chrisvoncsefalvay/vaers-outcomes huggingface dataset:
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
Person could not lift arm after vaccine and is still experiencing pain 8 weeks later and is going to her HCP to follow up.
No further AE; GARDASIL 9 given during a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 17-AUG-2023, the patient was vaccinated with an improperly stored of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (lot # w029724 has been verified to be a valid lot number hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date reported and established as 08-JAN-2025) (strength, dose, route of administration and anatomical location were not provided). The temperature of storage, time frame of the excursion, if a digital data logger was involved and if the vaccine experienced a previous temperature excursion were not reported.   No adverse event reported.
Red, raised, itchy rash around injection site. Approximately 4 inches by 6 inches.  On days 11 and 12. Treated with topical diphenhydramine x 4 applications over the two days. Rash and itchiness resolved after the two days.
fever 101-104 12FEB-15FEB;sl photophobia;morbilliform rash 14FEB-17FEB;
This spontaneous report was received from a office manager (also reported as healthcare worker) refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of VAQTA, (lot number, expiry date was not reported) which was improperly stored and no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Reported to Public Health by St Joseph Clinic who saw client on 02/21/2005. Had body and face rash x 2 days. Impression by PMD was a viral rash 2 days after MMR.  Given RX for Calamine lotion and Benadryl.
dizziness, heaviness in head, mild headache, constant high pitched buzzing in right ear
The next day she felt like very sluggish, fuzzy, and very tired; The next day she felt like very sluggish, fuzzy, and very tired; The next day she felt like very sluggish, fuzzy, and very tired; When I received that vaccine at the same day, I felt nothing/Since I got the vaccine it's not like steady, very tired; I felt like something in my body, kind of like tired like, chill kind of like, middle of numb; I felt like something in my body, kind of like tired like, chill kind of like, middle of numb; I always react to medication differently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 29Jul2021 (Lot number: SA7484) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: NOVOLOG MIX taken for type 1 diabetes mellitus; LEVEMIR taken for type 1 diabetes mellitus. The following information was reported: SLUGGISHNESS (non-serious), FEELING ABNORMAL (non-serious), FATIGUE (non-serious) all with onset 30Jul2021, outcome "unknown" and all described as "The next day she felt like very sluggish, fuzzy, and very tired"; FEELING ABNORMAL (non-serious) with onset 30Jul2021, outcome "unknown", described as "When I received that vaccine at the same day, I felt nothing/Since I got the vaccine it's not like steady, very tired"; CHILLS (non-serious), HYPOAESTHESIA (non-serious) all with onset 30Jul2021, outcome "unknown" and all described as "I felt like something in my body, kind of like tired like, chill kind of like, middle of numb"; ADVERSE REACTION (non-serious) with onset 30Jul2021, outcome "unknown", described as "I always react to medication differently". Therapeutic measures were not taken as a result of sluggishness, feeling abnormal, fatigue, feeling abnormal, chills, hypoaesthesia, adverse reaction.  Additional information: The consumer further asked whether she should receive the second dose or not because of this feeling  No follow-up attempts are possible. No further information is expected.
Pink rash with burning sensation. Treatment included ATARAX, Cephalexin, ORAPRED ODT. Rash on left thigh.
Thursday, Jan. 7, 2021 I felt a little strange.  Just not myself. A little dizzy.  Went to work overnight.  Got up at 5 am Friday, Jan 8, 2021.  Still felt odd.  Dizzy. Had to think before I did anything. I stood up from the bed and sat back down again as if I was dizzy and confused.  Drove myself home from work, fed the cats and went right to bed.  I felt very fatigued, had developed a monster headache.  Was dizzy, had chills, body aches, nausea.  I brought  water bottle over to the bed with me but after laying down just could not get myself up to get a drink.  Felt very fatigued.   Slept until 2 pm.  Took my temperature.  It was 101.5.  Had no energy, ate no food, took no meds, just went back to sleep.  Still nauseous, had headache, dizziness, fatigue, body aches, chills.  Woke up at 5:00 pm to feed cats.  That?s all I did, and go to the bathroom.  Took my temperature again.  It was 100.9.  Still felt awful:  nauseous, headache, dizziness, fatigue, body aches, chills.  Seemed like I could  not get warm.  Stayed in bed and slept.  Saturday, Jan.  9, 2021 I woke up around 7:30 to go to the bathroom.  I fed the cats also.  Still dizzy, moving slow.  My headache was gone, but still felt unsteady.  After feeding the cats,  I went back to bed.  Slept until 12:30 that afternoon.
HPI: 52-year-old. female with PMHx of thyroid cancer s/p thyroidectomy, uterine leiomyoma, anxiety and anemia who presented with COVID 19 infection. Patient reported her symptoms started 6 days ago on 10/9/2021 with fevers, nonproductive cough, chest pain, shortness of breath, generalized malaise and body aches. She was tested by her primary care 4 days ago for COVID-19 and influenza, and reports positive COVID-19 infection. She received her Johnson & Johnson vaccine approximately 6 months ago. Currently she reports she has had fevers, T-max 103F, last took ibuprofen at 12:30 pm. She reported intermittent nonproductive cough, intermittent chest pain and shortness of breath. She denied exertional component of her chest pain or shortness of breath. She denies lower leg swelling/tenderness, nausea, vomiting, diarrhea, constipation or abdominal pain. She called her primary care provider who recommended further ED evaluation.
Diagnosed with COVID-19 in the end of Dec-2021/ COVID-19; Patient had about four or five sinus infections/ Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19 in the end of Dec-2021/ COVID-19) and SINUSITIS (Patient had about four or five sinus infections/ Sinus infection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In December 2021, the patient experienced COVID-19 (Diagnosed with COVID-19 in the end of Dec-2021/ COVID-19) and SINUSITIS (Patient had about four or five sinus infections/ Sinus infection). At the time of the report, COVID-19 (Diagnosed with COVID-19 in the end of Dec-2021/ COVID-19) had resolved and SINUSITIS (Patient had about four or five sinus infections/ Sinus infection) outcome was unknown.            Relevant concomitant medications were not reported.  In Dec-2021, the patient received booster dose of Moderna COVID-19 Vaccine.  The patient had about four or five sinus infections since starting Rinvoq in Dec-2021. She stated that she was getting one about every four weeks. She was diagnosed with COVID-19 in the end of Dec-2021. She got it about two weeks after getting her Moderna COVID-19 Booster shot.  Treatment information was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  Reporter's causality for the event of sinus infections and COVID-19 with RINVOQ was not provided.  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.
The pt developed bumps on 04/14/2002 approximately 10 1/2 cm raised macules on hairline, back, and chest. No blisters noted.
Diagnosed with Takayasu arteritis (rare disease). Chronic back pain 3 months after 1st vaccination. Headaches in summer 2008. Elevated B/p in June 08. 11/20/08-records received-office note 11/20/07-C/O 3 month history of mid back pain. Impression mid back strain. 10/09/08-ambulatory BP monitor-hypertension.Major component stress and anxiety. 6/24/08-C/O headaches. DX: Takayasu arteritis. Hospitalized for lower extremity edema and blotchy legs on 11/3/08. 12/31/08-records received for DOS 11/3/08-admitted after just started amlodipine with C/O ankle swelling and blotchy rash, admitted for evaluation of vaculitis. Headaches begin in June 2008 and elevated blood pressure. Eye swelling, achy legs when walking. Mild anemia with hemoglobin 10. Renal doppler showed elevated velocities but no renal artery stenosis. CT scan showed renal artery stenosis. Impression:renovascular hypertension due to bilateral renal artery stenosis,  Takayasu arteritis.
Pt vaccinated with Pneumococcal developed swelling of entire lt upper extremity w/pain, tenderness, heat redness developed during first 24 hrs after vaccine; total duration 1 wk.
Pneumococcal R. Arm- Sore, low fever 1 day 99-100 deg. Better- no fever after 1 day. Sore about 3 or 4 days. Tired and not feeling great for 1-4 days.
Shakiness; Chills; Feeling jittery; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 76-year-old female patient received first dose of bnt162b2 (BNT162B2, Pfizer BioNtech Covid-19 vaccine) via unknown route of adminsitration on 15Jan2021 11:30AM on left upper arm at a single dose  for covid-19 immunization(lives in senior center and because of his age). Medical history and concomitant medications were none. He is a little shaky, but not had any dizziness or anything. He wanted to make sure it's okay and not interfere with him getting the next dose. Is this normal. Has also had a few chills, but not feeling too bad. Is a little jittery, but is staring to feel better. He did not receive any other vaccines the same time or 4 weeks prior. Did get a flu shot last October (Oct2020) with no problems or reaction. States no history of problems with vaccines in past. Vaccination Facility Type was unknown. No Vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine(s)) was none. AE(s) following prior vaccinations was none. Patient's Medical History (including any illness at time of vaccination; Provide other relevant medical history including but not limited to these conditions:  diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity) was none. Family Medical History Relevant to AE(s) was none. Relevant Tests was none. The events started from 15Jan2021 with outcome of not recovered.   Information on the lot/batch number has been requested.
patient received Comirnaty booster (dose 3); patient received Comirnaty booster (dose 3); Fever; Diarrhea; arm pain; sluggish and sleepy; sluggish and sleepy; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received third dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient Previously received dose 1 and dose 2 of BNT162B2 (COMIRNATY, solution for injection, Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date for COVID-19 immunization.  The patient received Comirnaty booster (dose 3) (off label use) and experienced fever, diarrhea, arm pain, she was sluggish and sleepy on an unspecified date. The patient stated that she experienced fever, diarrhea, arm pain, she was sluggish and sleepy, and she knew that she will be fine, but she noticed her side effects were a lot more intense than the second vaccine, at the same time it was probably going to work just fine, and she was not worried. She also told that her mom got her booster as well and she had Horton's Disease and she was an 84-year-old, she also had had similar side effects. The patient underwent lab tests and procedures which included body temperature: unknown on an unspecified date. The outcome for the events fever, diarrhea, arm pain, sluggish and sleepy was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101311877 Same reporter/product, different patient, similar side effects
administration of FLUBLOK to 17 years of patient with no adverse event; Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 17 year old female patient who was administered with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) (Product administered to patient of inappropriate age). Reporter would like to know if they were "covered" for influenza vaccination for the season.   Medical history was not provided.  Concomitant medications was not reported.  On 22-Dec-2020, the patient received a 0.5 ml once dose of suspect QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (Prefilled syringe) via intramuscular route in the left deltoid (lot UJ509AA and expiry date 10-May-2021) for prophylactic vaccination.  It was a case of actual medication error due to Inappropriate age at vaccine administration. (latency- same day)  At the time of report, no adverse event was reported. (None- adverse event symptoms were reported)  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
post auncular lymphanitis w/rhinitis & pharyngitis; indicative of mild rubella disease, poss retreable to an MMR vax given 25AUG95
flu; Initial information was received on 18-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves patient (unknown demography) who had flu (influenza), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Palpitations, chills, brain fog, and fatigue. pain at the injection site. Narrative:
This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ Lot # K008140 with expiry date of 03-MAR-2016 or L009119 with expiry date of 17-DEC2016 (orally, unknown strength and dose). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt awoke around 6:30 AM on 8/22/01 with grand mal seizure lasting about 2 minutes requiring Diastat to stop. Pt also noted to have an approximately 7" red area at injection site. The redness resolved over 24 hours. Pt had no other reaction. He was well on 8/23/01.
Patient called COVID vaccine clinic on 8/13/2021 to report that 3 1/2 hours after receiving COVID vaccine on 08/10/2021 she started to experience chest pain/pressure, fluctuating between 4/10 and 8/10 on pain scale.  Also reported mild shortness of breath on exertion.  Denied any other symptoms (no rash, no swelling, no GI symptoms, no light headedness).  Reported she went the following day (08/11/2021) to an Urgent Care clinic and reports she had an EKG that was "not concerning."  She was instructed by the provider she saw at Urgent Care to go to the ED for blood work and further work up.  Reported that she did not go to the ED.  When this provider spoke with patient on 8/13/2021, she reported she was still experiencing chest pain/pressure and dyspnea on exertion.  Patient was again instructed to go promptly to the ED for evaluation, which she stated she would do.
On 11-1-10 pt rec PREVNAR 13 & Influenza vaccine. At 300am, pt awoke with temp of 104.9. Pt given TYLENOL, ADVIL, cool compresses. Appt  with Dr. on 11/2/10.
FEVER; DIZZINESS; HE IS SO DIZZY THAT HE FELL AND HIT HEAD; dehydrated; Loss of taste; loss of smell; COULDN'T EAT NOR DRINK FOR SOME DAYS; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (CHILLS), PYREXIA (FEVER), DIZZINESS (DIZZINESS), FALL (HE IS SO DIZZY THAT HE FELL AND HIT HEAD) and DEHYDRATION (dehydrated) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced CHILLS (CHILLS), PYREXIA (FEVER), DIZZINESS (DIZZINESS), FALL (HE IS SO DIZZY THAT HE FELL AND HIT HEAD), DEHYDRATION (dehydrated), AGEUSIA (Loss of taste), ANOSMIA (loss of smell) and DECREASED APPETITE (COULDN'T EAT NOR DRINK FOR SOME DAYS). The patient was treated with NORMAL SALINE at an unspecified dose and frequency and CALCIUM ASCORBATE, MAGNESIUM GLUCONATE, MAGNESIUM LACTATE, POTASSIUM CITRATE (ELECTROLYTE + C) at an unspecified dose and frequency. At the time of the report, CHILLS (CHILLS), PYREXIA (FEVER), DIZZINESS (DIZZINESS), FALL (HE IS SO DIZZY THAT HE FELL AND HIT HEAD), DEHYDRATION (dehydrated), AGEUSIA (Loss of taste), ANOSMIA (loss of smell) and DECREASED APPETITE (COULDN'T EAT NOR DRINK FOR SOME DAYS) outcome was unknown.            This case was linked to MOD21-037815 (Patient Link).
Patient received the vaccination at 12:47pm and at 12:53pm began to having chest itching, shortness of breath and dizziness. She arrived to the walk in clinic for assessment and she was noted to have elevated blood pressure. Patient then developed a headache. Her shortness of breath and itching improved after she was resting in the clinic for about 20 minutes although she continued with her headache. She was given tylenol and sent back to the dorms with no other complaints.
This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 19-OCT-2015, the patient was vaccinated with a dose of GARDASIL 9 lot # L007560 (dose, route of administration and expiration date were not reported) that had experienced temperature excursion. No adverse reaction was reported. This is one several reports received from the same reporter. Additional information has been requested.