chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red rash at injection sight from Feb 3 thru Feb 5. Itching and size was 3?x6?. Took Benadryl orally and used cream. Was gone by Feb 6.
got vaccinated!!! She still got it bad/ suspected vaccination failure; She still got it bad; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter's aunt. The age at vaccination was not reported. The patient got vaccinated and she still got it (shingles) bad. The reporter stated that the vaccine was not the answer either. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
This case was reported on 14 September 2007 by the patient's mother, who is a health professional. A 12-month-old male patient with no reported medical history received "DT or DTaP", (lot number reported as U1577CA) on 30 May 2006. Vaccine was administered in the morning; by early evening, the patient's mother noted that the child became "very disoriented", and "would walk and then spontaneously fall down at times". The symptoms continued for three days, and subsequently received. No additional information was provided.
Warm in chest and arms; Tingling and warm in chest and arms; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (Tingling and warm in chest and arms) and VACCINATION SITE WARMTH (Warm in chest and arms) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PARAESTHESIA (Tingling and warm in chest and arms). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm in chest and arms). At the time of the report, PARAESTHESIA (Tingling and warm in chest and arms) and VACCINATION SITE WARMTH (Warm in chest and arms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Blood pressure measurement: 133/95 mmHg (normal) 133/95 mm HG, 145/95 mmHg (Inconclusive) 145/95 mm HG, 144/84 mmHg (Inconclusive) 144/84 mmHG and 147/89 mmHg (Inconclusive) 147/89 mm HG. On 12-Feb-2021, Heart rate: 96 96, 95 95, 82 82 and 76 76. On 12-Feb-2021, Oxygen saturation: 98 98, 97 97, 98 98 and 97 97. On an unknown date, Blood pressure measurement: 144/88 mmHg (Inconclusive) 144/88 mm HG. On an unknown date, Heart rate: 77 77. On an unknown date, Oxygen saturation: 97 97.     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.   Concomitant medications used were not reported. No treatment information reported.   Reporter did not allow further contact
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 5:Moderna/Dose Number: 4: Moderna/Dose Number: 3: Pfizer /Dose Number: 2: Pfizer/Dose Number: 1: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 28Jan2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 18Aug2021 at 17:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 14Sep2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose Number: 5:Moderna/Dose Number: 4: Moderna/Dose Number: 3: Pfizer /Dose Number: 2: Pfizer/Dose Number: 1: Pfizer". Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid was given as COVID 19 Treatment from 21Sep2022 to 25Sep2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Vacciniation in mid April Zostavax for shingles prevention. Broke out with Hives 10 days later. Hives have developed into chronic hives. They still exist. Some doctors feel that the Zostavax vaccine may have had an adverse reaction on my immune system. Cause is still unknow. But hives are serious.
joint pain; dull headache that ran down spine; chills; fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, after the second dose of cold vaccine, the patient experienced joint pain, dull headache that ran down spine, chills, and fever. The patient recovered from the events, which resolved within 48 hours, on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had left underarm swelling and redness (near lymph node area). Swelling traveled to left breast and a visible rash with irritation appeared. Patient also had left leg pain, inner thigh pain,  some back pain and discomfort.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In July 2014 the patients were vaccinated with an improperly stored GARDASIL (dose, route, lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Follow up information has been received from the Licensed Practical Nurse. The Licensed Practical Nurse stated that she did not have the information (patient identifiers, lot numbers, expiration dates, and dates of vaccine administration) available at this time. No further information was available at this time of report. Follow up information has been received from the Licensed Practical Nurse on 28-OCT-2014. The patient identifiers were reported and the patient was 11 years old child. The patient was vaccinated with GARDASIL on 09-JUL-2014 Lot was reported as H020901, expiration date 05-JUL-2015 for the vaccine GARDASIL. Additional information has been requested.
just had a sore arm so far; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 01-MAR-2023, the patient received Shingles vaccine. On 01-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: just had a sore arm so far). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 01-Mar-2023. This case was reported by the patient via interactive digital media. Follow-up would not possible as no contact details were available.  Upon internal review case was updated on 5th April 2023. Summary of changes: Case was processed as valid case.
Erythema to left deltoid approx. 9cm in diameter,  raised with  small amount of clear purulent drainage from the injection site. Firm to touch and itching.  Area began itching 24 hrs post injection with some redness. Subsided after 2 days and returned 48 hrs later. Continued to gradually worsen over the next 48+ hrs.  Reports some nasal congestion which could also be related to seasonal allergies.
it made her feel incredibly good, took away her fatigue, her sinuses drained, was able to smell again and made her feel better.; she has had chronic pain on a daily basis, which is still there; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: ER2613) at the age of 59 years as unk unk, single and administered in arm left, administration date 15Apr2021 10:00 (Lot number: EW0169) as 2nd dose single for covid-19 immunisation. Relevant medical history included: "Samters Syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "it made her feel incredibly good, took away her fatigue, her sinuses drained, was able to smell again and made her feel better."; PAIN (non-serious), outcome "unknown", described as "she has had chronic pain on a daily basis, which is still there".  Description of Product Complaint: Description of complaint: Vaccine Supplemental Form completed in additional context. States she thinks the vaccine must have taken the inflammation down after the 1st dose of the vaccine and the sinus drainage she had after that 1st dose of the vaccine was so much and gobs and gobs of drainage; States the next day she could smell. States her 1st dose was administered on 24Mar2021 with lot ER2613 and her 2nd dose was administered three weeks and one day later and was administered on 15Apr2021 with lot EW0169; states the vaccine did not take away her headache and that really disappointed her and she has been dealing with headaches for 24 years. Has orthostatic headaches and never goes anywhere in the afternoon due to the pain increases as the day goes on; Caller states she takes pain medication for headaches, takes Tramadol 50mg 5-6 times per day and it is in an yellow pharmacy bottle  and she does not have the lot, expiry and NDC number to provide and began taking it in 2009-2010.States she takes Oxycodone 5mg up to four times per week and began taking it after she was changed to it and tried all different things to try to help with her pain levels and she does not know when she started the Oxycodone but there was about a year or two when she was on a Fentanyl patch in between that time; states she started the Oxycodone around the same time she started Tramadol; tried alternative pain medications that she used during those years and has no lots, expiry dates, NDC numbers or dosages to provide for the Fentanyl, other pain medications or alternative pain medications she tried. States the dosage amounts of the Fentanyl was changed to the higher dose because she got used to it; no further details provided.  No follow-up attempts are possible. No further information is expected.
ACHES; FLU-LIKE SYMPTOMS; LOW GRADE FEVER UP TO ABOUT 101 DEGREES; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced aches. On 21-MAR-2021, the subject experienced flu-like symptoms. On 21-MAR-2021, the subject experienced low grade fever up to about 101 degrees. Laboratory data included: Body temperature (NR: not provided) up to about 101 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low grade fever up to about 101 degrees, aches, and flu-like symptoms. This report was non-serious.
Fever/chills - increased heart rate. Joint aches - sleeplessness. Overall body soreness, had no problems with 2010-11 vaccine.
This spontaneous report as received from medical assistant refers to unspecified patients of unknown age and gender. Medical assistant reported that an unspecified number of patients have received improperly stored M-M-R II (dose, route of administration, lot numbers and expiration dates were not provided) during the past 11 days. No symptoms reported. This is one of several reports from the same source. Additional information is not expected, because there was no consent to contact physician.
Abrupt onset DKA and new diagnosis of type 1 diabetes. Symptoms: confusion, headache, stomachache, blurry distorted vision. Went to ER, diagnosed with type 1 diabetes. No family history of type 1 only type 2. Admitted to ICU in severe metabolic acidosis.
Extreme joint pain far worse than previous pain from arthritis. Difficulty walking, throbbing pain, hips, knees, elbows.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 06-JUL-2015, the patient was vaccinated with an improperly stored dose of VAQTA 250U/0.5 ml injection (lot# K005323, expiry date 10-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified), lasting for 48 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccines were administered, 5 minutes after patient began to look pale and fainted while on chair. Amopia inhalant used patient given orange juice, vitals B/P 108/60 Pulse: 90 R: 20. Patient alert, responsive. Patient stated was nervous and scared prior giving shots per mother child had not eaten much in the morning. Patient monitored, no further treatment needed. Follow up came 8/28/07 10 am. Mother has stated pt was better now and is doing well.
daughter received GARDASIL 9 roughly around June 2019 and began experiencing hives within a few weeks; This spontaneous report was received from patient's mother reporting on her daughter, a female patient of approximately 12-year-old. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  Roughly around June 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for Human Papillomavirus (HPV) prevention(strength, lot #, expiry date, and route of administration were not provided).   Since receiving the first dose of vaccine, within a few weeks, in 2019, the patient had been experiencing hives (urticaria). She received all recommended doses, sought medical attention and had been going to an allergist and multiple allergy tests were performed with no results indicating a food or substance allergy. The patient began allergy shots as treatment around 6 months ago and at reporting time, she was receiving a shot every 4-6 weeks. The patient's mother stated she spoke with the doctor and after piecing the dates together, they believe it was possible that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) caused this experience.  At reporting time, the patient had not recovered from urticaria.
Muscle pain on all muscles on the same side as the vaccination. Really pain, not regular pain after the shot. I went twice to a doctor.
GENERAL BODY MALAISE; FEVER; This spontaneous report received from a patient via a company representative concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 07-APR-2021, the patient experienced fever. On 07-APR-2021, the patient experienced general body malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and general body malaise on 08-APR-2021. This report was non-serious.
Immediately following vax pt became unresponsive, experienced bilateral flushing from abdomen down, labored breathing, dolls eyes, seizures (tonic/clonic). Pt treated with Benadryl and transported via ambulance to ER.
Information has been received from a RN concerning a 30 y/o female pt who on 24Mar2003 was vaccinated with a second dose of varicella virus vaccine live. Subsequently in 2003, the pt wanted to conceive, her physician checked her IgG titer for varicella and it was negative. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 02-JUL-2013, the patient was vaccinated with first dose of GARDASIL (dose, route of administration, anatomical location, lot #: not provided). On 08-JUL-2014, the patient was vaccinated with the second dose of GARDASIL (dose, route of administration, anatomical location, lot #: not provided). No adverse effects were reported. Additional information is not expected, as the reporter refused additional contact.
19 month old was administered Kinrix; administered Kinrix instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7p5j5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 10th June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong 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: 10-JUN-2022 Reporter's Comment: The reporter reported that a 19 month old patient was administered Kinrix instead of Infanrix on the day of reporting. The reporter consented to follow up.  Additional Supportive information: A 19 month old patient was administered Kinrix instead of Infanrix ,which led to inappropriate age at vaccine administration and wrong vaccine administered.
This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 24-NOV-2015, the patient was vaccinated with improperly stored ROTATEQ oral liquid, lot # L008574, expiration date 22-NOV-2016 (dose and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient concerned regarding her blood pressure as she takes medication to control it.  Denies feeling anything out of the normal. Three blood pressure readings taken 122/74, 124/78, and 122/80
An hour after receiving the shot, I began to break out into hives. About four hours later, I went to the ER because they were getting much worse and I had tightness in the chest and throat. They began to subside on their own after about 12 hours.
had some discomfort; having periodic muscle aches in the arm injected; This is a spontaneous report from a contactable pharmacist. The reporter reported similar events for two patients, this is the first of two reports. A 77-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration in Sep2020 in arm at single dose for immunization. The patient's medical history and concomitant medications were not reported. Pharmacist calling to report administering pneumococcal 13-val conj vac (dipht crm197 protein) to a female patient in Sep2020 who had some discomfort at the time. She still reports having periodic muscle aches in the arm injected. Responds to heat from shower and paracetamol (TYLENOL). No radiating pain down arm, into hands, or in shoulder.  No swelling or bruising at site.  Caller reports no warmness, infection, or cellulitis. Patient has not received PPSV23 vaccine. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020483600 same reporter/drug, similar events, different patient
I don?t know what you mean. I started a fever at 1am after getting shot, headache, body aches
Adverse Events: Carotid pulsating, lost feeling in left leg, lost feeling in face, hard to breathe. Loss of breath and carotid pulsating is still ongoing   Treatment: Heart echo and ultrasound of arteries   Outcome: unknown
Change in gait followed by seizure like bilateral movements.  Transported to hospital and admitted.  2 days of testing and consults.  Symptoms gradually decreased and released 2 days later.
Walks into clinic 11-1-13 at 8:00 am. C/O redness and Rt arm swelling painful area and fever. Rt arm has area of erythema 7 cm x 5.3 cm Rt arm. Elevated liver enzymes. Low platelets.