chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Expired vaccine used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medications details were not reported by the reporter.  Reportedly, at the time of unannounced visit by an representative on 28-Sep-2022, 50 doses of moderna vaccines were left in the health department which were looked well but later on the day stated that were uncompliant due to the same lot of moderna vaccines had expired on 07-Jul-2022.  Additionally, it was mentioned that the expiration code on the packaging slip was not the expiration code, had to scan the QR code to determine the actual expiration code, thus failed to did by not reading carefully the packing slip.  Treatment details were not reported by the reporter.
I?ve developed Shingles after having the vaccine shots early in 2021 one month following my second COVID vaccine.
not feeling good; some chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling good) and CHILLS (some chills) 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 12-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced FEELING ABNORMAL (not feeling good) and CHILLS (some chills). At the time of the report, FEELING ABNORMAL (not feeling good) and CHILLS (some chills) outcome was unknown.            The  concomitant medications on use were not provided. No treatment information was provided.   Reporter did not allow further contact
C/o rash over body and hand swelling, resolved within 24 hours. Treated with oral loratadine.
High fever, chills, body aches, extreme fatigue for 24 hours.   Mild fatigue for an additional 96 hours.  Treated with Tylenol.
Extra dose of MMR, VARIVAX & HIB were given in error. Last dose of MMR & VARIVAX were given on 7-26-10. Last dose of HIB given on 4-26-11.
The day after the vaccine common side effects (fever, chills, body aches, headache). The following day body aches increased, numbness on the left side of my face and right lower leg, hives on my chest, neck and face, debilitating fatigue. Spoke with my PCP and treated hives with Zyrtec and Benadryl.  Hives went away quickly. After 5 days of intense body aches, they eased up. The only remaining symptom is the numbness in my face and leg. There is occasionally pain in my leg (feels like nerve pain).
Information has been received from a physician and an office manager concerning a 17 year old female with asthma who on 22-DEC-2006 was vaccinated IM, into the left arm, with a 0.5 ml first dose of Gardasil (lot#654540/0800P). It was reported that at the end of the administration the "safety spring plunger snapped back and caused the patient pain." The office manager explained that this incident was due to human error, the physician was unfamiliar with safety mechanism. On 22-DEC-2006, the patient experienced left shoulder pain and difficulty sleeping on her left arm. On approximately 12-FEB-2007, the patient saw an orthopedic surgeon. The patient underwent an X-ray which revealed no bony abnormality. The orthopedic surgeon recommended that the patient go to physical therapy. At the time of the report, the patient had not recovered. The physician considered the left shoulder pain and difficulty sleeping on her left arm to be disabling events. Additional information has been requested.
Diffuse red raised lesions in multiple crops. Some with vesicles, others excoriated. RX: Benadryl, Aveno Bath
Body aches; Fever (Body temperature 1 week after 99.3 Fahrenheit consistentaly); Large swollen lymph node on right clavical area (same side as injection site); headache; This is a spontaneous report from a contactable nurse (patient).  A 27-year-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 28Jan2021 at 08:15, for COVID-19 immunisation. COVID-19 vaccine was administered at Hospital. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included type 1 diabetes mellitus, hypothyroidism, irritable bowel syndrome (IBS) and anxiety and latex allergy, all from an unspecified date. Past drug event included drug hypersensitivity due to liraglutide (VICTOZA). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included insulin for type 1 diabetes mellitus, buspirone hydrochloride (BUSPAR), levothyroxine sodium (SYNTHROID), vitamin D and folic acid. On 28Jan2021 at 08:00 PM, the patient experienced large swollen lymph node on right clavical area (same side as injection site) and headache. Body aches and fever 24 hours after. No treatment was received. Body temperature 1 week after 99.3 Fahrenheit consistentaly. Post the vaccination, the patient has not been tested for COVID-19. Clinical outcome of the adverse events was unknown at time of this report.   The information on the lot number has been requested.
Got my Period 10 days after receiving the vaccination which was  13 days earlier than my normal cycle, which means I did not ovulate. My cycles have always been normal and right at 35 days I know this because I have been tracking for years, after the vaccine, it came 13 days early and then lead to 2 cycles after that being 44 days and 45 days long, that is 10-11 days longer than my normal 35 days cycle. My next cycle after the short and two long ones was 31 days and I got pregnant that cycle and miscarriage at 6 weeks gestation. My cycles have been messed up since the vaccine. My hair started falling out approximately in November of 2020 about 1 1/2 months after vaccine and is still falling out to this day, I have never experienced hair falling out like this before, this is still going on to this day. My periods have been painful and I have not experienced this prior to the vaccine and leading up to my period I have felt odd pain over my ovaries which I never felt before the vaccine . My left arm where the injection was done started shaking and jerking when in certain positions approximately around November of 2020, my left arm feels weak and shaky all the time. I have felt anxious over the last several month since the vaccine which I never struggled with before.
7 min. after flu shot was given, c/o feeling bad.  Heart rate-76/minand regular, respirations 16/min and regular.  C/o slight tightness in her throat.  At 10:00 a.m., c/o increased throat tightening.  Resp-16/min and regular, pulse-76 and reg.  No shortness of breath noted.  Color pink, skin warm and dry.  Taken to ER by government vehicle, accompanied by 2 fellow employees.
No additional AE reported; Caller states a 4 year old male patient was administered ROTATEQ on 20JAN2023 in error; This spontaneous report has been received from a medical assistant concerning a 4-year-old male patient. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 20-JAN-2023, the patient was vaccinated in error with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# 1908328, has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date not reported, but upon internal validation established as 17-NOV-2023) (dose, anatomical location and route of administration were not reported) (Product administered to patient of inappropriate age).  No additional adverse event was reported.
82 year old male with history of hypertension, hyperlipidemia, mild dementia presented with progressive worsening weakness over the past 2-3 weeks.   Patient reported that he has noticed whole body weakness that has progressively worsened over the past few days.   Reported that he has noticed feeling weak, fatigue and requiring more energy to do his daily activities over the past few weeks.   He went to his PCP's office yesterday and had laboratory tests for further evaluation.  Initially his PCP thought he might have PMR since he had bilateral UE soreness.  However, the labs returned reassuring and does not seem to suggest the diagnosis of PMR.  Since yesterday, he has noticed worsening of his weakness.   Reported that last week, he was still able to play golf.  Today, he was unable to get out of his car or get up from a sitting position without help.   Associated with unsteady and poor gait.   And reported that he has numbness in both hands and feels like his grip is weak.   Denied fever, chills, nausea, vomiting, diarrhea, constipation, chest pain, shortness of breath, headache, vision changes, no urinary/fecal retention or urinary/fecal incontinence.  Primary Discharge Diagnoses  1. Guillain Barr syndrome., 03/16/2021  Secondary Diagnoses: Guillain Barre Syndrome (AIDP) Hypofibrinogenemia Thrombocytopenia and Anemia, have been fairly stable for more than a week Hypokalemia Hyperlipidemia  Hypertension, BPs controlled  Mild dementia
Extreme soreness, limited range of motion, decreased strength. Symptoms have lasted over 3 months. Physician diagnosed as bursitis. Gave pt MRI and X-rays, and physical therapy recommended.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Rash appeared on left hand only-Mild
Patient reports receiving his first Pfizer vaccine on 02/08/2021.  The following day, he experienced fatigue and headache.  He received his second Pfizer vaccine on 03/01/2021.  The following day, he reports experiencing worsening headaches and extreme fatigue.  He states that headaches increased in severity and frequency over the next month, so he saw his PCP, who ordered a head CT scan.  He does not remember the exact date, but it has been "about a month" ago.  CT scan was normal per the patient report.  He has continued to experience up to 4 headaches per day, and takes Tylenol with little to no relief.  Patient states his PCP referred him to a neurologist, with whom he cannot get an appointment until September.
Myopericarditis 48 hours after 2nd dose of Pfizer vaccine with chest pain, shortness of breath, and nausea.
Pt reported redness and swelling that was descending down the (R) arm, still present 3 days after administration. General malaise/ill feeling. Tx doxycycline x 10 days.
Gave client vaccine; she denied any sexual activity since starting DMPA 12/09. Found out approx 20 min later that client had + UPT when preparing to give 2 DMPA injection.
gets the vaccination, shingles in her ear/Suspected vaccination failure; shingles in her ear; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 81-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster oticus (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the herpes zoster oticus and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster oticus and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's mother. The patient got the vaccination and unfortunately, a couple months before the date of reporting, the she got shingles in her ear. The patient was in lot of pain. The reporter stated she was okay at the time of reporting. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation for shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
Swelling in throat, feels as if something is in my throat that needs to be swallowed. Slight pain when I swallow. Swelling is on the right side of my throat located under my adams apple.
This spontaneous report as received from a registered nurse refers to her currently 36 year old daughter with none medical history and none drug reactions/allergies. The nurse reported that in approximately February 1999, when her daughter (the patient) was 15 months old, she was a dose of vaccinated with M-M-R II (dose/frequency, route and lot number not provided) (therapy type: HSA). No concomitant medication had reported. And an unspecified amount of time later, the patient experienced a measles like rash, ear infection and high fever. The patient visited physician's office for seeking medical attention. No lab diagnostics studies were performed. The patient was treated with unspecified antibiotic. The outcome of measles like rash, ear infection and high fever was recovered on an unspecified date. Additional information has been requested.
This spontaneous report was received from a certified medical assistant, referring to multiple patients of unknown age and gender. The patients concurrent condition and medical histories were unknown. On an unknown date, the patients were vaccinated with an improperly stored dose of M-M-R II (Lot # and expiration date unspecified) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from female consumer of unknown age, referring to herself. Medical history, concurrent conditions and concomitant therapies were not reported. In approximately November 2013, reported as "3 years" previous, the patient was vaccinated with a dose of ZOSTAVAX, reported as one time immunization (strength, frequency, dose, route, lot/batch number and expiration date were not reported). The reporter stated that she was diagnosed with Shingles 3 years after receiving ZOSTAVAX, in approximately November 2016 reported as "a couple of days ago". The outcome of shingles was unknown. The relationship of shingles and ZOSTAVAX was not provided. There was no Product Quality Complain (PQC). Additional information is not expected as the patient did not wish to provide healthcare professional (HCP) contact details.
11/26 evening feverish, chills 11/27 morning nauseau, fatigue, rash & swelling at injection site, swollen  lymph under arm (left arm, injection arm) 11/28 - 12/1  raised itchy rash on non injection arm (right), spreading to underarm & side right breast 12/1 prescription for triamcinolone acetonide ointment , 0.1%, 2x daily 12/6 rash abating
Patient contacted the pharmacy around 8:05 AM the day after her immunization stating that she was developing welts near the injection site that were spreading across her upper body. The pharmacist advised the patient to seek emergency treatment, the patient was agreeable. The pharmacist followed up with the patient that afternoon, where the patient reported that she had gone to an urgent care clinic where they noticed her tongue was swelling and sent her to an emergency department. The patient was then treated with IV medications, steroids, and discharged her with further medication for home. As of 5:30 PM the patient stated that she was feeling better.   I was not involved in the treatment of the patient's reaction. I administered the vaccine and advised her the following morning to seek emergency treatment.
I had my vaccination on 10/30/2021. On 09/28/2022 I started to experience a dry scratchy throat. I had a headache sore throat ear aches and aches and pains on upper torso on 09/29/2022 in which I tested COVID-19 Positive. I started the Paxlovid on 09/29/2022.
AE started about 10 to 12 hours after injection.  Developed in order- sore arm, full body aches, chills, severe headache, fatigue, fever.  All symptoms resolved in about 48 hours.
Had spell last pm playing, tripped and fell down 2 steps, crying immed. Mom picked up, she stiffened, then blacked out briefly then awoke, No colors, no shaking. Once awake, seemed initially a little drowsy, then normal. Taken to ER evaluated. No labs, temp 103 in ER. No suspect breath holding spell and unrelated fever. If fever persists will follow up. Mom reports frequently holds breath when angry.
Inability to sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Inability to sleep) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dementia, Blood pressure high and Diabetes. Concomitant products included LISINOPRIL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INSOMNIA (Inability to sleep). At the time of the report, INSOMNIA (Inability to sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details reported.
I have been having episodes of tinnitus for about 30 years. After the first vaccine, tinnitus was 24/7 with increased in sound.  After 2nd vaccine, unnerving - loud, constant, losing sleep.  Still loud, constant but must be getting used to it - able to sleep.  However, if I wake up early, cannot get back to sleep because of noise.
Pt received vaccine about 12:50 pm.  After about 10 min  while in observation, pt  reported through daughter that she was experiencing facial tingling, and then began to feel "arm heaviness".  Pt was taken to 1st floor urgent care at same facility for evaluation.  No intervention done in vaccine clinic.
Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vial did not undergo temperature excursions.  It was reported that date the vial was initially stored in the refrigerator was 31-Jan-2022.  No treatment medications were reported.   This case was linked to MOD-2022-525860.
On 11/03/2021, the day after receiving my vaccine, I notice what looked like pimples or little blisters on my upper chest. It then developed into a red rash all around. It got worse overnight and into the next day. When I went into the urgent care, the doctor said it was a reaction from the vaccine because I had not waited long enough to receive my vaccine after using steroids for my asthma. They gave me a steroid injection and also was put back on oral steroids for a few days. It resolved after that.
Escar formation on right upper arm,w/ positive cellulitis & positive induration; treated with Keflex
This spontaneous report was received from a health professional (nurse) refers to multiple unspecified patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were unspecified. On an unspecified date, the patients were vaccinated with improperly stored RECOMBIVAX HB. Concomitant medications were not reported. No adverse effects were reported. This is one of the four reports received from the same reporter. Additional information has been requested.
Patient received Pfizer COVID vaccine on 10/14/21 and 11/12/21. On 11/30/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure due to COVID-19 infection/pneumonia and multifocal PNA. As of today 12/7/22, patient is still admitted in the med/surg unit.
The patient felt hot and sweaty and was afraid of passing out. He was placed on the floor and his blood pressure was fine . His symptoms resolved after a few minutes.  I observed the patient for 30 minutes and he had no further problems.
sore arm; redness; This case was reported by a physician via sales rep and described the occurrence of pain in arm in an unspecifid number of patients who received Men B NVS (Bexsero) for prophylaxis  Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm and erythema. On an unknown date, the outcome of the pain in arm and erythema were unknown.   It was unknown if the reporter considered the pain in arm and erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were provided as follows: The age at vaccination was not applicable. The reporter stated that, after vaccination with Bexsero, the patient had sore arm and redness. The reporter did not consent to follow up.
After waiting for 15 minutes after the vaccination, the patient and her mother returned to the pharmacy. The patient had a heavy feeling in her chest and it felt like a lump in her throat. She was not having trouble breathing. I had her sit down next to her mother to monitor further. After about 5 more minutes, she felt like her symptoms were getting worse. She stated that she was feeling cold and shivering. I had her lay on the floor. I had my technician call 911. I stayed next to her to monitor. I had her also sit up to drink some water. She complained of her jaw starting to hurt and her head was throbbing. The paramedics arrived shortly after.