chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up on 12/30/20, one week to the day after my vaccine with an itchy red rash on my left arm about 2 inches below the vaccine site. It worsened throughout the day becoming larger, more red, hot and tender to touch. By the end of the day on 12/31/20 the rash was 5-6x bigger than when it started. I saw my PCP via telehealth appt that day and it was determined I likely have cellulitis based on presentation and symptoms. I started taking doxycycline that day and symptoms started to improve.
Today (11/17/21) at around 11:40 am, we had a walk-in vaccination for pt. Per patient's questionnaire and portal profile, she was deemed eligible to get vaccinated. After administering the vaccine, patient complained about dizziness in about 5-10 seconds. I had the patient remain seated in the chair. In about another minute, the dizziness had passed, but the patient now started breathing rapidly and stated that her back hurt. She wanted me to call EMS.   I called store leadership, paged department overhead, called EMS, and gave patient an ice-pack to place behind her neck/back. Patient's niece was outside; I called her in. The niece helped calm the patient down by rubbing her back and chest. Store leadership showed up at the pharmacy right away and I had them wait outside the room to give patient space. Paramedics arrived shortly afterwards. They tested her vitals which were within normal limits and her sugars were elevated. At this time, patient felt fine and refused paramedic offer to be taken to the hospital or be escorted to her car. She walked out with the assistance of her niece. Patient has an appointment with her provider later on.   I will follow up with the patient after a few hours today. As of right now, everything is taken care of. Let me know if you need further information.
13 year old patient was administered a dose of Adacel and Menactra vaccine which had a temperature excursion due to the malfunction with data logger at 52 F for about 31 hours and 31.2 F for 30 minutes/No AE; Initial information received on 26-Sep-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case 2019SA273650 (same reporter).  This case involves a 13 years old patient who was administered a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6521AA and expiry date: 26-Jan-2021) DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6128AA and expiry date: 20-Nov-2020) vaccine which had a temperature excursion due to the malfunction with data logger at 52 f for about 31 hours and 31.2 f for 30 minutes.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  At the time of report 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.  List of documents held by sender: none.
vaccine 1/20. 1/24 underarm pain, 1/27 diagnosed with swollen lymph nodes under arm
Pt. has history of Lymphangioma. Pt. presented with lump on chest that became inflamed and red after 9 days of receiving Covid-19  vaccine. Pt. presented with itchiness,  swelling, bruising, redness, fever, hot to touch and headache. Pt. used ice packs and Ibuprofen for treatment.
Pt passed for about 1 minute.  She came to and complained of being dizzy, she started sweating and stated being hot.
P/receiving a dose of Td, pt exp tenderness & swelling @ inject site; P/2 wks, a large knot that is red & hot to the touch, stills remains;
Two inch diameter area of induration and redness, tender to palpation w/ localized warmth.
Ems called at 1305. Ems on site and evaluated pt. Pt left vaccination site at this time. C/o sob and chest pressure.
This spontaneous report as received from a nurse practitioner refers to about 10 unspecified patients of unknown demographics. No concurrent conditions or medical history were provided. The nurse practitioner reported that (Oka/Merck) VARIVAX 0.5 ml injection, subcutaneously (indication, lot# and expiry date unspecified), that underwent a temperature excursion was administered to those patients on 25-AUG-2014. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
make me sick when I take them; Initial information received on 03-Nov-2021 regarding an unsolicited valid non-serious case from consumer/ non-health care professional via social media.  This case involves a patient (unknown age and gender) who was sick (illness), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medication(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 expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious event "make me sick when i take them" (illness) (unknown latency) following the administration of vaccine.  It was reported "My shot make me sick when I take them so therefore I don't take the flu shot."  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
TESTED POSITIVE FOR COVID-19; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of event. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JAN-2022, the patient experienced tested positive for covid-19. Laboratory data included: COVID-19 virus test (not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid-19 was not reported. This report was non-serious. This case is associated with a product quality complaint: Sender's Comments: V2-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Patient received 2nd booster; does not meet eligibility requirements.. Monitored for 15 minutes; departed clinic s/s adverse reaction. Patient updated of unauthorized dose. Stated, "I thought this was my first booster"
tongue is numb, loss of taste, right eye does not close fully and twitches, and pupil is dilated
The patient is a 58 y.o. female who presents to the Emergency Department with abdominal pain, vomiting, and fever at 101 degrees that began two days ago. She reports additional c/o diarrhea and bilateral flank pain.
Menstrual cycle was 12 days late. 0% chance of pregnancy.  Still experienced some PMS.  Prior cycles were regular.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The unspecified patients were administered GARDASIL (lot # K016966, expiration date 10-MAY-2017; lot # K008931, expiration date 04-MAR-10`7; lot # K011325, expiration date 08-APR-2017)( dose and frequency not reported), which were exposed to temperature outside of the recommended range since 05-NOV-2015. No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients was vaccinated with improperly stored doses of RECOMBIVAX HB lot # L048236, expiration date 31-MAR-2018 (dose and route of administration were not reported). The administered doses experienced the temperature excursion of 32 degrees Fahrenheit for 63 days. The temperature excursion was detected by a data logger. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccination adverse reaction; Pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), PAIN (Pain) and ARTHRALGIA (Joint pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Plaque psoriasis.    No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction), PAIN (Pain) and ARTHRALGIA (Joint pain). In 2021, VACCINATION COMPLICATION (Vaccination adverse reaction), PAIN (Pain) and ARTHRALGIA (Joint pain) had resolved.            No concomitant medications were reported.  Patient received Humira (1149378).  No treatment medications were reported.  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.
Pt says her arm started hurting right after vaccine administration. To this day, it hurst still every time she needs to use it to do her hair or put on her clothes.
Patient presents with left shoulder pain that has lasted for three weeks. It began after receiving her flu shot. The pain has lessened over time but some remains and she reports limits her range of motion. The patient's relieved with ALEVE OTC. She has not yet seen a doctor. She reports a previous shoulder injury in the same shoulder.
Pt with swelling on L side of face also with itchy watery eyes wheezing also heard in lungs pt given Benadryl 25 mg followed by Epi Pen Jr
Redness and knot at injection site.  Continued redness at site 2 days later.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Severe
Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium. Additional details: Patient contacted pharmacy on 08/19/2022. She shared with the pharmacist she experienced severe arm swelling localized to area and tingling. No numbness or difficulty in moving but severe arm swelling. Pharmacist recommended taking NSAIDs (i.e. Advil, Motrin, Aleve) to assist with decrease of inflammation and pain. But, if no resolve in 2 days contact a doctor.
The high-dose flu vaccine was given to a 46-year-old on 12/31/22. The patient was contacted on 01/06/2023 and reported that he has not experienced any problems or side effects from the vaccination since receiving it.
Nurse reported that one day post vax pt developed redness at the injection site. The area of redness measured 3-4" in diameter. No addtl info was available as of the date of this report. Manufacturer's Comment: This is 1 of 2 pts who developed injection site erythema following receipt of Prevnar lot 479-792. The reporter indicated that 3 pts experienced this event; however, 1 is presently not identifiable. An addtl report will be generated when identifying info is provided.
Information has been received from a physician concerning a pt who was vaccinated SC with a first dose of MMR II (lot number 646556/0813N). The physician reported that the child had a severe local reaction. A few minutes after immunization was given the child developed a 5.5 by 7 cm red swollen area. Medical attention was sought. The child was sent home and the mother was instructed to watch for any changes, but the child was not treated. Additional information is expected.
Pt developed keloid st site of MMR and varicella. Pt has no hx of keloid.
mild Headache; severe fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mild Headache) and FATIGUE (severe fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ADDEROLL (ADEROLL) for an unknown indication.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (mild Headache) and FATIGUE (severe fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, HEADACHE (mild Headache) outcome was unknown and FATIGUE (severe fatigue) had not resolved.
Large whelps developed w/in 30min p/MMR administered; Child became nauseated w/vomiting x 1; DPH given as ordered by MD;
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 11-JAN-2007 the patient was vaccinated with ZOSTAVAX, 1DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patent to contract a persistent strain of shingles. On or about 20-DEC-2015 through 24-DEC-2015, the patient sought medical attention at the emergency room for a painful skin condition. The patient was also treated at a family medicine clinic, for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster and post-herpetic neuralgia, a condition of chronic pain and nerve damage secondary to zoster infections. The patient has been prescribed KEFLEX, VALTREX and acetaminophen and NORCO for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages. Additional information has been requested.
I had intense underarm lymph node pain reaction in my left arm (same arm of the injection), which has been gradually diminishing over the past few days.
Rabavert (Rabies vaccine)#1 given 6/24/09. Pt. had no reaction.  Rabavert #2 given 7/1/09. On 7/2/09 client had sweating, chills (T97.9), muscle/joint pain, nausea, malaise, flu- like symptoms. Seen at Your Doc's In and told had "reaction" to vaccine. Symptoms resolved by 7/3/09.
pt recvd vax; 1 1/2 days later, fever to 103;2 1/2 days p/ vax, fever to 105.4R;mild cold sxs;
Swelling eye; Red eye; Sore on the eye; Fluid under eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swelling eye), OCULAR HYPERAEMIA (Red eye), EYE PAIN (Sore on the eye) and EYE INFECTION (Fluid under eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced EYE SWELLING (Swelling eye), OCULAR HYPERAEMIA (Red eye), EYE PAIN (Sore on the eye) and EYE INFECTION (Fluid under eye). At the time of the report, EYE SWELLING (Swelling eye), OCULAR HYPERAEMIA (Red eye), EYE PAIN (Sore on the eye) and EYE INFECTION (Fluid under eye) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment taken was Antibiotic cream.
Swelling, redness, pain and warmth at the injection site.  Patient also reports hives on her chest and legs.
Left thigh - cellulitis with possible development of vesicles. Red papules noted on (L) upper arm, behind ear and at vaccine site. All blanch with pressure. Tx with AUGMENTIN x 10D. Follow up PRN.
Tissue damage causing a lump and redness in the administered area  and pain.  Took around 2 months to heal.
I had a highly irregular/elevated heart rate. It went up to about 190 at one point and would fluctuate. I also experienced low amplitude shaking on my entire body.  I saw my PCP who referred me to a neurologist, cannot remember name, but they performed an EKG, which I believe, came back normal. As of today, I still received my second dose and booster shot and I was fine. I felt weak the following days from my adverse event, but I am good now.
A couple of days after my vaccination I noticed/developed an increasing weakness and pain in my shoulder.  I am unable to lift anything (right arm) without my upper arm supported against my body and cannot lift my arm up without difficulty and pain.  The symptoms seem similar to a torn rotator.
No adverse event; patient received first dose of Moderna vaccine on May-2021 and second dose on Aug-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose of Moderna vaccine on May-2021 and second dose on Aug-2021) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose of Moderna vaccine on May-2021 and second dose on Aug-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose of Moderna vaccine on May-2021 and second dose on Aug-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not reported.  Patient received third/booster dose in May 2022.  Treatment medication was not reported.   This case was linked to MOD-2022-627370 (Patient Link).
At injection site- Soreness, swelling, redness, firm (like a lump), measures 2" x 4", warm/hot to the touch. Started small hours after injection and continued to grow over last 24-36 hours.
pt recv vax 22JAN96 & 22JAN96 pt exp aching in lt hand & lt arm, joint pain devel blister-like bumps in fingers, especially the tips, swelling of the finger tips, fullness & numbness of the upper lip & was jittery & shaky;
This case was reported by a consumer via call center representative and described the occurrence of migraine aggravated in a 58-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of myalgia (1st dose received and other medication error events after receiving 1st dose, refer linked case US2018149815). Concurrent medical conditions included migraine headache. Concomitant products included sumatriptan succinate (Imitrex). On 7th August 2018, the patient received the 2nd dose of SHINGRIX. On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced migraine aggravated, influenza-like symptoms and fatigue. On an unknown date, the outcome of the migraine aggravated, influenza-like symptoms and fatigue were unknown. It was unknown if the reporter considered the migraine aggravated, influenza-like symptoms and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient experienced flu like symptoms consisting of fatigue and tiredness. The patient reported that since dose 2 was given, she had an increase in migraine headache. The permission to send letter asking for doctor information was given.
swelling from the inj site to the fingers & up to the neck;resolved w/in 1 1/2hr;
On approximately 11/02/2000, 2 weeks post dose, the patient broke out in a papular, vesicular appearing rash. On approximately 11/09/2000, about 1 week into the rash, it turned into roundish plaques in the same areas of the papular rash. The rash was diffuse all over not just at the injection site. Patient was not febrile but did exhibit cold symptoms. Additional information has been requested.
The patient developed hives the day after injection that are persistant. Other symptoms include fatigue, headache and chills. Patient denies fever. Patient's job tests for COVID twice a week, all results negative.
1st dose 46 days ago; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose 46 days ago) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose 46 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose 46 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no treatment and concomitant medication reported.
High BP (178/78), Low Oxygen, Increased Pulse, Heart burn, Left side facial numbness, "hot feeling"
Patient received  1st dose - about 10 minutes into monitoring patient returned to pharmacy counter with red face, stating lips were itchy and it was difficult to swallow water. Patient was given 2 capsules of Benadryl 25 mg. Patient returned to waiting area for additional monitoring. Less than 5 minutes later, patient was showing improvement of symptoms. Stated this had never happened before. Patient left store 15 minutes later in good standing, was instructed if symptoms worsened at home to seek emergency medical care. Called patient at about 8:30 pm that day to follow up - stated he felt fine.
Redness, itching at site, starting suddenly on Feb, 4, Tired and slight body ache all over
lower body paralysis. 7/9/09 Hospital records received DOS 5/29/09 to 6/1/09. Discharge Diagnosis: Lower extremity weakness, probable Guillain-Barre syndrome. Patient presented with headache, nausea, vomiting, back pain, decreased sensation lower extremities, lower extremity and hand weakness. URI. Nasal discharge and dizziness. Anxious.    ICD-9 codes: 3570, 72939