chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8/6/21 0 Noticed that the areas that I have psoriasis patches were inflamed and sore .  I have not had a flare up with my psoriasis in approximately 10 years. Hives started to appear on legs and were VERY itchy, feet and toes are swollen.  8/7/21 noticed the hives starting to spread up my leg and on to my stomach, I felt very itchy and warm all over. Noticed a tightness is my throat. 8/8/21 symptoms continue going to see doctor tomorrow.
pt had fever, swollen lymph nodes & a rash for 3 days; pt was taken to pvt MD who felt pt did not have rx to MMR; dx of 5th disease; mom stated that MD felt to much time had elapsed since pt's shots had been given to be a reaction;
Rec'd KD imm at WCE in office on 01/07/16. (+) 1st time seizure occurred 1/08/16 at daycare approximately 4:00 pm. Taken to hospital - head CT and CXR done = WNL. EEG done 01/21/16 -> normal. Appt with neuro 02/23/16. Local s/s = (+) redness (Rt) arm 01/08/16 -> resolved. (+) red, itchy area (Lt) arm -> seen for F.U. in office 01/14/16.
06/17/14 oral typhoid #1 taken. 06/18/14 headache, "couldn't walk a straight line, but not dizzy." 06/19/14 oral typhoid #2 taken. 06/20/14 headache, trouble walking, but "not as bad". 06/21/14 oral typhoid #3. 06/22/14 headache. 06/23/14 oral typhoid #4. 06/24/14 headache. Current (07/01/14): Headache 4x /week, nausea, cold/hot flashes. MD visit 7/1/14 pm. Behavior changes, irritability.
Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves an elderly male patient (age was not reported) who experienced the medial aspect of his left elbow had swollen lymph nodes and they are still swollen, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Oct-2018 at 01:30 PM, the patient received a dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine (lot number not reported) in the left upper arm. On 05-Oct-2018 at 10:30 PM, the patient developed a non-serious the medial aspect of his left elbow had swollen lymph nodes and they are still swollen (lymphadenopathy), 9 hours following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. No lab data reported. Final diagnosis was the medial aspect of his left elbow had swollen lymph nodes and they are still swollen. It was not reported if the patient received a corrective treatment. The caller repeatedly asked for medical advice, guidance on what this might be and how to treat it, what to be concerned about. He was referred to HCP. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for the event. List of documents held by sender: none.
wanted to die; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of suicidal ideation in a 70-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid vaccine (vaccinated 3 times, got covid, damn near died), Flu shot with an associated reaction of influenza (got 1st Flu shot and got flu, refer case US2023AMR057486) and Pneumonia shot (got 1st Pneumonia shot and got pneumonia, damn near died again).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced suicidal ideation (Verbatim: wanted to die) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the suicidal ideation and shingles were not reported.   It was unknown if the reporter considered the suicidal ideation and shingles to be related to Shingles vaccine.     It was unknown if the company considered the suicidal ideation and shingles to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR057486   Additional Information: GSK receipt date: 22-Mar-2023 The case was received form the patient's friend via interactive digital media. The reporter reported that the patient who was healthy all of his life, he recently turned 70, a very healthy person mind. The patient got his 1st shingles shot and got shingles and wanted to die. The patient asked that what did this tell you about vaccines. The patient stated that trust your own immunity. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR057486:same reporter
Large red itchy swollen circle around and down arm where/near injection site (?COVID ARM?)
Got my second shot / Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In June 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received 2nd shot of shingles last Wednesday of reporting date and it was very painful. No further details were provided.
subcutaneous discomfort of tendon and muscles without rash or joint involvement starting at medial right knee x1 day then migrating to right great toe x1day then medial right ankle x3days.
REDNESS, SWELLING, HEAT, PAIN ON INSIDE OF LEFT UPPER ARM
Nose bleed (unusual for me); Extreme fatigue; Headache; Spells of dizziness.; Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 15Mar2021 at 09:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced arm soreness for 2 days. On 08Apr2021, day after vaccination, the patient experienced extreme fatigue and headache and lasted 2 days. Followed by spells of dizziness, exhaustion and headache continues but to lesser extent. On 14Apr2021, the patient experienced nose bleed (unusual for her). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm soreness was recovered on an unknown date in Apr2021, after the duration of 2 days and of the events extreme fatigue, headache, spells of dizziness, exhaustion and nose bleed was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Swollen upper arm, severe arm pain. Chills, cold sweats, dizziness, low grade fever, leg pains.
Injection @ 2:47 p.m. on 1/15/21.  1/15/21 around 8 p.m. Bottom lip was swollen. Staff noticed.  1/16/21 @ 8:15  a.m. staff  viewed swollen lip. Patient reported no pain. 1/18/21 @   approximately 3:00 p.m. - Left eye watering, drooping and visibly swollen.  Home health nurse called Dr.   No pain reported. Blood sugar 128 and normal.  Patient went to ER to be seen as face drooping was worse. ER @ 4:45 p.m. on 1/18/21 - Dr.  evaluated and believes he has Bells Palsey. Ordered head CT & labs to verify.  Head CT normal ruling out stroke & labs normal.  Correlates   60 mg of prednisone daily for one week and 1,00 mg TID Valacyclovir for one week and artificial tears four times daily and cloth tape at night to hold eye lid shut.  First doses given in ER at 7:20 p.m. on 1/18/21.  1/21/21 - continue to tape eye at night, all symptoms remain.
Pt recvd Hep B vax in approx 1991 & exp pharyngeal swelling & devel deviated uvula;
I had my vaccination on 10/07/2021. On 10/16/2022 I started to felt nausea headache body aches and chills. On 10/17/2022 the symptoms exacerbated with pounding headache I was very fatigue and could not eat. I tested 10/17/2022 and was COVID-19 positive. I took a 5 day course of PAXLOVID. I still have cold like symptoms and fatigue.
Fever onset 22 hours after 1st shot.  102.5 lasted approximately 20 hours. Swollen arm and rash surrounding injection site.  Hard at injection site. Rash grew over next 3 days and became very itchy.  Lasting 3 days. Completely fine one week after 1st dose.
Improperly stored vaccine adminstration; shipment was received a day late; This spontaneous report was received from a an administrator via a field representative referring to a 66 years old female patient. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.   On 22-OCT-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shipment was received a day late (expected arrival date was 21-OCT-2020, product shipment delay) to the reporter's practice, they were not viable for use, and someone in the office mistakenly placed them in the vaccine fridge (confliction information: the box of vaccines got placed into a refrigerator at recommended storage range once received).   On 26-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # T020638, expiration date 26-FEB-2022; route was not reported) for prophylaxis (improper storage of product in use).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2010USA011251: US-009507513-2011USA015361: US-009507513-2011USA015362: US-009507513-2011USA015359: US-009507513-2011USA015363: US-009507513-2011USA015357: US-009507513-2011USA015358:
2 days p/vax pt nauseated, dizzy, passed out-pt husband found pt on hall wall said looked like sz-jerking all over-no hx of sz;lt arm swollen, red, warm to touch from shoulder to elbow;went to ER passed out;EEG & blood work gave med;
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 82-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 08-DEC-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) by a heath provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of herpes zoster was not reported. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
16JUL91 pt devel a rash & fever of 101; Has not seen MD;
This Spontaneous case, initially received on 17-Apr-2017, was reported by pharmacist and concerns a 74-years-old elderly female patient. The patient's drug history included unspecified pneumococcal vaccine (route of administration, anatomical location, dosage, batch number: not reported). Indication was not reported. Administration of Company suspect drug: On 14-Nov-2016, the patient was administrated by AFLURIA (TIV) (route of administration, dosage, batch number, expiration date: not reported and anatomical location: arm). Administration of Co-suspect drugs: On 14-Nov-2016, the patient was administrated by PNEUMOVAX 23 (batch number: M037669, expiration date: 05-Sep-2018, route of administration, dosage: not reported and anatomical location: arm). On an unspecified date, the patient was administrated by PREVNAR 13 (route of administration, anatomical location, dosage, batch number, expiration date: not reported). Adverse reactions/events and outcomes: On 14-Nov-2016, after administration PNEUMOVAX 23, the patient was also administered AFLURIA (TIV) on the same day, in the same arm, the patient experienced redness at injection site, pain at the injection site, swelling at the injection site, hardness at the injection site. Symptoms has spread to the joint in her inner elbow and patient has not been sleeping well because of symptoms. The action taken with influenza vaccine was not reported. The outcome of the events was Not recovered/Not resolved. Reporter's Assessment: The reporter did not provide the causality between influenza vaccine and events. This report was not serious.
LEFT THIGH BECAME RED AND SWOLLEN ABOUT FIVE MINUTES AFTER INJECTION WAS GIVEN. PATIENT WAS GIVEN 1/2 TSP ZYRTEC A COLD PACK WAS APPLIED TO THE SWOLLEN SIGHT. PATIENT WAS OBSERVED FOR ABOUT 30 MINUTES PATIENT WAS THEN CHECKED BY THE DR. PATIENTS MOTHER WAS GIVEN A SAMPLE OF ZYRTEC INSTRUCTED TO GIVE FOR THREE DAYS, ALSO IF SIGN & SYMPTOMS INCREASED AT ANY TIME TO GO TO ER.
Pt recvd vax & 48 hrs later exp arthralgias which lasted 1 month;
This spontaneous report as received from a registered nurse refers to a 17 years old male patient, who on 16-SEP-2013 was vaccinated with PROQUAD (lot number were not reported) 0.5 ml subcutaneous for vaccination (outside of prescribing information). Concomitant medications were not reported. No adverse effects reported. Patient did not seek medical attention. Nurse noted that patient was new to the country of the report. This case is linked to case 1310USA001432 via same reporter link. Additional information has been requested.
Dizziness, Headache, Fever, Diarrhea, NauseaVomiting, fatigue Narrative: Employee stated after receiving 2nd vaccine developed dizziness, nausea, fever 100, flushed, severe headache, and diarrhea.
4 hours after vaccine given pt started having tongue, face and neck swelling. She called ambulance and was taken to ED. Pt also states that she had a recent tick bite on her face and just had eaten red meat, she read an article regarding meat allergies after tick bites.
Pt given immunizations about 7 pm on 4/7/11. On 4/8/11 rash noted to chest. By evening rash had spread to chin & around Lt. eye. When pt woke on 4/9/11 her face was covered in a red rash. No raised areas. No itching. No fever. No irritability.
Information has been received from a 71 yr old Caucasian female RN with no allergies and no medical history who on 03Nov04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 6499130577P), high on her right arm. Concomitant therapy the same visit included influenza virus vaccine (unspecified), in the left arm. There was no illness at the time of vaccination. Subsequently, about 3-4 hrs after vaccinations, she developed pain and is now unable to use her right arm. She was treated with ice, ibuprofen and heat. Follow up reported that the pt developed swelling, redness, pain, flu-like symptoms lasting 36 hrs from onset. There were no relevant diagnostic tests or lab data. The pt took naproxen sodium (Aleve). No further information is expected.
Patient presented to facility with dizziness, palpitations, frontal headache and elevated BP readings x 1 week. Patient complained dizziness is worse with movement and when standing.
Received shingles vaccine (ZOSTAVAX) 9/16/14. Developed itching and redness at vaccine site on 9/17/14. Had 5.0 cm induration, slight erythema and warmth. By 9/18/14 area grew to 8 x 10 cm induration. Pt treated with BACTRIM with complete resolution of symptoms.
Expired Bexsero Administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB59AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: A pharmacist called to ask for information regarding the administration of an expired dose of Bexsero to a patient. Reporter asked for recommendation about patient re-vaccination. Consented to follow up. Additional supportive information: The patient received a Bexsero which was already expired, which led to expired vaccine used.
She noticed a small welt form at injection site the morning after the vaccine. By afternoon, another much larger welt (about 1/3 to 1/2 the outer upper arm) developed. It is painful and warm to the touch. The patient is going to go in and have her doctor look at it.
expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.
symptoms of syncope, low blood pressure, and headache.   symptoms began immediately.  patient was transported by ems to local hospital for treatment.
Patient was due for Bivalent booster and was given Monovalent. No symptoms were present.
As needle entered patient, pt. suddenly kicked leg, needle came out .  After discussion with patient's parent, pt was revaccinated in opposite leg.
I get a congestion in chest like (mucus) and cough, dizziness and fever. I am taking medication over the counter (Nyquil) but I am getting worse and I do not have way to be attended by doctor at this time because the holidays.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 63-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date in November 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced herpes zoster and was treated by a physician. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested
Vertigo - 8 days after the 1st and 2nd shot. For the 2nd shot -I got up in the AM and out of balance, supposed to go out, but while driving, it hit me and I stopped to get Dramamine. I felt unsteady like I was drunk. I went back home...I was afraid of driving home. Got home safely. Took Dramamine. The next day, the doctor on Mar19.2021 got to do some exercise. Left ear - there was a white, freeze fluid. Been doing exercise. Metrozine pill was prescribed. When I am I laying on my left left and tilt a side and the room would spin. Most of the the problems are on the left side...
He got a fever at 105 (rectal) made the call to the dr's office because it is required to contact dr if fever reached 105. The fever stayed for about one hr, administering ibuprofen 5mL. The fever broke... But the fever came back other times within the last 36 hrs of up, in which it spiked as high as 104.7. We continue to monitor him and now receiving fever reducing suppositories.
Sore Arm; Chills; Fever; Headache; Body aches; Arm was swollen from vaccine for 3 days; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient has no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 00:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. On 08Apr2021, 22:30 the patient experienced sore arm, chills, fever, headache, body aches and arm was swollen from vaccine for three days. No therapeutic measures were taken for the events. The clinical outcome of the events sore arm, chills, fever, headache, body aches was recovered on an unknown date in Apr2021 and arm was swollen from vaccine for three days was recovered on 11Apr2021.   No follow-up attempts are needed. No further information is expected.
Flu shot given at 11:35. 5 minutes later another provider observed the participant complaining of nausea and dizziness. Progressed to chest pain and back pain. They were tearful. The Lead provider was notified. The participant was observed in general distress. Red, raised rash was developing. 911 called. 0.5mg Epi given. BP 116/80. Continued to monitor participant. Breathing was still labored. After Epi was given, the participant was still anxious but in a reduced state of stress. The rash was spreading to upper body and arms. EMS arrives. Employee was questioning giving another Epi but EMS had taken over situation. Participant was transfered to hospital. Flu clinic was shut down.