chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cellulitis, warmth, pain at injection site KEFLEX 500 mg po BID x 10 days.
This spontaneous report as received from a consumer refers to a 62 years old male patient. Someone received on unknown date his first and second 0.5 ml IM doses of GARDASIL (Lot # not reported) at age 62. Additional information is not expected.
Myalgia, Fever, CoughWheeze, chills,, congestion, runny nose Narrative:
On Saturday, 8/19/2023, the vaccinating LVN did not remember which vaccine she administered in the client's left deltoid. The client did not appear to exhibit signs or symptoms.
Last dose was given when patient was 2 years; Received 3 doses of the D-tap series, the last was with 2 y/o; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (DTaP vaccine) for prophylaxis.   Co-suspect products included DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included DTaP vaccine (1st and 2nd dose received on an unknown date).   On an unknown date, the patient received DTaP vaccine and the 3rd dose of DTaP vaccine. On an unknown date, not applicable after receiving DTaP vaccine and unknown after receiving DTaP vaccine, the patient experienced inappropriate age at vaccine administration and incomplete course of vaccination. On an unknown date, the outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.  Additional details were provided as follows: The age at vaccination was 2 years old for the last dose that is 3rd dose The age at vaccination was not applicable for 5th and 4th dose. The Health Care Professional reported that the patient had received, 3 doses of the D-tap series,  The reporter was just inquiring about giving Boostrix to patient but it was not administered at the time of the call.  The reporter consented to follow up.
Kinrix administered to a 7y/o; Kinrix administered as 3rd dose in DTaP series; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were 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: 22-Sep-2022 Reporter's comment: The nurse reported that a 7 year old patient was administered Kinrix as the third dose in the DTaP series. At the time of reporting, the nurse did not have the patient details, date of administration, lot number/expiration date, or the information of what vaccines were given for the first two DTaP series.  The vaccine administration facility was the same as primary reporter.   The consent to follow up was granted. Additional Supportive information: The 7 year old patient was administered Kinrix as the third dose in the DTaP series which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. This case was one of 10 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022136453:Same reporter US-GSK-US2022136454:Same reporter US-GSK-US2022136455:Same reporter US-GSK-US2022136446:Same reporter US-GSK-US2022136451:Same reporter US-GSK-US2022136459:Same reporter US-GSK-US2022136461:Same reporter US-GSK-US2022136463:Same reporter US-GSK-US2022136465:Same reporter US-GSK-US2022136466:Same reporter
This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heartbeats increased), PRURITUS (itches all over), RASH (Skin rash) and VACCINATION SITE PAIN (Vaccination site tenderness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Heartbeats increased), PRURITUS (itches all over), RASH (Skin rash) and VACCINATION SITE PAIN (Vaccination site tenderness). At the time of the report, HEART RATE INCREASED (Heartbeats increased), PRURITUS (itches all over), RASH (Skin rash) and VACCINATION SITE PAIN (Vaccination site tenderness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant and treatment information not provided.
Resident died unexpectedly on 6/28/23 at 0510 a.m.  Resident showed no adverse signs or symptoms. Physician thinks it was a cardiac event unrelated to the vaccine.
Cold like symptoms; sore head, neck and arm; sore head, neck and arm; sore head, neck and arm; This is a spontaneous report from a contactable consumer. A 41-years-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 11:30 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 via an unspecified route of administration, administered in Arm Left on 26Jan2021 11:30 as dose 1, single for covid-19 immunisation. On 17Feb2021 07:00 AM patient experienced cold like symptoms, sore head, neck and arm. The patient did not received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Severe chills, fever, body and joint pain. Vomiting. Joint pain next day also.
difficulty staying awake; dizziness; difficulty walking/could hardly walk; received third dose; received third dose; tiredness; This is a spontaneous report from a contactable Consumer. A 76-years-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on 16Aug2021 at around 17:00 (age at the time of vaccination was 76-year-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration in Jan2021 (age at the time of vaccination was 76-year-old) as a single dose, second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. On 16Aug2021, the patient experienced tiredness, difficulty walking/could hardly walk and received third dose. On 17Aug2021, the patient experienced dizziness. On an unspecified date, the patient experienced difficulty staying awake. Subsequently experienced dizziness, tiredness, difficulty walking, and difficulty staying awake. Caller states he and his wife both received booster doses (third doses) of the Pfizer BioNTech Covid-19 Vaccine yesterday at 5PM. Caller states his wife began experiencing side effects such as ty walking, and difficulty staying awake. Caller states his wife has been lying down since she can hardly walk. Caller states his wife was sitting up now but her eyes are closed. Caller states they both received their first doses of the vaccine in Jan. He's calling about the Pfizer Covid 19 booster, clarified the third dose. He reports he and his wife both received their booster dose yesterday afternoon, 16Aug2021 around 5:00PM. In the last 10-15 minutes his wife got dizzy and could hardly walk, she had to lay down. He was asking if this could be a side effect. Outcome of all the events was unknown. Outcome of all the events was unknown.  The lot no number of the vaccine [BNT162B2] was not provided and will be requested during follow up.
Patient reports a mild rash. She reports that about 2 hours after the shot that she felt that her face was warm especially her cheeks and that there were some raised bumps on her left cheek, but did not notice a rash on the first day. That night she felt that some areas were warmer and itched a little. On the second day the rash was over the whole body, very small red dots that were not raised and without significant itch. Places where clothing rubbed are a little redder and more irritated. Reported no change on day three.
Mom called stated 5/2/07 child was in high chair and he turned blue and seemed stiff. EMS called and brought to ER for further evaluation. He was admitted for observation and management. 8/1/07-records received DC DX: Apneic spells not newborn. Possible seizure. Seen in ER per parent unresponsive and turned blue for 20-30 seconds. Patient was sitting in high chair and parent placed a piece of pizzza in front of him next time she looked at him he was cyanotic but food seemed to be untouched. Admitted for observation. PE WNL except for right tympanic membrane erythematous bulging.
Shakes, fever, hot flashes, soreness all over body. Really awful. Spent day in bed. Responds to TYLENOL.
No additional AE reported; Temperature excursion; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient. The patient's pertinent medical history was not reported. The patient's concurrent conditions, drug reactions and allergies were not reported. Concomitant therapies were not reported.  On 09-FEB-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W019627, expiration date: 19-DEC-2023, administered intramuscularly in right thigh for prophylaxis. On 20-JAN-2023, the vaccine underwent a temperature excursion in the range 6 Fahrenheit degrees to 14 Fahrenheit degrees  (-14 Celsius degrees to -10° Celsius degrees) for 1 hour. Digital data logger was involved (Product storage error). No additional adverse events (AE) reported (No adverse event).  This is one of several reports from the same reporter.
Patient received Flublok flu vaccine in our office, he then went to pharmacy and Fluzone was administered on the same day within 2 hours.
Moderna COVID-19 Vaccine EUA Rash near elbow on left arm (the injection arm.) Rash was raised, red, itchy welts covering an area 4 inches long and 2 inches wide. Treated with hydrocortisone and antihistimine starting on day 3. Now on day 9 it is fading but still visible. I had no idea it was related to the vaccination until I was told my son in law also had a rash on his injection arm after getting the Moderna shot.
This case was reported by a medical student and described the occurrence of electrical shock in a 45 year old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B) for prophylaxis. The subjects medical history included neurofibromatosis type 1. There were no concurrent medications. On 10/9/2002 the subject received 3rd dose of Engerix B lot ENG5285A6. At an unspecified time after vaccination with 3rd dose of Engerix B, on 10/09/2002, the subject experienced electrical shocks, tingling sensation, delayed verbal response time and forgetfulness. The medical student considered the events to be disabling and to jeopardize the subject. At the time of follow up reporting. on 3/1/2006, the events were ongoing. The medical student considered the events to possibly be related to vaccination with Engerix B.
they all felt like they were having heart attacks in the middle of the night; This is a spontaneous report received from a contactable consumer. The consumer reported similar event for two patients, this is the 2nd of 2 reports.  A patient of unspecified age and gender received bnt162b2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer stated she knew 2 other people had the Pfizer vaccine that were having same thing, they all felt like they were having heart attacks in the middle of the night. The outcome of the event was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021378115 Same reporter/product/event, different patient
This case was reported by a healthcare professional via a sales representative and described the occurrence of rotavirus infection in a 7-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On unspecified dates, the subject received 2 doses of ROTARIX (oral) at 2 to 4 months of age. At 7 months of age, the subject experienced rotavirus infection and vaccination failure as confirmed by laboratory testing. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. No additional information was provided.
Headache beginning 18:30 PM on 01/08 Following began at 03:30 on 01/09: Headache Body aches Severe muscle cramps Weakness Fatigue Chest tightness Inability to concentrate Difficulty sleeping Blurred vision Treatments: Ibuprofen 400 mg at 18:30 01/08 - headache responded Ibuprofen 800 mg at 07:00 01/09 - chest tightness had resolved spontaneously.  Headache, body aches,  cramps, visual disturbance, concentration, and chest tightness improved over next 4 hours Ibuprofen 400 mg at 11:30 01/09 - continued improvement of symptoms Naproxen 220 mg and ibuprofen 200 mg at 20:00 01/09 - continued improvement of headache and body ache symptoms with no return of overnight adverse events
Within 20-minutes of vaccination, the patient reported pain in their throat, SOB, tingling in their arms, and chest pressure. EMS evaluated patient on-site. Patient was hypertensive (184/96).  12-lead EKG was NSR, rate of 79 bpm, no ST elevation. FSBG was 137 mg/dL. ETCO2 was 40mmHg with normal square waveform. EMS initiated transport to Hospital Emergency Department. En route, patient became more hypertensive (200/106). In ED, she remained hypertensive and was admitted to inpatient telemetry unit. Patient had 1-night stay to rule out cardiac-related events. Anaphylaxis was ruled out. Discharged with diagnosis of vaccine reaction and chest tightness.
Inability to function in any capacity due to overwhelming feeling of illness, including but not limited to; headache, fever, chills, muscle and joint pain, nausea, congestion, and extreme fatigue. This was the worst illness I have ever experienced.
Incorrect diluent volume was mixed (the vial contents were diluted with a diluent volume of  0.8 mL instead of 1.8 mL), but a 0.3 mL dose was still administered. We have already talked to Pfizer-BioNtech. They told us that if the dose given in error is the first dose, a second should dose should be administered at the recommended interval of 21 days. If the dose given in error is the second dose, the series is complete, an no additional doses are needed. We have already informed the patients of the potential for local and systemic adverse events.
Sore arm, inflamed, sore lymph node in right arm pit, fatigue, slight body aches.  Ibuprofen taken one day. Fatigue/body aches lasted 1 day. Sore arm lasted 3 days. Lymph node is still inflamed/sore now on day 5.
Only felt tired from her first vaccine; A spontaneous report was received from a consumer concerning a 74-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt tired from first vaccine/fatigue.  The patient's medical history provided included diabetes. Concomitant medications reported were insulin.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, after receiving the first dose of vaccine the patient felt tired. On 19 Feb 2021, the patient experienced the events, aches, fever, headaches, chills, felt tired, blood sugar has been almost at 300. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.  At the time of this report, the outcome of event felt tired from her first vaccine was unknown.
This spontaneous report as received from a physician assistant refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX for vaccinatin. Lot # was unspecified. The physician assistant mentioned that she heard that a patient affiliated with another unspecified practice developed shingles afater receiving ZOSTAVAX. The outcome of shingles was unknown. The patient sought unspecified medical attention. Additional information is not expected.
Pt recvd 4 doses of vax & the following day exp a recurrence of prev sx; sx completely resolved w/in 48 hrs; no tx was provided x/for rest;
Started sneezing several times 10 mins; after vaccine Noticed sore on right nostril about 25 min; right eye irritation; sore on nose turned into bean size blister that broke and resurfaced several times; Right side of nose and eye on right swelled during the night around 2am.; Wrong vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 10:00 as dose 1, single (Lot number: GH9693) at the age of 67 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN; LISINOPRIL; TRAZODONE; ASPIRINE; B-12. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 27Sep2022 at 10:00, outcome "unknown", described as "Wrong vaccine administered"; SWELLING (non-serious) with onset 27Sep2022 at 11:00, outcome "recovering", described as "Right side of nose and eye on right swelled during the night around 2am."; SNEEZING (non-serious) with onset 27Sep2022 at 11:00, outcome "recovering", described as "Started sneezing several times 10 mins"; SKIN LESION (non-serious) with onset 27Sep2022 at 11:00, outcome "recovering", described as "after vaccine Noticed sore on right nostril about 25 min"; EYE IRRITATION (non-serious) with onset 27Sep2022 at 11:00, outcome "recovering", described as "right eye irritation"; BLISTER (non-serious) with onset 27Sep2022 at 11:00, outcome "recovering", described as "sore on nose turned into bean size blister that broke and resurfaced several times". Therapeutic measures were not taken as a result of sneezing, skin lesion, eye irritation, blister. Therapeutic measures were taken as a result of swelling.  Additional information: other medications in two weeks: rosuvastatin, lisinopril, trazodone, aspirin, B-12. Adverse event: Started sneezing several times 10 mins. after vaccine. Noticed sore on right nostril about 25 min. after vaccine and right eye irritation. sore on nose turned into bean size blister that broke and resurfaced several times. Right side of nose and eye on right swelled during the night around 2am. closing of air flow in nose. Eye was crusty. Used cold compress to reduce swelling. Swelling has decreased but still have blister on nose after 3 days. If treatment ae: No. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
passes out; walks like a drunk man; has a condition called FPIES (Food Protein Induced Enterocolitis Syndrome); food allergy; He eats a certain food and 2 or 3 hours later he vomits; diarrhea; blood pressure drops; he turns grey; temperature drops; shivers; Vaccine exposure via breast milk; This case was reported by a consumer via call center representative and described the occurrence of vaccine exposure via breast milk in a 6-month-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix (transmammary). On an unknown date, unknown after receiving Boostrix, the patient experienced vaccine exposure via breast milk. On an unknown date, the outcome of the vaccine exposure via breast milk was unknown.  Additional information was received as follows: The case was reported by patient's mother. The patient's mother received vaccine in the 1st trimester of her another pregnancy. On 25th January 2018, the patient's mother received Boostrix and the patient was fed via breast milk, which led to vaccine exposure via breast milk. The patient was 6 months old when his mother was breast feeding. This case has been linked to the case US2018046823, reported for mother.   Follow up report received from consumer on 13th December 2019: The patient mother reported that her son was over a year at the time of reporting. She said that her son had health issues and had seen many doctors  The reporter said the patient had something going on right now that the doctors could not seem to diagnose.  She said around the age of one her son started walking but he walks around like a drunk man. The reporter said that any of his health conditions were not related to the vaccines. She said the patient had condition called FPIES (Food Protein Induced Enterocolitis Syndrome). It was food allergy where he reacts to food. The patient ate a certain food and 2 to 3 hours later he vomited and had diarrhea and then his blood pressure dropped and he turned grey and his temperature dropped and he had shiver and then he passed out. Later his temperature came to normal and he wake up and the nurse breastfed but sometimes the patient would have to go to the emergency room and get IV fluids and Zofran. It was unknown if the reporter considered the faint, stumbling, feeling abnormal, allergic gastroenteritis, food allergy, vomiting, diarrhea, blood pressure decreased, skin discoloration, body temperature decreased and shivering to be not related to Boostrix.      Lab Comments: On an unknown date patient's blood pressure and body temperature was dropped
Arm soreness Fever of 100 approximately 17 hours after injection Headache Fatigue