with DTP experienced temp 105, brief febrile seizure. Taken to ER for evaluation. No residual effects noted at this time.
At site of injection redness, hard and painful. S/S radiate down to left elbow. Pt saw MD on Monday (6/9) was given antibiotic shot and course of Duricef Magnesium drainage.
Case number PHEH2015US019733, is an initial spontaneous report from a nurse received on 02 Oct 2015. This report refers to a 33-year-old female pregnant patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly on 30 Sep 2015. No adverse event was reported.
Case previously recorded as MA2009-3743. Initial case report received from a health care professional via Novartis Pharma on 05 NOV 2009.  A 3-year-old patient was vaccinated with 0.5 mL of S-OIV FLUVIRIN (batch no. 102040P1) i.m. into the deltoid, on 05 NOV 2009. No adverse events was reported. MedCom reference no.: NA09-007669.
refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case was linked to cases 2020SA032577, 2020SA038302, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350, 2020SA038351, 2020SA038352, 2020SA038468, 2020SA038469, 2020SA038470 and 2020SA03847 (same reporter).  This case involves a 08 years old female patient who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ254AC (Expiry date 30-Jun-2020) via unknown route in the right deltoid for Prophylactic vaccination on 17-Jan-2020 which was exposed to refrigerator down to 29.1F.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient did not receive any concomitant therapy.  It was an actual medication error case due to Product storage error temperature too low (Product storage error).  Patient did not have adverse event at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
My period was scheduled to start approximately 2 days after the vaccine and my periods never happened. I went 72 days with no period. I have never had irregular periods and no other lifestyle changes or stressors occurred to affect my period.
At 1855 observation nurse  assessed patient. Patient fainted in observation line per wife statement, presented with cyanosis of the lips, pale in skin color, diaphoretic and  incontinent. Vitals upon assessment: BP- 76/48, HR: 68, Temp: 35.1, O2 Sat: 75%.  Wife reported that patient took 0.25 mg of Xannax at 1400 and then again at 1615 to calm nerves. Second set of vitals obtained: BP- 86/50, HR: 69, O2 Sat: 97%. 911 called, they arrived around 1600 where patient left AMA.
Immunized 15MAR91; 22MAR91 had inc temp of approx 103F for 3d; 25MAR91 rash all over body, afebrile no local rxn noted;
Information has been received from a female patient with dermatomyositis which was symptomatic since November of 2011 who in February 2012, was vaccinated with a dose of GARDASIL (lot # not reported). In February 2012, the patient's dermatomyositis got worse since the vaccination. The patient had sought unspecified medical attention. Prednisone and PLAQUENIL were given to the patient as treatments. At the time of this report, the patient had not recovered. Follow-up information has been received from nurse practitioner. It was reported that the patient was currently being treated for a recent "diagnosis of dermatomyositis". It was reported that she was taking steroid and an immunosuppressants. It was reported that the patient did not feel that she had a reaction but that it was coincident. Additional information is not expected.
Vomited; Still queasy stomach and Nausea; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 70-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Feb2021 11:50 (Batch/Lot Number: EM9809, Expiration date was not reported) (at the age of 70-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 09Feb2021, the patient experienced vomited. On an unspecified date in 2021, the patient experienced still queasy stomach and nausea. Reporter stated that the patient (husband) got the shot yesterday around 11:50 AM in the morning (the virus shot of Pfizer). And last night 2:35 AM, he vomited and about two hours later at 4:25 AM he vomited again and right now have still queasy stomach. When paraphrased the concern, reporter stated that at 11:50 am in the morning, but he did vomit but now he is experiencing a queasy stomach, but he vomited this morning at 2:35 AM in the morning and 4:25AM twice. The patient received Emetrol for nausea (Expiration date: 05May2023). The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Immunization received 6/2/03. Pt experienced area of erythema approx 3" diameter around injection site. Seen in office 6/3/03.
Pentacel reached 33.5C; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658 and 2019SA192660 (same reporter).  This case involves a four months old patient (gender not reported) who was vaccinated with a 0.5 ml second dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ097AAA and Exp. Date 19-Sep-2020) via intramuscular route in unknown administration site on 09-Jul-2019.  The patient's medical history not reported and concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) both received 0.5 ml dose via intramuscular route on 09-Jul-2019 for Immunisation.  It was an actual medication error case due to incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
A Pfizer covid-19 vaccine was inadvertently administered for dose #2. Client had received a Moderna covid-19 vaccine as a 1st dose on 02/04/2021
Complained of feeling very fatigued in the weeks following following the vaccination, but was heathy prior to the injection.  Died of a massive heart attack exactly 3 months after the date of vaccination.  Death certificate notes Atherosclerotic Cardiovascular Disease as the immediate cause of death.
A 68-year-old, right-hand-dominant, male with significant past medical history of hypertension, type 2 diabetes, hyperlipidemia, chronic kidney disease with anemia, metastatic prostate cancer, prolymphocytic leukemia of B-cell type and gout presented to hospital on 11/22/2021 with report of left-sided weakness.
This spontaneous report as received from a physician refers to a 16 months old female patient. The patient was vaccinated with M-M-R II on 08-NOV-2012. Lot# was reported as H012142 with expiration date on 29-JUN-2014. It was reported that the M-M-R II was exposed to 60 degrees Fahrenheit for 12 hours. This was unsupported storage conditions and M-M-R II should not had been administered. No adverse effect reported. Additional information has been requested.