chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FluLaval given after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 7-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 5M2H2, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th February 2023, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 14th February 2023, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 Information: GSK Receipt Date: 15-FEB-2023 Reporter's Comment: The reporter reported a similar situation that involved Engerix B, but they realized that Flulaval QIV was also involved.  The reporter was consented to follow up. Additional supportive information: The patient received FluLaval Quadrivalent vaccine after a below temperature excursion, which led to incorrect storage of drug. This case is linked with case US2023025426 and US2023024476 reported by same reporter for other patients.; Sender's Comments:  US-GSK-US2023025426:Same reporter - other male patient US-GSK-US2023024476:Same reporter - Engerix B case
Patient recevied vasccines on 5/1/2023 returned on 5/2/2023 with rash on body for 1 day. Dr. assessed the patient and stated Dermatitis VS reaction to vaccines. He presccribed Hydrocortisone !% to apply BID. On 5/5/2023 I called paretn and she stated that rash is less.
got heavy arm pain; This is a spontaneous report from a contactable consumer (Patient) reporting himself. A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration in Left Arm on an unspecified date as single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 administered in Left Arm on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has not received any prior vaccination within 4 weeks. Patient stated he received both doses of vaccine, Second dose received on 06May2021 and had arm pain in area of arm where the vaccine was administered; when the pain started it was pretty bad, has lasted about a month now and is definitely better now but is still annoying. The seriousness of the event was reported as non-serious. Patient had no treatment for the reported event but is muscling it out and everyone in his family got the covid vaccine and he is the only one with this pain.The clinical outcome of the event was recovering.  Information on the Lot/Batch number has been requested.
A big red circle on the site of the injection, and is all swollen  and hard; Itchy bumps on the site of the injection; Big red circle swollen and hard; Started itching around the site of the injection; Big red circle swollen and hard; When press on it, it hurts; Only a little bit of arm  soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (A big red circle on the site of the injection, and is all swollen  and hard), VACCINATION SITE PAPULE (Itchy bumps on the site of the injection), VACCINATION SITE INDURATION (Big red circle swollen and hard), VACCINATION SITE PRURITUS (Started itching around the site of the injection) and MYALGIA (Only a little bit of arm  soreness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045j21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROPINIROLE, GABAPENTIN ENACARBIL (HORIZANT), METHOTREXATE, DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ), FOLIC ACID, BUPROPION HYDROCHLORIDE (WELLBUTRIN), LANSOPRAZOLE (PREVACID) and CRATAEGUS LAEVIGATA, MAGNESIUM CITRATE, PLECTRANTHUS HADIENSIS, THEANINE, THEOBROMA CACAO (HIGH BLOOD PRESSURURE) for an unknown indication.    On 22-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2021, the patient experienced MYALGIA (Only a little bit of arm  soreness). On 31-Dec-2021, the patient experienced VACCINATION SITE ERYTHEMA (A big red circle on the site of the injection, and is all swollen  and hard), VACCINATION SITE PAPULE (Itchy bumps on the site of the injection), VACCINATION SITE INDURATION (Big red circle swollen and hard), VACCINATION SITE PRURITUS (Started itching around the site of the injection), VACCINATION SITE SWELLING (Big red circle swollen and hard) and VACCINATION SITE PAIN (When press on it, it hurts). At the time of the report, VACCINATION SITE ERYTHEMA (A big red circle on the site of the injection, and is all swollen  and hard), VACCINATION SITE PAPULE (Itchy bumps on the site of the injection), VACCINATION SITE INDURATION (Big red circle swollen and hard), MYALGIA (Only a little bit of arm  soreness), VACCINATION SITE SWELLING (Big red circle swollen and hard) and VACCINATION SITE PAIN (When press on it, it hurts) outcome was unknown and VACCINATION SITE PRURITUS (Started itching around the site of the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported she took  antihistamine and doesn't itchy anymore. She is using High blood pressure Concomitant medication.
Nausea, vomiting, abd pain, HA - hurtingg all over body, diarrhea.  10/9/07 Reviewed hospital medical records which reveal patient experienced fever,  nausea, back pain, hypotension, pyelonephritis, dehydration.  Admitted 5/29-6/4/2007.  Transferred to ICU & improved.  D/C to home on continued antibiotics & antivirals. LABS: blood & urine c/s (+) e. coli.  Admit creatinine 2.9, d/c 1.1.  Echocardiogram WNL.  Admit WBC 13.9 (H) CT of abdomen revealed diverticulosis & stranding around right kidney. FINAL DX: sepsis, UTI, HTN, acute renal failure, herpes simplex labialis & HA. 10/19/07 Received hospital medical records for 6/28-6/29/07 admisssion which reveal patient experienced nausea, vomiting, abdominal pain, HA & myalgias x 1 day.  Tx w/IVF, steroids & pain/nausea meds w/complete resolution.  Instructed not to take further typhoid dose.  D/C to home. FINAL DX: adverse reaction to recent vaccination w/symptoms including nausea, vomiting, abdominal pain, HA & myalgias.
Four days after my second dose, I woke up to hives on my back thighs. It then spread all over my legs, up my back and behind, and on my arms. I immediately called my doctor and he told me to use over-the-counter antihistamines such as Benadryl/diphenhydramine for Claritin 10 mg once or twice daily, or Zyrtec 10 mg once or twice daily or alternating Claritin and Zyrtec for more severe cases and supplementing with diphenhydramine 25 mg every 6 to 8 hours.  My doctor believes the reaction was due to my second COVID vaccine.   I ended up taking 2 pills of the 12 hour Allegra 2x a day, depending on when the hives would start up again. Two in the morning and two at night.
nausea; vomiting; fever had returned; struggled with body aches/pain; mild fever; swollen left arm; red left arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen left arm), ERYTHEMA (red left arm), MYALGIA (struggled with body aches/pain), NAUSEA (nausea) and VOMITING (vomiting) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seasonal allergy. Concurrent medical conditions included Drug allergy (Medication allergies reported as sulfa, Effexor, Lexapro and Lyrica.), Autoimmune disorder, Fibromyalgia, Asthma, Chronic fatigue syndrome and Chronic migraine. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), MONTELUKAST SODIUM (SINGULAIR), SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]), VITAMIN D NOS, VITAMINS NOS (DAILY VITAMINS) and GABAPENTIN for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 06-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen left arm) and ERYTHEMA (red left arm). On 07-Feb-2021, the patient experienced PYREXIA (mild fever). On 10-Feb-2021, the patient experienced MYALGIA (struggled with body aches/pain). On 11-Feb-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever had returned). On 09-Feb-2021, PYREXIA (mild fever) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen left arm), ERYTHEMA (red left arm), MYALGIA (struggled with body aches/pain), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever had returned) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. On 07-Feb-2021, swollen red left arm was a lot worse. The patient had not reported the events to a HCP.
My daughter started having intense diarreah 4 hours after getting the vaccination (oral rotatech).  She was sick and up all night the night after receiving the vaccination.  She had some blood in her stool after many episodes of the diarreah.  She was also screaming uncomtrollably for several hours and pulling her legs up  like she was in pain.  After a few hours the screaming stopped but the diarreah continued for about 48 hours.  I then got sick with intense stomach cramping and diarreah a few days later.  About a week after all of this, my 2 year old also got sick.....really sick.  She had a fever of 103.0 degrees and was vomiting every 30-45 minutes for about 12 hours.  She had a fever for about three days and was vomiting for about 36 hours.  She then had bad diarreah.  We called the hospital and they told us she had rotavirus most likely and to be sure to keep her hydrated, whish was difficult because she could not keep anything down, even water.  We were able to keep her hydrated with ice chips and after three days she began to improve.
cellulitis; was administered subcutaneously; This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number CA374, expiry date 28th June 2021) for prophylaxis.   On 16th October 2020, the patient received Shingrix (subcutaneous). On 16th October 2020, unknown after receiving Shingrix, the patient experienced wrong route of administration. On 18th October 2020, the patient experienced cellulitis (serious criteria GSK medically significant). The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the cellulitis was not recovered/not resolved and the outcome of the wrong route of administration was unknown.   It was unknown if the reporter considered the cellulitis to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. After receiving dose of Shingrix, the patient experienced cellulitis. The patient received Shingrix subcutaneously instead of intramuscularly, which led to wrong route of administration. On 18th October 2020, the patient went to emergency room. The caller reported that the cellulitis was nearly resolved. The caller reported that the patient was still taking antibiotic. The patient required emergency ER. The reporter did not consent to follow up. The case was considered as medication error with harm.
limp-unresponsive state & temp R 105 w/in the first 24hr p/vax administration;
Patient reported a rash on her arm 3-4 days after getting the vaccine (dose 2). After about a week, the rash continues to spread and now is looking more like a burn. Patient was referred to see dermatologist for further evaluation.
No adverse reaction. Patient is pregnant and requested a preservative free flu shot and the regular flu shot was given.
Since 48 hours after the shot, my wife and I have been extremely fatigued and dizzy. The fist week we suffered severe migraines, abdominal pain, fatigue and dizziness to the point of being incapacitated. A week later, we are still too dizzy to work/operate our vehicle and are always tired.   Before this event, we are both in our 30?s, exercise at least an hour/ 5 days per week and have a very healthy diet. We went from the best shape of our lives to unable to function after this first shot.   I have reached out to my clinic regarding my symptoms and they have no answers.  I am terrified to get the second round as I have missed weeks of work due to this already.
Product used 3 days past use by date. Moderna notified, they advised no further steps be taken
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
None. 10/5/09 Autopsy received. Cause of Death: Sudden Infant Death Syndrome. Additional information abstracted: History of co-sleeping with both parents. Lividity present in anterior and posterior body with areas of blanching on left face and abdomen. Petechial hemorrhages of thymus and lungs. Pulmonary congestion and edema.
pt. developed a nickel sized swelling on the right thigh the day after administration of DTAP and HIB. The redness also increased on the same day. Pt. also developed fever, vomiting and diarrhea but was active.
Received the vaccination after a temperature excursion; The facility had a temperature excursion in the freezer/ received the vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (The facility had a temperature excursion in the freezer/ received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (The facility had a temperature excursion in the freezer/ received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received the vaccination after a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (The facility had a temperature excursion in the freezer/ received the vaccination after 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Received the vaccination after a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (The facility had a temperature excursion in the freezer/ received the vaccination after a temperature excursion).    No concomitant medication were reported.   The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures. At the time of the excursion vaccine was in frozen storage. Unbroken Cartons with vial size of 2.5 mL and 5.5 mL. Maximum or minimum temperatures reached was unknown, only had manual twice a day recording. The excursion duration was Unknown. The vials were Returned to the freezer at the time of reporting. Upon visual inspection vaccine state change was still frozen.  No treatment information was provided by the reporter.
Patient had pain and swelling.  The patient reported to an ED and was given and unknown antibiotic.
not feeling good; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MALAISE (not feeling good) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 40-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MALAISE (not feeling good) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, MALAISE (not feeling good) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter stated that her friend received vaccine and stated she was not feeling good.  Concomitant medication and treatment information was not reported by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow-up received on 24-Feb-2022 contains no new information.
06-13-2008 Patient was in clinic for first HPV vaccine & other vaccines.  A pre-administration urine pregnancy test was negative/ vaccine was given. Then on 7-30-2008, patient returned for HPV #2 and reports she is 3 months pregnant and says she knew that at the time of first vaccine, but did not report pregnancy.  No additional vaccines given and no known effect at this time.
Dizziness, Headache, As reported by employee on 6/22/2021: "Fatigue, No appetite:  Narrative: Employee reports: ******************** "What date(s) did you have symptoms: 1/19/21 1/20/21 What time approximately: 14:30 through 22:00 What were they symptoms? (DETALED): Headache/Fatigue Headache/Extreme Fatigue, No appetite, slight dizziness"