chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blind; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2), administration date 06Dec2021 (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: BLINDNESS (medically significant), outcome "unknown", described as "blind".  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and rug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of RECOMBIVAX HB (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up information was received from the medical assistant on 06-AUG-2014. The M.A. stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 11 year old patient who on 10-JUN-2014 was vaccinated with improperly stored dose of RECOMBIVAX HB lot# J006365, expiration date 05-DEC-2015 (dose and route of administration not reported). This is one of several reports received from the same reporter. Additional information is not expected.
pt recv vax 13JUN96 & in FEB97 pt exp chickenpox;9 other pt were reported as well (WAES 97030174, 97030176-97030182, & 97030184);
Ringing in ears, lightheaded. Vitals wnl. Felt better after lying down.
This is a spontaneous report received from a contactable reporter  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 42 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 18Feb2021 as dose 2, single (Lot number: EL3247) and on 10Oct2021 as dose 3 (booster), single (Lot number: FF2589) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUCELVAX QUADRIVALENT taken for immunisation, on 09Sep2022 as dose number unknown, single. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Dec2022, outcome "unknown" and all described as "severe flu-like symptoms / Home test COVID +". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2022) Positive, notes: Home test covid +. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The patient experienced severe flu-like symptoms on 25Dec2022 and had a home test covid positive (+) on 28Dec2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
No adverse effect reported; 1 dose of Varivax was administered intramuscular; This spontaneous report was received from a pharmacy student and refer to a 22 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 03-MAY-2019, the patient was vaccinated with one dose varicella virus vaccine live (oka/merck)(VARIVAX) injection, that was administered intramuscularly (dose, lot number, expiration date and frequency were not reported) for prophylaxis (incorrect route of product administration).     No adverse effects were reported. No product quality complaint (PQC) was involved.
Immediately following administration of the patient's second dose, the patient reported feeling "pulsation up to her neck". Vitals checked with HR in 160?s, BP 116/80, pulse 96. Denied chest pain, nausea, SOB and all other major symptoms. Tried vagal maneuvers, HR remained elevated. Called EMS.
Have shingles, had the vaccination/Suspected vaccination failure; Shingles, fourth time; Hurts, feels like bone is tearing through skin; This 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. The patient received Shingles vaccine several years ago from the date of reporting and thought he/she was through with them. After receiving Shingles vaccine, the patient got shingles for the fourth time and had them at the time of reporting for almost three weeks. The patient stated that, it hurt so bad sometimes it felt like his/her bone was tearing through skin. Additional supportive information: 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 test confirming shingles were unknown at the time of reporting.
Had experienced localized injection site redness, warmness and hives in injection site lower extremities; Had experienced localized injection site redness, warmness and hives in injection site lower extremities; Had experienced localized injection site redness, warmness and hives in injection site lower extremities; This spontaneous report was received from a nurse concerning a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On an unknown date (when the patient was 15 years old), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).         On an unknown date, the patient had experienced localized injection site redness (vaccination site erythema), warmness (vaccination site warmth) and hives in injection site lower extremities (vaccination site urticaria).      The outcome of the events was unknown.     The reporter considered vaccination site erythema, vaccination site urticaria and vaccination site warmth to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
Pt received a flu shot Sept 2016 and reported arm numbness and back pain within a week of injection that continues today.
powder component of Menveo was expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA380A, expiry date 31st August 2021) for prophylaxis.   On 30th September 2021, the patient received Menveo. On 30th September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was administered the expired powder component of Menveo, which led to expired vaccine used. The reporter consented to follow up.
pt recv vax & approx a few hr later pt devel welt @ inj site;welt was reported to have lasted a few days;
Beginning nine days after vaccination, developed large circular red, swollen, and itchy area at injection site. Called my primary care physician and sent her pictures. She told me it is called "Covid Arm." She told me to report it to you, and informed me that it is still safe for me to get the second injection.
Received annual influenza vaccine in L deltoid in the morning and by evening reported that she began to have tenderness and pain to L axilla that has progressively gotten worse.
I have been trying to call about my vaccine administration. I have called board of health as well as facility with no answer. As the injection was done I felt moisture. It started to run down my arm. I had to ask the nurse what it was and she said it happens. I am writing  you because  I am Concerned I did not get my second full dose and no one is answering me.
felt feverish had real bad cough (dry cough), sore throat, lost hearing & voice ringing in the ears; took Rubistussin DM & APAP-Tavist-D;
EKG: Sinus bradycardia with 1st degree AV block  Nonspecific intraventricular block  T wave abnormality, consider inferior ischemia  Abnormal ECG      CBC:     RBC'S 4.10 - 5.70 M/uL 5.74 High (H)    HGB 13.0 - 17.0 g/dL 12.0 Low (L)    HCT 39.0 - 51.0 % 41.3   MCV 80 - 100 fL 72 Low (L)    RDW, RBC 12.0 - 16.5 % 17.6 High (H)      Chem7:     NA 135 - 145 mEq/L 134 Low (L)      K 3.5 - 5.3 mEq/L 4.1     CL 100 - 111 mEq/L 107     CO2 24 - 33 mEq/L 18 Low (L)      ANION GAP4 SERPL 5 - 16 mEq/L 9     BUN 7 - 27 mg/dL 47 High (H)      GLUC 60 - 159 mg/dL 107  See comments  CREAT <=1.34 mg/dL 3.01 High (H)      ESTIMATED GFR >=60 mL/min/1.73 m2 20 Low (L)      UA GLuc > 500      -Covid test completed:   CORONAVIR PAN 2019-NCOV, NAA, QL COVID DETECTED        - Chart reviewed and care discussed with:   ED staff, pt, ED COC mng   - Level of care recommendation:  Possible observation  RN  7/31/2023 4:50 PM      Note Details  Author (R.N.) File Time 7/31/2023  5:37 PM Author Type REGISTERED NURSE Status Addendum Last Editor (R.N.) Specialty GENERAL, OTHER Hospital Acct Admit Date 7/31/2023  ED to Hosp-Admission (Discharged) on 7/31/2023  ED to Hosp-Admission (Discharged) on 7/31/2023   Revision History   Detailed Report  Note shared with patient Care Timeline  07/31   Admitted from ED (Observation) 1749 08/01   Discharged 1538
Stuffy nose, sore throat, fever, coughing starting 3/14/23. Tested COVID positive on 3/17/23. Paxlovid treatment started 3/18/23.
PREVNAR 13. Patient reports large area of right shoulder that is red, raised and hot to the touch. The area is approx 3 inches wide. She will follow up with PCP Monday 11/7/16.
Narrative:  Patient was administered an expired dose of the Janssen Vaccine based upon BUD dating and administration date. The beyond use date: date/time vial punctured was 06/21/2021 @1030 and administration date 6/23/2021 @8:33; punctured vial was stored in the refrigerator. Chief of Medicine (Attending) was contacted and it was determined that the best course of action was for the patient to receive another dose of Janssen Vaccine or 2 doses of Moderna. Patient was contacted by PCP, briefed on situation, and agreed to receive another Janssen vaccine which patient wants on July 15th (next visit). An event was entered to review a "system-based" solution.
Tiredness; Headache; Muscle pain; Joint pain; Feeling unwell/continually felt worst ever since; I never experienced this kind of pain and ache; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on Mar2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient had second shot of vaccine 2 weeks ago. On an unknown date in Mar2021, in first two three days after second shot patient did pretty good. The patient guessed continually felt worst ever since and patient was going over the paper with the list. The patient experienced tiredness, headache, muscle pain, joint pain and feeling unwell/ continually felt worst ever since. The patient never experienced this kind of pain and ache before, and the only thought could even relate to was that shot. The outcome of the events was unknown.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: negative Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment or concomitant medications were reported. Experienced mild flu-like symptoms. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: TCR Form - patient declined further follow-up, provided event outcome.
Child was given 0.2ml dose of undiluted Pfizer 5-12 year old vaccine.  Parent contacted 1/26/2022 and there had been no adverse reaction experienced to that date/time.  Parent stated sore arm only.
WIthin 30 minutes, same symptoms as 1st dose.  Severe stomach pain, fever, dizziness, vertigo, lethargy.  These symptoms lasted almost 1 week and he is still not right.
Warm to the touch at the injection site; red at injection site; sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch at the injection site), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE PAIN (sore at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter .  Concomitant products included ATORVASTATIN, LISINOPRIL, LEVOTHYROXINE SODIUM (L-THYROXINE [LEVOTHYROXINE SODIUM]), CALCIUM and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 06-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch at the injection site), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE PAIN (sore at injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch at the injection site), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE PAIN (sore at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
sore arm; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm and drug dose administration interval too long. On an unknown date, the outcome of the pain in arm and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Consumer states that her mother received dose 2 of Shingrix one year after dose 1, which led to which led to lengthening of the vaccination schedule.  She stated her mother also had a sore arm. The reporter did not give consent to follow up. Consumer did not have any more information for her mother's adverse event. This was 1 of 5 cases reported by the same reporter.
pt recv vax 30SEP97 & 6OCT97 pt devel a rash w/over 50 lesions;
Body aches, chills, fever 101 , severe dizziness throughout the night and next day and felt completely fine on 12/26
perception of floaters in the field of view; vison became impaired/had looked at a bright light too long (i.e. colored patch in the central area); slight blurriness; This spontaneous case was reported by a patient and describes the occurrence of VITREOUS FLOATERS (perception of floaters in the field of view), VISUAL IMPAIRMENT (vison became impaired/had looked at a bright light too long (i.e. colored patch in the central area)) and VISION BLURRED (slight blurriness) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Feb-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Feb-2023, the patient experienced VITREOUS FLOATERS (perception of floaters in the field of view), VISUAL IMPAIRMENT (vison became impaired/had looked at a bright light too long (i.e. colored patch in the central area)) and VISION BLURRED (slight blurriness). At the time of the report, VITREOUS FLOATERS (perception of floaters in the field of view) was resolving and VISUAL IMPAIRMENT (vison became impaired/had looked at a bright light too long (i.e. colored patch in the central area)) and VISION BLURRED (slight blurriness) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The patient's vision became impaired approximately 60 minutes after receiving the booster. The impairment presented as slight blurriness, and the perception of floaters in the field of view. It was unknown if the patient experienced any additional symptoms/events.   No treatment medications were provided.
shot recieved to left deltoid - left arm slightly swollen and painful - approx 2cm inderation to injection site
Severe dizziness; severe weakness; A spontaneous report was received from a consumer concerning a 78-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe dizziness, and severe weakness.   The patient's medical history included stroke. Concomitant product use was unknown by the reporter.  On 23 Jan 2021 at 10:30 am, approximately six hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 23 Jan 2021 at around 4:00 pm, she started experiencing severe dizziness and weakness. She went to the kitchen and didn't have energy to go back to the couch. That's when her husband took her to ER. They made her a brain scan, blood count and blood pressure (all normal).  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events dizziness and weakness was unknown.; Reporter's Comments: This case concerns a 78-year-old, female patient experienced non serious adverse event of severe dizziness and severe weakness. Based on the current information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Outbreak of cold sores on chin, otc medicine - abreva or left alone, still ongoing - but usually lasts a week or less.
Achy muscles Nausea  Headache  Approx. 36 hours after vaccination
This spontaneous report was received from a pharmacist regarding a 69 year old male patient. There was no information about historical medication. Patient had no drug reactions or allergies. On 01-DEC-2015, the patient was vaccinated with PNEUMOVAX 23 lot # L014420, Expiration Date- 23-FEB-2017, 0.5 ml, intramuscular. No concomitant medication was reported. On 01-DEC-2015, the patient developed redness, swelling and warmth at the injection site. No treatment was given for the redness, swelling and warm at the injection site. Patient contacted pharmacist to sought medical attention. No laboratory diagnostic studies were performed. The outcome of redness, swelling and warmth at the injection site was reported as not resolved. Causality between redness, swelling and warmth at the injection site and PNEUMOVAX 23 was unknown. Additional information has been requested.
Pt (PREGNANT) recv vax on 4/2/98; on 8/4/98 pt fetus exp negative heart tones & death (cord accident)
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 08-JUL-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # L003188 and an expiration date of 06-JUL-2016 (route and anatomical location of administration were not reported). The sum of hours in excursion were 64 and 32 hours and the lowest recorded temperature reported was 34 and 31 Fahrenheit (F) (1.11111111 and -0.555555556 Celsius (C)) respectively. The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Reaction happened ½ hour of flu shot on 9/25/2014. Shot was administered in the AM. Vital signs were taken when I felt symptoms, they were normal. Symptoms included disorientation, confusion, dizziness to the point of syncope, slurred speech, staggering, malaise and elevated pulse.  I entered the ER and was admitted near 11AM.  Meclizine was administered, I was admitted to the hospital later that night.  I am a transplant recipient as of 2/19/2014.
Information has been received from a pharmacist referring to a patient of unknown age. On 01-DEC-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # K026387, expiration date 15-DEC-2016, dose and route were unknown). No adverse event was reported. Additional information has been requested.
redness on arm distal to inj site @ 2D past inject;pt says rt arm was pneumococcal vax MD records show rt arm flu shot;
This spontaneous report as received from a medical assistant concerning a patient of unknown age and gender who was vaccinated in 2006 with dose 1 of GARDASIL (dose, route and lot # not provided) and in 2007 was vaccinated with a second dose of GARDASIL (dose, route and lot # not provided). No adverse events were reported. Additional information has been requested.
Patient feels sick.. Experiencing severe cough, fever, chills, fatigue, arm hurting.. Patient will go to urgent care