chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles). 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: 28-APR-2023 This case was reported by the patient via interactive digital media. The patient experienced shingles after receiving the shot. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
32 y.o. male who was seen at COVID Vaccine Clinic today for his second dose of the COVID 19 vaccination.    He denied any history of previous adverse reactions to vaccines.   He was given the Pfizer vaccination in the left deltoid muscle.   During his 30 minute waiting period after the injection, the patient began to experience allergy symptoms scratchy throat which is chronic.  He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and he was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to scratchy throat.Treatment included: no therapy and bottle of water. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.
Severe nausea and vomiting. Headaches.  Fever, chills. Widespread body aches (extremely tenderness and soreness).
My daughter received DTAP IPV (kinrix) and HEP B (Engerix-B) on the following dates : 1. 3/23/21 R arm swelling pain redness 2.8/3/2021 L arm facial swelling, site redness, pain, rash on thighs sent to immunology/allergy 3. 2/22/22 L arm shoulder pain, fevers, site pain/redness, lump, diarrhea, fatigue, neck pain  She was seen on 2/24/22 provider said it was "tense" and the reaction is normal and common. Instructed to ice it and f/up with peds.  Pediatrician seen 2/25/22 dx with vaccine reaction to DTAP-IPV  She received both HEP B and DTAP-IPV in same arm each time.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 01-FEB-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N013886, expiry date: 09-DEC-2018) (route: oral). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA004629: US-009507513-1802USA004636: US-009507513-1802USA004641: US-009507513-1802USA004647: US-009507513-1802USA004652: 1802USA004654: Original Case: 1802USA002182: US-009507513-1802USA004654: US-009507513-1802USA004658: US-009507513-1802USA002182: US-009507513-1802USA004671: US-009507513-1802USA004673: US-009507513-1802USA004686: US-009507513-1802USA004692.
injection site swelling and pain; passed out within 20 minutes of injection.  1st 2 days fatigue diziness and nausea. days 3-5 severe cramps, fever, diziness, nausea. day 6 began period more than 1 week early and continued cramps, fatigue, nausea.  This report is made on day 7 and early period, cramps, fatigue and fever continue.  Events were reported to physcian via phone on 10/10/08.
ACUTE RESPIRATORY FAILURE 4/28/2022 ADENOCARCINOMA METASTATIC TO LEFT LUNG HYPOXIA 4/28/2022 ADENOCARCINOMA METASTATIC TO LEFT LUNG ACUTE RESPIRATORY FAILURE 4/28/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION HYPOXIA 4/28/2022 SEPSIS WO ACUTE ORGAN DYSFUNCTION
Chills, fever, (101.4), headache, upset stomach, body ache, fatigue, pain at injection site. The symptoms lasted for 4 days.
11/30/11 - Legs are weak and he couldn't hardly walk had weak muscles since last visit and flu shot on Oct 24, is on calcium with D as instructed. No back pain now just weak muscles. Has gotten flu shot last 3 yrs in a row didn't have reaction like this, 10 yrs ago quit taking them because it gave him the flu. Barely able to get in and out of vehicle. Wants to sleep a lot. 3/28/2012 - Saw neurology 3/27 and is now on METANX now and is to DC pt for now. Neurology thinks problem is neuropathy and Guillain-Barre.
Received the shot 1710 on 12/21/20.  Restless sleep.  Awoke with body aches, took  1000mg Acetaminophen.  Felt fine until 1500, started with fever/chills, temp 100.8.  Went to sleep then, awoke at 1845 with oral temp at 103.4.  Took 2nd dose 1000 mg Acetaminophen.  Temp decreased to 102. 5 within 45 mins, dropped to 101 by 2030.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Lactating" (unspecified if ongoing), notes: Lactating individual. The patient's concomitant medications were not reported. The following information was reported: LACTATION DISORDER (non-serious), SUPPRESSED LACTATION (non-serious) all with onset 11Dec2021, outcome "unknown" and all described as "Decrease in my breastmilk supply / other medical history = Lactating individual". Therapeutic measures were not taken as a result of lactation disorder, suppressed lactation. Additional information: Patient has not taken any other vaccine in four weeks and patient has not taken any other medications in two weeks and patient had COVID prior to vaccination. Post vaccination Patient has not been tested for COVID. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Facial hives: resolved with PO Benadryl   Right eye/cheek muscle twitching (ongoing for 1 week and continuously occurring).
diarrhea, having trouble keeping foods on her stomach also; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea, having trouble keeping foods on her stomach also) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, lot number 0121204) on 28-Jan-2021, Moderna COVID-19 Vaccine (Dose 2) on 25-Feb-2021, Moderna COVID-19 Vaccine (Dose 4) and Moderna COVID-19 Vaccine (Dose 3). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 18-Apr-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced DIARRHOEA (diarrhea, having trouble keeping foods on her stomach also). The patient was treated with AMMONIA ongoing since an unknown date for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea, having trouble keeping foods on her stomach also) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.
Pt received 4 year vaccines; DTAP in upper left deltoid; Polio injection, SC, and MMR in right arm. Pt had redness and swelling at site of DTAP, measures 2" X 3" and a dime-sized bruise.
Acute Myocarditis requiring hospitalization. Treated with supportive care. Symptoms slowly resolving, will follow up with cardiology
After returning home from morning MD appt. Pt. stated she felt weak. Ate lunch and after lunch had seizure like activity x 1 min. Wasn't able to follow commands x 45 - 60 mins. Husband brought pt. to MD office. Upon arrival at office tympanic temp - 92.8. Pt. chilling. Per Dr., "pt back to her normal mental self in office". Pt. was transported to Hospital ER via EMS for further evaluation. Office VS: 92.8 P=77 BP=140/92 O2 Sat = 97% on room air.
pt recv vax 14APR97 same day pt exp severe swelling from arm to fingers that was bright red;pt also exp palpitations;
Patient received Pfizer Covid vaccine 12 years above; instead of Pfizer Covid Vaccine 5-11 on her second dose
BURNING SENSATION DURING INJECTION; FATIGUE FOR SEVERAL DAYS; LOW GRADE FEVER
patient received an expired dose of Boostrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (expiry date 15-JUL-2023) for prophylaxis.   On 21-AUG-2023, the patient received Boostrix. On 21-AUG-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Boostrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-AUG-2023 The reporter could not provide the lot number for the product.  No additional information was provided. The reporter consented to follow up. The reporter reported that the patient received an expired dose of Boostrix, which led to expired vaccine used.
Sore arm that was hard and swelled up; Sore arm that was hard and swelled up; sore arm that was hard and swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm that was hard and swelled up), SWELLING (Sore arm that was hard and swelled up) and INDURATION (sore arm that was hard and swelled up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, 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 experienced PAIN IN EXTREMITY (Sore arm that was hard and swelled up), SWELLING (Sore arm that was hard and swelled up) and INDURATION (sore arm that was hard and swelled up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm that was hard and swelled up), SWELLING (Sore arm that was hard and swelled up) and INDURATION (sore arm that was hard and swelled up) outcome was unknown.            No concomitant medication was reported.
Patient received vaccine at 1613, experienced dizziness and lightheadedness at 1625. Patient instructed to lie down, vs taken, given apple juice and observed.
aches; sore arm; low grade fever; had a bad rash all over her arm; Initial information was received on 07-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who had a bad rash all over her arm, sore arm, aches and low grade fever while receiving vaccine influenza usp trival a-b high dose subvirion vaccine [Fluzone high dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe of unknown frequency via unknown route in unknown administration site (with an unknown strength, batch number and expiry date) for immunization.   On an unknown date the patient had a non-serious event had a bad rash all over her arm (rash), sore arm (pain in extremity), aches (pain) and low grade fever (pyrexia) (unknown latency) following the administration of influenza usp trival a-b high dose subvirion vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Narrative: COVID infection following COVID vaccine series 02/04, Pfizer, dose #1 02/25, Pfizer, dose #2 12/27 COVID swab, result: detected 12/27 pt cc: exposure: unknown
Generalized itchiness, intermittent trunk hives and injection site herpes zoster-like rash. Benadryl 25mg tablets q4-6 prn with moderate relief. From onset (day 2 post vaccination) until present ( day 7 post-vaccination)
testing positive for Covid-19; testing positive for Covid-19; This is a spontaneous report from a contactable consumer (patient's wife) reported. A  62-year-old male patient received initial dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown. Expiration date: Unknown) via unspecified route of administration on 07 Apr2021 at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. He started to experience fever, chills, and a cough after receiving the vaccine and she thought these were normal side effects but he ended up testing positive for Covid-19. He is due for his second dose of the vaccine on 05May2021. Outcome of the events is unknown.  Follow-up attempts are possible; information about lot/batch number requested.
continuous crying for 8 hr same day of vax administration event occurred 6FEB94; pt re-vax 5APR95 same reaction;
Fainted twice in less than two minutes. Blood pressure was too low to read on an automatic cuff.
Information has been received from a registered nurse concerning an approximately 7-year-old white male who on 10/22/1999 was vaccinated SC in the left arm with a 0.5 Ml dose of varicella virus vaccine live (Oka/Merck) (lot #63116801710J). Concomitant vaccination on the same day included an IM fourth dose in the left thigh of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (lot #912A2), a SC first dose in the right arm of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl LyNN) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot #63116b/0710J), a SC third dose in the right thigh of Poliovirus vaccine inactivated (Vero) (IPOL) (Lot #P0040-2), and an IM third dose in the left thigh of Hib conj vaccine (tet Toxoid) (ACTHIB) (lot #412353A). In approximately November 2005, the patient developed a case of break through chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the registered nurse who reported that she was unable to contact the family for further details. No further information is expected.
Patient felt dizzy after receiving vaccines. Administer ammonia inhalant. Felt better. Had patient wait 15 min. Felt fine and left.
3 days following vax pt had pain, bruising & edema shoulder to elbow lasting approx 6 days;
This is a spontaneous report from a contactable other HCP received via a sales representative. A patient of unspecified age and gender received PREVNAR 13 (batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had a local reaction with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) on an unspecified date thus would like to discuss if PNEUMO 23 was contraindicated. The outcome of the event was unknown. The information on the batch/lot number and expiration date has been requested.
I woke up at 3:00 am with a SEVERE, PAINFUL muscle cramp in my left lower extremity from my left hip down to my left foot and toes.  The cramp was excruciating !!!   I was able to get out of bed with difficulty after several tries.  I was unable to bear weight on my left leg and foot.  The SEVERE cramp was not relieved by me attempting to "walk it out".
Employee reported a hard nodule to injection site with heat to touch. Employee reported all symptoms resolved within 24 hours.
Pt with (RT) upper arm swelling developed 3 days ago, pain for 1-2 days now resolved, however swelling remains (localized reaction). 9 cm diameter circular lesion, non-tender, mild erythema.
shingles; Information has been received from a lawyer, regarding a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not provided. On unspecified date in 2017, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (route, dosage, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions.  Subsequently, on unspecified date, the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of the of Zoster Vaccine Live (ZOSTAVAX) vaccine, she had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the reporting time, the reporter considered the event of shingles to be related. The patient had not recovered from the event.
04/14/21 8:30 AM 2nd dose    -sore arm after a few hours   * 11:30 PM (15 hours after) noticed mild Tinnitus in both ears, right side is the worst.         - arm is sore at Injection site when lifting it.           - arm hard knot at injection site 1.25 inch diameter   04/15/21   * 8:30 AM. (24 hours after)  Woke up        - Tinnitus in right ear no change.  Left ear seems to be normal.         - arm still sore when lifting it.        - arm hard knot at injection site 1.5 inch  diameter.        * 10 AM.            - took Claritin-D      * 12:30 PM (28 hours after)            - Tinnitus left ear normal, right ear less noise, not  very noticeable.            - feel slightly off,  clammy skin and feel hot.            - Temp: 99.4 f       * 6:30 PM ( 34 hours after)           - Tinnitus right ear back to original volume hissing noise, left ear very slight hissing noise.          - new, mild headache           - new, mild muscle aches          - arm less soreness when lifting it.          - arm hard knot at injection site 1.5 inch  diameter.           - Temp 101.2 f
general body hives occurring hours p/vax;no stridor, resp sx;sx persist 24hr p/vax;
nephrotic syndrome; hypertension; This is a literature report for the following literature source(s): "Report of three cases of minimal change disease following the second dose of mRNA SARS-CoV-2 COVID-19 vaccine".  A 41-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunisation. The following information was reported: NEPHROTIC SYNDROME (medically significant), outcome "unknown", described as "nephrotic syndrome"; HYPERTENSION (non-serious), outcome "unknown", described as "hypertension". Symptom Onset (5 days). The patient underwent the following laboratory tests and procedures: biopsy kidney: minimal change disease.  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 information provided and plausible temporal association, the causality between BNT162B2 and Nephrotic syndrome, Hypertension cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Kinrix administrated instead of Pediarix; 6 month patient administrated with Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3ks4f, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 6th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comment: The medical assistance reported that the patient received a dose of Kinrix instead of Pediarix.  No adverse event reported. The reporter consented to follow up. Additional Supportive Information: The six month old patient received Kinrix instead of Pediarix, which led to inappropriate age at vaccine administration and wrong vaccine administered.  This case had been linked with case US2022143284, US2022143285 and US2022143286 reported by the same reporter.; Sender's Comments:  US-GSK-US2022143284:Same reporter US-GSK-US2022143285:Same reporter US-GSK-US2022143286:Same reporter
Fever the night of the vaccination, diarrhea x1, vomiting x1 the morning following vaccination.