chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen face; Swollen lips; Swollen throat; Welts on the left side of her stomach and under her arm; Blisters on the left side of her stomach and under her arm; This case was reported by a consumer via call center representative and described the occurrence of welts in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tooth abscess and pain in jaw (began about 1 month prior). Previously administered products included COVID vaccine. Concomitant products included amoxicillin (Amoxycillin) and prednisone.   On 28th June 2022, the patient received the 1st dose of Shingrix. On 30th June 2022, 2 days after receiving Shingrix and an unknown time after starting Amoxycillin, the patient experienced welts and blister. In July 2022, the patient experienced swelling face, swollen lips and throat swelling. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the welts, blister, swelling face, swollen lips and throat swelling were unknown.   It was unknown if the reporter considered the welts, blister, swelling face, swollen lips and throat swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's comment: The patient received Shingrix vaccine in right arm.  About 2 days later she noticed that she had welts/blisters on the left side of her stomach and under her arm.   She went to the Emergency room on the same day because she was having pain in her jaw that began about 1 month prior.  She was treated for an abscessed tooth and was prescribed prednisone and amoxicillin.  The prednisone dose was 20mg daily for 7 days, and the amoxicillin was completed at the time of the call.   She also showed the Healthcare professional in the Emergency room her welts on her body but forget to mention that she had the Shingrix shot 2 days prior.   She was told to use oatmeal soak.  On July 3rd, she went back to the Emergency room to seek treatment for her blisters/welts. She did not had Chicken Pox or Shingles.  She was told to take Benadryl, which she took Benadryl on July 3 and July 4. Subsequently, less than 2 weeks after receiving Shingrix, she began experiencing swollen face, swollen lips and throat. She had to follow up for dental appointment on Friday. The consent to follow up was given.  The patient gave consent to follow up with Healthcare professional (pharmacy).  The patient had limited contact information for pharmacy.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient did not experience temperature excursion previously. On 26-APR-2016 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose and route were unknown, lot #: L050910, expiration date: 14-JUN-2017, therapy type: digital data logger (also reported as rHA) (incorrect product storage). The vaccine was exposure on 9.9 Fahrenheit (F) for 1 hour and 20 minutes. No adverse events were reported. This case was one of several cases received from the same reporter. Additional information has been requested.
Patient developed shooting pains in neck in April. By June, diagnosed with metastatic thyroid carcinoma requiring neck surgery.
Patient reported tingling in the vaccinated arm that would come and go. She states this did not happen in the other arm and began day of injection. The arm tingling has since resolved. Patient is now feeling tingling in her legs. The feeling comes and goes and alternates legs. She reports no muscle involvement or loss of function.
Vaccination failure; COVID-19; Her Blood sugar went up again because she has COVID again; going to the bathroom about ten times; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Dec2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 57 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EM5318), in left arm, on 26Feb2021 as dose 2, single (Lot number: EN6198), in right arm, on 05Jan2022 as dose 3 (booster), single (Lot number: FE3594), in left arm and on 12May2022 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood sugar abnormal" (unspecified if ongoing); "Blood pressure abnormal" (unspecified if ongoing). The patient's medical history, reported also as family history included: "Diabetes" (unspecified if ongoing), notes: Mom passed away in 2013 and had Diabetes. There were no concomitant medications. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset Apr2023, outcome "unknown", described as "Her Blood sugar went up again because she has COVID again"; FREQUENT BOWEL MOVEMENTS (non-serious) with onset Apr2023, outcome "unknown", described as "going to the bathroom about ten times"; COVID-19 (medically significant) with onset 16Apr2023, outcome "not recovered"; VACCINATION FAILURE (medically significant) with onset 16Apr2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: Blood glucose: (unspecified date) high, notes: Blood sugar went high; SARS-CoV-2 test: (16Apr2023) Positive, notes: testing positive on Sunday. Therapeutic measures were taken as a result of vaccination failure, covid-19, blood glucose increased. Clinical course: The patient stated that she had all 5 vaccines, Pfizer vaccines. Got COVID for the 2nd time. Got COVID again and tested positive on Sunday (16Apr2023). Patient was sneezing since Friday. She had party on Saturday for her birthday. She was cleaning house and thought it was dust. Tearing from eyes. Never wore mask and never thought she would get it again. She was not comfortable telling anyone that attended the party. She was 200% positive she would not get it. She was worse when she woke up Sunday morning. Whole body ached. Could not sleep all night and going to the bathroom about ten times and had chills. Figured out it was COVID again. Tested on Sunday positive. Tylenol -Taking for every 6 hours. Doctor gave Paxlovid and told her not to start it until Tuesday. She had it from Pharmacy. She said start it tomorrow, so she was waiting until then. When getting up to get vaccine card, she said she got dizzy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300159840 Same patient/product, different AE/dose; Report 3 of 3;US-PFIZER INC-202300159827 same patient, different dose/AE; Report 2 of 3;US-PFIZER INC-PV202300070779 same patient, different dose/event;
Severe shoulder pain whenever I lift arm. Pain at site of flu shot and around shoulder joint.  Pain shoots down arms to elbow at time and in hand.
Severe fatigue for 6 Weeks. Went to ER and was put on Heart monitor for 2 weeks.  Went to PCP diagnosis healthy. Lung Hull was mentioned but Pt never got Covid.
Swelling, itching, redness, warm Used OTC cortizone cream and benedryl
Received PREVNAR 13 pneumonia vaccine and 1 1/2 hour after receiving shot, I got very hot, weak, short of breath, and fatigued. I laid down to see if I would feel better and I did not. I have continued to feel this way ever since. Also my I am diabetic and my blood sugars have been elevated even though I have increased my insulin dosage.
lump under her armpit; This is a spontaneous report from a contactable other health care professional (nurse). A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: not reported, expiration date: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced lump under her armpit on an unspecified date. It was reported that the nurse practitioner's mother had the Pfizer COVID 19 vaccine and her mother got a lump but it was under her armpit and now it was barely going away and it has been 9-10 months. She was going to tell her nurse practitioner to call the Pfizer number so her nurse practitioner's mother can report her side effect. She has no further information for reporting. She does not know her nurse practitioner's mother. The outcome of the event was unknown.  No further information provided or obtained
Immediately following injection I felt lightheaded. I left the store and went home. At 9:30pm I was very tired and light sensitive. At 1030pm I was vomiting, had cold sweats and diarrhea. I went to the hospital and was told it was a coincidence and that I had a gastro issue. Blood was taken and a blood culture was taken before I was discharged. The blood test appeared normal the culture would take 48 hrs to come back. I went home at 4:30am. Saturday 11/3 and Sunday 11/4 I was tired, no appetite and laid around mostly. Monday 11/5 I went to work and felt tingling in my left hand and wrist. It was tingling continuously and I went to the medical hospital 630pm 11/5. Dr performed neurological exam, reviewed blood work and told me to follow up with my primary. Still having tingling feelings in my arm and now both feet is happening on Tuesday and now developing lightheaded and dizzy feelings as well. I took nothing for it. 11/7 I went to my primary who reported that it appears I had a reaction and I was told to rest and take an antihistamine.
Extreme fatigue and lethargic for three weeks since first dose.  Pimples appearing on eyelids after first dose.
Long Red Streak from rear deltoid to elbow.  Not reported until 11-19-2020.  I asked him to go to his physician and the physician called in Keflex 500mg twice daily and is treating it like an infection. Patient told me today 11-21-2020 that he remembers falling on that arm 3 days after the vaccination. This could be from that.
12 days after receiving the 2nd Moderna Vaccine, developed severe diarrhea that lasted for 3.5 months.  Prescribed Bentyl for the cramping and diarrhea.  Also used Pepto Bismol and Immodium.
Received Two Doses of Heplisav-B, No Titers Shown; Initial Report Received on 20-Apr-2023  An advanced nurse practitioner reported that a patient (gender, age, race, and ethnicity unknown), received two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had an undetectable titer.   Medical history, allergies, and concomitant medications at the time of vaccination were reported as unknown.  On 09-Feb-2023, the patient received the first dose of HEPLISAV-B vaccine (Lot # 941579; expiration date, NDC #, and route of administration unknown) in the right deltoid.  On 09-Mar-2023, 1 month after receiving the first dose, the patient received the second dose of HEPLISAV-B vaccine (Lot # 941582; expiration date, NDC #, and route of administration unknown) in the left deltoid.   On 19-Apr-2023, 70 days after the first dose of HEPLISAV-B and 42 days after the second dose of HEPLISAV-B, the patient had a titer drawn and the level was "not detected." The patient had no side effects.   No additional information was provided.  Company Comment:  The company assessed the event as non-serious. The event was not immunologically confirmed as the serological test was not provided.; Sender's Comments: The company assessed the event as non-serious. The event was not immunologically confirmed as the serological test was not provided.
Pt developed cellulitis in the area of injection. Had nausea, fever of 104F and high blood sugar.
This spontaneous report as received from a pharmacist refers to a male patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, lot #, exp date were not reported). The pharmacist reported that after an unspecified patient was administered a dose of ZOSTAVAX on an unspecified date, the patient developed redness and swelling at the injection site on an unspecified date. These adverse symptoms lasted for 4 to 5 days and the patient recovered on an unspecified date.  Additional information has been requested.
CLIENT RECEIVED PRIMARY SERIES PFIZER AS A BOOSTER DOSE. LATER A DUPLICATE RECORD WAS DISCOVERED AND SHOWED THE CLIENT RECEIVED 3 PREVIOUS DOSES OF MODERNA BETWEEN 10YO-11YO WHICH WAS NOT APPROVED FOR THAT AGE GROUP.   THE PFIZER DOSE ADMINISTERED SHOUL'DVE BEEN THE BIVALENT BOOSTER NOT THE REGULAR PRIMARY SERIES GRAY-CAP.
child recv vax 26DEC97 & 23JAN98 father devel a fever of 103;24JAN98 devel chickenpox too many to count;pt also exp malaise;pt was covered all over body w/lesions & felt gen poorly;lesions were vesicular type;acne;
Pt recv vax on unknown day; 7-10 day post vax pt exp rash
Narrative:  82 yo male admitted to a hospital (other than this facility) 9/24/2021 with progressive dyspnea and cough. Found to be Covid positive and have Covid pneumonia, despite vaccination with Pfizer Covid vaccine on 1/27/2021 and 2/18/2021. He went into acute hypoxic respiratory failure, treated with convalescent plasma, dexamethasone, and antibiotic course. Patient stable clinically and discharged on 10/21/2021 with supplemental oxygen @ 3L nasal cannula. He developed A flutter with rapid ventricular rate in the hospital and was started on Eliquis 2.5mg twice daily.
Headache, Myalgia, Fever, Nausea Vomiting, chills temp101.7 Narrative:
Patient report dizzy, clammy feeling. BP 99/60 pulse 58. Patient rested until feeling better and at 1:45 ate sandwich and drank tea. By 2:10 felt recovered with BP 99/61 and pulse 73. 20 hour follow up OK.
Active HSV2 lesions in buttock area, before shot received. Now have painful, bleeding sores appearing in random areas over entire body (left calf, right wrist, over vaginal and caudal area, and ESPECIALLY inside both nostrils- mostly the left nostril (resolved, then immediately returned). Extreme fatigue, sweating, hot-flushes, but no elevated temp.
It started out with fatigue,  and then progressed to pain, chills and fever much like a bad flu.  By the next day I had extreme nausea.  I couldn't eat solids until 4 days post vaccination.  The fever and chills continued for 3 days post vaccination.  It was like having a really bad flu plus bad food poisoning all at the same time.
19 yr old male with vesicles on left upper arm in area of recent tattoo placed 01 Jun. Per pt roommate was vaccinated with SPV on 20 May. Pt did not receive vaccine. Pt reported on 08 Jun, 1 wk post tattoo, he noticed the appearance of bumps on the upper area of his tattoo. The increased in size, were red, and he reports tender lymph nodes in his armpit. He denies fever. Was seen at clinic and sent to derm today for evaluation. Specimens obtained including culture for PCR on 13 Jun. SPV precautions reviewed with pt. Specimen pos for PCR. F/U on 17 Jun. Pt doing well. Area healing nicely. No drainage. NO new lesions.
aches and pains; little fever; sick; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date assingle dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter Mentions that her ear doctor had gotten sick, that she doesn't know if he got the Moderna or the Pfizer but he had aches and pains and a little fever. The outcome of the events was unknown No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to an 11 years old female patient with no drug reactions/allergies or pertinent medical history. The patient was vaccinated with  lot # (668051/0179AA) dose 1 GARDASIL on 08-JUN-2011 and lot # (0214AE, exp 13-OCT-2014) dose 2 on 30-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that a patient had an injection site reaction after her 2nd dose of GARDASIL. The reaction was a pruritic rash at the injection site which lasted 8 days and resolved without treatment. The rash looked like 10 poison ivy spots or pimples. The patient did not seek medical attention. No lab diagnostics studies performed. Additional information has been requested.
Initial unsolicited report received from the literature on 14 September 2015. This case is linked to 2015SA146032, 2015SA146043, 2015SA146044, 2015SA146045, 2015SA146046, 2015SA146047, 2015SA146048, 2015SA146050,2015SA146051, 2015SA146052, 2015SA146053, 2015SA146054, 2015SA146055, 2015SA146056, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146064, 2015SA146065 and 2015SA146066, 2015SA146067 (Same literature). The following is verbatim from the article: Background: Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods: ESP-VAERS monitors patients' electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the Health System, an integrated healthcare system. We queried the VAERS database to determine Health's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results: In the 8 months following implementation, 91,622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable pre-implementation period. Conclusions: An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. Keywords: Vaccine; immunization; adverse reaction; reporting; adverse event. This case involves patient (age and gender not reported), who was vaccinated with a dose of TDAP (manufacturer: unknown, batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On unspecified date following the vaccination, the patient had experienced Bell's palsy. Laboratory tests and corrective treatments were not reported. The outcome of the event was not reported. Documents held by sender: none.
Mom states injection site developed redness, warm to touch slightly raised with small pimples, approx size fifty cent piece, went away on its own. per mom pt had same reaction with 5/15/06 immuz same leg. Left thigh immuz at that time left Varicella, right Comvax.
1st shot - 8/27/2007 - felt like nurse put needle in bone, light headed, turned white, pain at injection site for 3 days.  2nd shot - 10/31/2007 - sore at injection site.  3rd shot - 2/20/2008 - site severe pain in muscles, joints, arm hurt for 3 days.4/10/08-office records received- 5/2/08-records received for DOS 3/11/08- Chief complaint: abnormal Positive ANA, high sed rate, after shots, achy joints, pain has increased since fall 2007, put on Prednisone 3/18/2008. Presented with recurring stress fractures, four since high school.  Chronic pain increasing since last fall. 12/2/09 Other correspondence and medical records received.   Medical records DOS 3/4/09: Final DX: Abnormal weight loss, arthralgias and joint stiffness, elevated sed rate, and positive ANA consistent with polyarthralgia blotchy rash, urticarial rash, HLA B27 positive, back pain out of proportion to other joint pains--suspicious for spondyloarthritis in setting of seronegative arthritis, Lymphocele is seen at T12 through L2 and MR lumbosacral area.  Pulmonary nodules, previous Gardasil immunization prior to onset of rheumatologic symptoms, positive SSA, multiple stress fractures, mostly asymptomatic, abnormal bone scan, bone biopsy pending after tetracycline loading.  Gardasil vaccine questionnaire noting the following sx beginning after vaccine #1 and continuing throughout vaccine series: dizziness, numbness, tingling, joint pain, muscle pain at inj site, rashes, blisters or skin disorders,  extreme fatigue, weight loss,  joint stiffness, night sweats, fevers, back pain, chest pain. All increasing over time. Short term steroid therapy no help. Unable to complete ADLs some days, often debilitating.  C/O Ankylosing spondylitis and connective tissue disorder s/p vaccines.   ICD9 Codes:  Noted as indication for MRI of spine 721.90, 724.5
This information has been received from a medical assistant referring to two patients of unknown age and gender. On 13-APR-2015 two patients were vaccinated with improperly stored GARDASIL (dose, strength, lot# and route not provided). No adverse effects were reported. Additional information has been requested.
On 2/6/21 at 6:00PM, resident experienced sudden left facial droop, left arm and left leg weakness. She was sent to hospital and they confirmed she had an acute ischemic stroke.
I have been in chemically induced menopause since October 2019. 15 days after receiving the first dose of the Pfizer covid vaccine I experienced a menstrual period lasting 6 days.
passed out; faint; Felt weak; Looked pale; dizzy; Looked to have a seizure like shaking; This case was reported by a other health professional via call center representative and described the occurrence of passed out in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA113A, expiry date 31st March 2020) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Menveo (intramuscular) .5 ml. On 27th August 2019, 5 min after receiving Menveo, the patient experienced passed out (serious criteria GSK medically significant), faint (serious criteria GSK medically significant), feelings of weakness, pallor, dizziness and tremor. On 27th August 2019, the outcome of the passed out, faint, dizziness and tremor were recovered/resolved. On an unknown date, the outcome of the feelings of weakness and pallor were not recovered/not resolved.   It was unknown if the reporter considered the passed out, faint, feelings of weakness, pallor, dizziness and tremor to be related to Menveo.  Additional details were provided as follows: The healthcare professional (HCP) stated that the patient received Menveo in the office this morning and 5 minutes later felt weak, dizzy, faint, and looked pale. The reporter stated the patient passed out and looked to have a seizure like shaking. The reporter stated that the patient recovered quickly of all symptoms except she was still pale and weak. The reporter stated that they took the patient's blood pressure and it was normal, blood sugar was 93, and oxygen level was normal. The reporter consented to follow up.