chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious, spontaneous report of administered expired FLUMIST in a 30 month-old female patient was received from a nurse practitioner in the United States. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 11 customers not discarding product fromt he previous season and 21 product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 24-Mar-2009 and incorporated into the narrative lot investigation results.
I noticed a new persistent bitter / metallic taste on my tongue that would not go away; I also have experienced, for the first time, nerve tingling in my feet (especially toes, but sometimes heels as well). The symptoms were so strong, I took a covid test to confirm I hadn't somehow come down with covid at the time of vaccination, but my test was negative. I also had a blood sugar test done to confirm it wasn't diabetes, but my fasting blood sugar level was in the normal range  (95).
This case was reported by a other health professional via call center representative and described the occurrence of chills in a 62-year-old female patient who received SHINGRIX (batch number H7JY4, expiry date 1st July 2021) for prophylaxis. On 19th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced chills and cold. On an unknown date, the outcome of the chills and cold were unknown. It was unknown if the reporter considered the chills and cold to be related to SHINGRIX. Additional information was provided as follows: The patient experienced chills down to the bone for about a week, shivering and cold for several days.
Pt received yellow fever (Stamaril) on 9/27/2017. On 10/4/2017 pt reports symptoms of tiredness, muscle ache and headache. On 10/5/2017 pt reported he woke up sweating profusely. He was seen by his primary care on 10/6/2017. No diagnosis- per pt it was a normal reaction from the vaccine. No medication or labs works done. Symptoms all resolved by Saturday 10/7/2017.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: EL0140), in left arm, on 30Apr2021 as dose 2, single (Lot number: EL1283), in left arm and on 08Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive. The patient was treated with Paxlovid from 03Mar2023 to 08Mar2023. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID-19, which is considered as failure of vaccine BNT162B2, and the administration of BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors.
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified date, the patient was vaccinated with an improperly stored dose of PROQUAD "rHA" injection (dose, frequency and route were not reported) lot # M044021 with expiration date of 01-MAY-2018, for prophylaxis. The sterile diluent (lot # and expiration date were not reported) used to reconstitute the PROQUAD was properly stored. The temperature excursion of the PROQUAD was between -9 °C and 8 °C for a time frame of 1 hour and 10 minutes. No previous temperature excursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested. Sender's Comments: US-009507513-1706USA005163: US-009507513-1706USA005174: US-009507513-1706USA005176: US-009507513-1706USA005177: US-009507513-1706USA005178: US-009507513-1706USA005179.
Chills fatigue, mainly very  Large increase in tinnitus, happened  after 2nd dose
First dose on 03/16/21:  Slurred speech, speech problems, chest pain Second dose from the same Lot # on 04/13/21 : Rapid heart beat, chest pain, swollen ankles and lower legs.
I've had extreme fatigue (cannot get out of bed and move a few feet without being winded), severe migraines, and nausea for a week now. Can barely do anything but sleep.
When I first got the shot, my left arm and leg went numb and was tingling. About a day later, my whole body started feeling stiff like I could not move. On Feb. 23, I went to the ER. They drug test (negative), blood work, and some x-rays. They could not find out what is causing this.
16-year-old male with no significant past medical history, now presenting with chest pain. Patient had 2 episodes of left-sided mid-chest pain. The initial episode was at ~ 3 am on 5/18 when the pain woke him up from sleep, lasted for ~ 20 minutes and he was able to fall back to sleep, he did not mention it to his parents at that time.  Then it recurred at 2.30 pm - pressure-like pain in the same area, which radiated to his left shoulder. There were no significant worsening or alleviating factors. No change in pain quality or intensity with position. No shortness of breath, near-syncope or syncope, no palpitations. Upon his second pain episode, he called his parents on video chat and they instructed him to take 81 mg of aspirin and the pain subsided after 30 minutes. His parents promptly took him to the urgent care where he was found to have ST elevation and elevated troponin. He was transferred to CICU for further management.   Admitted for myopericarditis with ST elevation and elevated troponin.  On motrin q8h ATC, 12 lead EKG and troponin levels q6h.  Underwent cardiac MRI on 5/20 which confirmed the diagnosis.
I experienced moderate body aches, a mild headache, and moderate-to-severe fatigue. These started when I awoke around 10am the morning after 2/4/21 getting the dose at 3pm the day before (2/3/21). By the end of the evening (8pm) on 2/4/21, I had mostly recovered from all of the symptoms and at 10am on 2/5/21, I felt fully recovered.
Patient (002956225) - received Moderna vaccination (Lot # 0011A21A) on 04/16/2021 at 09:02 in the left arm by RN. 0904 Patient began walking from the Vaccine station towards Observation.  After approximately 20? feet, LPN in another vaccine station down the line, noticed the patient stumbling towards the wall. She observed him stumble/fall into the wall, hitting his head, then began falling to the floor. LPN came around her partition, called for help and was immediately assisted by LPN.  The two nurses assisted the patient to the floor.  They reported his eyes were fully dilated and he began having light, full-body shakes.   The two nurses turned the patient on his side and held his head. Waters said the patient was able to answer all questions appropriately.  The full body shakes lasted approximately 30 seconds.  The Patient did not lose consciousness.  0905 Lead Nurse arrived noting the patient was lying on the floor in the prone position exhibiting mild seizure like activity and his pupils were dilated. Patient was rolled onto his side until the seizure like activity subsided, lasting for approximately 30 seconds.  0905 IC/PSC called 911, PD.   The site Medical Protocols plan was activated.       0906 Vital signs were obtained:   Blood pressure:  96/80, HR 78, 02 at 91% on room air. A neuro check was performed on the patient and he was noted to be alert and oriented x3. Patient stated he had not eaten anything prior to coming in. Patient was assisted to a seated position while still on the floor. Patient was given water, juice, a banana and other snacks.    Nurses in the Observation Station noticed the incident from across the arena and brought the EpiPens, AED, Blood Pressure Cuff and med bag. 0910 Vital signs were obtained:  BP 104/47, HR 50, 02 98% on room air and respirations 18. Patient remained fully alert and oriented but noted to have mild tremors of both hands.  0915 TFD, followed shortly by EMS, arrived on scene at and assumed care of the Patient.  0926 Patient decided to be transport to the Hospital and was removed from facility via stretcher.
Patient stated that she could not drink out of a bottle on 05/04/2022. that same night, patient stated her eyes were watering and painful. The following morning, the patient stated she attempted to drink out of a straw and was unable to. Patient stated she did not take any over the counter medications for her symptoms. on 05/06/2022, Patient stated that she was unable to close her left eye and the left side of her face began to droop. Patient reported to the Emergency room at Medical Center that same Friday, and stated she was given Valtrex 1g to take 2 tabs per day as prescribed by a Bio-neurosurgeon.
I recently got the vaccine. It hurt; It's worth the minor discomfort; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had Shingles when he/she was 15 and it was so painful he/she thought he/she would die).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and discomfort. On an unknown date, the outcome of the pain and discomfort were unknown.   It was unknown if the reporter considered the pain and discomfort to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient got Shingles vaccine and experienced pain and discomfort.
Severe shaking.  Spasms and body jerking.  High temperature. Confusion.  Imbalance.
HYPERSENSITIVITY; PRURITIC RASH; This spontaneous report received from a patient concerned a 24 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included plaque psoriasis. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection, batch number: UNKNOWN, route of admin was not reported) dose and frequency were not reported from 17-MAR-2021 for plaque psoriasis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced hypersensitivity. On 2021, the subject experienced pruritic rash. Laboratory data (dates unspecified) included: Skin biopsy (NR: not provided) Not reported. The action taken with covid-19 vaccine  was not applicable; and action taken with adalimumab was not reported. The outcome of the pruritic rash and hypersensitivity was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Complained of "bad headache" and "swollen red eyes" which started 2 hours after injection, seen by primary care physician who diagnosed "migraine" and prescribed medicine (unknown what), headache continued and she went to emergency room, meningitis was suspected.  Labs and "tests" done, refused spinal tap, spent a day in emergency room Percecet, compazine and IV fluids.  Recovered 48 hours after flu shot.
Severely swollen lymph nodes in left arm pit arm of the injection also swollen lymph nodes on collarbone at neck. Painful to put my arm down or lift anything with my left arm, stabbing pain in lymph nodes in armpit, feels like an underwire stabbing me in the armpit   Going on day three. Pain Keeps me awake at night.
6 hours, post vax, had hives on face. Seen in ER and treated. Call in the morning at home. No problems.
This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients of unknown demographics. It was reported that on an unknown date, unsupported doses of GARDASIL (lot number, expiry date, dose and route unspecified) which was exposed to 15 degrees Fahrenheit (F) for 18 hours may have been administered to patients. The reporter was unsure if administration had occurred. No concomitant therapy was reported. Additional information has been requested.
Still having dull headache on left side of face behind left eye.  Saw eye doctor, who reports loss of vision and is recommending surgery on eye to relieve pressure on optic nerve. Left ear complete loss of hearing.
Swollen lips, slight cough without difficulty breathing, hives on fingers and ankle.  Child's grandmother gave her Benadryl. Child's grandmother stated that the Benadryl seemed to help alleviate the symptoms.
Mom reported via telephone today 10/22/12 that her child developed rash and her face was swollen 2-3 hrs after her flu shot on 10/18/12. She gave the child BENADRYL symptoms persisted she took child to ER on 10/20/12 they tested child for strep came back neg. they Dx her with allergy to Flu vaccine. Rash was entire body also had fever 103.5. Mom alternated TYLENOL and MOTRIN, ER put child on steroids PO.
PATIENT CAME TO PHARMACY TO ASK ABOUT SIDE EFFECT OF THE PFIZER VACCINE. PATIENT STATED THAT HE EXPERIENCED WEIRD CHEST FEELING/PRESSURE, ALMOST LIKE POUNDING HEART. PATIENT CAN STILL FEEL THE HEART FEELING COUPLE WEEKS AFTER THE INJECTION OF HIS 1ST PFIZER DOSE. PATIENT WAS ADVISED TO SEE DOCTOR OR URGENT CARE TO GET THE HEAR CONDITION CHECKED ASAP.
Dime sized hive, redness at injection site and diziness: appeared 7 days after vaccination, remains 48 hours after appearance Fatigue, headache, congestion, severe arm pain: appeared 4 hours after injection, lasted 6 days
Patient passed away on 12/11/21 at 12:11pm from bilateral pulmonary emboli (air bubbles not DVT).  Final autopsy results pending toxicology results.
This spontaneous report as received from a nurse practitioner refers to a 37 year old female patient. There was no pertinent medical history, drug reactions or allergies reported. On an unknown date (the nurse presumed that the patient was inoculated when she was an infant, but had no records or definite information), the patient was vaccinated with a dose of M-M-R II injection (dose, dose number, lot/batch number, expiration date and route of administration were not reported). There was no concomitant medication reported. On an unknown date, the patient had the titers drawn because she was changing jobs and her titer results were negative for mumps and rubella. It was reported that the patient had not any adverse effects and had never had mumps or rubella. No product quality complaint (PQC) reported. No treatment was given for the events. The patient did not seek medical attention. The outcome of the event was unknown. The relatedness between the events and M-M-R II was not reported. Additional information has been requested.
immun given 4JAN93-no adverse reactions noted; pt brought to ER 17FEB93 DOA pt started on 5JAN93 terrible crying like alot of pain; cont awful crying everyday till passed away;
patient developed moderate to severe rash on her face and neck starting 1 1/2 hours after the vaccine. This lasted several hours. The rash came back the evening of 4/27 and on her legs the evening of 4/28.
Itchy Throat; Itchy Tongue; Voice was hoarse; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Itchy Throat), TONGUE PRURITUS (Itchy Tongue) and DYSPHONIA (Voice was hoarse) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), ATORVASTATIN, LOSARTAN, ACETYLSALICYLIC ACID (BABY ASPIRIN), VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced THROAT IRRITATION (Itchy Throat), TONGUE PRURITUS (Itchy Tongue) and DYSPHONIA (Voice was hoarse). At the time of the report, THROAT IRRITATION (Itchy Throat) and TONGUE PRURITUS (Itchy Tongue) was resolving and DYSPHONIA (Voice was hoarse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was provided as Benadryl.
My arm started swelling up again and my fingers started going numb again. This time no fever. My middle/ring/pinky started going numb. I was doing what my Doctor had me doing previously and it didn't get better so I went in to see her the following Monday. She said keep doing what your doing and if it's not better by Thursday to come in and she will send me out for Imaging for nerve  testing. She gave me prescription Ibuprofen and Benadryl.  That Thursday I called her because it was better than the previous week but it still bothers me and I don't get full motion of the arm, I can't hook my bra but I can't get any massage appointments. My lymph node is still large. The spot where the I was injected is still very sore and it wraps around my arm.
7/4/04: Puffy eyes/itchy eyes, diagnosed with OM. Prescribed but did not take amoxicillin (because of possible allergy). 7/6/04: Clinic. Temp 102.7. B posterior lymphadenopathy; alert, well appearing. 7/7/04 Seizure at home. ED; repeat seizure, apneic episodes 3 times. Flumazanil, Dilantin and transferred. Never regained consciousness. LP positive, WBC. Died 7/9/04. Labs. Nurse follow up on 08/02/04 states: "Complete." Autopsy report received stated patient experienced Epstein Barr infection and cerebral edema.
Patient is a pharmacy technician and was given the MMR vaccine due to her vaccine titers showing she wasn't fully protected.  She reports that she has never had a reaction to a vaccine.  She is allergic to PCN and Sulfa but she has never had problems with neomycin or gelatin.  She has never had problems eating gummy bears or etc  She reports that she got the shot at about 1530 and by 1715 she started noticing that she felt like she might have a URI coming on and then she started having a metallic taste in her mouth.  This sensation of not feeling well has persisted and she reports that the metallic taste has been present for about 24 hours.  She reports that she doesn't feel hungry due to this sensation.  She reports that over the last two hours she has been having some numbness in the nose and reports prior to this she had some numbness.  She denies stomach cramps.  No lightheadedness.  Possibly dizzy but not sure if it from being tired  she did not sleep last night due having a unusual nightmare like event.  She feels like the overall symptoms are not getting better.
FAST HEART RATE; FACE IS SWOLLEN; FEELING DIZZY; SHAKING UNCONTROLLABLY; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On MAR-2021, the subject experienced fast heart rate. On MAR-2021, the subject experienced face is swollen. On MAR-2021, the subject experienced feeling dizzy. On MAR-2021, the subject experienced shaking uncontrollably. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the face is swollen, fever, headache, feeling dizzy, fast heart rate, chills and shaking uncontrollably was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Pt recv vax on 4/15/99; on 4/16/99 pt exp local redness, mottling, swelling; tx=antibiotic
Lymph nodes swelled - shortly thereafter diagnosed with stage 4 Hodgkins Lymphoma.
prolonged joint pain; prolonged muscle pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (prolonged joint pain) and MYALGIA (prolonged muscle pain) in a patient of an unknown age and gender 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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (prolonged joint pain) and MYALGIA (prolonged muscle pain). At the time of the report, ARTHRALGIA (prolonged joint pain) and MYALGIA (prolonged muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
This spontaneous report as received from a nurse refers to a 4 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 12-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054:
pt recv vax 28JAN98 & approx 2wk post vax pt devel a rash & approx 10 skin lesions on trunk & arms;
10 days after flu vaccine, pt developed rt sided face and HA pain, tenderness over temporal artery. High ESR > 5 responding to Prednisone. Porbable arteritis. 60-day follow up on 02/11/04: "Pt has not recovered from adverse events. Persistant vasculitis-on Prednisone."