chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Abscess In Intestines; Active Crohn's; Fever; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4189072-00.  A 56 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01May2021 (Batch/Lot number: unknown) at the age of 56 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for crohn's disease. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Route of Adm: Intramuscular, Therapy dates/Duration: 01Apr2021 - 01Apr2021, On unknown dates, the patient experienced abscess in intestines and active crohn's, the first covid vaccine felt like had mild cold (from Apr2021 to Apr2021) resolved), administration date: 01Apr2021, when the patient was 56 years old, for COVID-19 Immunisation, reaction(s): "Abscess In Intestines", "Active Crohn's", "Mild cold". The following information was reported: ABSCESS INTESTINAL (medically significant), outcome "not recovered", described as "Abscess In Intestines"; CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Active Crohn's"; PYREXIA (non-serious) with onset May2021, outcome "recovered" (May2021), described as "Fever". The action taken for adalimumab was unknown. Clinical course; Patient had abscess in intestines, active crohn's, second dose of covid vaccine had fever and first covid vaccine felt like had mild cold with humira (ADALIMUMAB). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The causality of events with bnt162b2 and adalimumab (HUMIRA) was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of event pyrexia cannot be totally excluded and events abscess intestinal, crohn's disease mostly related to HUMIRA and not related to BNT162B2.,Linked Report(s) : US-PFIZER_INC-202101780643 same reporter/patient/drug, different event/dose
Dizziness, vomiting, muscle weakness, diff swallowing;dx Guillain-Barre synd;pt still hosp as of 22OCT956 in ICU;
Period schedule on and off the chart; Increased period bleeding; She experienced was headache which was resolved day after getting vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Period schedule on and off the chart), HEAVY MENSTRUAL BLEEDING (Increased period bleeding) and THERAPEUTIC RESPONSE UNEXPECTED (She experienced was headache which was resolved day after getting vaccine) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (Period schedule on and off the chart), HEAVY MENSTRUAL BLEEDING (Increased period bleeding) and THERAPEUTIC RESPONSE UNEXPECTED (She experienced was headache which was resolved day after getting vaccine). At the time of the report, MENSTRUAL DISORDER (Period schedule on and off the chart) and HEAVY MENSTRUAL BLEEDING (Increased period bleeding) outcome was unknown and THERAPEUTIC RESPONSE UNEXPECTED (She experienced was headache which was resolved day after getting vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab test included Pelvic test : normal   No Concomitant and Treatment medication were reported.
I started with a sore throat, headache, chills, body aches, fever, runny nose and fatigue. The fever lasted for 9 days and the headache and cough stuck around, The chest pain and breathing became hard on day 7. I went to the doctor they completed an EKG and chest x-ray. The x-ray was clear but the EKG was not. I went to a cardiologist and had a echocardiogram which was also clear. I went to the pulmonologist and had full blood panel with my primary care doctor and it was determined that I had a vitamin deficiency. My primary care doctor put me on a inhaler that was not effective. The pulmonologist prescribed a Trelegy which has been helping with my breathing. I have been on it for 5 or 6 weeks. The doctors have advised that I have long COVID-19. I crash at least once a week. I continue to have cough and feel tired and fatigued.
Pain over left deltoid where injection was given, unable to raise arm, onset within a few hours after immunization. Presents for follow up next day. Took single dose of ibuprofen 200mg without any improvement. On exam has tenderness of left deltoid muscle with slight induration at injection site. Pain with contraction of deltoid muscle, otherwise appears normal.
BEGAN AS WELT WITH SORENESS. OVER NEXT FOUR DAYS, EXPANDED TO 3" x 5" OVAL SHAPED, RAISED 0.5" WITH PALPABLE KNOT. REDNESS, EXTREME TENDERNESS, AND WARMTH. 1-2 DEGREE FEVER. D/DX AS CELLULITIS BY PA ON AFTERNOON OF 11/15/2014. CLINDAMYCIN HCL R00 MG PRESCRIBED.
pt recv vax & devel gen aching & inj site rxn characterized by redness, swelling & a knot;the reporter was not able to specify the number of pt who exp this event;addtl reports will be generated when identifying info is provided;
the powdered Hib portion of pentacel was administered, reconstituted with the wrong diluent with no reported adverse event; the powdered Hib portion of pentacel was administered, reconstituted with the wrong diluent with no reported adverse event; Initial information was received on 01-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient to whom the powdered Hib portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [PENTACEL (VERO)] was administered, reconstituted with the wrong diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live reassort oral 5V (Rotateq) and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 30-Aug-2023, the patient received a 0.5 ml, total (once) (dose 2) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot UJ865AA, expiry date: 31-Mar-2024, strength: standard) via intramuscular route in the left thigh for Immunisation and the powdered hib portion of pentacle was administered, reconstituted with the wrong diluent with no reported adverse event (product preparation error) (single component of a two-component product administered) (Latency: same day).  Reportedly, HCP asks if they can still use the liquid DTaP-IPV portion of the PENTACEL vaccine that was not initially used and then use a standalone ACT-HIB for the Hib component. Also, it was reconstituted with lidocaine HCl, sodium chloride 7mg.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (experienced after receiving 1st dose on 22nd June 2018, refer case US2018GSK225370). On 2nd December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, general body pain and pain in arm. Rechallenge with SHINGGRIX was positive. In December 2018, the outcome of the influenza-like symptoms, chills, general body pain and pain in arm were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, chills, general body pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 59 or 60 years. The patient experienced arm soreness, flu like symptoms such as chills and body aches which lasted about 3 days. The patient did not consent to follow-up.
Vaccines given on Aug. 4, 2009, went home started to have bilateral Jaw pain.  Pain behind his eyes, zoning out per mom.
No additional AE; patient who received an expired dose of PNEUMOVAX 23 (pre-filled syringe) with no prior TEs.; This spontaneous report was received from a licensed practical nurse (LPN) concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-SEP-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, 0.5 milliliter, lot #U034712, expiration date: 30-JUL-2023, administered as prophylaxis (strength, and route of administration were not provided) (Expired product administered).  It was reported that the vaccine did not have any prior temperature excursions. No symptoms or additional adverse events were reported.
Patient received a non-indicated dose of Tdap. Patient had received 4th Dtap after their 4th birthday. A fifth dose of either Dtap or Tdap was not indicated.
experiencing a headache and it has gotten worse; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable female consumer (patient, self-reported).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 08Feb2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she took the first dose in the morning but prior to that she was experiencing a headache and it has gotten worse since she hasn't taken her Sumatriptan. The patient asked was it okay to take it. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Fatigue, sore throat, weakness,  myalgia , pain in arm at the site, low grade fever, headache, itchy, scalp and body itchy, injection site red and swollen. Can't eat.
Pt recv vax on 2/20/96; on 1/28/99 pt exp varicella
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 vaccine were administered on 15NOV2021 after bein initially punctured on 12NOV2021 at 8:53 AM) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 029L20A and 011M20A) for COVID-19 vaccination. No Medical History information was reported.On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 vaccine were administered on 15NOV2021 after bein initially punctured on 12NOV2021 at 8:53 AM). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Moderna covid-19 vaccine were administered on 15NOV2021 after bein initially punctured on 12NOV2021 at 8:53 AM) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were provided.No treatment medications were reported.
Td vaccine administered 8/22/03 around 4pm, vaccine has given in L deltoid. Child was fine until 215am the next night when he woke up and was shaking all over, arm hurt at injection site, was aching all over and had a fever 102.8 F. Symptoms lasted approx 48 hrs-after symptoms disappeared, the child has been fine since. He was not seen by a physician.
This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in an infant subject of unspecified gender who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On an unspecified date in 2007 the subject received 1st dose (birth dose) of Engerix B.  The infant was tested for hepatitis B surface antigen an unknown number of days later and tested positive.  The circumstances for why the infant was tested were not known by the reporter.  No other information was known at the time of reporting.  The outcome of the event was unspecified.  Follow-up information was received on 15 November 2007; just prior to receiving the second Engerix-B dose, the hepatitis B surface antigen was negative.  The subject's antigenemia resolved, dates were unknown.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles anyway. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
This is 64 y.o. male who presented for the above procedure. Postoperative course was uncomplicated. Diet was advanced to regular diet and patient was taking sufficient PO intake to maintain hydration. Pain was controlled on PO medications. Patient was ambulating. The patient was deemed stable for discharge on 10/6/22.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 23-MAR-2014, the pharmacist reported that due to a product quality issue with ZOSTAVAX the patient was stuck twice with the needle attempting injection of ZOSTAVAX vial 0.65 ml (route, lot number and expiration date were not reported). No adverse experiences noted. The pharmacist also reported appearance and viscosity issues with ZOSTAVAX. Additional information has been requested.
Patient stated that she could not see clearly and became very pale. She was placed on the table and given crackers and juice and her BP was monitored.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-OCT-2007, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On 12-SEP-2016, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Additional Details: Ptient came to recieve her flu and moderna booster at the same time. She got a flu shot and shortly after recieving her moderna booster and said she forgot to mention she faints after injections. Patient then said she needed to lie down and proceeded to lie down on the floor. Shortly after, she became unresponsive. Emergency number was called and paramedics arrived. They took her vitals. patient regained consiousness later and left with her husband when her blood pressure was stabilized
About 9 x 10 cm area of redness and warmth around injection site and fever to about 104 degrees F.
since having the vaccine she develops hive-like skin eruption on skin that has been exposed to the sun
Per Patient she developed a rash that evening after getting the flu-shot on 1/21. She said the rash is on her face and neck and look like pimples but are not.  She also said the rash itches and that it has not gotten any worse or better.  As of 1/25/11, the rash has not gone away and she cannot get in to see her primary Dr., therefore, she is going to go to urgent care. She called the pharmacy on 1/25/11 at about 9:05 AM to report adverse reaction.
side effects as being "typical"; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effects as being "typical") in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (side effects as being "typical"). At the time of the report, ADVERSE EVENT (side effects as being "typical") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-095793 (E2B Linked Report). This case was linked to MOD-2021-095403 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095793:
Patient given PPD then Hep A. After Hep A, said she was dizzy. Patient then said she felt ok. Hep B given. Patient became limp, pale; said she felt like vomiting. Taken to lie down. Pulse weak, patient pale, shallow respiration, yawning. Elevated legs; no improvement. Pulse 44, BP 93/41 at 10:08. At 10:10, Pulse 120, weak. Gave Epi Pen Jr and called 911. Patient cleared by by MD per telephone call to ER from EMS and said to have vagal reaction. Released to home. EMS arrived at 10:15.
11/6/17 EVENING PT STATES THAT THERE WAS A RASH AT INJECTION SITE, AND SHE DEVELOPED A 101F FEVER; 11/8/17 (WHEN SHE CONTACTED PHARMACY), SHE STATED THAT SHE HAD BEEN AND STILL WAS WEAK, INJECTION SITE WAS PAINFUL, WARM TO TOUCH, HURTS TO TOUCH, CAN'T LIFT ARM, 103F FEVER, SHORTNESS OF BREATH, DIZZY, AND LIGHTHEADED.
Grandmother called and reported that child had vaccines on 5/10/2006 and 5/19/06 broke out with whelps on his abd that radiated to his groin that same day. They seen Dr and he prescribed Benadryl by mouth around the clock. On 5/21/06 the whelps spread to his back. On 5/22/06 the whelps began to clear up and by 5/23/06 the whelps completely cleared up. On 5/24/06 he stopped the Benadryl and began to break out that evening. On 5/25/06 the grand mother brought the child back to DR du to the reoccurrence of the whelps and tongue swelling but denied any shortness of breath. The Benadryl was restarted at that time and on 5/27/06 the whelps cleared up and the swelling of the tongue resolved. The Benadryl was stopped on 5/38/06 and the child was started on Zyrtec to continue until June 5/06. I instructed the grandmother that a follow up note would be required to administer any further vaccines.
Pt has dx molluscum contagiosum. Hx of eczema and dry skin. Tx with apple cider vinegar. Seen in office approximately 1 wk after MMR vaccine with worsening rash -> refer to Derm ? reaction to MMR vaccine.
He started to have a severe stutter. He had never stuttered before. Had a lot of difficulty with speech. We have encourage healthier eating, speech therapy, alternative therapies and speech therapy. Now speech has much improved as of 2023.
diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  Additional information: Patient asked to schedule the 2nd dose of the covid-19 vaccine. Patient experienced diarrhea after the 1st dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itching; 4/5 bumps; Sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), MASS (4/5 bumps) and PAIN (Sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PRURITUS (Itching), MASS (4/5 bumps) and PAIN (Sore). The patient was treated with IVABRADINE HYDROCHLORIDE (IVAREST [IVABRADINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching), MASS (4/5 bumps) and PAIN (Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 28 Jan 2021, the patient stated her achiness went away but the night before her arm was itching and around 4-5 bumps appeared. It woke her up in the middles of the night so she put some Ivarest on the area. She is a little sore from her shoulder to her elbow.