chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MMR vaccine given sq right deltoid. upon waiting in waiting room. Nurse noticed child was itching and wheezing Dr attended, Large hives was noted on right arm injection site. treated with Benadryl 25mg PO, monitor 1 hour great improvement.
Information has been received from a 26 year old female pharmacist who on 27 Dec 2006 was vaccinated with a 0.5 mL dose of Gardasil. On 30 Dec 2006, the patient developed bumps on skin, located mainly on the back, sporadic on the chest, 5-6 noted, and also on belly: none on legs. The pharmacist reported that they were painful and "felt like bruises," The patient's outcome was unknown. Additional information has been requested.
I had a headache, that lasted for about a day. No meds taken for the headache, just slept.
partial dose was received; amount of vaccine seen running down patient's arm and onto their foot; amount of vaccine seen running down patient's arm and onto their foot; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 1st December 2021) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and only a partial dose was received after the needle separated from the Tip-Lok syringe and a noticeable amount of vaccine seen running down patient's arm and onto their foot after administration which led accidental underdose, inadvertent exposure and exposure via skin contact. The reporter consent to follow up.
C/O very stiff neck, headache and fever starting 2/21/08 AM. Pt went to ER 2/22/08 at 4:00 PM. Stated in ER, he also had a sore throat. Temp 100.3 in ER. Dx: Acute/strep pharyngitis. Treatment 1 gm IV, Amoxicillin 875 mg BID x 10d.
developed flu like symptoms within 48 hours; severe body aches, fever of 102.0, runny nose, stuffiness, no appetite; excessive aches causing me to miss work.
No adverse reaction only to report that he was diagnosed with varicella 9/20/04 over 100 lesions-not ill. No temp.
WEAKNESS, ANXIETY, NAUSEA, DIZZINESS, TINGLING IN HANDS, UNPROVOKED SWEATING, CLAMMY HANDS, SHAKING, HEADACHE
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 22, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had lymphadenopathy (felt a lymph node on the left under my clavicle or collar bone), onset Mar 2021, with outcome of unknown. Additional information: Patient stated she understood that the vaccine can cause lymph nodes to be swollen in the same arm of the vaccine. She reported she can feel a lymph node on the left-side under her clavicle or collarbone. She asked if that could be from the vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Three days after receiving the vaccine, the swelling, redness, and itching was gone. By day number nine, i woke up with my left bicep (where the vaccine was injected) swollen, red, and itchy again. Even worse than when i originally got the vaccine.
Patient stated that he wanted a vaccine today while staff were in the unit. He denied receiving it prior. He was given the vaccine and upon documenting it was discovered that he receive the Modern vaccine 1st dose on 2/2/21 and 2nd dose on 3/2/21. Today he received Jannsen dose. He has no adverse effects and no complaints.
weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak). At the time of the report, ASTHENIA (weak) had not resolved.            No concomitant medication was reported. No treatment medication was reported. The patient states that this has been happening for the last two months and not just last week.   This case was linked to MOD-2021-417951 (Patient Link).
Pt has red , painful, swollen, arm. Pt went to doctors due to adverse reaction.
Headache stuffy nose Patient states he received his Covid vaccination on  Monday 1/4/2021. States he has stuffy nose and headache. States he  missed work today 1/7/2021.
her son (patient) received one dose of both the M-M-R Il and VARIVAX vaccinations concomitantly on the same day; crying uncontrollably; super high fever; measles like rash broke out head to toe; fussy; This spontaneous report as received from a patient's mother refers to her son of unknown age.  The patient's medical history, current condition, drug reactions/allergies and concomitant medications were not reported. Approximately on an unknown date in 2017, it was reported that patient received one dose of both the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) vaccinations concomitantly on the same day (inappropriate schedule of product administration) during a doctor's visit for (routine immunization). Other suspect therapies included sterile diluent. On an unknown date in January 2017, (reported as 5 days later),  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) vaccines were administered to him, the patient experienced a super high fever (pyrexia) which was around 105 degrees and a measles like rash broke out head to toe (rash morbilliform). He was also acting fussy (irritability) and was crying uncontrollably due to his adverse experience. On an unknown date in 2017 (reported as couple of days later), he was recovered from his high fever and his rash morbilliform was subsided (in about 4 or 5 days later). The outcome of rash morbilliform was reported as recovering/resolving. The outcome of irritability, inappropriate schedule of product administration and crying was unknown. Causality for the events pyrexia, rash morbilliform, irritability and crying was not reported.
feel a little sick, and horrible.; huge red circle in her left arm, and is hard and swollen like a golf ball; huge red circle in her left arm, and is hard and swollen like a golf ball; huge red circle in her left arm, and is hard and swollen like a golf ball; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feel a little sick, and horrible.), VACCINATION SITE ERYTHEMA (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE INDURATION (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE SWELLING (huge red circle in her left arm, and is hard and swollen like a golf ball) and NAUSEA (nausea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011f21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Immunocompromised. Concomitant products included TRAMADOL, LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN CALCIUM (LIPITROL [ATORVASTATIN CALCIUM]), VITAMIN D [VITAMIN D NOS], MIRABEGRON (MYRBETRIQ) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced ILLNESS (feel a little sick, and horrible.), VACCINATION SITE ERYTHEMA (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE INDURATION (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE SWELLING (huge red circle in her left arm, and is hard and swollen like a golf ball), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, ILLNESS (feel a little sick, and horrible.), VACCINATION SITE ERYTHEMA (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE INDURATION (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE SWELLING (huge red circle in her left arm, and is hard and swollen like a golf ball), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment medication were reported.  patient got the first dose of moderna vaccine on 15March202 with batch number 002b21a and received second dose on 12April2021 with lot number 031a21a both on her left arm.  She mention that on the 13April2021 felt tired, and didn't take anything and that symptom went away on the 14April2021.
raised red spot started to appear (like a bug bite). Quickly progressed to large raise circle area, Red, warm to the touch.
4 hrs p/vax pt had onset of somnolence & vomiting; pt was hospitalized for dehydration but cont w/emesis & hypersomnolence despite IV fluids; no diarrhea; no fever; no ill contacts
no adverse event; Dose administered after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jun-2023, 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 19-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        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 (Dose administered after Manufacturer Date of Expiry).    No concomitant medication was reported.  Vaccine was administered on 13-JUN-2023. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-731904 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731904:same reporter
Pt is ad marine who had anthra #1 12/12/02 and on 12/14/02 developed acute onset flu-like symptoms, SOB, coughing, nasal congestion, fever and sought medical attention at family care center while pt was on leave. MD dx with asthmatic bronchitis. Pt treated with qualifenisin, levoquin, robitussin with codeine and albuterol nebulizer for home use. Pt still with coughing and use of robitussin with codeine. Seen and pending allertist apointment tomorrow.
pt recvd vax 17MAY93 & about 20 hrs p/mom noted swelling & irritation of the area & brought in for a check;
I woke up with a red patch on my bottom left eyelid. My eyelid was red and the eye was swollen. Over the next two days it developed into more of a vesicle under the skin. On 15th I went to urgent care who said it was herpetic and stared me on valacyclovir. She recommended I see an eye doctor within 24 hours to confirm and to seek treatment for my eye. I saw an ophthalmologist on the 16th who confirmed it was shingles. At that time my eye was very red, uncomfortable, and itchy in addition to the eyelid being red and swollen as well as uncomfortable and itchy. The 17th was the most uncomfortable and itchy but slowly improved over the near week on valacyclovir and gel liquid tears every hour or so in my left eye and liquid tears ointment on the lesions themself.  It has healed now to just a pink mark under my eye.
Patient refers he awakened x 2 nights after immunization with tachycardia, agitated, referred he wanted to run.
8FEB94 t102, swelling site of DTP, shoulder-arm; 10FEB94 eyes swelling took to ER; had mom pick up DPH; 11FEB94 AM nl; swelling resolved yes;
This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), PAIN IN EXTREMITY (Pain in legs), FATIGUE (Fatigue) and PRODUCT DOSE OMISSION ISSUE (Refused to receive 2nd Moderna Vaccination/Now wants the 2nd Moderna Vaccination) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to allopathic drugs (allergy to codeine). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain), PAIN IN EXTREMITY (Pain in legs) and FATIGUE (Fatigue). On 03-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Refused to receive 2nd Moderna Vaccination/Now wants the 2nd Moderna Vaccination). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), PAIN IN EXTREMITY (Pain in legs), FATIGUE (Fatigue) and PRODUCT DOSE OMISSION ISSUE (Refused to receive 2nd Moderna Vaccination/Now wants the 2nd Moderna Vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications were not reported.
Kidney stone, treated with Flowmax, extreme pain for six hours, but stone moved on it's own without additional medical intervention
Initial unsolicited report received from a pharmacist on 19 November 2015. This case involves a 56-year-old male patient who was vaccinated with an intramuscular dose of ADACEL (batch number U5292AA, expiration date 14 April 2018, dose, dose in series, site of administration were not reported) on 13 November 2015. Illness at time of vaccination was not reported and patient had an allergy to tetracycline. Concomitant medications were not reported. On 16 November 2015, three days following the vaccination, the patient experienced shortness of breath. Lab data and corrective treatments were not reported. The patient was not recovered from event as it was reported that event continues till 19 November 2015. List of documents held by sender: none.
mom states that pt devel a rash about 5hr p/vax;pt was seen by ER & no tx given;rash got worse & was seen by MD;was allergic rxn to maybe the MMR: tx was DPH;
I started getting symptoms of headache, fatigue, sore throat, stuffy head, and cough. I did an at home COVID-19 test which was positive. I went and got another COVID-19 test which was positive. I did a telehealth visit and was prescribed Paxlovid. About 36 hours after taking Paxlovid, my symptoms diminished. I still have fatigue and stuffy head to this day.
pt had chickenpox vax & is now covered w/pox in mouth everywhere per mom;
Patient received Pfizer covid vaccine at @2.44 pm. Patient was a 30 minute wait due to known severe allergies to Sulpha drugs. At 2.49 patient complained of feeling tight in his ribs and said he had difficulty breathing. On examination the patient pallor was pale.. he was not having any observable swelling to his lips. He sat for @ 30 seconds with me in attendance to see if it got better ( he removed his mask to see if it would help) . he stated breathing was getting harder... at 2.50 pm 1 IM dose of epinephrine via epi auto injector was administered to his left thigh. Emergency services were called via 911. At 2.52 pm 1ml of Benadryl was administered to his right thigh. At 2.54 his blood pressure was recorded as 180/78. At this time EMS were in attendance and he was transferred to the ER via ambulance. the patient remained conscious and alert throughout.
Pt. received flu shot at mass flu clinic on 10/25/11. Saw PMD on 11/1/11 with c/o sore arm. MD documented (lt) upper arm with 2" x 3" raised, firm nodule, sl. wm to touch, mild erythema. ROM shoulder with decreased flexion secondary stiffness, can lift arm above head, grip strong, no arm/finger tenderness. Pt was given MEDROL dose pk & LORTAB for pain.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No treatment medications were provided.    This case was linked to (Patient Link).
Tinnitus in both ears (loud, intrusive, strange sounds-nonstop);  fatigue, occasional vertigo,  significant weight loss ( about 10-12% of body weight)
Seizure  secondary to 5 cortical strokes that happened within 1 month of the vaccine
the Ipol was exposed to 8.2 C for 5 mins with no reported adverse event; the Ipol was administered to 5 month old child with no reported adverse event; Initial information received on 06-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 months old male patient and the IPV (VERO) [IPOL] was exposed to 8.2 c for 5 mins with no reported adverse event and administered. .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Prophylactic vaccination.  On 31-May-2023, the patient received a 0.5 ml dose of suspect IPV (VERO) suspension for injection (strength: not reported; expiry date: 16-Jun-2025, lot W1A191M) via subcutaneous route in the left thigh for Immunization and administered to 5 month old child with no reported adverse event (poor quality product administered) (same day latency)  On an unknown date the ipol was exposed to 8.2 c for 5 mins with no reported adverse event (product storage error) (unknown latency).  Human error: YES; product administered to a patient: YES  Action taken:  not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
slight discomfort of the arm; pain in her chest/pain in her rib cage; pain in her chest/pain in her rib cage and shoulders; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 03Apr2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she had her first dose of the Pfizer covid 19 vaccine on 3Apr2021. She had slight discomfort of the arm, but she woke up on 12Apr2021 to intense pain in her chest, pain in her rib cage and shoulders. She took aspirin and the symptoms lasted for nine hours. She had her second dose tomorrow and wanted to know how she should proceed. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe acute urticaria from groin to neck. Initial treatment at Urgent Care - Cortisone injection and 6 day Prednisolone. Daily Zyrtec. Benadryl as needed apply Sarna Anti-itch cream to affected areas to relieve itch. Apply diphehydramine gel if needed  Primary Care physician  added daily Pepcid tablet and advised to continue topical treatment as required. Referred to Allegy specialist. Allergy specialist  recommended increasing Zyrtec to 2 tablets in morning and Pepcid 1 tablet at night with guidance to increase as high as 4 or each if required. As symptoms subside gradually wean off of Zyrtec and Pepcid. Follow up appointment on February 16, 2022
Bivalent dose given in error as primary series dose 1. No known adverse reaction. Patinet tolerated well. Physician notified patient/guardian of administration error. No concerns reported by patient/guardian. Patient is planning to finish series with on dose of monovalent (as dose 2) and then the bivalent following the series timeline requirements.
Skin rash: Generalized Erythematous macular papular lesions on his face, trunk and extremities. Slightly itching. Given BENADRYL and Prednisolone, too early to determine the course.
This spontaneous report was received from a registered nurse, refers to an unknown number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date, the patients were vaccinated with VAQTA (strength, dosage, route, lot# and expiration date were not reported). That had been improperly stored. No adverse effects were reported. This is one of several case received from the same reporter. Additional information is not expected because the physician refused to be contacted.