chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vertigo was reactivated; This case was reported by a physician via sales rep and described the occurrence of vertigo in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included vertigo.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was unknown.   It was unknown if the reporter considered the vertigo to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comment: The case was reported by patient himself who was MD. The reporter stated that during a luncheon for a clinical team one of the MD present stated they had an adverse event occur after his own Shingrix.   The reporter stated that, he felt as if after receiving the dose his vertigo was reactivated.  The reporter consented to follow up.
Myalgia fatigue Narrative:  sore arm for 2 days. fatigue on 2nd day
intermittent inconsolable fussiness without vomiting or diarrhea in 24hr period post vaccination. not formally evaluated for intussusception as resolved spontaneously, but parents now will not complete vaccination with rotavirus for child  10/24/08-office note for 7/14/08-frequent BMs. Normal growth and development. Evaluate for hydronephrosis. 11/3/08-office note for 9/17/08-well baby visit with discussion related to hydronephrosis.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was respectively vaccinated IM. with first, second and third dose of GARDASIL, 0.5ml, in month 0, months 2 and month 6. No other co-suspects were reported. No concomitant medications were reported. 10 days after the third dose, the patient experienced neurological problem and was hospitalized. Patient was hospitalized at hospital. The outcome of neurological problem was unknown. Additional information has been requested.
Information has been received from a nurse referring to a 11 months old patient of unknown gender. On 02-AUG-2007 (also reported as 02-AUG-2006) the patient was vaccinated with the first dose of VARIVAX (dose, route and lot # were not reported). This was 12 days before the patients first birthday which was before the recommended age. On 18-AUG-2010, the patient received the second dose of VARIVAX. No adverse effects were reported. Additional information has been requested.
I developed a temp as high as 101 degrees. Terrible headache that lasted for 5 days Muscle aches Fatigue, Weak                                     (I did have covid on March 27- was ill for 3 weeks.   Had antibodies still present when tested in August) Chills alternating with sweating
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: 4554) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (Mar2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: Days 6 COVID Ag negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had no known allergies. The patient was treated with Paxlovid from 06Mar2023 to 10Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300116338 Same patient, different product, different event;
Hives all over body. Anaphylaxis and taken to a local Hospital Emergency Room in December 24th 2021. Taken to an urgent care on December 17th 2021 to seek allergy testing.
Received Tdap x 2 1/5/14 and 1/23/14. No adverse reaction noted or known.
Swollen lymph node on right collar bone/neck (soft, squishy, no pain) [noticed it two days after vaccination and it's still there now, same size]
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 4:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 4:19 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 26.01  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  Vial was stored on cooler 1, on 15-Apr-2021, Excursion duration At 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM : 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a  traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was 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.  Treatment medications were not reported.
1mo p/vax pt devel alopecia-partial hair loss progressive w/new hair growth beginning shortly thereafter-no other dermatological etiology;(new shampoo used at onset)
Pt developed rash at injection site 48 hours post vax.  Pt had a slight fever for the next two days which was relieved with Tylenol. Rash moved from arm to under neck  approximately 3 days later, then to chest. There is an a fine, red, raised rash. Pts appetite and activity level had been normal. Referred  pt to PMD for rash evaluation.
Patient was admitted to inpatient level of care on 7-30. Patient had been admitted to hospital on 7-27 following hospital admission on 7/20 for treatment of  pneumonia due to Covid-19 virus. Patient had increased weakness and respiratory issues at home. Return to hospital for higher level care pursued.
A non-serious, spontaneous report of nurse offered without asking whether she was pregnant was received from a physician concerning an adult female. Neither past medical history nor concomitant medications were reported for this patient. The patient was six weeks pregnant when she received FLUMIST. On an unknown date, the patient received FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
This spontaneous report was received from a medical assistant referring to a 4 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 13-NOV-2014, the patient was vaccinated with the first dose of PROQUAD for prophylaxis (route, lot # and expiration date were not reported). Then, on 05-SEP-2017, the patient received a second dose of PROQUAD for prophylaxis (route, lot # and expiration date were not reported). Subsequently, on 06-DEC-2017, the patient was inadvertently administered a third dose of PROQUAD Lot # M049122, expired on 13-JUN-2018, for prophylaxis (route, lot # and expiration date were not reported). No adverse effects were reported.
Head to toe tingling, lightheaded, chest tightening, throat constriction, flush.
At 10:15 A.M, pt received Moderna Covid Vaccine, 1st dose. At 10:17, RN and APN were called over by worker and observer, in which worker was holding pt on the ground. When RN and APN arrived, pt was unresponsive for about a 1 second, then awakened. Pt got up on her own and was sat on a wheelchair. Pt was taken back to triage area. Pt told us her full name and DOB. At 10:20, vitals were taken, BP was 87/65, pulse was 57, O2 was 98. Pt was alert and oriented x4. Pt was accompanied by sister. Per pt, she has a history of this happening mostly every time she gets a shot. Pt reports being scared of needles, and this happening often. Per pt, she has no history of cormobidity, no history of allergies. RN offered pt to call an ambulance, in which pt declined. Per pt, this happens often when receiving a vaccine, as well as when she got one of her tattoos. Pt was given glucose water as well as a water bottle. BP was taken again at 10:25, pt BP 106/68, P: 70, O2 @ 98. Pt color beginning to return to normal, pt reports feeling better. Pt states she did not eat any breakfast this morning. RN spoke to observer. Per observer, he saw pt start to get pale, in which he grabbed pt, and assisted her to the ground. Pt did not hit head. Vitals were taken again at 10:35, BP @ 98/70, P: 85, O2 @ 99. SIster stated she is driving, and will not let pt drive, agreed with sister. Appointment scheduled for tomorrow for f/u with a provider. BP taken @ 10:55, BP was 100/ 64, P: 80, O2 was 99. Pt is alert and oriented x4. Pt was again offered an ambulance or to be driven to the ER, pt declined. Pt given strict instructions on when to go to ED, pt and sister agreed. Per pt, she has work today @ 2pm, RN advised pt to stay home and rest, pt agreed. RN will send letter to pt to excuse her from work. Due to pt BP being WNL, pt being alert and oriented, pt was wheeled out in the wheelchair by RN with sister. No further questions or concerns.
Pt  stated that her throat started closing 10 minutes after the vaccine. We called 911 right away and administered one dose of Epinephrine 0.3mg.
I have them and I had the shot/Suspected vaccination failure; Shingles, I have them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's Comment: This case was reported by a consumer via  interactive digital media.  The case was reported by the patient. The patient had shingles and he/she had the shot. The patient stated that, anybody could still get shingles even after they had the shot. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Patient received a Pfizer vaccine instead of a Moderna vaccine as a second dose. No adverse outcomes noted.
presented on 4NOV @ 926AM immed care w/ SOB, weakness, cyanotic, pallor, swelling lt arm-lateral forearm to hand;swollen since inj;T96.8;expired 4NOV97 @ home;
Information has been received from a medical assistant concerning a 10 year old "healthy" female with no past medical history who on 7/2/02 was vaccinated with the second dose of hep B vaccine. There were no concomitant medications. On 7/14/02 the pt developed blisters posterior to the site, on the inner elbow and at the top of the scapula. On 7/18/02 the site was blotchy and red and the pt was afebrile. The reporter stated that there were no adverse reactions noted from the first dose of hep B vaccine recombinant. The pt was treated with Claritin. The pt sought unspecified medical attention. Follow-up info from the medical assistant revealed that the pt was vaccinated at a health department and stated "everything is fine." No further info is available.
This is a spontaneous report from a contactable consumer for husband. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Apr2021 (Lot Number: ER8727) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included Parkinson symptoms, COVID-19 from Jan 2021. He has Parkinson symptoms and he had COVID-19 back in January (history), on 01 Feb 2021, he tested negative and he just got the Pfizer vaccine a week ago on Monday (26Apr2021). Now when he had COVID he was almost asymptomatic. He did not have very many symptoms but he tested positive. They were all positive here at house and since he got the vaccine, he has Parkinson symptoms, the medications (Unspecified Medications) that he took was not working anymore. The trimmer was not under control, had to go to the ER twice and the medication only last 1 to 2 hours, when it should last longer. They called his doctor, the doctor even changed the dose, even changed the type of pill, thought may be the pill (Unspecified Medication) is too big that is not absorbing fast enough. He put him back on some other Carbidopa, Levodopa that dissolves a lot faster for absorption. The medication he takes for his Parkinson symptoms is not really working.  So, at the ER all they do is give him Morphine and sedative to calm him down and send him home. He come home and that wear off and he started shaking, some of the Parkinson symptoms, he got the trimmers, his muscle spasm is really bad. His leg and feet locked up, he can't walk up, his arm hurts, so many symptoms that he did not have before the vaccine, so we are wondering if the vaccine is blocking somehow the medication that he takes to treat the trimmers. He was sick right now. He got joint pain. Outcome of the events was unknown.
HEADACHES; SEVERE NAUSEA; SEVERE VOMITING; FEVER; BODY ACHES; CHILLS; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CLUSTER HEADACHE (HEADACHES), NAUSEA (SEVERE NAUSEA), VOMITING (SEVERE VOMITING), PYREXIA (FEVER) and MYALGIA (BODY ACHES) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-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 CLUSTER HEADACHE (HEADACHES), NAUSEA (SEVERE NAUSEA), VOMITING (SEVERE VOMITING), PYREXIA (FEVER), MYALGIA (BODY ACHES) and CHILLS (CHILLS). At the time of the report, CLUSTER HEADACHE (HEADACHES), NAUSEA (SEVERE NAUSEA), VOMITING (SEVERE VOMITING), PYREXIA (FEVER), MYALGIA (BODY ACHES) and CHILLS (CHILLS) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
On 2/3/15 at 6:00 AM patient seen in ER reporting fever 104.9 degrees after receiving vaccines 12 hours prior and vomited ibuprofen. ER dept recorded 99.9 degree temp rectally. Child was discharged with TYLENOL and ZOFRAN.
Shoulder pain and stiffness.  Unable to move shoulde, or sleep on shoulder without pain.
12/9/03 1050: Temp 103.5 ax. 12/9/03 1700: Temp 104.2 ax. 12/10/03: Temp 101.6 ear. Seen in ER with rigors and febrile seizure. Given Tylenol/Ibuprofen prn. Medical records state dragging leg and rhinorrhea.
This case was reported by a nurse and described the occurrence of injection site induration in a 11-year-old female patient who received MENVEO (batch number X15099, expiry date unknown). On 9th June 2016, the patient received the 1st dose of MENVEO. On an unknown date, less than a year after receiving MENVEO, the patient experienced injection site induration and injection site redness. On an unknown date, the outcome of the injection site induration and injection site redness were recovered/resolved. It was unknown if the reporter considered the injection site induration and injection site redness to be related to MENVEO. Additional details were provided as follows: In the morning of reporting date, the sales representative called the office nurse and at this visit they discussed that there were a high number of patients with severe local reactions to the MENVEO and BEXSERO vaccines. These patients were returning to the reporter's office with very large, reddened, swollen, hardened, warm induration at the injection site and the surrounding area, many times measuring 6 inches or more from the injection site. The physician had prescribed oral antibiotics for most of these patients. The patient concerned in this case had experienced 6 to 8 mm induration and redness at injection site after MENVEO vaccination, which had lasted for 7 days. She was monitored for the events. The reporter had tried several different methods of mixing the vaccine (letting it sit, administering it immediately, etc) but none had proved effective in reducing reaction rates. The reporter requested for suggestions on how they could possibly reduce the potential for a local reactions. Also, they inquired if there had been any problems with certain lot numbers of the vaccine, so that they could compare those numbers to the vaccines which they administered to their patients. This case has been linked to 4 other cases (MENVEO vaccine), reported by the same reporter.
THIS WAS SECOND DOSE. GOT ALL SIDE EFFECTS: FEVER, CHILLS, HEADACHE, WEAKNESS, UPSET STOMACH,... STARTING ABOUT 10 Hrs. AFTER VACCINATION. WAS NOT ABLE TO SLEEP AT ALL THROUGHOUT THE NIGHT IMMEDIATELY AFTER VACCINATION. SIDE EFFECTS LASTED ABOUT 1 1/2 DAYS. NO NOTICEABLE SIDE EFFECTS ON FIRST DOSE GIVEN 1-28-21.
Chills, mild fever, muscle aches, left arm pain and swelling at injection sight. I felt better 28 hours after shot was administered.
Arm got really sore, applied ice. went to bed, tried to lay on ice pack, got cold. Woke up, her bed was wet. Awoke about 3:00 a.m., she thinks she may have passed out and lost her bladder. Got up to put pads on the bed. Was still cold, got back in bed, fingers were pale, toes were cold and face was pale, gums had no color. She took a drink of juice /water and slept until about 10a.m. Feels ok but carefully tried to get dressed with pain. Not as sore today as it was last night.
Upper 3rd rt arm red, swollen and tender 3 x 2 cm.
Bruising around injection, pain in entire left arm, body aches, and the injection spot is hot and a little swollen
Hot at the site of injection; Rash on arm at site of injection; Red arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE WARMTH (Hot at the site of injection) and INJECTION SITE RASH (Rash on arm at site of injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 16M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (history of allergy) and Autoimmune disorder NOS (Couple of auto-immune diseases). Concomitant products included RIVAROXABAN (XARELTO), CITALOPRAM, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), MULTIVITAMINS [VITAMINS NOS], FISH OIL, PROBIOTICS NOS, CALCIUM and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm) and INJECTION SITE RASH (Rash on arm at site of injection). On 14-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot at the site of injection). The patient was treated with CEPHALEXIN [CEFALEXIN] at a dose of 500 mg three times a day. At the time of the report, ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE WARMTH (Hot at the site of injection) and INJECTION SITE RASH (Rash on arm at site of injection) outcome was unknown.            The action taken for mRNA-1273 was not applicable.   This case was linked to MOD21-055164 (E2B Linked Report).; Sender's Comments:  MOD21-055164:
Red raised area measuring 2.5cm x 1cm with smaller blisters-2 inside.
Case number PHEH2016US023457, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 27-year-old patient of unknown gender. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).