chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed hives 3-4 days after being administered the dose of GARDASIL 9 which started on the patient's arms and then spread to the rest of her body.; This spontaneous report was received from a nurse, via a company representative, and refers to a 21-year-old female patient, who was not pregnant. The patient had no pertinent medical history, concomitant therapies, drug reactions or allergies.  On an unknown date in June 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot #, expiry date, exact dose and injection site were not provided) as a prevention of human papillomavirus (HPV) cancer. On an unknown date in 2019 (reported as 3-4 days after inoculation), she developed hives, which started on her arms and then spread to the rest of her body. On an unknown date in 2019, the patient called the doctor office due to the event and was given advice to go to an emergency room (ER), whether the rash got worse. No specific treatment was given at that time. She did not need to go to the ER as the rash cleared up on its own, on an unknown date in 2019.  The causality assessment was not provided.
I received my first Pfizer COVID-19 booster on 11/26/2021. On 4/30/2022, I woke up with a sore throat. I found out that some people I had socialized with recently had tested positive for COVID-19, so I decided to test myself. I took a home antigen test, and it was positive. I was out of work for a week, and by the time 5/4/2022 rolled around, I was pretty much back to normal. For the most part, my illness was very mild. I started off with a scratchy throat, which went away. I then had sinus congestion and runny nose, but I don't remember sneezing.
Patient received Varivax on 7/27/09.  Mother called the office the next afternoon stating that were the child received the injection was raised and about the size of silver dollar.  Patient was told to apply ice and take Benadryl as needed.
3/20/07 1:30am:  Hallucinating (Dr. said via telephone to proceed to Med. Center.  Hallucinations continued with and without fever.  At hospital the pt. became unable to walk or stand. The physicians agreed that he could be getting inflammation around his brain.  He was sent by ambulance to another Hospital.  He was there for only 2-3 hours and was released although he still had difficulty walking and was hallucinating without fever present.  30 min. after being released he had a grandmal seizure and was rushed by ambulance again to another hospital because he was having difficulty breathing.  He continued to not be able to walk for 5 days.  He continued to have seizure activity, fever, leg swelling, and personality changes for atleast 5 days after this. He had to be given Rectal Diastat to stop the grandmal seizure.  We have had to have MRI's of his brain and spinal cord and a sleep study after all of this. Those were normal which proves that he does not have a seizure disorder or tumor which could've caused these symptoms.  It was an adverse reaction to the vaccinations.  He continues to have personality changes which began after the vaccinations.  He is not the same child.  He even started biting us 2 days after the vaccinations.   We have encountered 3 ER visits, 2 ambulance rides, 2 MRI's, and a sleep study all because of this adverse reaction, not to mention the week that our whole family missed of work.  08/03/2007 MR received from PCP for several OVs beginning 4/23/2007 for F/U of sleep study and MRI for worsening of a seizure disorder with atypical characteristics such as hallucinations, ataxia, and bilateral lower extremity weakness.  He additionally has had increased snoring s/p T&A. Assessment (4/23/2007): Seizure disorder, Hallucinations, Bilateral extremity weakness, Bilateral lower extremity ataxia, Recurrent URIs, Excessive Snoring, Sleep disturbance.    08/06/2007 MR received for ER visit 3/20/2007 for Febrile Seizure  several hours after D/C from another facility.  Rectal valium given by parents which stopped the seizure after ~20 seconds. Child had an unusual gait although other symptoms had improved. DX: Febrile Seizure.   09/04/2007 MR received for ER visit 3/20/2007 for c/o fever and hallucinations. PE (+) crusty rhinorrhea and upper airway noise upon auscultation of lungs. ER MD discussed w/ Immunology-no further testing recommended. Final DX:  Fever.  Hallucination.  Additional ER visit for viral illness in 7/2007. 1/11/2010 My son continues to have tremors when he runs fever. In Nov. 2007 (the last time that he ran a fever) he had several episodes of tremors we had to rush him to the E.R several times. He never had these tremor episodes until after these vaccinations. These tremors began the day after the vaccination. These tremors are seizure activity. My son also complains of joint pain from time to time.  Follow-up: Patient has a time back in August where he became unable to walk again. He could walk at times with difficulty. He began crawling again. It lasted about 3-4 days. I would like to be contacted to know what trends / links were found.
diffuse red macular rash on face, chest, arms; eyelid swelling. describes as burning. appeared gradually after receiving injection 18-24 hours
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Booster dose on 19-JUN-2023 which was expired on 12-JUN-2023) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE on 20-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE on 27-Oct-2021 and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 19-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-Jun-2023,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Booster dose on 19-JUN-2023 which was expired on 12-JUN-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Booster dose on 19-JUN-2023 which was expired on 12-JUN-2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Booster dose on 19-JUN-2023 which was expired on 12-JUN-2023).    No concomitant medication was reported.  No treatment information was reported.
PFIZER VACCINE WAS ADMINISTERED UNDILUTED.  THE PATIENT WAS INFORMED BY THE PHARMACIST. THEN THE PHYSICIAN OFFICE WAS  CALLED AND LEFT THE MESSAGE WITH THE OFFICE. NOTIFIED THE CLINICAL COORDINATOR AND THE DISTRICT OFFICE
felt very drugged; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1:), for COVID-19 immunization, reaction(s): "she had scaly rash all over her neck for 4 or 5 months", "severe allergies", "they were not sure if her throat would close"; Bnt162b2 (Dose 2:), for COVID-19 immunization, reaction(s): "severe allergies", "had hives for another 4 months"; Bnt162b2 (Dose 3 (booster):), for COVID-19 immunization, reaction(s): "severe allergies", "caller's high blood pressure shot up really high", "rash all over her neck". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt very drugged".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pain and tingling immediately, whole arm down to fingers Moderate swelling of upper arm  within first hours after shot Within 24 hours, some itching on torso, spreading to upper thighs by hour 30 Within 36 hours, some dry coughing with wheeze; possible throat constriction and a feeling of difficulty breathing Presented at hospital 12/21/2019 at 4 am with diff breathing, tachycardia, high BP Swelling of arm, throat constriction, itching etc. relieved within 30-60 minutes of receiving oral dose of Prednisone 60 mg Contiuned with four daily doses of Prednisone 40mg
Within 10 mins of receiving the vaccine my  mouth began to have an adverse metallic taste.  It altered my taste the rest of the day and is till affected this morning, Friday 11/5/21.
Information has been received from a registered nurse concerning a 20 year old female staff who on 19-APR-2011 got splashed in her eyes with GARDASIL (lot # 666987/1016Z, expiration date 22-NOV-2012) during the administration of the vaccine. The patient felt some burning in her eyes but the pain was gone after using eye wash. On 19-APR-2011 the patient recovered from burning in her eyes and pain. The patient sought unspecified medical attention. No lab diagnostics performed. Additional information has been requested.
Experienced severe migraines on 4/4, 4/6, 4/8.  PCP prescribed rizatriptan rapid dissolve 5 mg Tbdi.  Was able to take this medication on 4/9 when I felt another migraine coming on.  It worked.  The migraines on 4/4, 4/6, and 4/8 began with an aura which lasted more than an hour.  The headaches were so severe that on 4/8 I had my son stay the night.  I never experienced such intense pain in the past.  I do have a history of migraines, but had not had one since 2016.  Typically, I would get the aura, lay down and close my eyes, and then the aura would diminish in 15 - 30 minutes.  I never get a headache with the auras.
very thirsty like she has cotton mouth; pain in the lower left backside above her hipbone; swelling in the arm site; red splotches; itchy; severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (very thirsty like she has cotton mouth), BACK PAIN (pain in the lower left backside above her hipbone), VACCINATION SITE SWELLING (swelling in the arm site), VACCINATION SITE ERYTHEMA (red splotches) and VACCINATION SITE PRURITUS (itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced THIRST (very thirsty like she has cotton mouth), BACK PAIN (pain in the lower left backside above her hipbone), VACCINATION SITE SWELLING (swelling in the arm site), VACCINATION SITE ERYTHEMA (red splotches), VACCINATION SITE PRURITUS (itchy) and HEADACHE (severe headaches). At the time of the report, THIRST (very thirsty like she has cotton mouth), BACK PAIN (pain in the lower left backside above her hipbone), VACCINATION SITE SWELLING (swelling in the arm site), VACCINATION SITE ERYTHEMA (red splotches), VACCINATION SITE PRURITUS (itchy) and HEADACHE (severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Very sore arm.  Extreme fatigue. Headache. Fever.  Symptoms improved after 24 hours of on-set. Treated with tylenol and ibuprofen
BOOSTER DOSE ADMINISTERED MORNING OF 11/17/21, INJECTION SITE RED WITH INDURATION.  LIPS FELT ITCHY, FACE FLUSHED, LOW GRADE FEVER AND HEADACHE.  IT IS NOW 11/19/2021 INJECTION SITE STILL RED WITH INDURATION THAT IS ABOUT TRIPLE IS SIZE FROM THURSDAY.
11:24  Patient stated my heart is going too fast. Immediate assessment by onsite NP and EMS.  Placed on cardiac monitor which showed sinus tachycardia, rate of 113.  SAO2 = 98% on room air.  11:29 Benadryl 25mg po with water.  Patient given bottle of water and cereal bar. VS P109; BP 187/139; O2 Sat 97 11:31 HR decreased to 98; 149/97; 97% on RA.  11:40 HR 92; 142/92- SAT 96% on RA. Discharged with wife @ 11:56.  Stated he felt much better.
This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 57-year-old female patient who received Influenza vaccine. The patient's past medical history included ovarian cancer (at the age of 29 years), lymph node excision (all infected parts as well as 66 percent of lymph glands removed), loss of voice (woke up last Monday with no voice) and walking pneumonia (10 years ago). Previously administered products included Influenza vaccine (Annually during 25 years). Concurrent medical conditions included cough (aggravated at the time of reporting). In 2015, the patient received Influenza vaccine. On an unknown date, less than a month after receiving Influenza vaccine, the patient experienced joint pain and cough aggravated. On an unknown date, the outcome of the joint pain and cough aggravated were unknown. It was unknown if the reporter considered the joint pain and cough aggravated to be related to Influenza vaccine. Additional details were received as follows: The patient was receiving Flu vaccine for last 25 years. In the end of September or in the start of October, the patient received Flu vaccine. By Thursday, less than a week after receiving Flu vaccine, the patient experienced pain in joints and muscles (did not mention headache). The patient did not go to doctor as she thought she was already suffering from Flu and she decided to just wait. The patient stated that, she never had the Flu and was sure that, as the sun came up her symptoms were dead and just dry aggravating cough remained (gotten worse). The patient stated that, on Sunday she was getting better but 2 weeks 1 day after vaccination, she felt like all the symptoms were starting over again. The patient stated that, she was pretty good in health. The patient stated that, she was staying hydrated but still she was exhausted.
Swollen arm, red arm, headaches, nausea, chills, fever all within 24 hours.  Two days later heliotrope rash around eyes, lesion on left hard palate in mouth, additional rash on face and neck, continued nausea and chills.  Heliotrope rash lasted one day.  Overall, sick for 7 days.
Swelled up 30 pounds water weight, rashes began, skin started coming off my hands and fingers, diagnosed with SLE (Lupus)
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored dose of ZOSTAVAX Lot # K000994; expiration date06-MAR-2015 (dose and route of administration not reported). The nurse stated that this might have been previously reported but she declined to provide any additional information including name of physician. Additional information has been requested.
The patient received Prevnar 13 on 11/20/2018 and again on 11/20/2020. No adverse event(s) have been reported. The patient was instructed to contact the pharmacy and file a VAERS report in the event an adverse event occurs.
Narrative:  Admission Date: Nov 5,2021 Discharge Date: Nov 8,2021 Condition of patient at discharge: Stable Disposition of Patient at Discharge: Home Primary Diagnosis during Admission/Treatment: COVID-19 PNEUMONIA 62 y/o female w/ PMHx of COPD (FEV1 14%, 2L NC baseline), alcohol use disorder, tobacco use disorder, OSA (on BiPAP) who presents with fatigue and progressive SOB found to be positive for COVID and have COVID pneumonia despite vaccination x 3 with Pfizer COVID vaccine (03/24/2021, 04/15/2021, booster 10/28/2021). She got her 3rd booster seven days prior to the Emergency Room visit 11/4/21. She reported feeling lousy with myalgias since the booster shot. Two days prior to the ER visit, she noticed significant fatigue, dry cough and inability to play with her grandchildren. One day prior to the ED visit, she reported a fever of 102 and started taking Tylenol. She had another fever of 103 prior to her ER visit and noticed that her spO2 on her home pulse ox was dropping into the 80s. She came to the ER the morning of 11/4 and was found to be covid-19 positive. She was on her home o2 oxygen requirements of 2L nasal cannula. She denies HA, chest pain, abdominal pain, n/v/d/c, or peripheral edema. In the ER, she was initially satting 78% and was placed on 5L NC with pulse ox going to 98%. ABG on 98% 7.43/47/97/31.5. She was given dexamethasone and admitted to the hospital for Acute Hypoxemic Respiratory Failure (AHRF). Brief Summary of Hospital Course: Presented with worsening dyspnea and increased oxygen requirement  from baseline 2L NC up to 5L NC with movement. Patient reports being COVID-19 triple vaccinated. Pro-cal is neg. MRSA nares negative. D-dimer 2.86 and Ferritin 471 were elevated, but CTPE without PE. CT chest also showing atypical PNA consistent with COVID and pronounced emphysematous changes. Treated with dexamethasone 6 mg PO for 10 days and Remdesivir and therapeutic enoxaparin during the hospital course. Due to concern for possible COPD exacerbation on top of COVID PNA we gave 3-day course of azithromycin before transitioning back to home dose of 3x weekly. Walk test on day of discharge with no increased oxygen requirement, continue 2L NC. Stable for discharge.
After the 1st injection, patient started to inhale. The 2nd 2 injections were given and patient made a slight noise as if he were trying to cry. MA instructed parents to pick him up and blow on his face to try to get him to cry and start breathing on his own. Mother picked up him and he was limp in her arms and his face had started turning purple. His eyes were closed but he did respond to being rubbed on the head. MA ran to get MD from her office 3 feet away and when MD first arrived, patient was limp and purplish and apneic in mother's arms. We placed him on the exam table and he started having spontaneous respiratory effort. A pulse ox showed SpO2 96%, HR 140. MD listened to heart and lungs and by this time his color had improved and he was breathing on his own. The apneic/limp period lasted for possibly 40 seconds at most.
Painful left foot toe area. Swollen joints on big toe. Research similar to Gout. Pain started 2/23/21 (3 days after vaccination) and increased to present 3/04.21. Painful walking and could not sleep well for several days. Took Ibuprofen, few aspirin. Ice cold pack provide some relief. Today 3/04/21 is first day of minor pain, perhaps a pain level 3 out of 10.  Roughly eight or nine days of pain level 7 or 8 out of 10 (very unpleasant)
May 8, 2021 - Rec'd #1 shot at 09:53 am, after leaving the pharmacy, experienced dizziness (20 minutes after injection). The dizziness became worse after 60 minutes. Two hours after injection, I experienced site injection arm pain. Four hours after the injection, I experienced generalized muscle aches in my extremities.  I took a tablet of acetaminophen, hydrated with Gatorade and water, and went to sleep.  The following day (May 9), the dizziness was gone, left arm injection site pain increased and generalized muscle aches continued.   Hydration with Gatorade and water continued.  May 10 - experienced slight headache, acetaminophen taken, continued with hydration.  May 11 - recovered from all adverse events.  Second dose scheduled for June 5 (Moderna).
Onset of strange behavior - acting withdrawn but not confused per family. Then developed nausea / vomiting / headache / fever and admitted for evaluation. No infectious etiology identified. Felt to be vaccine reaction vs. viral infection.
Patient and mom in waiting area after injections and mom called to front office staff that patient "choking." I went to waiting area immediately and patient having difficulty talking. Face red with swelling noted around eyes. We brought patient immediately to exam room for assessment and treatment. Patient coughing with O2 sat @ 97% RA. Patient able to answer questions. Verbally with labored breathing. Per Doctor - Epi pen Jr. admin started (L) thigh. BENADRYL 25mg and PREDNISONE 30mg. PO given with desired effect. 911 called and pt taken to hospital in stable condition.
Patient stated that she had numbness on her right side from her face to her toes.  She felt dizzy. and tingling in her whole side.  She said that she had a neurological reaction to a previous dose and has been see a neurologist.  Vitals were checked and all were stable.  Went to the er with the paramedics however.
Warm, egg shaped lump at injection site 5/5/14. Dr said "Hematoma, bruise" Follow up 5/7/14 - Not hurting now, Dr - rx'd "TYLENOL and warm compresses".
I had chills and felt run down after receiving the vaccine for about one day. I had a sore throat which led me to test for COVID-19 and it was positive 02/28/2023. I contacted my doctor and got a prescription for a steroid and an antibiotic. As of today, I have a little bit of a wheeze all the time.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # N011491 with expiry date: 04-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32 F to 35 F for a duration of 23 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved.
Information has been received from a registered nurse referring to a 12 month old patient. The patient's medical history was not reported. On 04-MAY-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) lot # K021934, exp 10-NOV-2016, 0.5 ml, subcutaneously in the left leg. No adverse effects reported at this time. No concomitant medication was reported. Action taken and outcome were not reported. This is one of several reports from the same source. Additional information has been requested.