chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.; No Adverse event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Vial was individual vial with multi dose 0.5 ML. Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.  This case contains information about patient 14th out of 19 adult patients.    This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master case (Patient 1)
Increased pain with deep breaths; dizziness 6/10 and "different"; a sharp pain/Increased pain; This is a spontaneous report from a contactable pharmacist.  A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3302), intramuscular from 25Jan2021 16:00 at SINGLE DOSE in left arm for COVID-19 immunization.  Medical history included allergic rhinitis, depression, hypertension, and lupus. Concomitant medications included salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), bupropion, hydroxychloroquine, olmesartan, colecalciferol, folate sodium, magnesium, omega-3 fatty acids, pyridoxine hydrochloride, vitamin b12 nos, vitamin e nos (SUPER OMEGA 3 [COLECALCIFEROL;FOLATE SODIUM;MAGNESIUM;OMEGA-3 FATTY ACIDS;PYRIDOXINE HYDROCHLORIDE;VITAMIN B12 NOS;VITAMIN E NOS]), curcuma longa rhizome (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]).  The patient previously took codeine and experienced Known allergies, hives, itching, throat swells. The patient had first dose of BNT162B2 on 04Jan2021 15:15 at 52-years-old. It was reported that the patient experienced usual chest pressure related to lupus condition but after getting Covid vaccine it is now a on 25Jan2021 16:00, sharp pain, reports dizziness 6/10 and "different". Increased pain with deep breaths. denies nausea. Taken to ED (Emergency department) with RR. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included investigation: 6/10 on 25Jan2021, respiratory rate: unknown results on 25Jan2021. The outcome of the events was unknown.
Cellulitis (3 cm diameter) at R biceps area. Inoculated at right deltoid with FLUVAX & Pneumovax on 10/7/09, proximal to site of infection.
Stabbing headache back Right (constant or intermittent like an icepick), by 24 hrs later also on Left temple/front. Took 500 mg tylenol at 4 pm 12/30, no improvement. Another 500 mg around 6 pm got rid of headache. Sore shoulders and back also better. Brief night sweat 12/30 but no temp taken. Only sore injection site shoulder and fatigue by 2nd day. Opposite shoulder also sore in same place but may be from previous exercise?
After DTaP, Hib, IPV, Prevnar, HepB vaccine, baby slept for 3 hours, unarousable. After he woke up, he becaome pale, limp, unresponsive for 10 minutes. He subsequently had a worsening of his eczema (started after his first hep B vaccine at 2 weeks). He then signs of autism.
SORE ARM; LIGHT HEADACHE; This spontaneous report received from a patient concerned a 55 year old of unspecified sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: not reported) dose was not reported, administered on 08-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headache on 10-APR-2021, and had not recovered from sore arm. This report was non-serious.
My arm is all red and puffy, and has a big knot in the middle of it. My arm hurts when I try to move it.
Information has been received from a nurse concerning a 4 year old child who, over the past month, in approximately July 2006, was vaccinated with MMR II. Concomitant therapy included PEDIARIX. Unspecified medical attention was sought. About 2 days after injection, in approximately July 2006, the patient experienced cellulitis at the injection site. About five days after injection, in approximately July 2006, the patient recovered. The reporting nurse also reported the experiences of 4 other patients with MMR II (WAES # 0607USA05076, 0609USA00642, 0609USA00643, 0609USA00644). Additional information has been requested.
On 03/31/2022 I took a test because my spouse tested positive. My at-home test came back Negative on Thursday. I did continue to test every 24 hours. I tested positive on April 2, 2022. Mid-day on 03/31/2022 I did start to feel headache, neck pain, scratchy throat, fatigue, and some shortness of breath. They progressed pretty significant fatigue, breathing, sore throat, congestion, headache, and body aches. I did go to Urgent Care on Sunday morning 04/03/2022 My O2 and BP was normal, Temperature also normal, and lungs were clear. I had a Monoclonal Antibodies infusions (Sotrovimab) on Tuesday 04/05/2022. It honestly didn't make me feel much different but I did not get worse. The symptoms persisted for another 3-5 days. The cough continues to persist.
Patient came in for a booster dose - converting from Pfizer to Moderna. Mother wanted her to get Moderna because of availability. It was only after receiving the immunization that it was caught that the patient was not 18 years old (will be turning 18 at the end of Jan.) When discovered, called to discuss with mother and patient - reported no adverse effects other than soreness at injection site.
20 minutes after receiving nasal mist H1N1, patient developed stuffy nose, sore throat and sinus pressure like it 'would' "burst". Developed cough, shortness of breath and low grade fever persisting for at least 4 days.
55 patients received a dose of a vial after 12 hours of initial puncture; Vial punctured 6/1/21,Vial stored in refrigerator once punctured, in freezer prior to puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Vial punctured 6/1/21,Vial stored in refrigerator once punctured, in freezer prior to puncture) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (Vial punctured 6/1/21,Vial stored in refrigerator once punctured, in freezer prior to puncture). On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Vial punctured 6/1/21,Vial stored in refrigerator once punctured, in freezer prior to puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported   This case was linked to MOD-2021-418964 (Patient Link).
Nausea and fatigue for a few hours after injection. No treatment taken. Still feeling nauseated now, so I do not yet know the eventual outcome.
Headache; Itchiness, swelling, discomfort from injection site almost down to elbow involving about 2/3 circumference of arm. On the third day after that appearance I had discomfort/pain in both legs for about 24 hours. Treated it with Advil.
within 2 weeks of reciving vaccine I started with ringing in my left ear, with an echoing and humming sound that never went away, it was constant 24/7 I went to walk in clinic after months ofpraying it would go away, only to be told that my ears looked beautiful and I should see a ENT, saw ENT at end of july who gave me a medrol dosepak and sent me hearing tests and MRI, at age 53 I am diagnosed with Left SNHL hearing loss, I correlate this occurance to having the vaccine as I have never had ear issues and I dont fit criteria for early onset hearing loss, I was never in the service, i dont go to concerts or listen to loud music
COVID-19 breakthrough infection. Pt received Moderna on 3/27/21 and 4/24/21.
Given the Pfizer vaccine. Heavy limbs and itchy face right after injection. Given Benadryl and was let go after 45 mins. 4-5 hours later hives appeared on stomach, sides, back and legs. Throat started to feel tight. Went to the ER. Was given a shot of Benadryl and Pepcid. Hives were gone the next morning.
Dizzy and headache Nov. 2; Nov 3: bad headache, shaky, stomach upset, recurrence of upper (R) arm ache which had initially occurred after 2014 flu shot. Nov. 5: sx continue. Tingling (L) foot. Nov 7: awoke and severe pain in hip. Other sx continue. Nov. 8 hip pain improved. Present: (R) arm and (L) arm (2015 site) continue intermittently with pain.
Pt. presents today with itching post receiving 1st pfizer covid vaccine on 2/22/21 to right arm on 2/22/21 at 14:38 pm/ Pt. states that she started having itching shortly afterwards. Pt. denies shortness of breath, denies
13days following injection noted to have 4x5cm round erythematous plaque at injection site. Blanches. Resolved nearly completely by 1/11 with only 1 dose of Claritin in on 1/8.
Pt was 2 months old when received Hep A vaccine on 4/28/06 it was not noticed until came in for a URI on 9/22/06.
Reddened area with blisters around injection site.  Some red spots on stomach and back.  No fever today, acting normal.  Blisters for 2 days per Dad.
Patient developed rash about 1 1/2" in diameter at injection site. White in center.
States "felt dizzy and throat felt like it was closing".  Benadryl 25 mg given by mouth.
Arm red; Arm itchy; Arm warm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm red), PRURITUS (Arm itchy) and FEELING HOT (Arm warm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M029) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Arm red), PRURITUS (Arm itchy) and FEELING HOT (Arm warm). At the time of the report, ERYTHEMA (Arm red), PRURITUS (Arm itchy) and FEELING HOT (Arm warm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were antibiotic for drug use for unknown indication. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-jun-2021 is significant . TCR added event outcome is updated to recovered / resolved.
Vaccine administered after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:16 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the fridge on 06-Apr-2021, moved to clinic on 15-Apr-2021 and proposed beyond use date was 09-May-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On 15-Apr-2021, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit, as reached by the vial.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
had an anaphylaxis problem 6 weeks after 2nd covid shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "had an anaphylaxis problem 6 weeks after 2nd covid shot".  The lot number for bnt162b2 was not provided and will be requested during follow up.
65 y.o. male who presents with chest pain.  Patient reports he has been having intermittent chest pain since Friday.  Patient reports the episodes last only a few minutes to maximum 2 hr.  Patient states his episode of chest pain hit him this morning around 7:00 a.m. after he got up.  Patient reports his pain is currently a 4/10.  He describes it as a sharp pressure located in the center of his chest.  He denies any radiation the pain.  Patient denies any associated symptoms of shortness of breath, lightheadedness, dizziness, diaphoresis, nausea, or vomiting.  Patient does have cardiac risk factors including hypertension, hyperlipidemia, diabetes, family history, obesity, and former smoker.   Of note, patient states he was recently diagnosed with angina and placed on metoprolol and given sublingual nitro to take as needed.  Patient reports he has not used his sublingual nitros.  Patient sees HCP.  Patient had exercise stress test with nuclear scan that was negative in January of 2021.
This spontaneous report was received from a registered nurse via company representative referring to a female patient in her 20's. The patient's medical history and concurrent conditions were not provided. On an unknown date in 2015, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, (lot number, expiration date and route were not provided). Concomitant medications were not reported. On an unknown date in 2015, the patient experienced pain in extremity, headache and abasia reported as "the worst pain in her thigh, she could not walk and she had the worst headache". Because of these adverse events, the patient decided to discontinue the series after the first dose and had not gotten another dose since. The outcome of abasia, headache and pain in extremity was reported as recovered after stopping therapy on unspecified date in 2015. No product quality complaint (PQC) was reported. The primary reporter did not provide the causality between GARDASIL and abasia, headache and pain in extremity. This is one of two reports from the same source. Additional information has been requested.
Pt was given a Moderna vaccine booster dose, 0.25ml,  from a vial that was opened longer than 12 hours.  The vial was opened 5/6/22 at 9:00.  The patient was notified and given another dose from a newly opened vial.
10 x 12 cm induration, temp l/upper outer arm post injection lasting 4 days.  Extreme lethargy, slow mentation.
patient reported she was hospitalized with guillain-barre after vaccination with comirnaty. Specific information unknown to pharmacy
nausea & vomiting, fever with chills and night sweats, headache, sore throat, productive cough, stuffy nose, fatigue and loss of appetite. Severe dehydration from inability to keep anything down, including water. I went to the ER after 24hrs of vomiting up any intake, where I received 2L of NS, one dose of Zofran and one dose of Toradol.
Bells Palsy on March 7, 2021 (about 6 weeks after 2nd vaccine dose).  Duration of condition is still on going 2 weeks post onset.
Mixed - product Covid 19 series. Received 1st does Covid 19 vaccine: Pfizer 3/25/21 - Lot EN6202,  received 2nd dose Covid 19 vaccine: Moderna 4/15/21- Lot 036B21A. Monitored x 30 minutes post administration. Denies symptoms or complaints. Notified patient of event.
SHE GOT A FLU SHOT RECENTLY AND ENDED UP WITH FULL BLOWN ECZEMA ON HER FOREARMS AFTER THIS; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 53 years old female patient (129.2 kg) who got a flu shot recently and ended up with full blown eczema on her forearms after receiving vaccine INFLUENZA VACCINE and while treated with DUPILUMAB [DUPIXENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing allergies: latex, doxycycline hyclate, demerol, penicillin vk, benadryl, zyrtec, sulfamethoxazole, cefuroxime notes: allergies: latex, doxycycline hyclate, demerol, penicillin vk, benadryl, zyrtec, sulfamethoxazole, cefuroxime.   On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection 300 mg /2 mL Pre-filled syringe QOW via subcutaneous route (with an unknown batch number and expiry date) for Dermatitis atopic.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got a flu shot recently and ended up with full blown eczema on her forearms after this (eczema) (unknown latency) following the first dose intake of DUPILUMAB and following the administration of INFLUENZA VACCINE.  Action taken with DUPILUMAB (DUPIXENT) was unknown. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Developed rough rash 2-3 days after vaccine, had arm soreness.  Still has darkened skin underneath vaccine injection site. Denies other symptoms
1 day after injection - Injection site swelling; starting 1 day after injection and continued for several days with headache; Joint swelling and pain from upper body to lower body (started 2 days after injection; rash - macular/papular back to sides with itching, also started 2 days after injection.  Allergist diagnosed employee with "serum sickness."
Approximately two days of mild fever, acute body aches, headache, severe fatigue, chills, night sweats, lymph swelling and soreness, injection site soreness for approximately one week.
This spontaneous report was received from a female consumer of unknown age reporting on herself. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) last Wednesday (on 05-SEP-2012). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that a couple of days after she had gotten the vaccine she felt that the left side of her mouth inside and out was hurting. The patient also felt that her jaw was swollen. No rash was reported. The patient sought medical attention by talking to the pharmacist. No treatment information was reported. The outcome of left side of her mouth inside and out was hurting and felt that her jaw was swollen was reported as not recovered. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Pt states shoulder/muscle issue that has persisted since administration on 12/20/2016.