chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a bruise for 7 days and it hurt a lot for several days; Had a bruise for 7 days and it hurt a lot for several days; swelling on the arm; The first time it was only purple/purple stain on her arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in arm on an unspecified date in 2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had the first vaccine three or four months ago, 4 hours later she had a bruise for 7 days and it hurt a lot for several days not where the vaccine was applied but in the middle of the injection arm on an unspecified date in 2021. Had like a bruise, purple stain on her arm. It was very hard. The first time it was only purple on an unspecified date in 2021. All around the arm there was swelling on the arm on an unspecified date in 2021. The patient stated that the swelling was not too much. It was the color purple. It was on the middle. The patient stated that it was just after the first dose. It was not where the vaccine was applied, it is in the middle of the injection arm. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in arm on an unspecified date in 2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The case was assessed as non-serious. The outcome of the events had a bruise for 7 days and it hurt a lot for several days was resolved on an unspecified date in 2021. The outcome of the other events was unknown  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-Jul-2022).    No concomitant medication information was reported. Patient received half dose. The vial was initially stored in refrigerator on 04-Jun-2022. The vial did not undergo any temperature excursions. No treatment drug details was reported.
A report was received from a health care professional concerning a 66 year old female vaccinee who inadvertently received expired Fluvirin SC on 11/10/03. On 11/10/03, the vaccinee inadvertently received expired Fluvirin SC. The vaccinee had not experienced any adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Low-lying placenta; Vaccine exposure during pregnancy; This is an observational study case, initially received from other health professional on 03-Oct-2019, concerning a 36-year-old, female pregnant subject of body weight: 127 lbs, height: 61.5 inches and body mass index (BMI): 23.6, enrolled in a prospective observational safety study.   The subject's past medical history included urinary tract infection.  The subject's relevant medical history included Herpes Simplex I, seasonal allergies, acne, left breast fibroadenoma. The subject's obstetrical history included two previous pregnancies in which there was one preterm live birth and one spontaneous abortion. The subject had no history of offspring with major congenital malformation (MCM) and no relevant maternal and paternal medical history. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   The concomitant medications of the subject included Prenatal vitamins (minerals nos, vitamins nos) for pregnancy, clindamycin for acne and Baby aspirin (acetylsalicylic acid) for prophylaxis. The subject had a risk factor of an advanced maternal age.   The subject's last menstrual period (LMP) date was 10-Apr-2019. The subject's estimated date of delivery (EDD) was reported as 15-Jan-2020 and corrected estimated date of delivery (CEDD) was reported as 20-Jan-2020. The type of pregnancy was singleton.  On 03-Jun-2019 and 01-Jul-2019, the subject underwent ultrasound and no MCM was noted.   0n 29-Jul-2019, the subject underwent maternal serum alpha-fetoprotein (MSAFP) screening and no MCM was noted.   On 26-Aug-2019, the subject underwent ultrasound and no MCM was noted.   On 23-Sep-2019, at gestational age of approximately 23 weeks, the subject was administered Flu Vaccine Egg Split QIV CSL [Influenza Vaccine, batch number: P1001185562 dose, route of administration, anatomical location and expiration date: not reported] (explicitly coded as Vaccine exposure during pregnancy') for an influenza immunization.  On an unspecified date, after vaccination, when pregnancy status was collected it was noted that the subject had a low-lying placenta.   At the time of initial reporting, the outcome of low-lying placenta was not reported.; Sender's Comments: The subject experienced placenta praevia associated with the suspect product Flu Vaccine Egg Split QIV CSL. Reportedly, vaccination occurred during pregnancy at gestational age of approximately 23 weeks. Temporal relationship is implausible because the placenta is fully formed by 18 to 20 weeks. Advanced maternal age may have contributed to development of the event. Causality was confounded by use of concomitant drugs, clindamycin and aspirin. Causal relationship between the suspect product and exposure during pregnancy is assessed as not related per company conventions. Causal relationship between the suspect product and the event placenta praevia is assessed as not related.
Sore arm. Feels like tendinitis in my left arm where the shot was given and also tendinitis in my left wrist. These symptoms were not present before flu shot was administered. It is now 11 days later and symptoms are still present. Range of motion has been limited with my left arm and this has affected my activities of daily living.
This patient received TD #1 and MMR #1, for immigration purposes on 10/24/00. The patient was informed at time of immunization for the need to avoid pregnancy for 3 months and condoms were given. Her husband was also made aware, he was able to speak english fluently and verbalized understanding. No adverse effects noted at that time for MMR. The patient's last monthly period as of 10/24/00 was 10/21/00. No pregnancy at the time of immunizations. The patient is seeing a doctor for continued follow up.
This spontaneous report as received from a 40 year old male patient (who is also a company representative) refers to himself. The patient's medical history included chickenpox twice and shingles. On 06-NOV-2014 the patient was vaccinated with VARIVAX (Merck) subcutaneous (lot number reported as: K002921, dose, units, anatomical location were not reported). Concomitant therapies included ADDERALL and testosterone shot. On 08-NOV-2014, the patient experienced blisters on the arm, trunk and legs, and itchiness on the trunk after receiving VARIVAX (Merck). The patient's symptoms have been confirmed as the chickenpox at that time. There was no treatment given for the adverse event. The patient did not seek medical attention. The outcome of event was reported as not recovered. The relatedness between the event and VARIVAX (Merck) was not reported. Additional information has been requested.
Patient is a 72 y.o. male with a history of GAVE on tranexamic acid, GERD, OSA, type II DM, CKD stage IV and HTN that was admitted to hospital on 10/2 for symptoms of cough, weakness and fever that began on 9/23. He tells me the fever was for only one day. He had O2 sats in the 80s on RA at the time of his initial admission. He was found to be COVID positive. He was started on dexamethasone and received Tocilizumab on 10/4. He was not eligible for Remdesivir due his poor baseline renal function. He had increasing O2 needs and was becoming increasingly fatigued from a respiratory standpoint and wished to remain full code and was therefore transferred to another hospital for further management.  In discussions with hematology prior to transfer, it was recommended the tranexamic acid be held due to the thrombotic risk. On arrival here, he mainly complains of shortness of breath. He did not lose his sense of smell and taste at all. He has not had any N/V or diarrhea, but has had a poor appetite. He admits to chronic right ankle pain, but denies any leg pain.
Dizziness, NauseaVomiting,arm soreness Narrative: When she woke up today, she woke up so dizzy she felt she was going to fall, was very tired and slept until 9:00am. Dizziness is resolving. Took Ibuprofen OTC for her arm soreness.
patient received an expired dose of Daptacel, no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3-year-old female patient who was received an expired dose of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included POLIO VACCINE INACT (IPV) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCIN) for Immunisation.  On 29-Oct-2019, the patient received a third dose (0.5 mL) of expired diphtheria-15/tetanus/5 ac pertussis vaccine (lot number: lot C523LAA; expiry date: 05-Oct-2019) via intramuscular route in the left anterior thigh.  It was a case of actual medication error due to expired vaccine administered.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Myalgia, Arthralgia, Fever, HYPERtension, CHILLS, SHAKING Narrative:
Redness, heat and swelling at injection site approx 9 days after shot. Feels hot, and a little swollen.
Patient developed full body aches, headahce, nausea, lightheadedness, chills, and fatigue about 10-14 hours after getting the vaccine.
On my way home I immediately began to feel strong knife pain on site and in shoulder. I came home and took 2 Ibuprofen which took the edge off.  It left me w/ no strength in my left arm and an ache that wouldn't stop. I waited to see if it would get better.  It is now 3 weeks. Some days it is only weak but other days I feel the pain in the immediate spot and pain in the upper arm w/ no strength. I am not able to lift my arm w/o help.
3 days after DTaP was given right thigh became erythematous and very edematous, no treatment necessary.
STIFF NECK; ITCHY; RED DOTS ON SHOULDER OF INJECTION SITE ARM; INJECTION SITE PAIN; EXHAUSTION; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced stiff neck. On MAR-2021, the subject experienced itchy. On MAR-2021, the subject experienced red dots on shoulder of injection site arm. On MAR-2021, the subject experienced injection site pain. On MAR-2021, the subject experienced exhaustion. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stiff neck, injection site pain, red dots on shoulder of injection site arm, itchy, exhaustion and headache was not reported. This report was non-serious.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in March 2016 (reported as excursion occurred "at the beginning of the month (March 2016)"), the patients received improperly stored (refrigerated in temperature of 31.3 degree Fahrenheit for 1 hour; previously temperature excursion was reported as 2 times: less than 34 degrees Fahrenheit for 20 minutes each time) doses of RECOMBIVAX HB Lot # L038018 and expiration date: 13-SEP-2017 (dose and route of administration were not reported). No adverse effects were reported. The is one of several reports received from the same reporter. Additional information has been requested.
Quarter size notch. Achy joints/pain over whole body and burning rash and swelling from injection site to the elbow.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 18-MAY-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008878) 0.5 ml (expiration date, route and site of administration were not reported) that underwent 159 hours temperature excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-AUG-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was not product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This is a literature case, initially received on 19-Feb-2019, concerning an 84-year-old, elderly, female patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. The patient's current condition included hypertension and allergy to penicillin. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, 2 minutes after the vaccination, the patient felt funny and then collapsed. The patient had ventricular ?brillation (later speculated because of hypotension), which progressed to cardiac arrest. On examination, the patient also had wheezing. It was reported that, there was no documented evidence, but medical records indicated diagnosis of anaphylactic reaction. The author considered this case as serious (death). The author concluded that anaphylaxis of severe or life-threatening severity was very uncommon but could occur even among the persons without hypersensitivity. Most persons recovered fully with treatment, but serious complications, including possibility of death is a rare event. This case is cross-linked to the original case: 201902085 due to the same reporter.; Reporter's Comments: An 84-year-old, female patient with current condition of hypertension known allergy to penicillin felt funny, collapsed and experienced ventricular ?brillation (later speculated because of hypotension), which progressed to cardiac arrest, within minutes after administration of INN Flu Vaccine. The case meets level 2 of Brighton Collaboration criteria of diagnostic certainty for anaphylactic reaction. The indicated cause of death was anaphylactic reaction. Considering the plausible temporal relationship between vaccination and reported fatal events (ventricular brillation, cardiac arrest and anaphylactic reaction) and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the events (cardiac arrest, anaphylactic reaction, Ventricular fibrillation) as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic reaction.
Red, itchy, red bumps on left arm.  PT denies chest pain, shortness of breath and any other symptoms. Was given 25mg Benadryl and water. Remain in observation for 30 more minutes. Pt stated that her arm was no longer itchy.
pt recv vax; rash noted 8 days p/ vax, greater than 50 varicella eruptions over trunk, face;low grade fever; very cranky; fever 102 11jun95;some scabbing, dph given, oatmeal baths & apap;
Confirmed no side effects or symptoms reported.; HBP reports PROQUAD was administered accidentally to a patient who already received full dosing schedule of MMR containing vaccines but was administered it incidentally when it was meant for their sibling 10/13/2023.; Patient in question received first dose of PROQUAD on 11/22/2022 and received MMRII dose 1/14/2022; This spontaneous report as received from a health business administrator, and refers to a patient of unknown age and gender.      Information regarding the patient's concurrent conditions and medical history was not provided.  On 14-NOV-2022, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II), then, on 22-NOV-2022, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot#, expirations date, route of administration and anatomical location were not provided for any vaccine) (Inappropriate schedule of product administration). Both for prophylaxis. A sterile diluent was reported to be administered; however, it was not specified if it was used with all the vaccines reported.  On 13-OCT-2023, when the patient had already received full dosing schedule of  Measles, Mumps, and Rubella (MMR) containing vaccines,  the patient was accidentally administered with a second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) 0.5 ml, lo# X009130 (Expiration date was not reported, but upon internal validations it was established as 24-SEP-2024) (route of administration and anatomical location were not provided) for prophylaxis. The reporter stated that the vaccine was administered incidentally when it was meant for their sibling  (wrong patient received product). It was confirmed that their sibling received their measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)according to schedule. Confirmed no side effects or symptoms reported.
The shot was adminstered on October 11.  Usual symptoms followed such as tiredness, and low grade fever.  However, by the 2nd day following the shot, fevers were common about every 6 hours.  Fever ranged from 99.5 to 103.2.  This is still going on as I type.  High fevers and almost 6 days since the shot was given.
Within minutes of injection Mom started getting nauseous.  When she stood to leave she was very light headed.  The nausea lasted about 3 hours, the lightheadness lasted all day, diminishing as the day went on, but still a problem at bed time.  She did sleep a lot that day. When she awoke the following day, symptoms had abated.
Pt reported having a painful and itchy rash formed in a circle around the injection site with a nickel sized diameter 2 weeks after the shot.  She reported also having a fatigue, headache and some cold-like symptoms for 2 days after the shots.  Per pt, her medical adviser thought that the rash was associated with shingle.  However, it has not yet been confirmed by a MD.  Pt is not being treated for the rash but has been monitored by her health care provider.