chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concomitant medications, drug reactions or allergies were not reported. On unspecified dates, improperly stored doses of PNEUMOVAX23 (dose, route and site of administration, lot # and expiration date were not reported) were administered to the patients. The vaccine was stored in the temperature between 46 and 77 degrees Fahrenheit for 15 minutes and between 32 and 36 degrees Fahrenheit for 18 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports received from the same source.  Additional information is not expected as no consent for contact with the reporter was given.; Sender's Comments: US-009507513-1702USA006676: US-009507513-1702USA006711: US-009507513-1702USA006712: US-009507513-1702USA006713:
Patent had swelling in her injection site arm after her first or the second vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Patent had swelling in her injection site arm after her first or the second vaccine.) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032Z0A, 041620A and 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Patent had swelling in her injection site arm after her first or the second vaccine.). At the time of the report, VACCINATION SITE SWELLING (Patent had swelling in her injection site arm after her first or the second vaccine.) outcome was unknown.            Patient received her Moderna Booster dose on 26OCT2021 no Adverse reactions reported. Concomitant medications were not provided. Treatment information was not provided.  The patient's weight was reported to be 14 lbs.
Patient reported feeling lightheaded and nauseous. After 15 minutes of observation the patient reported feeling better and fine. All vitals taken before patient left were within normal limits. Patient left after receiving education on what signs and symptoms require seeking further medical attention.
reported feeling a "little lightedheaded" still after sitting in observation lot x 15 mins. - blew horn to request permission to "sit a little longer."    no medicale history; no medication;  h/o' not doing well with needles or blood draws"    mask removal - air flow ; car seat reclined x 5 mins. until sx abated - po water & OS sat upright after 5mins - reported she was "good"  drove off lot.
Swelling; Itching; Muscle pain in both legs; Chills; Fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of SWELLING (Swelling), PRURITUS (Itching), MYALGIA (Muscle pain in both legs), CHILLS (Chills) and FATIGUE (Fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Fatigue). On 06-Jul-2021, the patient experienced SWELLING (Swelling), PRURITUS (Itching), MYALGIA (Muscle pain in both legs) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and CORTISOL [HYDROCORTISONE] (topical) ongoing since an unknown date at an unspecified dose and frequency. On 30-Jun-2021, FATIGUE (Fatigue) had resolved. At the time of the report, SWELLING (Swelling), MYALGIA (Muscle pain in both legs) and CHILLS (Chills) outcome was unknown and PRURITUS (Itching) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.
pt recvd vax & c/o redness & tenderness & lump (5X6 cm) area induration & redness;
No adverse effect reported; Names of vaccines involved: PROQUAD; This spontaneous report was received from a licensed vocational nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 14-AUG-2019, the patient received an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live rHA (PROQUAD) 0.5 mL, for prophylaxis lot number R022566 and expiration date 04-FEB-2020 (anatomical location and route of administration were not reported) which was diluted with sterile diluent. No adverse effects reported.  It was reported that on an unspecified date, the vaccine was exposed to a temperature between 47 Fahrenheit degrees and 77 Fahrenheit degrees for 11 hours and 30 minutes. The vaccine was also exposed to a temperature between 6 Fahrenheit degrees and 14 Fahrenheit degrees for 30 minutes; and in the recommended frozen range between 58 Fahrenheit degrees and 5 Fahrenheit degrees for 30 minutes (conflicting information). The call was placed because of a Digital Data logger report.
Swollen gland / node in left armpit.  Painful to touch, approximately half the size of a golf ball.  No treatment yet, except for warm compresses and OTC pain reliever.
Pt reports developing nausea, vomiting, dry heaving and feeling ill after vaccine. States she developed muscle aches and pains. All sx started once she went home (within 1-2 hours after vaccination).
Flu injection caused extreme pain the night of injection and was unable to lift/raise my arm. Since then I have pain with lifting my arm & performing certain ADL's. The shoulder/upper arm is tender to touch.
Since getting the vaccine all I can smell is cigarette smoke and I am a non smoker and not around smokers? It has since given me headaches due to the smell.
numbness in left thumb; high fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in left thumb) and PYREXIA (high fever) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HYPOAESTHESIA (numbness in left thumb) and PYREXIA (high fever). On 07-Feb-2021, HYPOAESTHESIA (numbness in left thumb) and PYREXIA (high fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-039663 (Patient Link).
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of Pneumovax 23 (lot #651373/0320F). Subsequently the patient experienced a local reaction including redness, soreness and swelling. Unspecified medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
anaphylactic reaction.  7/17/07 Received ER med records from hospital which reveal patient seen 4/19/07 after seen by pcp for vax same day.  Developed facial swelling, rash & periorbital edema.  Tx at pcp office then transported to ER by EMS.  Edema improved by arrival in ER per parents but still noted to by significant by ER.  Tx w/additional steroids & antihistamines & observed in ER.  Improved & was d/c to home. FINAL DX: acute allergic reaction.
Progressive numbness, tingling, weakness to functional impairment. Started about month after first vaccinations. Multiple hospitalizations, outpatient treatment with Plasmaphoresis and physical therapy. Follow Up: Diagnosis was GBS. Medical Records received on 12/29/2004 states pt experienced demyelineating neuropathy.  Discharge Summary reviewed states patient experienced SOB, hypertension and chest pain. Per annual follow up: she has primarily recovered, except for residual sensory and motor difficulty.
No additional adverse effect reported; Caller stated that ROTATEQ that underwent a temperature excursion was administered.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-MAY-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot # 1707447, expiration date: 20-FEB-2022, orally (exact dose was not provided) for prophylaxis.  The administered vaccine experienced a temperature excursion of 9 degrees Celsius to 25 degrees Celsius (9.92 degrees Celsius) for 1 hour and 21 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA000775:
It appears patient had a localized reaction to the PNEUMOVAX 23 immunization. Patient still denies any allergies to latex or eggs. Advised patient to take OTC BENADRYL for the rash and avoid future exposure to PNEUMOVAX.
Developed marked dyspnea on exertion with SOB at rest and occasional cough productive of red sputum.  Condition deteriorated despite intervention. Additional terms added from Discharge Summaries rec'd 12/28/2005: Hypoxia, lab test abnorm, leukocytosis, Inc. BP, Hyperglycemia, atrial fib, anemia, dyrhythmia, resp failure, cardiomegaly, pneumothorax, ileus, broncholitis, pneumonia/sr
pt recv vax 17JUN98 & 24hr later devel erythema, swelling & pain over the inj site in a 11x20cm area;given zithromax, claritin & medrol dose pk;resolved w/o sequella;
This spontaneous report as received from a nurse refers to a 11 month old patient. The nurse reported that on 29-DEC-2005, eight days prior to patient's birthday, initial doses of MMR II subcutaneous injection, therapy type HSA (dose, route and lot # not provided) and VARIVAX subcutaneous injection (dose, route, lot # not provided) were given (in the "usual route"). Patient received boosters for both VARIVAX and MMR II on 07-APR-2009. No adverse effect was reported. Additional information is not expected.
Direct skin exposure to vaccine/feeling liquid running down arm; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA SKIN CONTACT (Direct skin exposure to vaccine/feeling liquid running down arm) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced EXPOSURE VIA SKIN CONTACT (Direct skin exposure to vaccine/feeling liquid running down arm). At the time of the report, EXPOSURE VIA SKIN CONTACT (Direct skin exposure to vaccine/feeling liquid running down arm) had resolved.            Concomitant medications included birth control medications.  No treatment information was reported.  Action taken with mRNA-1273 in response to the event was not Applicable.
Measle-like rash covering torso back & front; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered on left arm on 25Mar2021 13:30 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation. The patient medical history was not reported. Patient was not pregnant. No other vaccine in four weeks. Vitamin supplements was taken in two weeks. The patient experienced measle-like rash covering torso back & front on 01Apr2021 which resulted to a physician office visit. Unspecified treatment (anti itch pill) was given as treatment. Outcome of the event was recovering. Patient was not diagnosed with covid prior to vaccination and has not been tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Information has been received from a certified medical assistant concerning a 52 year old female with no known allergies, breast cancer and hypothyroidism who on 26, Feb 2007 was vaccinated IM in the right deltoid with one single dose of zoster vaccine live (Oka/Merck) (lot# 656412/1476F). Concomitant therapy included divalproex sodium (DEPAKOTE), tiagabine hydrochloride (GABATRIL), escitalopram oxalate (LEXAPRO), tamoxifen citrate. levothyrcxine Na (SYNTHROID) and cimetidine (TAGAMET). A few days after vaccination, on approximately 01, Mar 2007, the patient developed swelling, redness, pain and warmth at the injection site. The patient had decreased range of motion of her right arm. The patient was examined on 02, Mar 2007 and was prescribed a course of cephalexin (KEFLEX), prednisone and acetaminophen (+) oxycodone hydrochloride (PERCOCET). There were no lab studies performed. Follow-up exams on 05, Mar 2007 and 09, Mar 2007 revealed that the injection site was still swollen and painful but the redness and warmth had resolved. There was no product quality complaint involved. Additional information has been requested.
Redness near injection site; Shingles or insect bites; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles or insect bites) and VACCINATION SITE ERYTHEMA (Redness near injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO historical condition reported.). Concomitant products included ATENOLOL and LORAZEPAM (ATIVAN) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HERPES ZOSTER (Shingles or insect bites). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness near injection site). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) ongoing since an unknown date at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles or insect bites) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness near injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up received from 16-JUL-2021,added new event and its outcome.
Pt recvd DTP on lt arm on 6AUG91 that evening arm was swollen from elbow to shoulder lasting 2 days; On 9AUG91 swelling had dec remarkably; no fever;
No other AE for this patient; The caller said a patient received PROQUAD after a temperature excursion; This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-AUG-2022, the patient was vaccinated with an improperly storage dose of measles, mumps, rubella and varicella rHA (OKA-MERCK) virus vaccine live (PROQUAD) (valid lot #U022729, expiration date: 16-JAN-2023) (strength, anatomical location and route of administration were not provided) for prophylaxis. Temperature excursion occurred at 11.5 Fahrenheit (F) for 52 minutes. No additional information or adverse event was reported.; Sender's Comments:  US-009507513-2208USA008698: US-009507513-2208USA008545: US-009507513-2208USA008719:
pain at injection site swelling at injection site extreme fatigue and generalized muscle soreness chills rash on neck severe headache
I received the injection and was told to wait for 15 minutes. Shortly after receiving the shot, I had to use the restroom, so I asked if it was ok to do that before I sat for the 15 minutes. As I was walking to the bathroom, I felt a warm tingling sensation go through my arms (almost as if I could feel the injection going through my veins) and then the sensation traveled down my legs and my heart started RACING. This all happened within two to three minutes after receiving the shot. At first I just thought it was odd, but as I kept walking my heart rate continued to skyrocket and I did not like the way I felt. I went to the EMTs and they laid me down and hooked me up to a blood pressure machine. My blood pressure was significantly elevated (which is very unusual for me). As someone with neurocardiogenic syncope, my blood pressure typically drops - the way I felt was not at all in line with a syncopal episode.  My heart rate remained elevated while at rest, but did come down a little bit after about 20  minutes; my blood pressure would also  come down a bit while at rest but as I would lift my head (even just a little bit) to drink something my blood pressure and heart rate would again sky rocket. This went on for 1.5 hours. After about 2 hours, I was finally able to sit up without my blood pressure and heart rate going through the roof, but I felt simply awful. For the next two weeks I felt light headed (as if my head was detached from my body) and dizzy. I couldn't get out of bed in the morning without drinking a gatorade as I felt so weak and shaky. I developed significant heart palpitations that lasted for a solid month.  Additionally, I am someone who has always gotten a period at 27-28 days. I had my regular period two days after vaccination (which was when it was due), but then I got it again 16 days later. That has never before in my life happened to me. Not during illness or times of high stress.  Somehow I had a significant reaction to this vaccine and my cardiologist advised that I do not get the second.
My mother can't stand for a long time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and follow-up spontaneous report from Pfizer-sponsored program Support CEP 159558.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DYSSTASIA (non-serious) with onset 2021, outcome "unknown", described as "My mother can't stand for a long time".  Additional Information: Reporter stated that "My mother (patient) and my sister got their first dose on 27Feb2021 and they are scheduled for their second dose on 23March2021. My sister is currently in the hospital and has pneumonia in her right lung. My mother can't stand for a long time so do I need to reschedule her appointment"   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Hospitalization due to nausea and vomiting. 6/5/2021 - 6/7/2021
1wk p/vax pt devel marked spotted macular rash covering entire body;also fever 102-105;dx as erythema multiforme;
Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Lab details were not provided by the reporter.  Treatment for the events were not provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recv vax 27MAR96 & reported problems on 6APR96 which cont to present;pt unable to work & is being covered for benefits under workers compensation;f/u info recv sx were muscleache, fever, joint pain, fatigue, malaise, chronic fatigue synd
Sore arm Fever of 103 Chills Headache Nausea  Fatigue Body Aches
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2019SA071131, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071154, 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149 and 2019SA071156 (same reporter). This case involves a pediatric patient of an unknown demographics who was accidentally administered with FLUZONE HIGH DOSE lot UJ043AB via unknown route in unknown administration site instead of FLUZONE QUADRIVALENT on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to wrong vaccine administered, inappropriate age of vaccine administration and overdose. No side effects had been 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. List of documents held by sender: none.
Patient stated when she got home she was feeling tired and had some SOB at night time, fever, body aches  as well as tingling and numbness in the hands bilaterally.  Patient took ibuprofen. Went to ER 07/02/19, UA done at the hospital.
On 9/29/21 I received te Pneumovax 23, and the seasonal flu shot on the same day at my work. I've had the flu every year, but never the Pneumovax 23. I had the Pneumovax 23 some years ago. About 10 hours after the vaccines, my arm which received the Pneumovax 23 was very swollen, and hot. Then I became very dizzy during the night. At midnight I woke up to the room spinning. I went back to sleep. By 5:00 am Thursday, October 30, I was so dizzy and sick to my stomach I couldn't walk. My husband had to stay home with me because I couldn't walk at all from being so dizzy. I was dehydrated from vomiting. I was completely off my feet for about 36 hours.
Flushing  skin, Itching all over, lump in throat, feeling short of breath, rapid breathing, rapid heart rate. elevated blood pressure
Fever, headache, nausea.  Sore, Red, feverish injection site.