chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature 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) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 11:04 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 10:58 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient 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) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 51.15 for dose administered on 02-Mar-2021 and 51.23 for dose administered on 30-Mar-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27 degrees Fahrenheit at 9 AM, 29 degrees Fahrenheit at 10 AM, 32 degrees Fahrenheit at 11 AM, 33 degrees Fahrenheit at 12 PM, 35 degrees Fahrenheit at 2 PM and 36 degrees Fahrenheit at 3PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021  Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Patient reported tight coughing and itching to lips.  Vital signs remained stable. SPO2 99-100% on room air.  Medicated with racemic epinephrine, solumedrol, pepcid, benadryl. Patient denies any improvement in her symptoms. Monitored overnight as an observation patient. Was then discharged the next day to home.
Pharmacist administered vaccine on upper right deltoid (intramuscularly). Patient reports a tingling in the right arm that traveled to the right index finger after vaccine administration. The reaction occurred almost immediately. The patient was asked to remain seated to be monitored. After a few minutes the patient reports the tingling subsided. However, patient reports his right index finger is numb. We will continue monitoring and follow-up in two weeks on 06/02/2021.
Right arm swelled from elbow to shoulder couldn't lift arm, was cold in bed for 3 days.
My husband has fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The age at vaccination was not reported. The patient experienced fever after getting Shingrix approximately 14 hours ago. The patient asked was there a safe medicine he can take to bring down the fever.
Date the vial was initially stored in the refrigerator: 07-Jun-2023; No adverse event; Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 07-Jun-2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-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 08-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 07-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 07-Jun-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 (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 07-Jun-2023).    Dosage text for suspect product was reported as unknown. Concomitant medication was not reported. Individual vials or intact cartons were 4 of vial size 2.5 ml. Date the vial was initially stored in the refrigerator was 07-Jun-2023. Vial did not under go temperature excursion.  Treatment medication was not reported.  This case contains information for the 4th of 5 doses described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728778 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728778:Master case(Dose 1 of 5)
pt recv vax & devel an inj site rxn characterized by redness, pain, & swelling which extended half-way to the elbow;the area was hot to touch for 2wk;this is one of two pt from this site;
Fever; Nausea; Headache; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced fever, nausea and headache. On an unknown date, the outcome of the fever, nausea and headache were unknown.   It was unknown if the reporter considered the fever, nausea and headache to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but could be between 51 or 52 years. The reporter stated that the patient received the first dose of Shingrix and experienced fever, nausea and headache. Date of birth was not provided but the reporter mentioned that he was sure that the patient was 52 years old. The reporter consented to follow up.
¨i have terror symptoms¨; ¨could not eat anything¨; ¨My stomach aches a lot ¨; ¨ i could not sleep at night¨; ¨a lot of nauseas, urge to vomit¨; ¨my head is splitting ¨; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (¨i have terror symptoms¨), EATING DISORDER (¨could not eat anything¨), ABDOMINAL PAIN UPPER (¨My stomach aches a lot ¨), INSOMNIA (¨ i could not sleep at night¨) and NAUSEA (¨a lot of nauseas, urge to vomit¨) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CALCIUM and ASCORBIC ACID (VIT C) for an unknown indication.   On 12-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced FEELING ABNORMAL (¨i have terror symptoms¨), EATING DISORDER (¨could not eat anything¨), ABDOMINAL PAIN UPPER (¨My stomach aches a lot ¨), INSOMNIA (¨ i could not sleep at night¨), NAUSEA (¨a lot of nauseas, urge to vomit¨) and HEADACHE (¨my head is splitting ¨). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 UNK. At the time of the report, FEELING ABNORMAL (¨i have terror symptoms¨), EATING DISORDER (¨could not eat anything¨), ABDOMINAL PAIN UPPER (¨My stomach aches a lot ¨), INSOMNIA (¨ i could not sleep at night¨), NAUSEA (¨a lot of nauseas, urge to vomit¨) and HEADACHE (¨my head is splitting ¨) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The treatment information was unknown. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-127310 (E2B Linked Report). This case was linked to MOD-2021-083394 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127310:
Evening after the injection - upper arm pain, swelling, redness pain bad enough to miss work.
Patient was fully vaccinated with COVID-19 Vaccination Moderna on dates 1/14/2021 and 2/8/2021 and was COVID-19 positive on 7/8/2021.  Patient is currently asymptomatic. This is a breakthrough case.
This case was reported by a healthcare professional and described the occurrence of arm numbness in a 52-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included allergy to gluten. Concurrent medications included Levothyroxine. On 3 May 2013 the subject received a dose of BOOSTRIX (.5 ml, unknown route, right arm). On the morning of 4 May 2013, 1 day after vaccination with BOOSTRIX, the subject experienced arm numbness and leg numbness. The numbness occurred in the left arm and left leg. These events resolved. On 24 May 2013, the subject sought medical attention from the doctor with "numbness in the left arm and numbness in the left leg and this resolved itself as well." The doctor referred the subject to a neurologist for evaluation. Per the reporter, the physician was "not sure if this [was] a reaction to the vaccination or not." At the time of reporting the events were resolved. Follow up was received from a physician on 10 September 2013. The physician documented that the events onset on 4 May 2013, 1 day after vaccination with BOOSTRIX. The physician documented that the outcome was unknown; however, the events were previously reported as resolved. The physician did not consider this case serious.
Redness, swelling and pain surrounding the injection site and extending four inches outward along with the arm, duration of 3 days.
pt recv vax & exp breakthrough rash @ inj site which consisted of approx 5 to 6 papules;
Muscle ache; Chest pain; Fever; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old pregnant female patient received BNT162B2 (Pfizer BioNTech Covid 19mRNA vaccine, Batch/lot number: 6206), via unknown route of administrated on her left arm on 16Mar2021 at 11:45AM (at the age of 28-years-old) as a single dose for Covid-19 immunisation. The patient's medical history included Penicillin allergy. Concomitant medications included Yasmin. Patient had no symptoms associated with COVID-19. Patient was not enrolled in the clinical trial. Patient had not been tested positive for COVID-19 since having the vaccine. The patient experienced Chest pain, Fever, Fatigue and muscle ache on 16Mar2021 at 16 hours. It was unknown if patient received treatment for the events. The clinical outcome of these events chest pain, fever, fatigue and muscle ache was reported as not recovering at the time of this report. No follow-up attempts are possible. No further information is expected.
Partial hearing loss in both ears. A drumming sound in both ears after I exhale breath.
large erythematous area at the injection site/redness at injection site; reactogenicity; This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema and reactogenicity event. On an unknown date, the outcome of the injection site erythema and reactogenicity event were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and reactogenicity event to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid about 2 months ago and stated he experienced reactogenicity with a large, red, erythematous area at the injection site. It did not inhibit his daily activities, but lasted about a week. The patient stated that his experience would not prevent him from getting the 2nd dose to provide him with protection from shingles. He requested not to be followed up with as he expressed his experience was within what he may had expected.
Pt fainted and fell from chair hitting the floor. Vital signs were taken and were elevated. Pt was assessed, and pt became alert immidetly after ending up on the floor.  He did not complain of pain anywhere, vital signs started to trend towards within normal limits. No medication was given.  pt left indepently with normal walking gait and partner waiting outside. Pt was educated on when to seek urgant care.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with the ZOSTAVAX vaccine by a pharmacist or physician at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2013, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Itching of face, lips , tongue, neck, back bumps in whole mouth of skin. Wheezing, coughing, sore throat.
bad abdominal pain; This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (had shingles from September through December 2020) and acid reflux (oesophageal) (had acid reflux and procedure to treat acid reflux).   On 3rd February 2021, the patient received the 1st dose of Shingrix (intramuscular). On 4th February 2021, 1 days after receiving Shingrix, the patient experienced abdominal pain. On an unknown date, the outcome of the abdominal pain was recovering/resolving.   It was unknown if the reporter considered the abdominal pain to be related to Shingrix.  Additional details were provided as follows: The reporter reported for himself. The patient received 1st dose of Shingrix in the left arm. By the thursday on 4th February 2021, the patient experienced abdominal pain and was now slowly getting better. The reporter did not consent to follow up. This case was linked with case US2021034626, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021034626:same reporter
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On unspecified dates the patients were vaccinated with improperly stored M-M-R II (dosing regimen unspecified) (L003858 (also reported as 1003858), exp: 05-FEB-2017). No concomitant medications reported. No adverse effects reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 12 month old white female child with an allergy to amoxicillin who on 24Feb03 was vaccinated with a first dose of varicella virus vaccine live. Concomitant vaccinations that day included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). There were no other concomitant medications. On 07Mar03, 11 days post vaccination, the pt developed a macular, papular rash which started on her face and then spread to her arms, trunk, and legs. The reporter indicated that there was no fever, no vesicles, and no blisters. It was noted that the reported is not sure if this is wild type virus or possible transmission. Unspecified medical attention was sought. Follow up information indicated that the child was agitated all day on 06Mar03, and in the evening of 05Mar03 developed a rash all over her body which worsened  on 07Mar03. The rash was described as red, maculopapular, round, 1/4 cm lesions that were scattered on her face, arms, legs, chest, back, and abdomen. No itching and no fever were noted.  The physician indicated that it appears to be a post vaccination varicella. The mother denied any use of new shampoo, new soap, new moisturizer, or new foods. It was also noted that on 07Mar03 the child had 1 looser than normal stool. The physician instructed the mother that the child should not come into contact with other children until her rash resolved completely. The child was treated with acetaminophen (Tylenol) prn. On 11Mar03 the child returned to the physician's office and it was determined that the child was status post varicella rash which had resolved. It was noted that one single erythematous macule on left thigh is last vestige of rash so clinically resolved. This is a amended report. The patient's adverse event now reads rash vesicular instead of rash maculo-papular. The adverse event of loose stool was added. No further information is expected. This is a corrected report as amended.
Pt started sneezing, and eyes got very watery and red, he started coughing a lot, and then the face got all swollen. 8/18/09 Pt came in for F/U and he still was a little swollen from the face. Will come back tomorrow. See attached.
Patient was called cause she recievied the Moderna vaccine and was told about the new Bivalent vaccine that is available.
This spontaneous report was received from a clinical supervisor who was a medical assistant, regarding to multiple (unspecified number patients). Patient demographics were not reported. Information on concurrent conditions, medical history and drug allergies of the patients were not reported. Illness of the patients/siblings at the time of/prior to vaccination were not reported. On an unknown date in January 2016 (at unspecified times between 09-JAN-2016 and 15-JAN-2016) the patients were vaccinated with RECOMBIVAX HB (lot # L029631, expiry date 14-AUG-2017), (lot # L018501, expiry date 22-JUN-2017), (lot # L004754, expiry date 10-NOV-2016) (dose number, dosage units, route and anatomical location not specified). Concomitant medication were not reported. On an unknown date in January 2016 (at unspecified times between 09-JAN-2016 and 15-JAN-2016), the reporter stated that unspecified number of patients received unspecified doses in series of RECOMBIVAX HB that were improperly stored. Temperature at which the vaccines were maintained was reported to be 54.1 (units not provided), time frame was 3.5 hours, no previous temperature excursions were performed. No adverse effects were reported. Additional information has been requested.
ATE JELLY BEANS ABOUT 15 MINUTES BEFORE THE LAST DOSE; This spontaneous case report was received from an other healthcare professional (PVX2019-221) on 23-Jan-2019. The report describes a female consumer who "ate jelly beans about 15 minutes before the last dose". The consumer was receiving Vivotif for an unknown indication.  It was reported that the consumer ate a few jellybeans about 15 minutes before the last dose.  The action taken with Vivotif with respect to the event "ate jelly beans about 15 minutes before the last dose" was not applicable.  The clinical outcome of the event "ate jelly beans about 15 minutes before the last dose" was unknown.  Company's Comment: The causality of the event "ate jelly beans about 15 minutes before the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "ate jelly beans about 15 minutes before the last dose" was considered as not applicable.
Got shot at 8am 22 Jan. Slight soreness in arm developed later the same day, but no problem. Everything was normal and went to bed. Woke up approximately 2-3 h later with extreme vertigo, dizziness, imbalance, completely clogged left ear, tinnitus in left hear and nausea. Within about an hour I was hyperventilating and had cold tingling sensation in hands and feet. About 2am went to hospital. They did a bunch of tests including a CT scan which revealed nothing adverse. They kept me over night and gave me an MRI the next morning. Again nothing adverse found. I was released that next day with orders to see PCP. Got an appt 2 days later. PCP immediately started me on Prednisone and referred me to ENT doctor. Got an audio test 2 days later and because of the severity of my symptoms (sudden, acute tinnitus and complete hearing loss in left ear) ENT prescribed higher dose and duration of prednisone. I am on day 5 of the 24day course prescribed by ENT with no appreciable improvement. Still have no hearing in left ear and tinnitus, imbalance and trouble focusing and walking.  No causal link has been ascribed to the vaccine, but I am terrified of having the booster shot which is schedule for 12 Feb.