chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product storage error; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vaccines were stored in the fridge on 30-Jun-2021, there were different administration dates, starting on 02-Aug-2021 until 20-Sep-2021 being the last one. Patients did not report any side effects.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master Case ID
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information provided.   This case was linked to MOD-2021-395985 (Patient Link).
Swelling - OU. Urticaria (over body) acute itching and irritability. EPI Jr 0.15 mg - BENADRYL 12.5 mg. Occurred within 30 to 40 minutes after shots.
adm to hosp 17JUN94 w/fever 104.8; dx on hx & physical bilateral OM; no sz activity;
This spontaneous report was received from a healthcare worker (certified medical assistant) refers to patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not specified. On unspecified dates, the patients were vaccinated with improperly stored VAQTA lot # L002717, expiry date 02-JUN-2017 (dose, strength, route, dose numbers, vaccination site unspecified). The previous temperature excursion for the lot # L002717 was reported at a temperature of 34 degrees F for 15 hours. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Jan 17, 1997 pt developed alopecia, appetite loss,irritability, cellulitis and "red hot at inject site." It was reported pt is still not imp and rpt md stated that "it appeared to be similar to an infection."
After being Vaccinated, the patient begins to present weakness, paleness, nausea and blurred vision. The necessary assistance was provided and blood pressure was taken, which reflected 89/57. Dad was oriented to keep the minor in the waiting room under the supervision of the RN. Patient shows improvement after several minutes and was alert and oriented at the time of leaving the clinic.
Mom states that 4 hours after immunization that patient complained of "butt & thighs are numb & chest feels jittery". Did not call physician and symptoms were gone in the morning.  Mother refuses future HPV.
Within 10 minutes of  receiving shot, I was nauseous, extreme stomach discomfort, vomiting, lite headed and dizzy.
got sick and I ran a high fever; got sick and I ran a high fever; sore arm; This is a spontaneous report from a contactable consumer. These 64 years-old female consumers (patient) reported for herself.  A 64-year-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6203, Expiration date: unknown), via unspecified route, administered in right arm on 23Feb2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes sclerotherapy and varicose veins from an unknown onset and unknown ongoing and concomitant medications were not reported. On 23Feb2021 after the vaccination, the patient experienced sick and she ran a high fever on Saturday, but she has been around someone that was sick, so it could have been that. she had a sore arm for 2 days and was sick for 24 to 48 hours. She didn't' feel well until today. she is scheduled for sclerotherapy on the veins in her legs this week, but doesn't know if she should postpone that, she had it back in December, for superficial clot in her veins and they are fixing them. she had the ablation and trying to get the sclera therapy, they will be injecting the foam in her legs. she has varicose veins. The events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. Date the vial was initially stored in the refrigerator was unknown. The vial didn't undergo any temperature excursions. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant information received.
Feb 24, the injection site was itchy all day. I felt tired for most of the day. Feb 25 the injection sight was red, swollen and raised in an oval shape about 3.5 inches by 2 inches. It was warm to the touch.  I had a headache and felt tired all day, along with some muscle weakness.   I did have a delayed reaction to a bee sting in 2014. The sting became swollen and warm and itchy 8 days after it happened.
Myalgia, Fever, NauseaVomiting, diaphoresis lasting approximately 2 hours, feeling fatigued, onset of symptoms 0245 12/29/2020
Got shot at 04:15 pm - symptoms started within 15 minutes; Excess mucus in my throat and having to clear throat constantly and the Benadryl kicked in and it went away within an hour.  By evening of the next day, Chills and that started about 05:00 pm. On 2:30 am on Sunday, I woke up with a 103 fever. That only lasted a few hours and I was not allowed to come to work on Monday because of fever. I took a rapid Covid test and it came back negative. Temperature was back to normal.
The patient called in to the pharmacy around 11:15 am on 7/9/2022 to inquire about a possible adverse reaction to the shingles vaccine that they received on 7/5/2022. The patient stated that they started to notice the reaction overnight after receiving the vaccine. They stated that they started to notice a rash and redness around the injection site, and that the rash became itchy. They stated that they also noticed that their back became itchy as well, and as of now the rash is located on their left arm, but on the opposite side of the arm where they received the injection. The patient stated that the rash is sometimes itchy and stinging. The patient denied any redness or irriation to their back at this time, stating that it seems to have disapated, but the stated the rash on their arm itself has gotten worse over the last couple of days. I informed the patient that redness and irritation at the injection site is a normal reaction to the vaccine, but the worsening of the rash and the location on the opposite side of the arm as the injection was puzzling so I suggested that they seek a doctors medical opinion as their may be something else at play and it would be best to have it looked at. The patient expressed understanding and stated they will follow up with their doctors office.
Second dose of Moderna vaccine given within 14 days; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine given within 14 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine given within 14 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine given within 14 days) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator No treatment medications provided by the reporter.
4 doses of the Moderna Covid-19 vaccine administered after 30-day Use By Date; Moderna Covid-19 vaccine administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses of the Moderna Covid-19 vaccine administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine administered after 30-day Use By Date) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses of the Moderna Covid-19 vaccine administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses of the Moderna Covid-19 vaccine administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine administered after 30-day Use By Date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The reporter did not have any information about the patients height, had no allergies and was not tested positive for Covid-19. The patients did not receive any other vaccine within 1 month prior to Moderna's and, at the time of the vaccination. The patients did not have any acute or chronic illnesses. The caller could not provide any information about the first and the second dose of the vaccine, but only recalled that they were Moderna's. The patients did not receive a third dose of the Moderna Covid-19 vaccine and they are not experiencing any symptoms yet. Number of doses or vials was 4 doses 1 vial. On 18-Jan-2022, the vial was initially stored in the refrigerator.  The vial was not underwent any temperature excursions. No concomitant and treatment medication were reported. Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2022: Follow up document contains reporter contact details was updated.
Gout flair up; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 10Jun2021 at 13:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19.The patient had no known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC) for allergy from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Jun2021, two days after vaccination, the patient experienced gout flair up. Therapeutic measures were not taken as a result of the event. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19.  On an unknown date, the patient underwent nasal swab test and the result was unknown. The clinical outcome of the event gout flair up was not recovered at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was considered medically important. Information regarding PREVNAR 7 was received from a healthcare professional regarding a 7-year-old male patient who experienced a positive culture for streptococcal pneumoniae. The patient received the second dose on 05-Dec-2005. The patient experienced a positive culture for streptococcal pneumoniae (bacterial culture positive) (pneumococcal infection). The physician felt that the PREVNAR would have covered the strain (drug ineffective). The child is being treated for infection (unspecified) and had an ENT consult. Outcome was unknown.  No additional information was available at the time of this report.
- Heart arrhythmias roughly every 5 minutes for 48 hours (May 24, 25). Frequency decreased to 2x arrhythmia  / week for over six months. - ECGs show the arrhythmias as PVCs
Presented for cough, SOB, hypoxia. Admit for COVID PNA. Hx HTN. Tx w/ abx, steroid, vit C, zinc, O2. DC'd on home O2.
This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. No information about medical history, concurrent conditions was reported to the patients. On an unknown date the patients were vaccinated with unspecified number of improperly stored doses of (Oka/Merck) VARIVAX lot # L005301, expiration date 17-FEB-217 (strength, route unspecified). No adverse effects reported. No product quality complaint was involved. This is one of the several reports from the same source. Additional information has been requested.
Patient described feeling light headed and itchy throat after leaving the store. Pharmacist asked patient if needed to call 911, patient declined. Patient was administered benadryl and symptoms improved. Patient's husband arrived to take her home after symptoms improved.
I was given a vaccine on Dec17th, on Dec21st I tested positive for Covid; I was given a vaccine on Dec17th, on Dec21st I tested positive for Covid; This is a spontaneous report from a contactable nurse. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. There was no relevant medical history. The patient's concomitant medications were not reported. The patient was given a vaccine on 17Dec2020, the on 21Dec2020, the patient tested positive for COVID. The outcome of the event was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
I had severe headache and aphagia that started at 5AM May 8, 2022. I went to the emergency where they ran a CT scan, MRI, ECG, EEG, complete blood panel. I am still having intermittent much milder headaches and much confusion.
Bell's Palsey per Dr. appt 2-1-22 provided steroid shot and pills and should recover in next 2months to 1 year
I had abdominal pain and was hospitalized. Put on antibiotics. It was an appendicitis - but they have not yet had to removed the appendix. I was sent home with a prescription of antibiotics.
Got the Shingles that had the shot/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the Shingles that had the shot/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 24-APR-2023 This case was reported by consumer via interactive digital media. The reporter reported that he or she know the patients who received Shingles vaccine and still experienced shingles. The reporter stated that the vaccine was not 100 percent going to keep you safe from getting the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. The follow-up could not be possible as the as no contact details were available.
Nothing happened after the vaccine and it was wonderful. I was fine. Then I got up and left and went to work and nothing was going on. Through time, I kept feeling more exhausted and the exhaustion turned into extreme body aches and it felt like I had the flu. They said this could possibly happen and that never went away. I took some time from work, and complained about it after about 2 weeks. I took some time off because I couldn't get out of bed for a bit which is really hard to do. It never stopped. It kept going from there. I haven't felt the same ever since. Extreme muscle pain and joint pain, headaches, swelling in random joints. One of my joints will swell up, ankles, knees, wrists, fingers. It just hasn't stopped. There has been a few times since the last year where I haven't been able to get off the bed or off the couch because it hurts or I'm too exhausted to use my muscles. I feel like a 60-80 year old at 38. Haven't been the same since. 4 doctors have indicated this could be RA.
Pain in my head and injection sight, very slowen and painful lymph notes in my under are on the injection side
Moderna COVID-19 Vaccine EAU Rash and swelling at point of injection
pt recvd vax & 23JUN92 had severe pain on lt side of face around the trigeminal nerve; 27JUL92 was seen by neurologist who dx neuralgia; 30AUG92 had paresthethesia in lt leg; 1SEP92 paresthesia in lt hand & foot;
5.5cm x 7.5cm indurated erythematous warm and tender lesion area right lateral thigh at site of vaccine injection.
The morning following my 2nd dosage I became dizzy when I stood up or did anything physical.  This continued for a couple weeks, then was only when I would stood up which last until mid August 2021.
Severe exhaustion, hot and cold sweats, severe muscle aches, headache, arm at shot site was very painful, pain radiated into shoulder and chest which all lasted for 36 hours. Then I started to get very itchy around the shot site for another couple days. Did not full recover for a WEEK
High fever, shaking, chills, severe arm and neck pain, projectile vomitting, severe headache, body aches
No additional AE; customer reporting administration of expired Gardasil 9; Information has been received from the pharmacist, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant therapies were not provided.   On 09-DEC-2020, the patient received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, route of administration, and lot number were not provided), which expired on 07-DEC-2020 (expired product administered), for prophylaxis. No adverse event was reported.
Started evening with soreness. Fevers began at night. On 9/20/04; taken to ER for fevers of 103. Arm swelled and very red. Patient very sore. On 9/23/04 mother contacted;health department contacted. Child very sleepy. 9/24/04 Patient arm looked at. Discharged home.
Per MD Note:  She developed the shortness of breath on 06/25, which was four days after she received her first dose of the mRNA Pfizer vaccine.  The child describes experiencing shortness of breath, but denies any cough, tightness of the chest, or fever.  Since onset, her shortness of breath has been occurring random episodes, but more so at rest than with activity.  She mentions that these episodes do not make her conscious of her breathing.