chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to a patient of currently 64 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Client admitted to Hospital on 11/17/2021. She had a fall this 11/17/2021 and was tested at the emergency department and came out positive. She is asymptomatic for COVID but has CHF and is being treated for other injuries. All information received. This writer does not have any additional information. If additional information requested the hospital information is: (Privacy).
This spontaneous report as received from a registered nurse refers to an unspecified number of patients (gender and ages not reported). On unspecified dates the patients were vaccinated with the second dose of GARDASIL, intramuscularly (Lot number and dose not reported). It was reported that the patients received the "vaccination series late". No adverse effects were reported. Additional information has been requested.
Post 1st Janssen injection, became sweaty, semi conscious, thready pulse. Patient was  sitting when he lost consciousness, did not fall to floor, remained in the chair when the medical staff attended to him. When he became conscious, he was provided water, which he drank, and he was transferred into a wheelchair and then moved unto the cot. While in the wheelchair he started to go in and out of consciousness again. Dr. tended to the patient, BP 110/60, weak pulse, EMS was called at 12:44. At 12:53 EMS arrived, patient was conscious and talking, BP 120.  EMS asked the patient a series of questions, rechecked BP, and pulse - all within normal range. Patient was able to sit up and stand without feeling lightheaded and refused EMS transport. EMS left, the patients spouse left to move their vehicle closer to the mall entrance, patient was offered and accepted a granola bar, when his spouse arrived back at the clinic the patient was wheeled to the mall entrance door in the wheelchair,  as recommended by EMS as precautionary, and then walked to his vehicle from the mall entrance door with his spouse. When patient left he was talking normally, responsive, and reported feeling well.
Severe restlessness/irritability, rash and vomiting. Also no interest/has not been eating- this personality change with change in eating habits have now lasted a month and have not subsided.
Pt devel jerky movements of extremities & head noted by mom 18-24 hrs post vax; Hospitalized x 24hrs;
initial: pPin at injection site on left arm. Current: nodual under skin at injection site and indented on the surface; skin appeared dry and purple.
hospitalization - patient was admitted for non-covid issue.  COVID-19 was an incidental finding at discharge to a Rehab facility.  Patient is asymptomatic.
Placed in the fridge on 11-Jan-2022 and administered on 20-Apr-2022; patient administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 20-Apr-2022) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 016M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Placed in the fridge on 11-Jan-2022 and administered on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  A pharmacist, the vaccine coordinator in their health care facility reported that they inadvertently administered expired dose of the Moderna COVID-19 vaccine. Date the vial was initially stored in the refrigerator was on 11-Jan-2022, which meant that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. The vial did not undergo any temperature excursions. They identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. Patient received 2nd booster dose on 20-Apr-2022 and not reported adverse reaction to the HCP's knowledge.  No treatment drugs were reported.
Headache and elevated blood pressure, first recorded on 4/2/2021, but might have been prior. Saw primary care doc on 5/12/21 with headache, palpitations, and faintness. BP was 199/81. Doc put me on 2 BP meds.
had temperature; Body ache; Headache; Loss of taste; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via an unspecified route of administration on 23Dec2020 16:45 at a single dose for COVID-19 immunization. The patient has no medical history and concomitant medications. The patient got her vaccine on Wednesday and had some side effects. She would like to make sure that it was normal, but she was pretty sure it would be going to go away. How long will it take for the side effects to go away. The patient had temperature, body ache, headache and loss of taste as well on 24Dec2020. She said it's going to be 3 weeks from the date she got the first one but she didn't know exactly what date. The patient received Aleve liquid gel as treatment and threw that bottle away. The outcome of the events was unknown. The reporter believed that the adverse events was caused due to Pfizer BioNTech COVID 19 Vaccine.  Information on the lot/batch number has been requested.
pt reports flu sx, watery eyes, sneezing, coughing, inject where MMR given red, warm to touch w/ 2.5cm induration;checked by MD instructed to apply warm compresses & return to clinic if condition worsens;
inadvertently administered YF-VAX intramuscularly rather than subcutaneously with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a patient of unknown demographics who was inadvertently administered yf-vax(YELLOW FEVER VACCINE) intramuscularly rather than subcutaneously with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.25 mL to 2 mL of suspect YELLOW FEVER VACCINE- (formulation, strength: unknown) lot number not reported via intramuscular route in unknown administration site as Immunization. Lot number was requested.  On an unknown date the patient was inadvertently administered yf-vax intramuscularly rather than subcutaneously with no reported adverse event (incorrect route of product administration) same day following the administration of YELLOW FEVER VACCINE. Caller asked if there was any guidance on what they should do, asked if it was necessary to revaccinate the patient with YF-VAX via the subcutaneous route?  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (inadvertently administered YF-VAX intramuscularly rather than subcutaneously with no reported adverse event).  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Noticed swelling around injection site on 04/17/2021. It was roughly two inches around, fevered, raised, and painful to touch. Monitored it to see if it grew any bigger until I could contact my doctor. 04/18/2021 I became sick. Extremely nauseous and dizzy with diarrhea, body aches, headache, and extreme exhaustion. Felt very sick after eating. Quickly became constipated in the following days. The swelling around the injection site is not as red, but it is now, as of 04/21/2021, roughly six inches big and the left arm is visibly swollen and the site is hot to the touch. Contacted doctor 04/21/2021.
Information has been received from the author of a literature article, title stated above concerning a healthy 16 old male who more than 8 years after vaccination with VARIVAX (Merck), presented with keratouveitis, severe inflammatory glaucoma in his left eye, and Hutchinson's sign. He was treated with systemic acyclovir, topical steroids, cycloplegics, and glaucoma medications for a full recovery two months after presentation. It is unclear whether the source of herpes zoster which reactivated in this patient represents wild type virus or his previous vaccine strain. Herpes zoster ophthalmicus is very rare in the pediatric population after varicella vaccination but can cause severe inflammatory glaucoma that required aggressive therapy. Upon internal review, it was determined herpes zoster ophthalmicus and severe inflammatory glaucoma were other important medical events. No further information provided.
Chills then fever which were gone by morning.  I had blotchy red marks around the site, but no itching.  Redness was gone by Sunday night.
rash on the upper part of my arm/Small rash circles, not red raised skincolor circles like a bunch of pea sizes circles or smaller; This is a spontaneous report from a contactable consumer (Patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration on 26Jan2021 at 10:15 (at the age of 37-year-old), as single dose in right arm for COVID-19 immunisation at Doctor's office/urgent care. The patient's medical history included allergic to eggs, seasonal allergies and cats. Patient was not pregnant at the time of vaccination. Concomitant medication included multivitamin. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. On 27Jan2021 at 06:15, the patient woke up with a rash on the upper part of her arm. Small rash circles, not red raised skin colour, circles like a bunch of pea sizes circles or smaller. They did not itch, but they seemed to be closer to the injection site with less on the outer arm area. Patient continued to monitor. There was no treatment received for the adverse event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event was not recovered.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Cardiac arrest of unknown etiology.  Sudden collapse with PEA  requiring  CPR and intubation. Now has severe anoxic encephalopathy and expect death.
C/O pain and decreased mobility of deltoid/shoulder, getting progressively worse since vaccination administered. Onset of pain @ time of vaccination, decreased mobility a few days later. No swelling or ecchymosis @ site. To have appointment evaluated by PCP 11/11/2008. Per follow-up: She was seen by her PCP on 11/11/08 and provided with anti-inflammatory medication. She feels well now.
Patient received her second dose 4/19/21 but wanted it noted that she developed a localized rash around the injection site with her first dose (on 3/22/21).  rash resolved on its own without medical intervention
Sore & heavy arm, warmness at injection spot, slight rash on arm, extreme fatigue, body aches, low grade fever, foggy head.  Treated with ibuprofen, ice compress, beneadryl and rest. Symptoms have mostly gone away 48 - 72 hours later.
No adverse effects; A patient was administered improperly stored PROQUAD; Information has been received from a medical assistant regarding a 4-year-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 05-SEP-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, for prophylaxis, lot number S009759 with expiration date in 27-SEP-2020 which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (dose, strength and anatomical location were not reported).  The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F (17.6 F) for the time frame of 56 hours and 40 minutes. A previous temperature excursion was reported of 6 °F to 14 °F (6.2 °F) for 10 minutes. The call was not because of a data logger.  No adverse effects reported.
Injections given and patient asked to lie down for 5-7 minutes since receiving  Gardisil vaccine.  Patient in room with sibling. Sibling reported that after about 5 minutes patient got up from supine position, stood, became weak and fainted.  Sibling called for help. Patient was pale, clammy and semi- alert.  Placed back on bed in supine position and attended to by physician.  After about 25 minutes skin color pinked up and she was alert and felt well.  She got up to leave and in the waiting room became weak, dizzy and almost passed out again.  Patient was pale again and alert. She felt dizzy.  Placed in supine position on bed with knees up. Blood glucose level checked and at 99. B/P was at 72/40.  Given oral fluids and pretzels to eat.  Patient observed about 45 minutes and B/P was at 98/69.  No longer pale, alert and oriented and dizziness improving.  Patient rechecked by physician  and released to home.
Extremely tender at injection site with erythema next day after injection; fever and headache, some associated nausea. Temp 101.9 F Tx: Doxycycline hyclate 100 mg BID x 7 days. Warm compresses, rest and fluids.
No additional AE details; a patient received an expired dose of MMR-II; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.   On 01-FEB-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # S037500, expiration date 20-NOV-2021; dose and route were not reported) for prophylaxis (expired product administered). Other suspect therapy included sterile diluent (manufacturer unknown) (dose, route, indication, lot# and expiration date were not provided). No additional adverse event (AE) details.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies or medical histories were not provided. On unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9, lots# M030380 and M023169, expiration date 01-FEB-2019 and 13-JUN-2018 respectively (strength, dose, frequency and route of administration were not reported) for prophylaxis. It was reported that the temperature excursion was for 20 minutes at 9 degrees Celsius, according to the data logger. There was no previous temperature excursions. No adverse effects were reported. No product quality (PQC) complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt has swelling and redness at injection site on left thigh. Recommends supportive care from clear triage, and to call back with further questions.
Information has been received from a certified medical assistant concerning a 17 year old female with no drug reactions/allergies who on 05-JUN-2008 was vaccinated with GARDASIL (lot number 659962/1740U) 0.5 mL IM. Concomitant therapy included SYNTHROID, LEXAPRO and LUNESTA. On 06-JUN-2008 at about 4 AM the patient experienced 2 seizures a few minutes apart. The patient was taken to the emergency room (ER), evaluated, released and referred to a neurologist. On an unspecified date a magnetic resonance imaging (MRI) and electroencephalography (EEG) was performed but results were not available. No other information was available. Upon internal review seizure was considered to be an other medical event. Additional information has been requested.  6/24/08 Reviewed PCP vax rec & medical record of 6/5/08 which reveal pt w/dysmenorrhea & on Yasmin.  Otherwise in usual state of good health.  7/4/08 Reviewed ER medical records of 6/6/08. FINAL DX: weakness, dehydration & hypothyroidism & vasovagal syncope.  Records reveal patient experienced syncope x 2 followed by seizure activity & then confusion while at home.  No further seizure activity while in ER & d/c to home.
Sinus headache, shaking chills, 100 degree fever day of injection. Evening chills and acidy nausea week 4 and 5. Extreme exercise end of March triggering nausea, headache and temperatures between 102 and 102.7.
Patient not feeling well taken to medical observation at 2:45 PM BP 133/78 HR 89 Pulse ox 99 3:04 PM BP 141/83 3:13 BP 139/76 HR 83 Pulse ox 96 sitting 3:18 BP 137/84 standing HR 88 Pulse ox 98 3:20 PM discharged from medical observation via wheelchair to exit in stable condition
Case number PHEH2015US000542 is an initial spontaneous report received from a medical assistant on 02 Jan 2015. This report refers to a 3 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1413901) multi dose vial (MDV) intramuscularly on 31 Dec 2014. No adverse events were reported following the medication error.
Woke up on March 12 with itchy bumps all over both hands and feet. They then bloomed into a rash known as Erythema Multiforme. It is now July and I still get small bumps that appear on my fingers.
Case completed his Covid vaccine series in March 2021, then was hospitalized and died in October 2021
22 patients received expired Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna COVID-19 vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter stated that she had 22 forms (from the CDC) about patients that were administered expired vaccines, she was asking if they should revaccinate those patients. Number of doses/vials: 22 The date of vial initially stored in the refrigerator was unknown. Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022.  The patient received his first booster in his left arm. The vial did not undergo any temperature excursions. No treatment information was reported.
Patient described that she experienced chills, elevated heart rate, and shortness of breath after receiving high dose influenza and Prevnar vaccines.
Inject 21NOV90 rxn 25NOV90 temp to 103(r), vomiting & diarrhea, irritable x 2 days.
10/24/2009, body aches, 10/26 right hand dexterity shaky problem, fatigue- over the next few weeks body aches, tingling in all extremities, heaviness in bilateral legs, twitching & muscles spasms. Irritated feeling on skin, pain cervical spine/pressure. Burning pain to muscles, weakness to legs, tingling to all extremities. Hospitalized 11/19, 11/20, MRI brain, cervical/ thoracic negative lumber puncture,negative CPK elevated-still elevated in March 2010 + body aches. Also hands & feet red when dependent & developing skin changes.
Extreme tired Headache Achy and sore body Swelling and  pain in armpit.
Excessive thirst; alternated feeling hot and cold throughout the night; excessive sweating through the night that soaked his bedding;excessive bathroom trips; This spontaneous case was reported by an other health care professional and describes the occurrence of THIRST (excessive thirst), POLLAKIURIA (excessive bathroom  trips), HYPERHIDROSIS (excessive sweating through the night that soaked his bedding) and FEELING OF BODY TEMPERATURE CHANGE (alternated feeling hot and cold throughout the night) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced THIRST (excessive thirst), POLLAKIURIA (excessive bathroom  trips), HYPERHIDROSIS (excessive sweating through the night that soaked his bedding) and FEELING OF BODY TEMPERATURE CHANGE (alternated feeling hot and cold throughout the night). At the time of the report, THIRST (excessive thirst), POLLAKIURIA (excessive bathroom  trips), HYPERHIDROSIS (excessive sweating through the night that soaked his bedding) and FEELING OF BODY TEMPERATURE CHANGE (alternated feeling hot and cold throughout the night) outcome was unknown.            No treatment or concomitant medications reported.; 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.
Pt recvd vax & 36 hrs later devel myoclonic activity (flexing arms & legs) was seen 8MAY when notified exam nl; ? benign myoclonus;