chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had them twice after the shot /Suspected vaccination failure; Had shingles twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had them twice after the shot /Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had shingles twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
pt exp an inject site react, sore arm, fever for 24-48 hrs, & h/a; pt recovered;
Maculopapular rash - face. No fever, no respiratory or circulatory compromise.
Autoimmune encephalitis vs Listeria infection - 78 yo F with encephalitis. Second Moderna vaccine on 3/6/2021, admitted on 3/31/2021.    4/18 IM Progress NOTE states: #Limbic encephalitis, improving. Treating for Listeria given inflammatory findings in addition to lymphocytic CSF and few gram-positive cocci on stain. CSF paraneoplastic antibodies are negative therefore anticipating that the serum antibodies will also come back negative Depressed flat affect consistent with limbic inflammation -improving Repeat MRI 4/14 shows improvement Ampicillin, tentative plan for 4 to 8 week course for possible listeriosis Gentamicin, completed 1 week course 4/15. Continues on Keppra                                                                                                        4/20 Neurology Progress NOTE: Impression - Meningoencephalitis, presumed to be secondary to listeria.                                                                                                              4/27 ID progress NOTE : Patient found to have limbic encephalitis and possible infectious cerebritis.  CSF exam, was performed after about 2.5 days of antibiotics due to patient anticoagulation, showed 27 white blood cells, 96% lymphocytes; protein 146, glucose 69.  Meningitis encephalitis PCR panel negative.  Gram stain with rare intracellular GPC's, culture negative. Per micro lab, 2 different techs each visualized 2 different fields with an intracellular GPC.  Clinical picture was thought compatible with Listeria (which is a bacillus, but could be mistaken for a coccus).  Completed 10 days of empiric vancomycin and ceftriaxone on 4/10.  was on ampicillin CNS dosing, plus gentamicin for synergy started 4/9, now off of gentamicin.  Ampicillin changed to meropenem due to drug eruptions.  Continued slow clinical improvement; repeat MRI brain 4/13 showed radiographic improvement.  Noted to have negative coccidioides serology but not titre came back at 1:8, repeat titre negative.  Repeat LP shows similar findings with 28 WBCs, with lymphocytic predominant, slightly low glucose and elevated protein.  Awaiting Coccidioides CSF and fungal cultures.  Continue fluconazole 400 mg daily, renally adjusted.  No evidence of QTc prolongation.  Continue to monitor rash. No evidence of DRESS, TENS or SJS. Patient has eosinophiluria.  Continue current plan of care.  Diagnosis:  -Limbic encephalitis  -Positive coccidioides titre of 1:8  -Possible infectious cerebritis  -Rash and pruritus - improving.  -Breast cancer in remission s/p mastectomy, radiation, chemotherapy  -Atrial fibrillation with RVR  -AKI with eosinophiluria Discharged on 4/27/21
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 75-year-old female patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diabetic; "Knows that she has a lot of sensitivities to mediations." (unspecified if ongoing), notes: Knows that she has a lot of sensitivities to mediations.; "Has a lot of allergic reactions" (unspecified if ongoing), notes: Has a lot of allergic reactions; "Takes blood pressure medication" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EL3246, Dosage text: Left arm), administration date: 21Jan2021, when the patient was 74-year-old, for Covid-19 immunization, reaction(s): "bone pain", "Bad headache", "Dizzy"; BNT162b2 (DOSE 2, SINGLE, LOT: EL9265, NDC, EXP: Unknown), administration date: 11Feb2021, when the patient was 74-year-old, for Covid-19 immunization, reaction(s): "just ached all over", "Bad headache", "Dizzy". The following information was reported: HEADACHE (non-serious) with onset 08Oct2021, outcome "recovered" (10Oct2021), described as "Headache was awful"; DECREASED APPETITE (non-serious) with onset 08Oct2021, outcome "recovered" (10Oct2021), described as "hardly eat"; PAIN (non-serious) with onset 08Oct2021, outcome "recovered" (10Oct2021), described as "pain was terrible."; HYPOKINESIA (non-serious) with onset 08Oct2021, outcome "recovered" (10Oct2021), described as "she could hardly move"; MALAISE (non-serious) with onset 08Oct2021, outcome "recovered" (10Oct2021), described as "sick". Additional Context: Had booster, 08Oct2021, which was a Friday. That Friday when she had her booster, caller was so sick, she could hardly move. Headache was awful, pain was terrible. Started almost right away that Friday. Saturday was just really bad, could hardly eat. Was in such pain, could hardly move. Sunday did finally fall asleep. When she got up, husband asked her how she was feeling, caller stating, she just needed one more nap and should be fine. With this booster, it took a little longer to feel better. By Sunday, was kind of getting a little bit better. Everything was ok by Sunday evening. By 10Oct2021, she was okay. Just took longer to get over it. Sender's Comments: Linked Report(s): US-PFIZER INC-202300077890 same product, patient, different AEs, different dose;
approx 7mos p/vax pt exp varicella w/blisters. treated w/acyclovir & benadryl
Rash on injection arm. I think it activated my psoriasis on my leg. It had been clear. Rash started about one week after the first injection. I still have the rash, and have taken five days of prednisone, and it seems to have helped a bit. Got an Rx for steroid cream, since I don't want to take prednisone for very long.
Initial unsolicited report received from patient via social media on 31-Dec-2017. This case involves an unknown age female patient was vaccinated with INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had the flu. Reported as it sucked. Lab data and corrective treatment were not reported. Event outcome was not reported at the time of reporting. List of documents held by sender: none.
Initial report received on 30 October 2009 from a consumer. A 28 year old female patient who "used to be asthmatic" and also reported a history of a mild reaction such as chills, headache, fever, and body aches with a prior flu vaccination (manufacturer and date were not provided). On 26 October 2009 the patient received an intramuscular left deltoid injection of FLUZONE SV (lot number unknown). On that same day the patient complained of muscle aches, chills, and pain "everywhere" but was most prominent in the back, knees, and neck. The patient was seen in the emergency room 2-3 days later. Erythromycin was prescribed by the family physician. A chest x ray was completed and results were clear. The patient also complained of a sore throat at the time of the report. Her symptoms persisted. The patient's recovery status was reported as not recovered. List of Documents held by Sender: none.
pt recv vax; reddened area, slightly raised measuring 11cmx15cm; T 99;
Pt. Was given vaccine before she was 18. She said her boss told her to come in, and she would be 18 by her 2nd vaccine.
Patient admitted through ED for hip fracture after a fall.  Incidentally, she tested positive for COVID (fully vaccinated) during procedural screening.  Some congestion in throat with coughing during her stay.  Required oxygen for O2 sats under 94% (documented as low as 79%) during ED stay.  After surgery no there were no further oxygen concerns.  Patient with no further COVID complications noted during stay.
No adverse effects; incorrect product storage; This spontaneous report wsa received from a registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medican history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 23-JUL-2019, the patient was vaccinated with an improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis, lot #R001529 and expiration date 07-NOV-2020 (strength, dose, frequency and route of administration were not reported). No adverse event was reported.   The temperature excursion was reported as above 47°F/9°C (9.9°C) during a time frame of 1 hour and 50 minutes. No previous temperature excursion was reported.   No digital data logger was involved.  This is one of several reports received from the same reporter; Sender's Comments:  US-009507513-1908USA004312:
PATIENT RECEIVED 0.2ML DOSE. SHE WAS SUPPOSED TO RECEIVE 0.3ML DOSE.
Mom reports swelling, redness to the right leg.  Mom states she feels like child is feverish but is unable to obtain a temperature.
Pt recvd 1st dose of Hep B on 4FEB91 & lab eval on 27FEB91 revealed total bilirubin 2.09 & direct bilirubin 0.31; pt recvd 2nd dose of vax on 4MAR91 & repeated tests on 5APR91 showed total bilirubin 1.19, & direct bilirubin 0.20;
Pt received Janssen Covid-19 vaccine this morning at 10:40am.  About 10-15 seconds after immunization, pt turned pale white and slumped sideways in armchair.  Also in the IMZ room were patient's mom and sister.  I had CPht call code White and 911.  After about 10 seconds, patient came back conscious and coherent to questions correctly of name, time, date and place.  The pt's mom and I continued to talk with her and monitor her.  Emergency personnel arrived within 10 minutes, talked with her, took vital signs (BP - 119/73, Pulse 85, Oxygen 100%).  Patient remained stable and chose not to go to hospital. She stayed at pharmacy for another 30 minutes before leaving.
No additional adverse events reported; The pharmacist reports that a patient only received a partial dose of PNEUMO VAX 23; The pharmacist had no problem with the plunger it was when removing the needle from the arm that the "needle sheared off while when activating the BD safety glide on the needle".; some liquid (PNEUMOVAX 23) ran down the patient's arm; Information has been received from a pharmacist, referring to a female patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-NOV-2020, the patient was vaccinated with a partial dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T028093, expiration date on 24-APR-2022 (anatomical locations and administration route were not reported) for prophylaxis.  The reporting pharmacist stated that the patient only received a partial dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) because when she withdrew the needle some of the vaccine "ran down the patient's arm". It was not known how much was actually received. No problem with the arm where the vaccine ran down. No additional adverse events were reported. A product quality complain filed as a precaution, however the pharmacist actually believed the issue was with the needle that was attached (not Merck) but could not be 100 % sure . The needle was not provided with the syringe and the pharmacist used a 25 gauge 1 inch needle. The pharmacist had no problem attaching the needle and the prefilled syringe looked fine. The pharmacist had no problem with the plunger it was when removing the needle from the arm that the "needle sheared off while when activating the safety glide on the needle". combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Tested positive for Covid; Case reference number US-BN-2022-001322 is a spontaneous case report initially received on 21-Jun-2022 from a nurse (reference number: USBAV22-0371) and concerns a female patient.  The patient's medical history and concomitant medication details were not provided.  On 16-Jun-2022, the patient was vaccinated with the first dose of RabAvert (Rabies Virus (Inactivated, Strain Flury LEP), batch number: unknown), at an unknown dose, via unknown route of administration, for pre exposure immunization.   On an unknown date, an unknown amount of time after the first dose, the patient tested positive for Covid.   The seriousness and causality assessment of the event 'COVID-19' was not provided.  Additional information received from Bavarian Nordic on 21-Jun-2022 included local case ID.; Reporter's Comments: A female patient experienced a non-serious event of COVID-19 on an unknown date, an unknown amount of time after the vaccination with the first dose of RabAvert for pre-exposure immunization. COVID-19 is not listed for RabAvert according to the insert and Datasheet. Time-to-onset was not provided, therefore chronology needs more clarification. The patient's medical history and concomitant medication details were not provided. The event of COVID-19 has been considered as not related to the suspect vaccine, but to a viral infection. This case is considered as non-serious.; Sender's Comments: A female patient experienced a non-serious event of COVID-19 on an unknown date, an unknown amount of time after the vaccination with the first dose of RabAvert for pre-exposure immunization. COVID-19 is not listed for RabAvert according to the insert and Datasheet. Time-to-onset was not provided, therefore chronology needs more clarification. The patient's medical history and concomitant medication details were not provided. The event of COVID-19 has been considered as not related to the suspect vaccine, but to a viral infection. This case is considered as non-serious.
Red patch approximately 4" long near injection site; significant edema, soreness in left arm (per mother's report).
Reportedly within 7 minutes after the YF-Vax was given the pt noticed a rash at the site. The rash disappeared 1 hour later, no anaphylaxis.
330PM pt recv vax & exp arm sore in evening; 02MAY95 5PM felt feverish, h/a, sore, hard painful lt arm, upper abd pain; skin felt burning & crawly; rx APAP
Initial misuse report received from a healthcare professional on 23-Sep-2013. The case was received on 21-Mar-2014. This case concerns a child patient (unknown gender) who took expired vaccine. A patient had received 2 doses of TRIPEDIA (Lot # unknown and expiration date 2012) on an unknown date. The reporter stated that a child was administered 2 doses of TRIPEDIA that expired in 2012. No adverse event was reported. List of documents held by sender: none.
Patient is a 35 y.o. yo male presenting to the ED with dizziness. Patient has known past medical history of ADHD, autism spectrum disorder, intellectual disability, Lennox-Gastaut syndrome, seizure. Patient recently discharged from hospital on 10/7 for significant episodes of aspiration pneumonia.  Now has PEG tube placed.  Covid bivalent booster given during his last hospitalization.  At home patient seemingly to do fine yesterday with some slight worsening ataxia, this morning woke up with a headache and significant dizziness, this worried his mother who states this is not how he normally acts and brought him to the ED for further evaluation.  During his hospitalization he is having break through seizures, has had 2 on 10/11.
Pt broke out in a rash from the elbow up to shoulder, with welts and swelling of the shoulder
On 03/05/2023, I think I came down with a cold. I began having a sore throat and a bit of a fever. Over the course of the next day or so, I got a lot of congestion and coughing. I took a COVID-19 test on Monday and it was negative. I went to a local urgent care on Friday. They tested for Flu and COVID-19, and both were negative. They diagnosed it as a particularly bad cold. As of today, I am still affected by it a little bit but feel like it's close to the end.
Vertigo has been non-stop, Vertigo started the day of vaccine and has not stop since; This spontaneous case was reported by a physician and describes the occurrence of VERTIGO (Vertigo has been non-stop, Vertigo started the day of vaccine and has not stop since) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo, Chronic kidney disease stage 4 since 19-Dec-2018, Anaemia since 18-May-2020, Hypertension since 2008, Restless legs since 2014 and Drug allergy (Allergy to nitroglycerin patch). Concomitant products included MECLIZINE [MECLOZINE] for Vertigo.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VERTIGO (Vertigo has been non-stop, Vertigo started the day of vaccine and has not stop since). At the time of the report, VERTIGO (Vertigo has been non-stop, Vertigo started the day of vaccine and has not stop since) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter mentioned that mRNA vaccine has been added as an allergy to the patient list as she thought vertigo was probably due to a derivative in the vaccine. Patient taking Meclizine for treating Vertigo.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up information includes Patient demographics and Medical History On 19-Jul-2021: Follow up information contains No New Information On 19-Jul-2021: Significant Follow up information includes Event details , Vaccination Record, and Correspondence information
Started experiencing problems around 9/6 or 9/7. First thought they were related to recovery from surgery. Tightness in arm, stomach, hands, pain in back, weakness, imbalance, joint pain. Increased in severity. Has not been feeling well for about 2 weeks. Will contact doctor today.
This is a spontaneous report from a consumer or other non-HCP (patient's parent). The reporter is the parent. A 15-year-old male patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# FJ8757),  at the age of 15, in left arm, on Dec 14, 2021, single dose, for COVID-19 immunisation. No medical history reported. Concomitant medications included: Zyrtec and Xyzal. Vaccination history included the 1st dose of BNT162B2 (Comirnaty, batch/lot# FH8028), at the age of 15, left arm, on Nov 23, 2021, single dose, for COVID-19 immunisation. The patient reported constipation, onset Dec 17, 2021, with outcome of recovering. Therapeutic measures were taken as a result of constipation. Additional Information: The patient has no known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, patient has not tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment for constipation included laxative.
Hx of Eczema 30 Lesions on trunk and proximal extremities most papular erythematous, but few vesicular lesions
Several days after receiving the Covid vaccine in her L arm the patient presented with redness, swelling, heat, and tenderness in same are. The redness was marked and grew past outline, moving all the way down to her hand. She was started on Keflex with no improvement. Doxycycline was started; then discontinued when there was no change. Claritin, Benadryl and Kenalog cream was then started. Redness continues but has not grown.
1 day after injection, low grade fever, fatigue and nausea subsiding after 2 day. 5 days after injection severe rash on left arm around injection site.
I now hear a ringing in my ears which does not go away. I am assuming it is tinnitus. So far it has been less than one day and I am hoping that it will go away, but I am scared it will not.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 03-AUG-2013, the patient was administered with a dose of VARIVAX (merck) (Lot # H012351, expiry date 21-JUN-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
sore arm; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ABDOMINAL DISCOMFORT (upset stomach) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, PAIN IN EXTREMITY (sore arm) and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up information received on 06-May-2021 included contact information.