chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vial was initially stored in the refrigerator on 02-Jun-2022, vial was administered on 02-Aug-2022; No adverse event; vaccinated 6 patients after the 30 day use by date on the Moderna Covid-19 vaccine had passed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated 6 patients after the 30 day use by date on the Moderna Covid-19 vaccine had passed), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Jun-2022, vial was administered on 02-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 03H21A, 029L20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated 6 patients after the 30 day use by date on the Moderna Covid-19 vaccine had passed). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Jun-2022, vial was administered on 02-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated 6 patients after the 30 day use by date on the Moderna Covid-19 vaccine had passed), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Jun-2022, vial was administered on 02-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome 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 (vaccinated 6 patients after the 30 day use by date on the Moderna Covid-19 vaccine had passed) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Jun-2022, vial was administered on 02-Aug-2022).    No concomitant drug was reported. The patient received first dose on left arm shoulder deltoid muscle. On 09-Dec-2021, patient received first booster dose. On 02-Aug-2022, patient received second booster dose. No adverse reactions were known after receiving first, second, first booster dose and second booster dose of vaccine. No treatment drug was reported.
Patient received 1st dose 1 year ago didn´t get the 2nd dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (1st dose received about 1 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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter comments: The case was reported via interactive digital media. The patient received 1st dose of Shingrix about 1 year ago from the date of reporting but did not receive 2nd dose yet. The reporter enquired if he still get the 2nd dose. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Follow up would not be possible as no contact details were provided.
Had a pneumonia vaccine on 10/22/2020 and today 10/26/2020 realized that my arm had a big red patch and was itching
We were sitting at the dinner table and she put her head back and her body went rigid and her eyes rolled back for about 30-45 seconds, then she started to come back around.  She said she could hear us talking but it was all black.
Patient was administered Pfizer vaccine as second dose rather than Moderna (Moderna administered as first vaccination).
Expired dose given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 9-year-old female patient who received HBV (Engerix B) (batch number 73h93, expiry date 10th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th January 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 26th January 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were reported as follows: Medical assistance reported that On 26th January 2022, the patient received dose of Engerix B that was already expired on 10th January 2022, which led to expired vaccine used. No adverse event was reported. The reporter consented to follow up.
fever of 100.4 Degree F and 100.6 Degree F; This is a spontaneous report from a contactable consumer (patient) via medical information team.  A 70-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 05Mar2021 the patient experienced fever of 100.4-degree F and on 06Mar2021, patient had 100.6-degree F. Patient wanted to know if she was contagious and also reported that her 30-year-old daughter was due to get the Pfizer vaccine and asked would she get any side effects from it. Patient queried if both doses are 0.3 and that if moderna covid vaccine have the same side effects. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a 72 year old female with diabetes, sulfonamide and a history of tetanus who about one and a half to two years ago, was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included Metformin and LANTUS. On 08-Feb-2009 the patient experienced shingles. The patient was prescribed acyclovir as treatment. The patient sought medical attention through an office visit. At the time of this report the patient had not recovered. Additional information has been requested.
difficulty walking; small fever; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (difficulty walking) and PYREXIA (small fever) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 017B21A) for COVID-19 vaccination.     The patient's past medical history included Neurological disorder NOS.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (difficulty walking) and PYREXIA (small fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (difficulty walking) and PYREXIA (small fever) outcome was unknown.
pt rcvd vax; screamed 1 & 1/2 hrs; twitching of head;
Change in menstruation.  Day after shot noticed blood color was brown and flow was much less than normal. Menstrual cycle time was normal.   The next 2 menstrual cycles after September 2021 were irregular, meaning odd blood color and light flow.
Large 14 x 14 area of erythema with blistering. BACTRIM DS given/prednisone given.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome 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 (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022).    No concomitant product use was reported.  Reportedly, Patient received half dose.  Vial did not undergone any temperature excursions.  No treatment information was provided.
Information has been received from a medical assistant concerning a 54 year old female patient who on 11-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #651319/1007P). Concomitant therapy included Fluvirin (unspecified), administered at the same visit in separate arms (separate sites). On approximately 11-OCT-2006 the patient developed a reaction in arm where the Pneumovax 23 was administered, that ranged from redness to blothiness to pain. Medical attention was sought. Subsequently, the patient was feeling better. The medical assistant requested a lot check. No product quality complaint was involved. Follow up information has been received from the Certified Medical Assistant concerning the patient with hypertension, type II diabetes mellitus, "cholesterol", and allergies to KEFLEX, BIAXIN, and amoxicillin who on 8:15 a.m. on 11-OCT-2006 was vaccinated IM in right deltoid with a dose of Pneumovax 23 (lot #651319/1007P). Concomitant therapy included Flurivin, administered in the left deltoid at 8:10 a.m. the same day. It was reported that on the same day the patient's right arm got swollen and red with pain. She also stated that she wasn't feeling that well for several days after the vaccination. Her outcome was not reported. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
a patient was administered a dose of improperly stored Varivax; No additional adverse effect reported; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 28-JAN-2020, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX), subcutaneously, lot # S024364, expiration date reported as 06-AUG-2021 (dose and frequency were not reported), for prophylaxis.  Administered doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced the temperature excursion from -14 to -10 C (-12.6C) for 9 hours 53 minutes. There was previous temperature excursions reported. The administered doses of the suspect vaccine experienced the temperature excursion from -14 C to -10 C(-13.00C) for 14 hours 22 minutes. The digital data logger was involved to capture the temperature excursion. No additional adverse effects were reported.   The is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA001483: US-009507513-2002USA001480: US-009507513-2002USA001517: US-009507513-2002USA001358: US-009507513-2002USA001459:
Patient reported that he started having chest pains and other symptoms of heart attack (pain running down his arm) and shortness of breath early in October 2021.  He went to the doctor, where tests were performed and a blockage was found.  Operation was completed on October 28, 2021.  Both of patients parents had open heart surgery.  Patient reported that under his doctors recommendation, he received COVID-19 immunizations and booster.   Pfizer vaccinations were received on: March 3rd Lot#EN6199  March 24th Lot# EP7534  August 18th Booster Lot#EW0175
KINRIX given to 2 y/o, indicated for 4-6y/o. Age of patient at time of event: 2 years.
pt recv vax 22JAN98 & on 10FEB98 pt exp hive-like rash which was itchy & gen all over entire body;also exp edema of both hands, redness of both palms & swollen eyes;looked like allerg type rxn;
Within 3 days of receiving her first dose of the Pfizer Covid vaccine, she started experiencing severe myalgias and dyspnea.  She was seen in the ER - diagnosed with lactic acidosis and acute exacerbation of her COPD.  She was given IV fluids, solumedrol and discharged  with prednisone and discharged home.
Left testicle hurts; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TESTICULAR PAIN (Left testicle hurts) in a 30-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TESTICULAR PAIN (Left testicle hurts). At the time of the report, TESTICULAR PAIN (Left testicle hurts) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Swelling of arm w/erythema/wheal; sl numbness of arm; onset of concurrent vaginal rectal bleeding;
I developed a twitch in right thumb that persisted for five days on May 5th. The twitch was involuntary and occurred a few times a minute. When it stopped, I felt a slight pulse in my thumb and index finger and very minor twitching for the next two months. Shortly after my tumb, my right big toe began to move involuntary, especially when I went to sleep and woke up. Other toes on my right foot and less frequently on my left foot would also occasionally twitch.  At the same time, I had difficulty texting with my thumb and made many errors when I tried. I felt weakness in my extremities (for example, my grip on the steering wheel felt less secure). I also felt restlessness in my legs.    These symptoms have subsided somewhat up this report, but they still remain.
22hr later devel fever to 104 & protracted crying for 8hr period;pt inconsolable;recv blood, urine cult & spinal tap;all labs negative;
Patient's daughter called and indicated the patient was vaccinated a our clinic last night (2/2/21) and begin feeling very ill this AM. Called and spoke directly with patient to obtain more information. Patient reports fever of 101, chills, nausea, body aches. Patient also disclosed she had covid19 > 1 month ago. Patient attempted to call her primary care physician and the doctor was not in. Staff evidently advised her to go to ED is she felt that bad.
NO ADVERSE EFFECT; expired dose of rotatteq inadveretently administered; This spontaneous report was received from a Nurse refers to a 9 week old patient. No information was provided regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies. On 24-SEP-2019, the patient was administered properly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R002805, expiry date: 23-SEP-2019) for prophylaxis. The vaccine was expired one day prior to administration (expired product administered). No adverse effect reported. The nurse confirmed that the product did not have any temperature excursion. No PQC involved. No additional information provided.
Mom states noticed thigh very red and firm to touch after child was swimming in afternoon of 9/2/10.  Child complained of pain when Mom touched red area, but tolerated regular activity.  Mom denied fever.  Did not give Tylenol or Motrin.  Did not apply compress.
Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021 at 10:19 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 10:19 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 72.84.  No concomitant medication was provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    No treatment medication was provided
achy; fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN (achy) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.In August 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.In September 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (achy) and PYREXIA (fever). At the time of the report, PAIN (achy) and PYREXIA (fever) had resolved. No concomitant medications were reported. No treatment information was provided.This case was linked to MOD-2021-382345 (Patient Link).
Breakthrough case admission after 3 vaccines  pfizer 2/11/21 ot# EL9269;  Pfizer 3/4/21 lot# EN6206;  Pfizer 8/27/21 lo0t# EW0173
I received the Pfizer COVID 19 vaccination on the morning of 2/17/21 with no resulting initial sequelae other than injection site tenderness. Approximately 2 weeks post-injection, I developed coryzal symptoms of nasal stuffiness and congestion without fever, chills, headache, or myalgias. On, or about, 3/3/21, I noticed diminution of hearing in the left ear without signs of drainage, fever, or dizziness. This was treated with a Z Pac, nasal and oral decongestants, and nasal steroids. Over the course of 10 days, the hearing decline had improved, but a clinical exam and testing by an ENT on 3/12/21 confirmed evidence suggestive of sensorineural hearing loss, with asymmetric impairment in the affected (left) ear.
Medical Assistant gave Bivalent Booster for age 5-11year old without diluting the product first. Pt received 0.2ml of undiluted Bivalent 5-11 yr Vaccine in her left deltoid. Patient (Grandparent)  has been contacted. Employee has been placed on suspension pending investigation. Patient has a follow up appt to check up in a couple of days
Expired vaccine was administered. No adverse reactions were reported. Informed patient to follow up with provider for any adverse reactions and further re-vaccination.
multiple patients were vaccinated with improperly stored VAQTA on multiple dates; no adverse effect; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-FEB-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
The following morning after the shot I woke up with 5 large, itchy hives on the right side of my abdomen  - almost like large mosquito bites. A couple of hours later I got one more closer to the center of my abdomen. I don?t know if this is related or not. I used hydrocortisone creme on the areas.
24 hrs after dose, scrotal and penile swelling, 36 hrs afterward- urticaria and wheezing.
patient called the pharmacy on monday july 18 and complained on pain in his arm since the administration of the covid vaccine on may 25 2022 which is interfering with his daily activities.
She pretreated with Claritin and tums. About 20 minutes after the injection she began having tingling and numbness in her mouth that persisted all day. The following day the tingling had improved but there was residual numbness. She also noted fatigue and body aches.