chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. Other information related to product is vial was initially stored in the refrigerator on 31-AUG-2021. Product first punctured on 05-SEP-2021 11AM Kept in Refrigerator. Total amount of time the vial was exposed to room temperature range (46° to 77° F): "From 06SEP2021 9:00AM and discarded vial after 4:30PM.
AFTER RECEIVING 2ND VARICELLA VACCINE, 5 DAYS LATER BROKE OUT WITH 5 CHICKEN POX ON HER BODY.
Patient reports right arm burning one week post vaccination. Burning then travelled to right breast. She had right-sided sciatica pain that travelled down leg on the same day. Colleagues told her she seemed mentally delayed that day as well. Denies airway difficulties, breathing difficulties, or noticing a rash. Symptoms resolved by the next day.
sweating only;BP 138/80, t98.6, P64, R16;pt states each time has any kind of vax feels sweaty & a little dizzy on the first one but has no problems w/the next;
Information has been received from a certified nurse midwife concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with Gardasil (lot# unknown).  On an unspecified date the patient experienced a high fever.  Medical attention was sought.  The patient went to the emergency room.  At the time of reporting it is unknown if the patient had recovered.  No further information is available.  This is one of two reports from the same source.  Additional information has been requested.
On day 8 I was awakened by a very itchy arm. When I got up I noticed a signicant rash on my left arm that ran from the injection site almost to my elbow. If continued to be very itchy that day but by the following day the itching stopped but the rash didn't go away. Today February 4th the rash has gotten smaller but is still in the area of the injection
Sore in arm; Small bump in injection spot; Itchy; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 06Apr2021 at 15:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to food, medications, or other products. Concomitant medications included vitamin d nos (VITAMIN D) and birth control; both for unknown indications from unknown dates. Prior to the 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 four weeks prior to the vaccination. On 07Apr2021, the patient experienced sore in arm, small bump in injection spot and itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore in arm, small bump in injection spot and itchy was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
fever 24hrs p/vax t103.0R,cranky w/sl upper resp sx;
Received vaccine approx. 9:30am, symptoms began 4:30 pm  Dizziness at onset, painful joints (knees), work around 2:30am next morning to fever (~99 degrees F), extreme join pain, difficulty sleeping, sweating; fever continued ~12 hours, resolved with ibuprofen; painful joins persisted 24 hours; most symptoms resolved by 8am 5/3 - fatigue persists
Fever, bad chills, lymphadenopathy in the arm/clavicle area where shot was given, bad headache, fogginess. Subsided by 1/29 AM
First Vaccine given on 2/27/2021. Pharmacy. Moderna. Lot: 013A21A. Intramuscular - Right Arm.
Had an itchy rash appear just above butt crack. Started out itchy, then got painful. Internet search pointed to shingles. Urgent care doctor confirmed it. Also, a day after the second dose, I started having heart palpitations. Received Moderna booster on 12/1/21,  and had heart palpitations the following day again. Also, after second dose in March and booster on 12/1/21, I had a lymph node flare up in my arm pit.
patient received an expired dose of vaccine/No AE; Initial information was received on 30-Jul-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 17 years old female patient who received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).   Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication were not reported.  On 30-Jul-2020, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE once [vial, lot U6208AD, expiry date: 08-Jul-2020] via an intramuscular route at the left leg for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  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 and Module VI of the 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.
Patient developed red patches on left arm that was painful and itchy a couple hours after the shot. It lasted 3 to 4 days.
for my face to go numb/my arm to go numb on the side of the injection site?"; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, and Expiry Date are unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that is it normal to loose, for her face to go numb and her arm to go numb on the side of the injection site? on an unspecified date. The outcome of event was unknown.  Follow-up attempts have been completed. Batch/lot number is not available for [BNT162B2]. No further Information is expected.
About one hour after my shot I felt a numbness/tingling on the tip of my nose on the left side. Within several days it spread to my upper lip and chin on the left side. It feels like I've had a novacaine shot for dental work  that is wearing off.  At the time of  my second vaccine on March 2, 2021, I mentioned this to the nurse. She said maybe when they injected me they hit a nerve and to let my doc know if it doesn?t go away.  It didn?t go away and in fact spread to my left cheek and left side of my face. At my last two appointments, one with my GP and one with my oncologist they said if it doesn?t go away, they would have me come in for tests.
Rash on her arm where booster was injected; Vomiting; Feeling tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US108572_NS   A 22-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; secukinumab (COSENTYX), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed; manufacturer unknown), for Covid-19 immunization. The following information was reported: VACCINATION SITE RASH (non-serious), outcome "unknown", described as "Rash on her arm where booster was injected"; VOMITING (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown", described as "Feeling tired". The action taken for secukinumab was unknown.  Additional information: The patient was not sure if the events occurred due to booster or her Cosentyx.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shingles diagnosis; Dose 1: 21Apr2021, Dose 2: 03May2021; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 03May2021 at 09:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to almonds. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included mometasone spray (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and olopatadine spray (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 21Apr2021 at 09:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27May2021 at 09:15, the patient experienced shingles diagnosis. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with Valtrex. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event shingles diagnosis was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 21-Jun-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. On 21-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date).    Concomitant product use was not provided by the reporter.  Staff gave patients vaccines past the use date of 18-Jun-2023.  On 21-Jun-2023, 3 doses were administered at administration site 2.   Treatment information was not provided.  This case contains information for the 23rd patient out of 47 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received suspect vaccine details added, iNarrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case (Patient 1)
pt recv vax 12MAR98 & the next morning 13MAR98 pt broke out in hives all over face a few hr (4-8), arm all red from elbow up rash from site of inj;
maladministration of kinrix as a 4 months old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: maladministration of kinrix as a 4 months old patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUN-2023 The reporter consented to follow up. 4 month old patient received Kinrix (maladministration), which led to inappropriate age at vaccine administration.
Received flu vaccination; about nine hours later, experienced sudden vision change and dizziness, horizon was moving while standing and sitting still; symptoms last for at least a couple of hours, still felt unwell the next morning but with improved vision and no dizziness; took until about midday to feel like myself again.
Very hungry; Swelling at the injection site; Pain at the injection site; Muscle Pain; Tiredness or fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HUNGER (Very hungry), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle Pain) and FATIGUE (Tiredness or fatigue) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle Pain) and FATIGUE (Tiredness or fatigue). On 07-Mar-2021, the patient experienced HUNGER (Very hungry). On 06-Mar-2021, VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), MYALGIA (Muscle Pain) and FATIGUE (Tiredness or fatigue) had resolved. At the time of the report, HUNGER (Very hungry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Patient called to informed she was diagnosed with cellulitis (given antibiotics cipro) after receiving a HD flu vaccine and pneumovax vaccine together in the same arm. She stated she had irritation and swelling prior to being diagnosed. Her diagnosing provider stated she should have only gotten 1 vaccine at a time and that the pharmacist was wrong in giving both. Patient had received HD flu vaccine from same location for past 3 years w/o any issues or concerns. Upon further questioning, patient stated the vaccines were given about 1 inch apart, and was informed it was common practice to give more than 1 vaccine in one sitting but some give them in opposite arms. Also, patient was told proper protocol and procedure was taken but would be followed up to ensure no steps were missed.
Initial information received on 19-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 10 years old patient who vaccinated with 0.5 ml dose of FLUBLOK QIV lot QFAA1818 and Exp. Date 30-Jun-2019 via intramuscular route in the arm, on 14-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that a 10 year old was given FLUBLOK by mistake. No adverse events were reported. 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. Documents held by sender: none.
Myalgia SORENESS AT INJECTION SITE, HOT FLASHES, SLEEPLESSNESS, CHILLS Narrative:  Other Relevant History:
fatigue, shortness of breath, heart palpitations, eye twitching, sweating, dizzy spells - all for 9 days. Neck muscle pain radiating to the ear-for two days. Anxiety and unable to sleep- still present
Tinnitus. I previously developed tinnitus after the first dose of Moderna in January. I delayed getting my 2nd dose because of it. My tinnitus from the first dose did begin to improve over time starting in June but not fully resolved. I received my 2nd dose and exactly 5 hours later, I developed louder tinnitus in bilateral ears.
gave doses from a vial 1 day past the beyond use date; Date the vial was initially stored in the refrigerator: 18-Feb-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave doses from a vial 1 day past the beyond use date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 18-Feb-2022) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 18-Feb-2022). On 21-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave doses from a vial 1 day past the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave doses from a vial 1 day past the beyond use date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 18-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. Vail did not undergo any temperature excursions. No treatment medication was provided by reporter.   This case was linked to MOD-2022-518738 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2022: Follow-up received with non significant information.
In the afternoon and evening of 1/2, the patient developed redness, swelling and pain at the injection site on the left anterior thigh. On 1/3, the pain decreased but the swelling continued to increase through 1/4. Upon examination on 1/4, the left anterior lateral and posterior thigh were red, warm and swollen but not painful. At 11cm above the patella, the right thigh was 29cm and the left thigh was 31.5cm.
no additional effects reported; pateint was given 2 doses of Pneumovax on 02-APR-2020 and on 14-APR-2020; pateint was given 2 doses of Pneumovax on 02-APR-2020 and on 14-APR-2020; This initial spontaneous report as received from a pharmacist refers to an adult patient of unknown age and gender. No information regarding concurrent conditions, pertinent medical history, drug allergies and concomitant therapies were provided.   On 02-APR-2020, patient (resident in one of long term care facilities) was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, lot #, expiration date, route of administration were not reported) for prophylaxis. On 14-APR-2020, patient was given second dose of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, lot #, expiration date, route of administration were not reported). He or she were given inadvertently  2 doses of the suspect vaccine. No additional effects reported.
Father called and reported that about 2-3 weeks after son received 2nd dose of Pfizer vaccine, he noticed that he was having trouble with his vision (seeing colors, shapes, etc.)
Pt has rash on  face which itches and has swollen eyelids. Patient has been treated with Dexamethasone and Depo-medrol injection.
Solider stated throat, "swollen effect"/instructed solider chain of command take solider to emergency room for evaluation and treatment. (See attached paperwork).
Patient called and reported severe pain in right shoulder where Pneumovax was given earlier in the day, also reported swelling at site as well. Advised patient to take benedryl in case this was an allergic reaction and to go to the emergency room or urgent care for physician's evaluation.
KINDRIX, PCV13, Varicella, and MMR administered by County Health Department at 12:00 noon on 9/20/10 and entered into the immunization registry. Medical Center administered PENTACEL, MMR, Varicella, and PCV13. According to mother, child running fever from 9/20/10
First sympton, nausea, chills, fever (just over 100°), severe muscle and joint pain, skin pain, skin rash, tightness in chest and labored breathing. Not able to sleep due to pain. Symptoms were in full swing by 9:00pm, less than 6 hours after injection. Had to endure the pain for two days, felt better by Sunday but felt like I had been through a battle. 4 days later still fatigued and feeling like I am getting sick, chills and headache.
Hot flashes/night sweats resulting in loss of sleep. Oncologist temporarily stopped my Anastrozole (08/18/2021) to see if that was the cause of my symptoms. However, symptoms continued with less intensity which maybe cooler temperatures.  PCP restarted the Anastrozole on 09/13/201. Currently no change in symptoms.