chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Enlarged lymph nodes on left side (vaccination side) in recent mammogram; This is a spontaneous report received from a contactable consumer reporting for himself. A 50-year-old female non-pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; Lot Number: EL3247; Expiration date was not reported), via an unspecified route of administration on the left arm on 27Jan2021 12:15 as single dose for COVID-19 immunization at workplace clinic. The patient's medical history was reported as none. The patient had no known allergies. The patient's concomitant medications included unspecified birth control pills. The patient did not receive other vaccine in four weeks. On 16Feb2021, the patient underwent mammogram which revealed enlarged lymph nodes on left side (vaccination side). No treatment was received for the event. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. The outcome of the event enlarged lymph nodes was not recovered.
Patient presented to ED on 1/23/22 with generalized body aches, nausea, vomiting, and headache. PMH is significant for HIV, hepatitis C, and asthma. Patient fully vaccinated with Pfizer on 8/22/21 and 9/12/22. Transferred to ED for admission on 1/23/22. Discharged on 1/25/22.
death; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  An elderly male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "resident in a long-term care facility" (unspecified if ongoing), notes: with many comorbid conditions. The patient's concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the event unknown cause of death and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death
9 days after dose 1 of Moderna, patient developed rash/hives on neck and chest and lips were tingling. (she described the tingling as feeling like she had eaten spicy foods).   She self-treated with 10mg of loratadine and it resolved with that single dose.
Parent noted wheezing, pronounced breathing 24 hours after administration of vaccine. Seen in PMD office 6/20/03. Administered albuterol nebulizer and Orapred. With some relief Mon. noted wheezing after last Prevnar dose as well but not as symptomatic.
1/2 after injection dizzy, weak, tired, shaky, mentally cloudy. BP, pulse OK. Given juice. Sent ER for evaluation.
After receiving a dose of HAVRIX and TYPHIM, the patient fainted in the chair for 2 to 3 minutes. She regained consciousness on her own. She was aware of her surroundings and was able to verify her name and date of birth and that she was getting vaccines. She stated she last ate at 1130am and had a few samples in the store warehouse prior to the vaccines. EMS were called and check the patient over and released her. No further complications were expected.
soreness on the arm; pain; discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), DISCOMFORT (discomfort) and PAIN IN EXTREMITY (soreness on the arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced PAIN (pain) and DISCOMFORT (discomfort). On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness on the arm). At the time of the report, PAIN (pain), DISCOMFORT (discomfort) and PAIN IN EXTREMITY (soreness on the arm) outcome was unknown. Not Provided       This case was linked to US-MODERNATX, INC.-MOD-2021-083927 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083927:First dose
ZOMBIE LIKE; NO ENERGY; This spontaneous report received from a patient via a company representative concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dykinesia with parkinson's disease, covid-19, diverticulosis of intestine, opioid dependence, repeated fall, ventricular tachycardia, continuous positive airway pressure, and flopping like a fish. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included amantadine hydrochloride for dykinesia with parkinson's disease, carbidopa/entacapone/levodopa for dykinesia with parkinson's disease, carbidopa/levodopa for dykinesia with parkinson's disease, rotigotine for dykinesia with parkinson's disease, levodopa for dykinesia with parkinson's disease, and flopping like a fish, calcium, carvedilol, celecoxib, colecalciferol, entacapone, estradiol, ezetimibe, fluoxetine, gabapentin, hydrocodone, loratadine, mirabegron, nortriptyline, ramipril, tapentadol hydrochloride, and vitamin e nos.  On 16-MAR-2021, the subject experienced zombie like. On 16-MAR-2021, the subject experienced no energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from zombie like, and no energy on 20-MAR-2021. This report was non-serious.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 23-OCT-2014, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 17-MAR-2015, the patient was treated the a physician for the onset of a severe vesicular rash which was diagnosed as shingles. The patient was prescribed Valtrex and Hydrocodone for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
pt recvd vax;pox at inject site;urticaria all over trunk; seen in hlth dept;vesicle pox on back & inject site;excessive fatigue, HAs; some swelling behind knees & hot flashes;
Pt presented with 1-2 week hx of weakness, cough, and dizziness. Granddaughter tested positive for COVID early Jan.  In the ED was incidentally found to have her blood sugar and was not in DKA.  Her A1c is 8.5.  She is unaware of any prior diagnosis of diabetes.  She was also found to have COVID-19 with mild symptoms of weakness cough.  Chest x-ray did show signs of atelectasis versus early infiltrate in the right upper lobe.  She was out of the window for monoclonal antibody therapy and was tolerating room air and supportive treatment.    At the time of discharge, the pt was afebrile, clinically stable without active complaints.  Warning signs for which to return to the hospital were discussed with patient who verbalized understanding and agreed with the plan of care.
Within approximately 30 minutes post vaccination, the patient returned to the pharmacy stating her tongue was tingling and her chest felt very tight. She did not appear to be in any distress. Despite this we had epinephrine at the ready. At this time she offered that her last flu vaccine caused this kind of response but this time it was worse. When asked why she did not share this initially, she said, " i didnt see a place on the sheet for it". Over the next 30 minutes her tongue tingling resolved, however her chest remained tight. Her tongue tingling then recurred, at this time I suggested she needed a more appropriate setting to be monitored. The patient agreed, we called 911 and EMTS transferred her to the local hospital.  At the time of transfer, the patient appeared stable without visible symptoms.
Dizziness, Headache, dry mouth, arm swelling; Dizziness, Headache, dry mouth, arm swelling; Dizziness, Headache, dry mouth, arm swelling; Dizziness, Headache, dry mouth, arm swelling; other vaccine same date vaccine date on 20Dec2020; This is a spontaneous report from a contactable other health professional (patient). A 33-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot umber: Ej1685), intramuscularly on 20Dec2020 08:00 AM at left arm, at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received other vaccine same date on 20Dec2020 (lot number: Ej1686), and experienced dizziness, headache, dry mouth, arm swelling all on 20Dec2020 08:30 AM. No treatment was received for these events dizziness, headache, dry mouth, arm swelling. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events dizziness, headache, dry mouth, arm swelling was not recovered. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
On January 21, 2015, client, age 15 years, received 5 vaccines including Tdap, IPV, Hepatitis A, Hepatitis B, and MMR. Approximately 1 minute after vaccines were complete, client became extremely pale, lost consciousness and became very rigid with some uncontrolled movements to bilateral arms. This episode lasted approximately 20 seconds, following which, client regained consciousness and was A/O x 3. Client remained very pale, dizzy, nauseous, weak, and tired following the episode. These symptoms gradually improved over the course of 5 minutes while client drank juice. Client was fully recovered after 5 minutes and ambulated to the waiting room, where she remained seated to wait an additional 15 minutes prior to leaving clinic. Clients color was completely restored and all other symptoms were completely resolved at the time client left clinic approximately 15 minutes following the episode.
Difficulty breathing, fast heartbeat, dizziness and weakness, tiredness, headache , chills, throat pain , feeling unwell, swollen lymph nodes in arm pits and groan area, arm pain / swelling/ hot at injection site.
cold painful stuff in my arm; feeling chills; fever; nauseated; began feeling sick; Headache; felt very weak and tired; felt very weak and tired; I've been constipated since; burning painful; all that night hard time sleep; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration on 13Mar2021 at 07:50 (Lot number : not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included historical vaccine received first dose of bnt162b2,Inoperable lung cancer from 2010 to an unknown date stage 3B lung cancer, metastases to lymph nodes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter stated that she felt the second one "immediately, like the solution hit a nerve or something. I said out loud, "ouch", felt like a cold painful stuff in my arm and immediately my arm started to get pain, and during the time we had to wait afterward, my arm got very sore, hard to pick up my arm. When I got home, I began feeling sick, chills, fever, legs felt like 100 pound weights on them. nauseated felt like lumps in the back of my head. Headache, fever, chills, nauseated, ached all over. I don't know if this is part of it, but my bowels, she have been constipated since, and normally have no issue having bowel movements. she felt very weak and tired. She states that she could feel it Immediately going in my arm, she told the nurse after first, you were good. After the second, It was burning painful, going in on the second dose. (the vaccination provider) " she have never felt an injection to feel that solution to feel painful going in." Caller states, We had gotten ours 7:50am 13Mar2021, I immediately felt it, as soon as she got home, started getting sick, all that night hard time sleep, next day 14Mar2021 all day all night, same feeling, Yesterday, when she got awake it was better. The events were considered as non-serious. The outcome of the event all that night hard time sleep was reported as recovered on 14Mar2021 and other events were reported as unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Right thigh with some induration, warmth and splotchy pink rash over injection site (DTaP 2 days ago). Rash over about 5cm diameter area. No fluctuance, purulence or cellulitis.
COVID+ 12/23/22.  Vaccination status - pfizer x3 BRIEF OVERVIEW: Discharge Provider: PRIVATE MD Primary Care Provider at Discharge: PRIVATE MD Admission Date: 12/23/2022 Discharge Date: 12/24/2022   DISCHARGE DIAGNOSES 1. Vitamin D deficiency 2. Pathologic compression fracture of T6-8 3. COVID -19 4. Leukocytosis - resolved 5. AKI DETAILS OF HOSPITAL STAY: HOSPITAL COURSE: Patient is a 21 y.o. male with no significant past medical history who presented to emergency department on 12/23 with sudden and significant back pain that woke him up at 3:00 a.m. notably, there was no inciting events.  He denied recent trauma of any kind as well as prior pain.  He does not play any sports.  He has not had any recent flu-like symptoms.  He denied bowel or bladder incontinence.In the ED his VSS, his CMP returned wnl no protein gap, crp normal, ESR 14, blood cultures drawn, CBC with WBC 19, he was given 1L NS, toradol for back pain. COVID returns positive.  He was asymptomatic.  He had tenderness to his thoracic spine and weakness of upper extremities. He underwent MRI whole spine, which showed subacute fractures of T6-T8 with <50 vertebral height loss T6, 50% or greater at T7 and T8. Degenerative changes of spine. Neurology and ortho spine consulted in ED and recommended inpatient admission for work up.    Further workup is as follows.  CT with contrast demonstrated prior mentioned subacute compression fractures of T6-8, as well as hypodensity of the pancreatic head.  MRI with MRCP to evaluate this was unremarkable.  A scrotal ultrasound demonstrated a small epidermal cyst with no concern for mass.  A full bone scan demonstrated only the above-mentioned fractures with no other suspicious for lytic lesions.  Initially his complete blood count demonstrated leukocytosis, however, this did resolve after admission.  Peripheral smear demonstrated reactive leukocytosis with a left shift.  Beta HCG, AFP, CEA CA19-9 were negative.  PTH and TSH were normal.  Vitamin-D was 9, representing severe deficiency.    He was started on 50,000 IU vitamin D weekly, and his painwas well controlled with acetaminophen and a lidocaine patch. NSAID's were avoided during hospitalization due to AKI after contrast. He was given a small bolus of fluids and recommended to follow up with PCP for further monitoring. Ortho Spine was consulted be noted that he did not need a brace, and gave him 10lb lifting restrictions until follow up in the clinic in 2 weeks. Hematology on consulted and recommenced outpatient follow up.    He was discharged on 12/24 with instructions to follow up with PCP, Heme/onc, and othro. He was educated on his activity restrictions and instructed to continue the vitamin D, and tylenol/lidocaine and ibuprofen for pain. He, and his parents, were in agreement with the plan and had no questions or concerns at the time of discharge.
complaint of "ball like sensation" to throat and itching to bilateral forearm and redness. Benadryl 50 mg administered orally Patient observed for additional 45 mins Pt symptoms resolved. ER precaution  Pt verbalized understanding
Moderna Covid-19 Vaccine 03/11/2021 received first dose of Moderna. By next day, expected flu-like symptoms were apparent such as chills, headache, and body aches. Then, full body muscle twitches and motor tics began. The continue six weeks later. On the 7th day post-vaccine, early AM sleep paralysis/seizure sensation 4-5 times before falling back asleep. When awoken, unilateral weakness (right side). Right eye vision blurry. Right ear muffled. Subjective weakness and numbness in right arm and leg. Went to ER and was admitted under suspicion of TIA or mild stroke. CT w/oC appeared unremarkable. Scheduled for a brain MRI following day (3/19) WWO contrast. Appeared unremarkable, so acute ischaemia was ruled out. Blood work was done repeatedly during stay (CBC, metabolic, CRP, sed rate, urinalysis). Everything was unremarkable. Discharged with instruction to follow-up if symptoms did not improve. The unilateral weakness is intermittent six weeks later. On 4/20, allergist tested against components of Moderna vaccine intradermally. This showed a reaction compared to the negative control. Allergist advised to avoid further vaccination with any of the ingredients in Moderna. Allergist posited that symptoms could be a latent reaction to the allergy, but wasn't sure as prolonged presentation seems unlikely. Future follow-ups: rheumatologist to rule out acute autoimmune reaction, 4/21/21. Neurologist second opinion 5/4/21. Primary care evaluation, as PCP was on leave for several months, 5/19/21.
Patient received HPV vaccine in (L) deltoid following by Hepatitis A. Pt observed blood on arm, eyes rolled back Pt assisted from sitting to lying position with feet elevated BP 126/80 - Pulse 86, O2 Saturation 98%. Initially unable to answer questions but within 1 minute, pt responsive, alert & oriented to person, place, time provided juice, Pt kept in supine position.
Adverse Reaction to Covid Vaccine   Approximately five minutes following injection of Covid Vaccine patient began to voice concern that her neck, tongue, lips and throat were beginning to "feel funny" She was flushed hot and anxious. She denied SOB, throat tightness or dizziness. BP 142/78 PO 97 pulse 87. Ice pack applied. Temp. 98.2 which client states is above baseline of 97. Benadryl 25 mg PO administered per protocol at 0905. Client continued to voice concern that S/S may progress. EMS notified and dispatched.  S/S began to improve however client continued to voice concern about itchiness in the scalp and tongue irritation. No visible signs of swelling noted. EMS left. A second benadryl 25 mg was administered per protocol at 0940. Client verbalized desire to return home with plan to go to ER if S/S worsened; my contact information was provided. Patient left with her husband. Dr. on call for PCP was notified of above. 3/14/2021 Reached out to patient she stated that she is doing very well today. She had to take Benadryl twice yesterday afternoon. Encouraged her to discuss concerns with PCP.
Patient presented to hospital with URI symptoms, fever, myalgia, fatigue, and diarrhea.
This spontaneous report was received from a pharmacist referring to a 54 year old patient of unknown gender. There were no concomitant medications, concurrent conditions and medical history reported. In September 2015 (reported as "between 10-SEP-2015 and 18-SEP-2015"), the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 03-JUL-2016). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Product storage error; No adverse event; Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and PRODUCT STORAGE ERROR (Product storage error).    Concomitant medication was not reported. Patient administered doses of the bivalent vaccine which was beyond use date on 08-Jan2-023. Administration dates are reported as 09Jan2023 (2 patients) 10Jan2023 (2 patients) 11Jan3023 (4 patients) 12Jan2023 (4 patients) 13Jan2023 (3 patients). All the patients were 12 years and above, but HCP did not have the information if some of them were below 17 years old.   Case contains the information regarding patient 11 of 15 reported.  Treatment drug was not reported.   This case was linked to MODERNATX, INC.-MOD-2023-698566 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698566: Master case
Vaccine was administered after the beyond use date.  It should only be stored in the fridge for 30 days, and it had been in the fridge for 33 days when we administered it.
Severe chills and muscle aches.  Lasted 24 hours Bedridden for one full day, the one day of recovery. Missed two days of work. Lots of fluids, mix of tylenol and ibuprofen