chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives on legs, then spread throughout. Developed facial swelling. Took OTC meds including Benadryl, zyrtec, Pepcid. Then prednisone and Keflex. Facial swelling resolved and lesions remain.
4/29/03: Red areas noted to both thighs in evening after taking immunizations. Worse in AM - red areas spreading, warm to touch, sore; child with malaise. 4/30/03 3 x 2cm on right thigh; 3 x 4cm left thigh, indurated. 5/1/03: right thigh 1" more than yesterday. Left thigh improving. Started Keflex 375 mg POTID for 10 days; ice, Tylenol PRN and Benadryl 1.5 tsp TID; ice PRN.
female patient received an expired Shingrix dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Herpes zoster (Shingrix) (batch number KK3JM, expiry date 25-SEP-2023) for prophylaxis.   On 27-SEP-2023, the patient received the 1st dose of Shingrix. On 27-SEP-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: female patient received an expired Shingrix dose).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 28-SEP-2023 The Medical Assistant reported that day before reporting a female patient received an expired Shingrix dose which led to expired used. The reporter stated that this would be patient's 1st dose. The reporter declined to provide Date of birth, age and initials when asked. The reporter consented to follow up.
Have these red spot on my arm; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was not recovered/not resolved.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the 1st dose of Shingrix and less than a week after the vaccination the patient had all the side effects but also had red spot on his/her arm. The reporter asked was that normal.
I had a delayed allergic reaction. I broke out on a rash on my upper left arm (wear I got the shot). Most of the rashes were in the inner arm. I have a picture, but there isn?t a way to upload it. I took Benadryl and use some stop itch cream and it wasn?t away a couple of days later.
patient fainted after 20 minutes wait. . when she woke she was worried she was having an allergic reaction so the took 2 benadryl. we laid her down and she recovered in 20 minutes. chief complaint was sore head as she hit her head when she fell. her sister drove her home and after a while at home she began to have chills and shaking. family took her to the er where they diagnosed her with a UTI and gave her antibiotics. she does not have a concussion per the er md.  sister says she is fine now.
Injection site is extremely sore; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site is extremely sore), CHILLS (Chills) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M014) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site is extremely sore), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, INJECTION SITE PAIN (Injection site is extremely sore), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient's wife reported having developed shingles after her husband received the ZOSTAVAX vaccine 1 1/2 weeks prior.
Left thigh swollen & hot to touch 7/3/09 at injection site. Tender, painful. Pt would not put pressure x2d. Resolving today 7/6/09 swelling decreased (+) walking.
Pt c/o headaches, severe @times (6/10) lasting for 10 days post immunization. During 1st 24hrs post vaccine, also c/o lightheadedness / dizziness - resolved in 24hrs.  3/5/09  MR received from PCP.  WCC 2/18/09 with vax given. TC from parent next day with c/o lightheadedness, dizziness, blurry vision and H/A. Not seen at this time. OV 2/25/09 for continued H/As, other sx resolving. Mom notes "not her usual perky self". PE (+) for DTRs 1+. Otherwise WNL. TC from parent 3/3/09-H/A are fine.
12:56 patient received first dose of pfizer vaccine and was brought to the observation room for a 30 minute observation due to history of medication allergies. 1310 he began to complain of feeling dizzy with blurred vision and some nausea. He denied any shortness of breath or chest pain. Injection site without swelling or irritation. Transported the patient via wheelchair to Med A for further evaluation and reported out to RN who took over care
impinged nerve in injection site arm; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of NERVE COMPRESSION (impinged nerve in injection site arm) and PAIN IN EXTREMITY (sore left arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE, ALLOPURINOL, ROSUVASTATIN CALCIUM (CRESTOR) and ADALIMUMAB (HUMIRA) for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced NERVE COMPRESSION (impinged nerve in injection site arm) and PAIN IN EXTREMITY (sore left arm). On 13-Mar-2021, PAIN IN EXTREMITY (sore left arm) had resolved. At the time of the report, NERVE COMPRESSION (impinged nerve in injection site arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant therapy included physical therapy.  No treatment information was provided.    Patient went to the physician on 12 Apr 2021 and the physician did not feel that it was related to the Moderna Covid-19 vaccine. Physician diagnosed it as an impinged nerve in the left arm. After further diagnostics the physician reported that it is not  be vaccine related. Although the vaccine did bring the condition to the surface or just weird timing.   This case was linked to MOD-2021-091032 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received included non significant information.
On 8/8/2016, pt received the Gardasil 9 vaccine. Pt was fine immediately after shots and walked to the checkout counter with no issues. About 5 minutes after vaccination, pt experienced a syncope episode at the checkout window. When nurse checked on pt he was coming back around and responsive. Pt was able to follow commands and sit up on his own. Pt drank a cup of water and ate a granola bar without difficulty. Pt was moved into an exam room where Dr. examined him. She noted no abnormalities at that time, but mom was concerned because he hit his head when he fell. She had pt stay for 15 minutes longer and then reassessed. Mom was concerned at that point because pt could not remember anything around the time of the syncopal episode. Mom stated she wanted to take pt to the ER to be further evaluated. Dr. informed her that loss of memory is common with syncope, but she could take him to the ER if that would make her more comfortable.
Shingles shots and having a mild case of shingles/Suspected Vaccination Failure; mild case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles shots and having a mild case of shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: mild case of shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-APR-2023 The case  was received from the patient wife via interactive digital media. The patient got Shingles shots 6 years ago did not prevent from having a mild case of shingles recently.  The reporter enquired that could COVID had interrupted the protection that they should have had from the shots? The reporter stated that it was stopped from being terrible probably from the shots. 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. The follow-up could not be possible as no contact details were available.
Next period was 5 days late and then extremely extremely extremely  heavy. I have been a 27 day cycle person for literally decades. Usually I have flow for four days and it is never much. . I am getting a bit old : (:) ) but this would not be the first sign of menopause.  Won?t stop me from being an advocate but you need to research this....what would be the mechanism for this?  I will also tell my doctor.
Was to get the Bivalent, but received Monovalent  Spoke to patient, no adverse side effect she was advised that she can have the Bivalent in 2 months by the report on the CDC website.  Attending notified in the clinic of event, filing report and time frame that she can get the next booster by the CDC website Guidelines
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 9:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 9:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) 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 52.15.  Concomitant products were not provided.  Excursion time, vaccine temperature details and other vaccine storage details were not provided.  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 Fisher brand 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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This spontaneous report as received from a physician via a company representative refers to a female patient who was currently approximately 18 or 19 years old. No medical history and concurrent conditions were reported. On an unknown date the patient started therapy with GARDASIL injection (dosing regimen, frequency and route unknown) (lot number and expiry date unknown). There were no concomitant medications reported. On an unknown date at the age of 16 years, the patient completed receiving the series of GARDASIL. On an unknown date the patient was diagnosed with cervical cancer (medically significant). On an unknown date, the patient underwent a pap smear test which revealed cervical cancer. It was also reported as therapy with GARDASIL was discontinued. It was also reported that the patient was currently "fine and cleared". The outcome of cervical cancer was considered as recovered. The relatedness of the event cervical cancer to the therapy with GARDASIL was unknown. There was no product quality complaint (PQC) reported. Upon internal review, the event cervical cancer was considered to be medically significant. Additional information has been requested.
Initial and follow up information has been received from a physician's assistant concerning a 19 year old female student with seasonal allergies (spring), allergies to cats and a history of occasional migraines. It was reported that the patient's "parents preferred no childhood vaccinations and "no vaccination to "dT" in 2003". It was reported that the patient had been vaccinated subcutaneously in the "arm" with the first and second dose of Japanese encephalitis virus vaccine (JE Vax) (Lot# EJN216B) on 05 May 2005 and 12 May 2005. On 13 May 2005, the patient was vaccinated subcutaneously in the "arm" with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot #647110/0470P). At that same time, the patient was vaccinated subcutaneously in the "arm " with the first dose of poliovirus vaccine inactivated (IPOL) (lot# X0771). At the time of the vaccination the patient noted to be "well". On 14 May 2005, the patient was vaccinated intramuscularly in the "arm" with the first dose of hepatitis A vaccine (inactive) (Havrix) (Lot # AHAVB032BA) and vaccinated subcutaneously in the "arm" with the third dose of Japanese encephalitis virus vaccine (JE-VAX) (Lot # EJN216B). On 24 May 2005, at 20:00, the patient experienced a "24 hour development of erythematous maculopapules" (previously reported that on approximately 24 May 2005, "about 11 days post vaccination," the patient developed a rubella-like rash over her entire upper body and a general feeling of malaise). It was reported that the erythematous maculopapules started at the core (trunk) with a recent spread to the limbs. The patient was "non-pruritic" and denied other symptoms. The patient sought unspecified medical attention. There were no laboratory diagnostic studies performed. On 10 June 2005, the patient was vaccinated subcutaneously in the "arm" with the second dose of poliovirus vaccine inactivated (IPOL) (lot# 40298). It was reported that the patient had recovered in "less than 7 days" (exact date unknown) from the events. No further information is available.
Patient presented to the COVID clinic today January 14, 2020 for his first COVID-19 vaccine.  He  was given 0.3 mls of the vaccine IM in the left deltoid.at 2:40 pm.  He pulled around to the observation area and at 3:12 pm.   He reported that he was experiencing tightness in his chest, dizziness and SOB.  Sp02 was 97% on RA.  HR was 57.  Oxygen applied via non-rebreather mask at 6L .  Sp02 went up to 100%.  At 3:05 patient reports that his chest tightness was feeling better and reported that it was easier to breathe.  He denies any numbness or dizziness.  Sp02 was 98% at this time.  BP was 138/84.  At 3:12 patient reports that the tightness in his chest has subsided and that he was "feeling better".  Sp02 was turned off.  After observing patient for several minutes she was found to be in stable condition to leave the observation unit.  He was agreeable to this plan.  He will notify her PCP with any further symptoms.
Cough  fever chills then on 1/22/2021 coughs fever chills severe abdominal pain nausea vomiting indigestion
PT. STOOD UP AND IMMEDIATELY BECAME WEAK AND LISTLESS. PT HAD ONE PERIOD OF VOMITING AFTER WHICH PT SLIGHTLY LETHARGIC AND UNRESPONSIVE FOR A PERIOD OF APPOXIMATELY 10 MINUTES.    AFTERWHICH, PT BEGAN TO BECOME ALERT AND RESPONSIVE TO STIMULI, "WOULD YOU LIKE THIS STICKER?" PT TOOK FROM MEDICAL ASSISTANT'S HAND. EMT ARRIVED ON SITE AT APPROXIMATELY 4:40 PM. PT SITTING UP AND DRINKING WATER AT THIS TIME. MOTHER LEFT THE DECISION TO TAKE CHILD TO EMERGENCY ROOM TO MEDICAL STAFF AND CHILD WAS TAKEN TO EMERGENCY ROOM VIA AMBULANCE.
I suffered cerebral venous thrombosis, I was hospitalized for 7 days, I had never stained problems in my blood, I had severe headaches, dizziness, vomiting, chills, I am currently medicated
HYPOXIA 4/10/2021 ARTERIOSCLEROTIC CARDIOVASCULAR DISEASE WO ANGINA HYPOXIA 4/10/2021 ADENOCARCINOMA METASTATIC TO PLEURA
Patient complains of nerve pain at injection site down to whole arm, presented about 1 month after vaccination.  Informed patient to go see PCP as soon as possible.  Contacted PCP to inform him to follow up with patient.
Initial misuse case was received from a health care professional on 25 October 2013. Cases were received on 21 March 2014 at GPV. A 15-year-old patient whose demographic details, medical history and concomitant medications were not reported received a dose of FLUZONE Intradermal on unspecified date. (Route, site, dose and batch number not reported). It was reported that on an unspecified date patient received an incorrect product. Laboratory investigation were not reported. No adverse event was reported. Lit of documents held by sender: none
Patient received a Pfizer Monovalent booster instead of a bivalent booster.  Patient informed of the immunization error.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On  09-MAY-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sore and stiff arm at injection site only; Sore and stiff arm at injection site only; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: EN 5318, expiration date unknown), via an unspecified route of administration on left arm on 27Jan2021 at 11:45 AM at a single dose for COVID-19 immunization. Medical history included asthma, moderate to marked outdoor allergies. Allergies to medications, food, or other products was none. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), triamcinolone acetonide (NASACORT) and montelukast. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced Sore and stiff arm at injection site only on 26Jan2021 at 17:00. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has not recovered from the events.
Still got the virus four times / got worse after she took another booster.; Still got the virus four times / got worse after she took another booster.; Still got the virus four times / got worse after she took another booster.; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP).  A 92-year-old female patient received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine ((manufacturer unknown), via an unspecified route of administration, on an unspecified date (batch/lot number: unknown), as DOSE NUMBER UNKNOWN), for COVID-19 immunization, reaction: "COVID-19"; Covid-19 vaccine (manufacturer unknown), via an unspecified route of administration, on an unspecified date (batch/lot number: unknown) as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE) for COVID-19 immunization, reaction: "COVID-19." The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), DISEASE RECURRENCE (medically significant) all with onset 2022, outcome "not recovered" and all described as "Still got the virus four times / got worse after she took another booster." Per Comirnaty Testing, the reported stated her mother is 92 years old and she has had all the vaccines and boosters and she still got the virus four times and got worse after she took another booster. [Note: it was unknown what vaccine(s) this person received].  No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200111579 same patient and suspect vaccine; different dose number and events.;