chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a certified medical assistant concerning a 13 year old female patient who on in September 2010 was vaccinated with the third dose of GARDASIL (Lot # and route not reported). The certified medical assistant reported that the patient developed hives post vaccination and still had hives at the time of the report. The patient was seen by a dermatologist and her allergy tests were negative. Follow up information has been received from a physician concerning the female student patient with no known allergies who on 15-SEP-2010 was vaccinated with the third dose of GARDASIL (Lot# unknown). There was no concomitant medication. The physician reported that on 29-NOV-2010, the patient presented to office for urticarial eruption (generalized) of 3 months duration. Initial eruption occurred after the third dose of vaccine in approximately 15-SEP-2010. Blood tests were performed by allergist, all were normal. The patient was treated with ZYRTEC, 10 mg, every other night. At the time of the report, the patient had recovered. No further information is available.
took vaccine got shingles/suspected vaccination failure; shingles / shingles on head/ had shingles last year on the right side of my head; This serious 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, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: took vaccine got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles / shingles on head/ had shingles last year on the right side of my head). 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: 19-Mar-2023 and 20-Mar-2023 The case was received from the patient via interactive digital media. The patient got the shingles vaccine 5 years ago and got shingles last year on the right side of his/her head. The patient stated that you might think you were good. The patient still good, had shingles with the vaccine, nobody in his/her family took the vaccine and never got the shingles except him/her and he/she took the vaccine. No more vaccines for him/her. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
broke out with the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient got shingles shot and within a couple of weeks broke out with the shingles and could not even hug his/her 3 great grandkids. The contact details were not reported hence follow up not possible.
Immediately after injection, left arm was tingling. During 15 minute wait cold tingling sensations moved across face, lips, tongue,  then on to right arm.  During  ride back to work right after injection, had cold tingles throughout body, cold water sensations running down head. Had lunch when returned to work, but tasted burnt. lips/tongue burning sensations and cold tingles throughout body continued, and have not gone away since.  Arm soreness began later that same day and persisted for several days.  April 26 lymph nodes under left arm  very swollen and painful for about 1 week. Second shot spoke to military doctor at vaccine site, who recommended I still receive the shot, said it was rare, but possible it may have triggered MS, but to follow up with my doctor at already scheduled June appointment if still having sensations. Second shot did not change tingling sensations, 9 hours later fatigue body aches which continued to next day, and also 102 fever next day.  Body and face cold tingles persist today (they are constant and move around all over body in single points that last for a second or two in whatever spots they are in), they are not painful, but that has been my fear that they will turn into pain at some point.  The tingles seem to worsen with anxiety (become colder, more pronounced). Lip & tongue burning sensations are also constantly there.  All of this was reported to V-safe since first shot check in.
I have not had a menstrual cycle in 15 years. Started having cramps and started bleeding 08/10/21. light bleeding lasted 2 days.  Again on 09/03/21 started cramping and light bleeding. eased off and then a light again on 09/07/21.  Third even on 11/03/21. cramping and light bleeding. All events the blood new and bright red (not old dark blood like I remember seeing when I used to have regular cycles years ago.  I have also just reported to my physician's office today so I have not yet been contacted if I need to follow up with doctor for any testing etc.
8 hours after vaccine I experienced stomach pain and nausea.  I then became very ill and extremely weak. I was laying on floor. Very difficult to talk and very dizzy.  Unable to walk.  Called 911 and went to ER. Had chest pressure and cardia work up was done. Dx wi ST elevation.
Fever 100 degrees plus x 24 hr 7/27 - 7/28, headache since 7/26, nausea since 7/27, body aches since 7/27.
p/vax pt exp redness; swelling; stiffness; numbness; & tingling in arm (inj site); redness; swelling; stiffness & tingling resolved; still exp stiffness & numbness;
Large area (>3 inches) of redness, swelling and warmth at injection site developing several hours after injection and continuing 24 hours later.
vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease, CKD-MBD and Glaucoma. Concomitant products included DONEPEZIL HYDROCHLORIDE (ARICEPT) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) to be not related.    No Concomitant Medications were Reported. No Treatments were Reported.
I can't keep my balance/ I can't go back to work; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (I can't keep my balance/ I can't go back to work) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (I can't keep my balance/ I can't go back to work). At the time of the report, BALANCE DISORDER (I can't keep my balance/ I can't go back to work) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up document contains Non significant information
Localized redness and swelling of injection site. Affected area the size of a golfball and hot to touch. Treatment included Benadryl, cool compress to area, and Tylenol or ibuprofen as needed.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. Since 30-NOV-2015, the unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ (lot# K011952; expiry date: 17-JUN-2016, lot# K013868; expiry date: 27-APR-2016, lot# L008059; expiry date: 18-DEC-2016, lot# K004795; expiry date: 11-FEB-2016). No adverse effects were reported. Additional information has been requested.
Patient arrived for 2nd dose of Pfizer vaccine. Administered with no difficulty. Approximately 20 mins after receiving vaccine, patient began to report shortness of breath and chest tightness and rash to chest, that continued to worsen.  She was brought into  the urgent care (on-site) and was evaluated by MD and urgent care team.  Intravenous access was established, placed on cardiac monitoring and supplemental oxygen was administered. Benadryl, Pepcid, Epinephrine (2 doses),  Solumedrol, normal saline intravenous transfusion was administered.  SOB and chest tightness resolved, rash improved. Monitored in urgent care for additional 5 hours, discharged home with prednisone and epi-pen.
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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:23 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:23 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 46.42. Concomitant products were not provided. On 07-jan-2021, Excursion time was 09 AM and 10 AM, with temperature as 34, and 34 respectively. Total doses given for the day was 96 for 9AM vials. Condition of vaccine prior to administration was not frozen. 9 AM and 10AM vaccine was moved to fridge on 05-Jan-2021 and. Vial was moved to clinic on 07-jan-2021. 6 vials from 9 AM and 10 AM were sent to clinic. Vaccine BUD date was 27-jan-2021 for 9AM,10 AM respectively. On 07-jan-2021 no hourly temperature recordings available 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 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 case was linked to MOD-2022-566976 (Patient Link).
received an Engerix-B dose subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th July 2021, the patient received Engerix B (subcutaneous) and Engerix B Pre-Filled Syringe Device. On 30th July 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received an Engerix-B dose subcutaneously, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), MYALGIA (muscle pain), HYPERSENSITIVITY (allergies) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 32-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. Concurrent medical conditions included Allergy NOS (had allergies once and never again) in 2009. On 08-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jul-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced PAIN (body aches) and HYPERSENSITIVITY (allergies). On 26-Jul-2022, the patient experienced MYALGIA (muscle pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) in July 2022 for Adverse event, at a dose of yesterday night. At the time of the report, PAIN (body aches), MYALGIA (muscle pain) and HYPERSENSITIVITY (allergies) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.  No concomitant medication was reported. Patient never had COVID positive test or diagnosis. It was reported that symptoms have worsened.
Rash on arms, chest/Benadryl & Hydrocortisone  recommended seeking medical attention if no improvement
rash on right thigh - approximately  20 cm long and 2 cm wide. it had mild itching that was treated successfully with benadryl lotion.  it disappeared after 3 weeks.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patient received a dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided), that underwent a supported temperature excursion. No adverse experience was reported. Additional information has been requested.
J&J Dose 4/10/21 (1808980) COVID Positive 4/27/21  4/29/21: Presented to ED and admitted.  4/30/21: Pt. is a 49-year-old female with history of persistent asthma who was diagnosed with COVID-19- 5 days ago. The patient tested positive for COVID-19 infection on 04/25/2021.  Since then she had dry cough, on and off wheezing, worsening shortness of breath.  Since yesterday she became extremely short of breath for which she decided to come to the emergency room.  Earlier yesterday she was evaluated by an ED  physician and she was advised to be admitted because of hypoxemia and pulse oximetry of 87%. Patient declined admission and went home.  She came back with worsening shortness of breath.  On exam patient was comfortably breathing on 2 L with oxygen saturation 95% ; chest examination was significant for bilateral extensive rhonchi with good air entry and no wheezing.  Blood work shows sodium 133, potassium 2.4, BUN 5, creatinine 0.5, albumin 3.4, D-dimer was elevated at and follow-up with CT of the chest with contrast was done.  It showed bilateral extensive multilobar pneumonia .  There was no pulmonary thromboembolic disease.  5/4/21: Patient is a 49-year-old female who was diagnosed COVID positive on 4/25/2021.  She presented to the emergency department on 4/30/2021 with worsening shortness of breath and was noted to be hypoxic.  She was admitted to the medical floor with acute hypoxic respiratory failure, secondary to bilateral COVID-19 pneumonia.  She received 1 unit of convalescent plasma.  She was started on Rocephin, Zithromax, dexamethasone, and Remdesivir therapies.  She had a persistent dry cough for which codeine/guaifenesin was effective.  Her potassium was also noted to be low, and it was supplemented.  She was started on oral therapy and this has maintained it.  She is no longer requiring supplemental oxygen. She reports she is feeling much better. She has completed her Remdesivir therapy today and is requesting to go home.
Fever; chills; intermittent mild to moderate headache; mild raised rash on upper back / Rash spread to spides / rash was found to have spread to full torso, arms and upper legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 16:00 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VENLAFAXINE HCL; VYVANSE; WELLBUTRIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 20Apr2021, when the patient was 40 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 30Mar2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 16Nov2021 08:00, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 16Nov2021 08:00, outcome "not recovered", described as "chills"; HEADACHE (non-serious) with onset 16Nov2021 08:00, outcome "not recovered", described as "intermittent mild to moderate headache"; RASH (non-serious) with onset 16Nov2021 08:00, outcome "not recovered", described as "mild raised rash on upper back / Rash spread to spides / rash was found to have spread to full torso, arms and upper legs". The events "fever", "chills", "intermittent mild to moderate headache" and "mild raised rash on upper back / rash spread to spides / rash was found to have spread to full torso, arms and upper legs" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, headache, rash.  Additional information: Known allergies: No. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:Yes   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On Sunday at 10:00PM she checked her temperature and it was 100.6 degrees; she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly; she felt some slight joint pain in her left knee; she didn't feel good; she felt off balance after receiving her second COVID-19 Vaccine dose. She said she only felt off balance the first day after she received her second vaccine shot.; felt a little off; Chills; Ache; Headache; Injection site pain; soreness under her left arm; This is a spontaneous report from a contactable 76-year-old female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264), via an unspecified route of administration on 06Feb2021 17:15 at single dose in arm left for covid-19 immunization. The patient historical vaccine included BNT162B2 on 16Jan2021 for COVID-19 immunization and he she had Injection site pain (Lot Number: EL3247, Expiry Date: Unknown, Route: Intramuscular, Anatomical Location: Arm, Left, No. of Previous Doses: None) and about 10 years ago she had a flu shot, and she had a reaction that felt like she got the flu for a day. On 07Feb2021, the patient woke up and she felt a little off in the morning. On Sunday afternoon, between 1:00-2:00PM, she had chills, felt achy, slight headache and she didn't feel good. She said she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly. She said it dawned on her at 10:00PM Sunday night that maybe she had a temperature. She said she checked her temperature, and it was 100.6 degrees. She said she called to ask a nurse if she could take Tylenol for her fever. She said she had read about not taking Tylenol with the COVID-19 vaccine, but nurse told her it was OK to take Tylenol. She said she felt some slight joint pain in her left knee, too. The patient stated that she had a little bit of injection site pain with her first COVID-19 Vaccine shot. She said she thought the injection site pain was due more to where the COVID-19 Vaccine shot was given, and not from the COVID-19 Vaccine itself.  She said with her second COVID-19 Vaccine shot, she had pain at the injection site and soreness under her left arm.  The patient took the generic Tylenol Pain Reliever 325mg for her fever and chills. The outcome of the event felt a little off, ache and didn't feel good recovering on an unknown date, chills, headache, temperature was 100.6 degrees resolved on 08Feb2021 and she was cold, had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly were resolved on 08Feb2021. injection site pain and soreness under her left arm resolved on 10Feb2021 and She said she only felt off balance resolved on 07Feb2021.
a child recvd vax;child's mom devel macular,vesicular lesions on the distal portion of the legs, proximal arms&in mouth;the oral lesions caused a difficulty eating;was noted that there was no documentation of the vaccinee devel lesions
Moderna COVID-19 Vaccine EUA  Tightness in throat lasting at least 6 hours. No problem breathing or swallowing but it was concerning.