chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient woke up at 1am on 8/25, the day after getting The shot. Threw up once with a temperature of 103'F, with a second reading of 102'F. Patient has not thrown up since the first time. No apparent problems with injection site, but Patient did complain about pain in the arm. No Dr visit as of now.
Lt axillary swollen lymph nodes; lt (left) arm pain; Night sweats; Fatigue; Migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 18May2022 at 10:30 as dose 4 (booster), single (Lot number: FL3179), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EW0217, prev dose lot unknown=False, prev dose administration date=08Oct2021, prev dose dose number=3, prev dose vaccine location=Left arm), administration date: 08Oct2021, for Covid-19 immunization; BNT162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number= EP6955, prev dose lot unknown=False, prev dose administration date=02Apr2021, prev dose dose number=2, prev dose vaccine location=Left arm), administration date: 02Apr2021, for COVID-19 immunization; BNT162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number= EL3247, prev dose lot unknown=False, prev dose administration date=12Mar2021, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 12Mar2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 18May2022 at 16:00, outcome "recovered" (May2022); LYMPHADENOPATHY (non-serious) with onset 18May2022 at 16:00, outcome "recovered" (May2022), described as "Lt axillary swollen lymph nodes"; MIGRAINE (non-serious) with onset 18May2022 at 16:00, outcome "recovered" (May2022); NIGHT SWEATS (non-serious) with onset 18May2022 at 16:00, outcome "recovered" (May2022); PAIN IN EXTREMITY (non-serious) with onset 18May2022 at 16:00, outcome "recovered" (May2022), described as "lt (left) arm pain". Therapeutic measures were not taken as a result of lymphadenopathy, pain in extremity, night sweats, fatigue, migraine.  Additional information: Patient did not receive any other vaccines within four weeks and did not receive any other medications within 2 weeks. Patient did not have covid prior vaccination and patient did not tested post vaccination. Known allergies and Other medical history reported as No.
expired vaccine is stored and then administered; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. On 04-Nov-2021 vial was placed in refrigerator.  No treatment medication information provided.
Breakthrough Covid-19 infection, not a direct reaction to the vaccine.  Mild nasal congestion similar to a cold on 7/3/22 with a 99.5F fever.  (I always have a chronic cough, some fatigue, and SpO2 in 91-94 range from bronchiectasis that all remained the same during the infection.)  Unable to test due to travel until at-home rapid test on 7/6/22, which was positive.  Called healthcare provider the same day, had a telehealth visit, and started Rx for Paxlovid that evening (day 4).  Paxlovid created bitter tasting saliva throughout the 5 day treatment.  Felt completely better and tested negative on 7/11/22 (day 9).  No lingering effects.
Patient received Adult Hep A dose instead of Pediatric Hep A dose. Provider notified and due to patient's weight, it was determined that dose should not adverse effects for patient. Patient made aware.
plunger stopped at a certain point and would not push all 5ml with no AE; plunger stopped at a certain point and would not push all 5ml with no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 27 years old male patient who received partial dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6321AA, expiry date: 07-Jun-2021) via unknown route and on an unknown date for prophylactic vaccination whose plunger stopped at a certain point and would not push all 5ml with (incorrect dose administered by device and device issue).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  No concomitant medication was given to the patient.  It was an actual medication error due to device component issue and Partial dose delivery by device.  At the time of report, no adverse event was reported.  Disclaimer :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 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.
3-4 hrs post vaccine: fever 100 degrees severe fatigue over next 3 days chest heaviness - feeling of swelling "thyroid" area - developed 1 pock. Combo of symptoms lasted 7 days. All resolved.
Patient contacted pharmacy on 8/17/21 in the afternoon concerned with arm soreness from Covid 19 Pfizer vaccine administered on 8/13/2021. Patient complained of a knot at the injection site along with some redness and soreness. I explained that this might be a normal injection site reaction, but to call us back if there were any changes or worsening of symptoms. Patient's mother, called back today 8/18/21 and explained that the knot on patient's arm was now  the size of a lime, and that she had swelling up her arm into her neck, and the side of her face was swollen. She said she had taken a Benadryl. I instructed them to seek medical attention ASAP, and to call us with any updates. Patient's mother also noted that the injection site seemed "low"  on her arm.
felt like I had the flu cause I acked; ache; One year after my first Shingrix shot I got another; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received one year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, pain and drug dose administration interval too long. On an unknown date, the outcome of the influenza-like symptoms, pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the influenza-like symptoms and pain to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. One year after first Shingrix shot the patient got another shot which led to lengthening of vaccination schedule as patient forgot to take vaccination.  The patient had another shot and had bad reactions, felt like had the flu cause he/she ached.
A large lump near my collar bone.  The lump was tender to the touch. Also, in addition to arm soreness, I was unable to turn my neck to the left. Felt like a pinched nerve.
Blister-type rash on L shoulder and arm, in clusters appearing shingle-like in small areas only.
Patient observed multiple rashes (red bumps the size of a dime to nickel) on left arm only approximately four days after receiving vaccination on 02/09/2021.  Rash did not itch.  It took about 2-3 weeks to for the rashes to disappear.
ONE OF THREE PATIENTS WHO EXPERIENCED A BURNING SENSATION UPON INJECTION AND HAD AN INJECTION SITE REACTION (RED,PAINFUL) FOLLOWING IMMUNIZATION.
In December, I started having worsening pain in my right arm. Nerve pain down my arm and partially in my neck. I started seeing my chiropractor again which offers temporary relief from the pain. On December 14th I began seeing a physical therapist for my neck pain. I am still currently being seen by my physical therapist and doing the advised exercises and stretches but the pain persists.
The child provided a different date of birth and received the Moderna vaccine under the age of 18.
Pt recieved vaccine at 1214 and at 1220 reports dizziness and nausea. VS  102/70 hr 65 o2 100, pt stated she had to vomit, pt vomited into garbage. RRT called, laid Pt down on stretcher. RRT team arrived. VS rechecked 108/70  HR68 97%. RRT MD cleared pt to stay in vaccine area. pt monitored until 12:50 and feeling better and left with her husband.
She cant get the second dose because she is allergic to it.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "She cant get the second dose because she is allergic to it.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Per RN at Group Home where patient worked, on 3/19/21 he called the RN with complaints of a "low grade" fever (99-100 degrees) but otherwise reportedly felt fine. He was advised to stay home, was offered Covid testing but refused. On 3/22/21 the RN received an email from patient's supervisor that he still felt unwell and reported vomiting and diarrhea. Was offered a Covid test but refused.  -Per patient's friend (a nurse who informed us of the case) various friends spoke with patient up until the morning of 3/25 and he reportedly had no respiratory or cardiac complaints. They were unable to reach him the evening of 3/25, nor the morning of 3/26 so sent the police for a well check and patient was found dead. He lived alone. -Per OSME. Patient did not receive an autopsy but did have an "inspection" which includes an external exam, toxicology and other testing including Covid testing which was positive. The specimen has been sent for sequencing. -Of note, Patient worked in a group  home that had an outbreak of Covid in Jan/early Feb. His last exposure to a + person was likely 2/8/21 but possibly 2/10/21. He had a Covid test 2/15/21 that was "inconclusive". The test was re-run (same assay) and was also "inconclusive"
Nosebleed 20 minutes after leaving the venue, but went away quickly. Another nosebleed later that night. Next day, tinnitus/ears ringing off and on throughout day.  Fatigued, slight vertigo
Patient received Twinrix vaccination at 1:52 PM and became unresponsive at 1:54 PM. During this time, EMS was called. Pharmacist attempted to get patient to become responsive and was successful after roughly 15 seconds. Patient was given water, a fan, and another chair to prop her feet. EMS arrives and checks her HR, BP (~90/60), and glucose (normal range). After sitting in chair for about 20 mins, she begins feeling better. She declined to go to ER with EMS. It was recommended for her to go to hospital or see PCP. Her husband picked her up and when she left pharmacy, she was coherent, steady on feet, and stated she "felt better."
Punctured vial was stored at room temperature for over 12 hours; Patient received vaccine after allowed expiry time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after allowed expiry time) outcome was unknown and PRODUCT STORAGE ERROR (Punctured vial was stored at room temperature for over 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Post vaccination employee (patient) called EHS Dept noting she did not feel well. States she felt dizzy, weak and with blurred vision. Recommended she call 911 but declined and had friend stay w/ her. Denied problems w/ other Hep B injections.
Had Prevnar 20 on 11/19 and fever and arm soreness started after 2 hours, slight swelling and redness noticed on the site. Haven't taken any medication. No more for last 3 hours. Feeling better and swelling and redness stay same
Woke up at 5am with fever symptoms, all over body aches. 8am still had elevated temps, was very dizzy and experienced moderate nausea. Was told to stay home from work
Expired vaccine injected to patients at Various Pharmacy locations/Drawn up syringe given after 12 hour/administered 3 doses of Moderna Covid-19 Vaccine  to 3  patients which were withdrawn the night before ( more than 12 hours  ago ).; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine injected to patients at Various Pharmacy locations/Drawn up syringe given after 12 hour/administered 3 doses of Moderna Covid-19 Vaccine  to 3  patients which were withdrawn the night before ( more than 12 hours  ago ).) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine injected to patients at Various Pharmacy locations/Drawn up syringe given after 12 hour/administered 3 doses of Moderna Covid-19 Vaccine  to 3  patients which were withdrawn the night before ( more than 12 hours  ago ).). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine injected to patients at Various Pharmacy locations/Drawn up syringe given after 12 hour/administered 3 doses of Moderna Covid-19 Vaccine  to 3  patients which were withdrawn the night before ( more than 12 hours  ago ).) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Patient identifier- Group of patients.  Complaint Title :Expiration date on Vial Label Faded( Labelling issue).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Non-Significant Follow-up On 29-Jun-2021: Non-Significant follow up appended to
Patient had first vaccine yesterday around 5 PM, and today has had fever of 101. He is asking if he can take any Tylenol. RN stated he can take Tylenol, or Advil, which ever he uses for a fever He stated he is also tired, and has a headache.
Child's mom called 01/03/2019 @ 1005 to report 12/28 or 12/29 he started to get little red bumps "like pimples" close to where he had vaccines bilateral thighs- denies history of vaccine reaction at 2 month vaccination. Mom also reports "fever, a small light fever" questioned how high mom reports "100 degrees" states "it was over the holidays so I couldn't get in to see the Dr., but I called today and left message for nurse to call me" RN at clinic asked to let the health department know after talking with or see the child's primary care physician. Plan to follow up with child's mom later today 01/03/2019.
Information has been received from a nurse practitioner referring to unspecified multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored (Merck) PROQUAD (lot # L023112, expiration date 24-DEC-2016; lot # L027634, expiration date 21-JAN-2017) (dose and route were not reported). The defrost cycles of vaccine temperature of -14 Celsius degrees occurred 6 days in October 2015, and -13 degrees Celsius for 5 days in September 2015. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
The symptoms arose the day following the injection. Vaccine received 04Jan21. All of the following occured around the same time (7:30pm) except for the headache: Headache (around 11:30am is when this settled in), fatigue, body aches and chills, slight loss of taste.
left arm is completely numb; This is a spontaneous report from a PFIZER-sponsored program. A contactable female consumer reported for herself that on an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported, NDC number and expiry date of was not provided) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced left arm is completely numb. It was reported that warm transfer from a PFIZER-sponsored program. patient was calling for an adverse event felt after the first dose of PFIZER COVID vaccine. The left arm was completely numb. She confirmed contact details upon transfer. Patient was calling to find out what she was going to do about it since her arm was not like this before. She went to the Hospital, clarified she went to the ER. She was told by the hospital that PFIZER would be scheduling nerve test to be done. She stated if the vaccine was what caused this to her arm, then she was asking for help from the manufacturer. Stated this was a new year and her deductible was starting out all over. She had to go to ER since her hands was so swelled out. She did not have a left arm to use since it was completely numb. She went to her doctor and the ER and nobody has been able to help her. Her arm was fine before the vaccine and now she has no arm, clarified her arm is completely numb. Describes that it was like when your leg gone to sleep and felt. It's coming out of sleep and it hurts that was what her arm felt like and it has been ten days. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Diarrhea; GI symptoms; fatigued; Nausea; Headache; chills; right arm soreness; muscle soreness; righ arm soreness at the injection site; broke out in hives that were on her stomach; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (GI symptoms), PAIN IN EXTREMITY (right arm soreness), URTICARIA (broke out in hives that were on her stomach) and FATIGUE (fatigued) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Essential tremor, Eczema, Vitiligo, Connective tissue disorder (undifferentiated), Drug allergy, Adhesive tape allergy, Allergy (Lactose), Allergy (Hibiclens) and Rosacea. Concomitant products included AZELAIC ACID for Rosacea, WOMEN MULTI and KETOCONAZOLE for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced MYALGIA (muscle soreness) and VACCINATION SITE PAIN (righ arm soreness at the injection site). On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (right arm soreness). On 01-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (GI symptoms), FATIGUE (fatigued), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (chills). On an unknown date, the patient experienced URTICARIA (broke out in hives that were on her stomach). On 04-Jan-2021, NAUSEA (Nausea) had resolved. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (GI symptoms), PAIN IN EXTREMITY (right arm soreness), URTICARIA (broke out in hives that were on her stomach), FATIGUE (fatigued), HEADACHE (Headache), CHILLS (chills), MYALGIA (muscle soreness) and VACCINATION SITE PAIN (righ arm soreness at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Per follow-up source, it was noted that the patient contacted her PCP and she was advised to see an allergist prior to receiving the second vaccine dose.  No further information was provided.   Treatment information was not reported.   This case was linked to MOD-2021-163093 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Updates include additional event, medical history and concomitant medication use.
Narrative:  A 78yo with PMH of General Weakness, abnormal findings with diagnostng imaging of urinary organs, Primary Malignant Neoplasm of Prostate, Gout HTN, Onychomycosis and Dysphagia Received Pfizer Covid - 19 vaccine per policy and protocol without complications First dose on February 22, 2021 and the second dose March 15, 2021 NO ADE reported The system showed this patient passed away April 9, 2021