chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JUL-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ oral liquid (lot # L000571, expiration ate 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Broke out in hives; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 21-JUL-2022, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced hives (Verbatim: Broke out in hives). The outcome of the hives was resolved.   It was unknown if the reporter considered the hives to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the hives to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 28-JUL-2023 The reporter stated that a patient that had a reaction to Bexsero. He stated that the Healthcare Professional reported to him that an 18 year old female broke out in hives when she received her first dose of BEXSERO last year. So there was some concern about her getting her second dose. The reporter consented to follow up.
FEVER AMD SSWELLING AT SITE INFECTION1D POST MISSED 1/2 D WORK
Right arm is sore and soreness in both legs; stiffness in back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm is sore and soreness in both legs) and MUSCULOSKELETAL STIFFNESS (stiffness in back) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included WARFARIN, LOSARTAN, MULTIVITAMIN [VITAMINS NOS], UBIDECARENONE (COQ 10) and HYDROCHLOROTHIAZIDE for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Right arm is sore and soreness in both legs) and MUSCULOSKELETAL STIFFNESS (stiffness in back). At the time of the report, PAIN IN EXTREMITY (Right arm is sore and soreness in both legs) and MUSCULOSKELETAL STIFFNESS (stiffness in back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Starting on Wednesday December 1st, I found some mild itching on the back of my neck and lightly scratched it.  A few minutes later, the area I scratched was red and the mild itch was now a burning itch.  I took some benadryl and put on lotion and thought it would be gone the next day.  But the next day I found that anywhere on my body where even the slightest amount of pressure was applied, a rash/hives/itch would appear a minute or two later (Dermatographic Urticaria).  My fingers would itch after holding something.  My ears would get hot and swollen if my finger brushed against them slightly.  You could tell the shape of anything that touched me because it would leave behind a rash or hives.  By Friday December 3rd I realized that the benadryl wasn't helping very much (and maybe was even giving me heartburn?) and went to an urgent care, they basically said "see a dermatologist, here's some 4 mg Methylprednisolone".  The steroid helped, but was a temporary fix, as whenever it's about time to take the next pill the symptoms returned.  I saw a Dermatologist, Dr  on Monday December 6th, who diagnosed me with Eczema/Atopic Dermatitis, and gave me a hydrocortisone injection.  This once again only helped temporarily.  She described the diagnosis and symptoms as possibly being stress related, as she did not see any other possible cause (I did not voice my suspicions that it might be an adverse vaccine reaction), and since I have had Asthma since childhood it is likely this is a similar Atopic reaction.  Ever since the dermatographia and eczema are being managed with 24 hour Claritin, which does not prevent the red blotchy skin but does seem to prevent it from itching, and Coconut Oil, which I apply to my skin and seems to work for ~ a day before I begin to itch again.
The patient experienced inject site swelling, redness, warmth, pain, unable to lift the arm, and was diagnosed with Cellulitis after receiving the PNEUMOVAX 23 vaccine; This spontaneous report was received from a 68 years old female patient regarding on herself with high cholesterol. The patient was allergic to aspirin. The concomitant medication was unknown.  On 06-SEP-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (route unknown, in upper arm, one shot; lot # and expiration date were not reported) for pneumonia (prophylaxis).  On the same day, the patient experienced inject site swelling, redness, warmth, pain, unable to lift the arm, and was diagnosed with cellulitis after receiving the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine. Patient was hospitalized for 3 days on 09-SEP-2018. The patient treated with alprazolam (ATARAX), intravenous of antibiotics (unspecified). The patient sought for medical attention. Blood work was performed (result was not provided). The patient was recovered on 04-OCT-2018. The causality assessment was not provided.   Upon internal review, cellulitis was determined to be medically significant.
Severe chills, fever, muscle aches for 36 hours, joint pain for 72 hours and frequent BM X4 days, ear pain X 36 hours
Pt recv vax on 1/19/99; on 1/23/99 pt exp febrile seizure, runny nose, diarrhea
Secondary effects on February 26 2021, Fever of 102.6 degrees, Strong headache, Bone pain, nausea. I didn't take anything. On March 2 at 5:00 PM. Allergic reaction with a red rash, itching on the injection site. At 6:20 PM is still present.
After 24 hours patient developed a rash (subcutaneous lumps around injection site) which radiated to the other arm. Lumps fully disappeared after 2 weeks. Worst of it was within the first 5 days. Patient also experienced very high fever for 3 hours.
Tinnitus and hearing loss in left ear 2 days after shot.  Hoping this goes away as it is very bothersome.  I have not experienced this before.
This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 17 year-old male patient of unspecified race and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date in Jan2016 for immunization. The patient medical history and concomitant medications were reported as none. The patient experienced arm reaction red swelling and it was warm to the touch at place of injection on an unspecified date. Outcome of the events was unknown. The patient's mother was afraid to continue the series.
Generalized vaccinia. Multiple papuals/ pustulas distributed on lower back, legs and arms.
Became dizzy/lightheaded, overhead & nauseated. Had him lay down with feet up, offered water and paramedics did vitals which were ok except low b/p 74/42. Drank some more water and b/p up to 105/65. BLS sugar 105. Felt better after about 1/2 hour. Wheelchairs to car.
Swollen lips about 2 hours after shot.  Hives at armpits, groin, waste, and head in about same period.  Took Benedryl about 7 hours after the shot.  This seemed to knock down the hives.  Swollen lips persist into second day. ***No airway problems***.  I do not have a history of allergies or reactions to this shot.
Information has been received from a reporting and administering physician concerning his 58 year old wife with an unknown relevant past drug history of pulmonary fibrosis for that reason in 2006 she became a part of along transplantation program. In 2006 the patient's blood showed 0 hepatitis B antibodies. On 20-Sep-2006 was vaccinated IM with 1 ml of a first dose of with hepatitis B virus vaccine rHBsAg as a requirement for a lung transplant program (lot number: 653786/0502F, expiration date 08-May- 2008) in the right arm. It was reported that on 06-Oct-2006 and 10-Mar-2007, the patient was vaccinated IM with 1ml of the second and third dose of hepatitis B virus vaccine rHBsAg respectively in the right deltoid as a requirement for a lung transplant program (dose and lot number not reported). Suspect vaccines included: On 10-Sep-2006 a first dose and an unspecified date the second dose of hepatitis A vaccine (inactive) IM, 1 ml respectively for the treatment of lung transplant in the left arm and in the right arm respectively (lot number first dose: 655211/0780F and lot number for the second dose not reported). Other concomitant therapy included acetylcysteine, interferon and aspirin once a day. It was reported, in 2006 her blood showed 0 hepatitis B antibodies. On 22-Oct-2009, the patient had computed tomography scan that showed a possibly lung cancer. On 09-Nov-2009 needle biopsy of the right upper lobe of lung proved lung cancer on 23-Nov-2009, another test for hepatitis B and hepatitis A antibodies revealed she did not seroconvert for hepatitis B and she had never been exposed to the disease, but she did seroconvert for hepatitis A. As 27-Nov-2009, the physician was trying to get the hepatitis B virus vaccine rHBsAg as soon possible to give to his wife further explaining that his wife's transplant team would like his wife to be re-immunized as soon as possible to try and give her immunity because she was trying to receive a lung transplant which could be any day now. At the time of the report she would not need the hepatitis A virus vaccine series and she continues to have lung cancer. Upon internal review, cancer was determined to be an other important medical event. Additional information has been requested.
Received bug bite likely on same day as having received the 2nd dose of vaccine.  Noticed it the same evening, but it appeared unremarkable.  I washed it and applied neosporin.  On 4/28 about 7AM, I noticed the area was red, swollen, and itchy,  By mid morning the area had expanded to a half dollar size and I washed it, drew a circle around the affected area and applied neosporin.  Later in the morning to early afternooon, the area expanded significantly beyond the lines I drew previously.  I contacted my doctor, via the Health patient portal.  I sent her pictures of the site.  She prescribed Bactrim DS BID.  I took the first dose about 6PM.  The affected area later that evening expanded up my arm  just before my armpit. I emailed the progression to my doctor via the portal with updated pictures. The right arm was now swollen, misshapen at the forearm, very red, hot, burning, and painful.  I contacted the doctor and she saw me virtually by 2PM on 4/29.  I continued to take the Rx as prescribed.  The area expanded into my armpit.  I noticed the same evening a quarter sized abnormally black area on my skin.  The area expanded about an inch beyond armpit toward my right breast.
Patient received first dose 0.5ml Moderna. Walked off the bus with out abnormalities noted. Patient states she is now having issue with ambulating also notes vision loss right eye. Vision test notes Patient unable to see right eye. FAST test done slight weakness noted left. Patient having difficulty following commands for tasks of test.   Vitals done  Blood pressure - 90/42 manual  Pulse - 78  Spo2- 97% room air Ems and fire have arrived on scene. Patient left in their care.  Patient is going to urgent care POV by grandmother.
Injection site became red, slightly swollen warm and began itching about 24 hours after immunization was given.
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 23-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant follow up consists of patient information updated, vaccinations details updated. On 24-Jan-2023: Live Non-significant follow up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:case
01/15/2021 evening: noted mild intermittent itching mainly on both sides of abdomen with erythematous rash; lesser amount of itching on both upper arms and thighs without obvious rash. Mild intermittent itching and rash on abdomen persists as of now. 01/13/2021 evening: noted some soreness in both calves; resolved spontaneously by 01/15/2021 01/12/2021: right upper arm soreness started after vaccination with increased pain on abduction of shoulder; resolved spontaneously by 01/15/2021 No medication taken or medical care sought for above symptoms
I have high fever, in and out, vomiting for the last 8 days. I got dizzy with the shot. 3 symtoms, fever, dizziness, and vomiting and cant get sleep.
cant grasp, hand start to shake; can barely lift without elbow pain; pain on injected arm; Elbow pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (cant grasp, hand start to shake), PAIN (can barely lift without elbow pain), PAIN IN EXTREMITY (pain on injected arm) and ARTHRALGIA (Elbow pain) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (he was born with rheumatoid arthritis), Seasonal allergy and Shellfish allergy. Concomitant products included LISINOPRIL for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced TREMOR (cant grasp, hand start to shake), PAIN (can barely lift without elbow pain), PAIN IN EXTREMITY (pain on injected arm) and ARTHRALGIA (Elbow pain). The patient was treated with PREDNISONE at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, TREMOR (cant grasp, hand start to shake), PAIN (can barely lift without elbow pain), PAIN IN EXTREMITY (pain on injected arm) and ARTHRALGIA (Elbow pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 8 to 9 (abnormal) Pain scale could range from 8 to 9 out of 10, 10 being the highest, indicates Very severe pain.         The patient stated  that he was born with rheumatoid arthritis, but after his 1st dose, his knees swell incredibly.  After 2nd dose, it was not nearly as bad but he can barely lift without elbow pain. Pain scale could range from 8 to 9 out of 10, 10 being the highest.   This case was linked to MOD-2021-295807 (Patient Link).
Patient had vaso-vagal reaction from the vaccine. Within 2 minutes of getting the vaccine the patient became flushed and very pale. He as sweating profusely and had vision loss. He was sitting while this all happened which I think prevented him from fainting. I got him water, an ice pack and called ems. By the time EMS arrived the patient was starting to feel better. EMS did their evaluation on site and the patient was able to go home 20 minutes later.
LEFT AND RIGHT ARMS WERE NUMB AS IF THEY WERE ASLEEP. NO FEELING IN EITHER ARM.  ARMS WERE ALSO COLD WITH TINGLING SENSATION.
Mild headache and severe nausea and vomiting to the point the patient called 911 to come to the emergency department. The symptoms started approximately 36 hours after the vaccination and did get better with IV fluids and antiemetics.
First started right after the vaccination and there was pain at vaccination site which lasted until Wednesday.  Sunday about 8 evening I felt like someone had put a hot match at the injection site, the site was itchy and hot. Whole muscle went hard, around the deltoid into her back and collarbone.
Patient experienced: GI side effects (diarrhea, nausea), pain in injection site, redness/swelling in injection site, headache, shivering, cold sweats. Event started a few hours after vaccination was given has continued until now (4 days later). Patient took ibuprofen to help with the pain. She reports symptoms getting better slowly.
7:02 - Temp taken - 97.5 7:03 - Patient given flu vaccine 7:13 - Patient feeling fine with no problems -leaves, goes back to work. 7:25 - Patient comes  back, not felling well - nausea, vomiting, dizzy,  no redness at site, no hives or SOB. 911 called and paramedics in route as a precaution.  7:50 - Patient continues to feel bad, Temp. 99, lies down on floor (L) side 7:57 Patient sits up very suddenly, begins to have  trouble breathing, gasping and  making noise when struggling to breathe. Moving and reaching out both arms to grab  something. EpiPen given in (R) outer thigh. 911 called again. 8:01 am - Patient sitting up and breathing normally.  8:04 - Ambulance at company, patient taken to  Hospital Main Emergency Department. Tests run,  and MD states patient had allergic reaction to flu shot with syncope episode and to never  take flu shot again. Patient discharged and home doing well.
MALAISE, JOINT PAIN, NUMBNESS IN EXTREMITIES, FEVER OF 103. ONSET 2 DAYS AFTER VACCINE ADMINISTRATION. SEEN IN OFFICE 5 DAYS AFTER VACCINE ADMINISTRATION, FEVER WAS REDUCED, NUMBNESS GONE. STILL EXPERIENCING MALAISE AND SOME JOINT PAIN.
Patient feinted several hours later at home nearly 6 hours later, falling on her back. Patient doesn't remember falling.
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 62-year-old male patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. On 5th November 2018, the patient received SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient experienced a rash on the neck. The exact time to onset was unknown. The pharmacist did not consent to follow up.
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's medical history, concomitant medication and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored dose of VARIVAX from lot # M027886 with expiry: 27-JUL:-2018 and lot# M027886 with expiry: 03-JUN-2018, for prophylaxis which were reconstituted with sterile diluent (MERCK STERILE DILUENT). The product were exposed to temperature of 6°F to l4°F for 40 Minutes; l5°F to 46°F for 3 Hours 10 Minutes. They had no previous temperature excursion. The temperature excursion was detected by digital data logger.
My daughter was diagnosed with Granuloma Annulare. It started as a raised bump by injection site. It was the size of a mosquito bit, raised. Intermittently itchy. Today, it is the size of a quarter. We saw a dermatologist who prescribed Clobetasol .05% (topical steroid ointment). Today, her arm appears to be significantly better.
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 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 3:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 3:06 PM, 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, 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.   Concomitant products were not provided.  On 24-May-2021, Excursion time was 08AM and 09 AM, temperature was 35, total doses given for the day was 39, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 03-May-2021 contains one vial and vaccine BUD date was 06-Jun-2021. Another slot was moved to fridge on 18-May-2021 contains 3 vials and vaccine BUD date was 17-Jun-2021. Vial was moved to clinic on 24-May-2021.  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.
Received shots. One hour later mom returned to office. Child with red, blotchy, hivey rash to both calves.