chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Refrigeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jul-2022 at 3:03 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Jul-2022 at 3:03 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant drug information was provided.  Patient had received later 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 1 anatomical site was also reported as deltoid.   It was unknown if the patient had ever tested positive or been diagnosed with COVID-19.  The vial(s) moved from freezer to refrigerator on 07-Sep-2022.   It was reported that the vaccines had undergone several temperature excursions in Aug 2022.   Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation. No adverse reactions were reported for any of the patients at the time of the report.  No treatment information was provided.
Breakthrough case admission after 4 vaccines Moderna 3/18/21 Lot# 045A21A;  MOderna 4/15/21 Lot# 016B21A;  Moderna 12/1/21 Lot# 013F21A;  Moderna 11/16/22 Lot# 021H22A
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient medical history and current condition was not reported. On 27-APR-2015 the patient was vaccinated with improperly stored PEDVAXHIB of dose 0.5 ml via intramuscular route. Also reported that the patient was vaccinated with M-M-R II (date unspecified) (medication error). No adverse effects were reported. Product quality complaint was not reported. The outcome of the events was unknown. Additional information has been requested.
Hospitalized 11/20/2021; COVID-19 positive 11/20/21; fully vaccinated  Discharge Summary      Admission Date: 11/20/2021 Discharge Date:  11/23/2021   CONDITION ON DISCHARGE: Stable and improved. Long Term Acute Care w/ Planned Readmission     HOSPITAL COURSE:   Patient admitted with COIVD, by day 4 she no oxygen dependency and was to go home on room air. Main symptom is weakness and lethargy.   This admission was complicated by her Type 1 diabetes, dementia, CAD, HLD, HTN, AS   I continued her on a few days of dexamethasone on discharge.
Just as I finished administering the injection, the patient fainted. He was sitting down at a table, so when he fainted his head hit the table. When we moved the patient to the floor, he had a seizure that lasted a few seconds. He regained conciousness and was alert right after the seizure. He was checked out by his regular physician and then sent home for the day, with no further follow-up needed. The patient has had flu shots before with no problems, but did mention he had a slight fear of needles.
didn't feel good; she felt fatigued; flu-ey; arm felt sore; This case was reported by a other health professional via call center representative and described the occurrence of feeling unwell in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included dermatomyositis and systemic lupus erythematosus.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling unwell, fatigue, influenza-like symptoms and pain in arm. On an unknown date, the outcome of the feeling unwell, fatigue, influenza-like symptoms and pain in arm were recovered/resolved.   It was unknown if the reporter considered the feeling unwell, fatigue, influenza-like symptoms and pain in arm to be related to Shingrix.  Additional details were provided as follow: The age vaccination was not reported. The patient was vaccinated with Shingrix within the last 3 months. After vaccination patient did not feel good, felt flu, srm sore and fatigued. The symptoms were resolved within 24 hours. The reporter did not sure if the symptoms started the night of vaccination with Shingrix or the next day. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020190518:same reporter US-GLAXOSMITHKLINE-US2020190557:same reporter
Nosebleeds began March 25, 2021. Most were in the morning and from left nostril. Dates of nosebleeds: March 25, March 27, March 30, April 3, April 5 (3 nosebleeds that day), April 6, April 7, April 10 and April 26. April 26 involved both sides and the left side bleeding lasted more than 60 min. At home treatment, pinching nostrils, applying cold packs. Saw Dr.  April 21 who ordered blood tests and checked lungs/heart.
Patient complained that he tatste the medicine  and also dizziness after he received the first dose of  pfizer vaccine. Assessment done  and patient sent home in stable condition. Patient stated that he feels a lot better.
Hispanic female accompanied by  her father.  Filled out paperwork and was allowed through by clerical person to receive inj.  Nurse vaccinated client.  Clerical supervisor saw DOB after vaccination completed by nurse and informed her.  Client was kept 20 minutes.  No adverse reactions.  Father informed she was underage and we can not administer her second vaccine and to not get any other vaccines for covid unless notified by us or her personal physician.   Father did not speak English well.  His daughter translated our information. No questions or concerns  asked.
Novartis FLUVIRIN received 10/1/12 to (L) deltoid Lot # 1205401 Exp 6/2013. 10/2/12 Noted increase burning and tenderness to site. On 10/3/12 awoke with positive redness/heat. On exam at 1205 P 10/3/12 2x2 very light pink area, tender to touch with very light erythema, (+) Pulses. No neurovascular changes. No other c/o.
PT c/o'd of severe burning at time of injection. Burning cont'd over 1 hr with severe pain to upper arm. PT became diaphoretic, dizzy and pale. PT's physical status was improved with severe pain, redness, swelling to left arm.
Patient received Moderna bivalent booster doses that had undergone a temperature excursion.; Patient received Moderna bivalent booster doses that had undergone a temperature excursion.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion.) 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. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion.).    This case contains information for the 67th of 77 adult patients described by the reporter. Concomitant product use was not provided by the reporter.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
J96.00 ACUTE RESPIRATORY FAILURE 7/6/2021 TOXIC MULTINODULAR THYROID GOITER W THYROTOXIC CRISIS J96.00 ACUTE RESPIRATORY FAILURE 7/6/2021 HYPOXIA
Monovalent mRNA vaccine administered for a bivalent mRNA dose.  Patient was given the monovalent mRNA vaccine, as I was not aware at the time, that the EUA had been withdrawal by the FDA.  My supervisor received noticed on 05/01/2023 from Health Department with a link which announced updates to Covid-19 vaccines.  That the Bivalent Moderna & Pfizer BioNTec vaccines were to be used for all doses administered to those 6 months of age and older.  In the announcement, NO where did it state that this change had gone into effect the month prior. I was forwarded the email announcement  on 05/02/2023 and it was read on 05/03/2023 as soon as I returned to the clinic office from doing vaccinations I destroyed all remaining doses of our Pfizer monovalent mRNA FP7136 vaccine.   The patient suffered NO adverse affects and had NO adverse events following his vaccination. This patient was vaccinated on 04/21/2023. I didn't find out about the withdrawal of the EUA until  05/03/2023, which at that time, I though that was the effective date of the withdrawal, not realizing it went all the way back to 04/18/2023. This patient wasn't notified prior to his release that he needed an updated Pfizer Bivalent vaccine as he was released on 05/13/2023 and the phone number that he provided at the time of his incarceration has not been answered.
This spontaneous report has been received from an office manager concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 21-SEP-2018, the patient was vaccinated with improperly stored GARDASIL 9 with lot number R002344 and expiration date on 16-NOV-2020, 0.5 ml once (dose number, route of administration and anatomical location were not provided), for prophylaxis. It was reported that on an unknown date, the vaccine was exposed to a temperature of -0.3 Centigrade degrees for 3 hours. It was unknown if there was previous temperature excursion. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported.
Patient's wife states that she woke up next to her husband 2 days post vaccination and realized he was having a stroke. He was immediately hospitalized.
After receiving Moderna Vaccine on 3/16/2021, I started experiencing extreme pain, itching, fever and redness in arm below injection site about 4-5 days after initial injection.  As of 3/29/2021, still experiencing same symptoms in left arm. Redness has grown in size.  Went to Health Department and they said I was experiencing ?Covid Arm?.  I was told to take Advil or Tylenol for pain. Benadryl for itching and cold compresses for swelling.
Headaches; hot flashes; dry eyes; burning sending under skin on location where received fillers smile lines, cheeks; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 09:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 10:15, the patient experienced headaches, hot flashes, dry eyes, burning sending under skin on location where received fillers smile lines, cheeks. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headaches, hot flashes, dry eyes and burning sensation was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient.; No adverse event; Patient was administered vaccine which had undergone several temperature excursions.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient.), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions.) and NO ADVERSE EVENT (No adverse event) in a 25-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2022 at 6:58 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Sep-2022 at 6:58 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient.), POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna and Bivalent vaccines have undergone several temperature excursions and administered to patient.) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered vaccine which had undergone several temperature excursions.).    No concomitant product use was reported.  It was unknown whether the patient was diagnosed/tested positive for COVID-19.  The patient received previous 3 dose of vaccine intramuscular in deltoid.  Anatomical location of bivalent vaccine was reported as deltoid.  It was reported that the vaccines had undergone several temperature excursions in August 2022.  Refrigeration excursions identified and vaccine was housed in the units. There were excursions noted. Manufactures were notified and the department made aware of the situation. No adverse reactions reported for any patient at the time of report.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654158, US-MODERNATX, INC.-MOD-2022-654537.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654158:Same Reporter US-MODERNATX, INC.-MOD-2022-654537:Same Reporter
sore right arm after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore right arm after first vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced MYALGIA (sore right arm after first vaccine). At the time of the report, MYALGIA (sore right arm after first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. Treatment information not provided.       Reporter did not allow further contact
Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On or about 2014, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). On or about 2015, the patient was treated by a physician for shingles, as the patient was diagnosed with shingles or other related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient had and would continue suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries; significant medical an related expenses as a result of these injuries, included but not limited to medical losses and cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions. At the time of report, the patient was not recovered from emotional distress, injury and pain. The outcome of vaccination failure, quality of life decreased, herpes zoster and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the events to be disabling, life-threatening and medically significant.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for two patients. This is the second of two reports. A 17-year-old patient of an unspecified gender received TRUMENBA and  meningococcal vaccine A/C/Y/W (MCV4); both via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was given meningococcal group b rlp2086 and MCV4 on the same visit at different locations. The patient ended up having severe headaches and vomiting and needed to be hospitalized and ended up getting a spinal tap on an unspecified date. It was reported that the events took place after the use of the products. Outcome of the events was unknown. Information on the batch number has been requested.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect drug trumenba contributed to the development of the reported events severe headaches and vomiting.,Linked Report(s) : US-PFIZER INC-2018350846 Same reporter / drug / event, different patients.
Pt became lightheaded, nauseous and sweaty with 2-3 minutes of receiving the vaccine.  He stood up to alert us he was feeling lightheaded and then fainted.  We applied an ice pack because the patient was hot.  No sign of reaction at the injection site, nor did the patient state he had trouble breathing.  Over a period of 30 minutes, the patient  recovered and did not lose consciousness again.  Patient left under their own power.
Information has been received from a nurse practitioner concerning a 20 year old female who on 08-AUG-2006 was vaccinated with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI CYCLEN).  Following the vaccination, on an unspecified date in August 2006, the patient experienced diarrhea.  Unspecified medical attention was sought.  At the time of this report, the outcome of the diarrhea was unknown.  Additional information has been requested.