chrisvoncsefalvay/vaers-outcomes huggingface dataset:
they had an expired ActHib given to a patient/No AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information (Reference number- US-SANOFI-00342350) and transmitted to Sanofi on 02-Nov-2020.  This case involves a 7 months old male patient who received second 0.5 ml expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ081AAA, expiry date: 02-Oct-2020) via intramuscular route in the left leg on 08-Oct-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V).  It was an actual medication error due to the expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  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 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.
Received first dose of Pfizer vaccine on 4/6/21 and second dose on 4/13/21 due to scheduling error. Consulted with COVID-19 vax consultation, they were not aware of potential adverse events related to this scheduling error. No adverse events being noticed by patient.
Occasional soreness/tenderness/muscle pain on site on Saturday (4 days after the shot) and still experiencing up till this day. On and off migraine up till this day and fatigue (experienced more heavily Monday and Tuesday 6/21-22).
Approximately 15 minutes post-vaccination, patient reports shortness of breath and feeling "funny". Patient has asthma and required use of her albuterol rescue inhaler.  Patient remained on site for another 15 minutes with husband who is a physician. He will continue monitoring her offsite.
Throat sweling; Had to clear throat constantly; Throat was extremely dry; He said it just didn't feel right.; a lot of mucus.; extremely thirsty; stomach gas; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL SWELLING (Throat sweling), THROAT CLEARING (Had to clear throat constantly), DRY THROAT (Throat was extremely dry), FEELING ABNORMAL (He said it just didn't feel right.) and SECRETION DISCHARGE (a lot of mucus.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergy (History of allergies, no further specification).    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Throat sweling), THROAT CLEARING (Had to clear throat constantly), DRY THROAT (Throat was extremely dry), FEELING ABNORMAL (He said it just didn't feel right.), SECRETION DISCHARGE (a lot of mucus.), THIRST (extremely thirsty), FLATULENCE (stomach gas) and HEADACHE (headache). At the time of the report, PHARYNGEAL SWELLING (Throat sweling), THROAT CLEARING (Had to clear throat constantly) and DRY THROAT (Throat was extremely dry) outcome was unknown and FEELING ABNORMAL (He said it just didn't feel right.), SECRETION DISCHARGE (a lot of mucus.), THIRST (extremely thirsty), FLATULENCE (stomach gas) and HEADACHE (headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Vital signs measurement: normal (normal) Vitals were normal..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use includes unspecified herbal supplements.   The patient was evaluated in the Emergency Room approximately 6-7 hours after vaccine administration/symptom onset, he was not admitted and discharged home. No other treatment information was reported.  On 26-APR-2021, patient was improving and feeling well.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: adverse events added (dry throat, pharyngeal swelling, throat clearing). Patient was not intending to get his second vaccine dose next week. On 02-Aug-2021: Non-significant follow up received- Further consent denied; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt was given OPV/TINE/MMR & approx 1-2 min p/vax pt became flaccid then arms & legs become rigid & stiffened, pt was placed supine; p/approx 5 hrs grunting noise & pt stopped breathing; poss sz;
Patient walked away from vaccination room and passed out and fell backwards to the floor.  The patient regained consciousness in about 30 seconds.  After sitting on the floor for about 30 minutes the patient got up and continued to walk around for a few minutes
Mom called on 5/11/04 to report that on 5/8/04, her daughter developed, redness and swelling on right upper arm at site of immunizations. Mom took daughter to doctor at 6:30 PM on 5/8 for evaluation of symptoms. Per mom, doctor advised ice packs and Benadryl. As of 5/11/04, daughter is doing much better and symptoms are resolving.
neuropathy; ataxia; neurological deficits with headache; Headache; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm left on 16Mar2021 (Lot Number: En6208) (at age of 47-year-old)  as single dose for covid-19 immunization. Medical history included high blood pressure, there was no known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 23Feb2021 (Lot number: En6198) for covid-19 immunization. There was no other vaccine in four weeks. Adverse event: Headache occurred 10-15 mins after second vaccination. Persistent headache after 3 weeks of 2 COVID vaccination. After the 3 weeks (also reported  as on 26Mar2021) started experiencing neurological deficits with headache. Symptoms include: motor sensory weakness, ataxia and neuropathy. Admitted to hospital for neuropathy and ataxia on 21Apr2021. AE results in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: negative  on 21Apr2021.There was no COVID prior vaccination. The outcome of the events was not recovered.
On 08/18/2021 at 12:30 PM, the patient received a COVID-19 Moderna booster (Dose-3) in the left deltoid (Lot # 026D21A). On 10/25/2021 at 3:30 PM, the patient had a Visit conducted with Dr. to discuss her arm soreness. The diagnosis codes selected at the conclusion of the appointment include: S49.80XA (Primary) and M25.512. Patient symptoms concluded to be a result of SIRVA. The relevant Office Note can be provided if requested. On 11/08/2021, the patient requested physical therapy for her shoulder. A physical therapy order was faxed to the Physical Therapy at the patient's request.
Right arm had bruise where vaccine administered but concern was underneath had large red box that appeared to possibly be allergic reaction (PREVNAR).
Booster dose administered; Off- label use; A few days after dose 2 had sore arm; Shortly after that I developed pink eye; This is a spontaneous report from a contactable consumer, the patient. A 87-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Feb2021 at 11:00 (at the age of 87-years-old) and a third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Feb2021 (at the age of 87-years-old) as a single dose for COVID-19 immunisation. Medical history included two coronary stents, left anterior descending artery (LAD), two knees and allergic to penicillin. Concomitant medications included Statins and olmesartan (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 15Feb2021, a few days after dose number two the patient had sore arm. Shortly after that developed pink eye. Therapeutic measures were taken as a result of pink eye and included treatment with antibiotic eye drops. Since the vaccination, the patient had been tested for COVID-19. On 15Feb2021, the patient underwent COVID-19 test via nasal swab and the result found to be negative. The clinical outcome of the events a few days after dose number two the patient had sore arm; shortly after that developed pink eye was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Large patch of redness, swelling and itching around vaccination site.  Continued for about 7 days.
I got the 2nd shot on June 4th, woke up on June 5th with a red spot about the size of a quarter. Later that afternoon, my left arm started hurting really bad along with my whole body. I called the after hour clinic, doctor told me to call back if it gets bigger. I called the next day (June 6) because it was about the size of a baseball. Doctor told me to take Benadryl and put Hydrocortizone cream on it. Today (June 7) it is the size of a softball. It burns and is itchy. It has made the whole top of my arm and the under arm hurt so bad.
Received phone call at about 1:45 pm. Client stated that he was at the ER because of swelling in the mouth and hives likely from Yellow Fever vaccine. He had received IV fluids and Benadryl as at 3pm; when he stated that swelling had subsided but itching still present.
Tested positive for COVID on 03/24/2021; greater than 14 days after completing vaccine series.
Passed the 37 days mark for the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Passed the 37 days mark for the second dose) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Passed the 37 days mark for the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Passed the 37 days mark for the second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
his wife "experienced a "fever of 100.5 F, chills, and disorientation; his wife "experienced a "fever of 100.5 F, chills, and disorientation; experienced the same swelling and tenderness in her arm where the shot was given; his wife had a severe, whole body reaction; his wife "experienced a "fever of 100.5 F, chills, and disorientation; experienced the same swelling and tenderness in her arm where the shot was given; experienced a "mild, localized reaction" at the injection site with "swelling and tenderness at the site; experienced a "mild, localized reaction" at the injection site with "swelling and tenderness at the site"; experienced a "mild, localized reaction" at the injection site; This spontaneous report was received from the patient's husband and concerns to a 58 year old female patient. Concomitant therapies included rosuvastatin calcium(CRESTOR). The patient's drug reactions or allergies included penicillin and erythromycin. And the patient don't referred pertinent medical history.   On 18-MAR-2019, the patient was vaccinated with the first dose of zoster vaccine live (ZOSTAVAX) as shingles prevention (route of administration, anatomical location, lot number and expiration date were not reported).   On the same date, upon receiving the first dose of zoster vaccine live (ZOSTAVAX) the patient experienced a mild  localized reaction at the injection site (injection site reaction) with swelling (injection site swelling) and tenderness at the site (injection site pain).   On 10-JUL-2019  at 10 or 11 A.M., the patient was vaccinated with the second dose of zoster vaccine live (ZOSTAVAX) as shingles prevention (route of administration, anatomical location, lot number and expiration date were not reported).      On the same day (reported as around 9 P.M), the patient had a delayed reaction, she experienced a severe whole body reaction (injection site reaction),  fever of 100.5° Fahrenheit (F)(pyrexia), chills and disorientation. Also, the patient experienced the same swelling and tenderness in her arm where the shot was given (injection site pain and injection site swelling).  The patient was admitted to the hospital and given intravenous (IV) saline fluid, acetaminophen (TYLENOL), diphenhydramine hydrochloride (BENADRYL), anti-nausea medication, and potassium.  A complete blood count was performed however, the results were not provided.  At the time of the report, the patient was recovering from all events.   The causality between the aforementioned events and zoster vaccine live (ZOSTAVAX) was not provided.
4hrs after vaccine mild right arm hand Parasthesias in a radial distribution.  These have persisted.  Same eve mild facial Parasthesias.  This has progressed  Now primarily left sided and have objective fasiculations and tongue deviation.  Also mostly left lower leg Parasthesias. Some right.
This spontaneous prospective pregnancy report was received from a 31-year-old female patient who was reporting on herself. The patient pertinent medical history included asthma and unspecified heart problems. The patient had allergy to latex and experienced drug reaction to DEMEROL. The patient was vaccinated with GARDASIL when she was at age 17, 18 and 19 (captured in MARRS # 1811USA012530). The patient was taking unspecified prenatal medication. At the time of the report the patient was 29 weeks and 5 days pregnant. The patient became pregnant with estimated last menstrual period (LMP) of 08-APR-2018 (calculated based on subtracting 29 weeks and 5 days of gestation age from the date of the report) end estimated delivery date of 13-JAN-2019. The pregnancy outcome was pending and fetal outcome was unknown. On 02-NOV-2018, the patient was supposed to receive diphtheria toxoid, pertussis acellular vaccine (manufacturer unknown) to protect the baby from whooping cough but instead she was vaccinated with GARDASIL 9 (lot number, expiration date, dose and strength were not provided) by shot in the left arm. After receiving GARDASIL 9, she started to experience nausea, weakness (unspecified) and headache. The patient reported that the office stated the GARDASIL 9 was in the diphtheria toxoid, pertussis acellular vaccine box (manufacturer unknown). At the time of the report, the outcome of the events was reported as not recovered. The reported did not provided causality assessment between the events and suspected therapies. This is one of the two reports from the same reporter who is also the patient. Sender's Comments: US-009507513-1811USA012530.
Nurse with information that wife is having difficulty swallowing. Patient received second Moderna vaccine at 1415 and at 1424 taken to side room and placed on monitor. Patient able to talk and stated no difficulty breathing ,but did sound raspy and continued difficulty swallowing. VS @ 1425     HR 75, O2 sat 98% and BP 179/112. Patient sitting and continued with difficulty swallowing, with patient consent Epi 0.3mg delivered via Epi pen in left vastus lateralus at 1429 and 911 called. VS HR 74, O2sat 95% and BP 208/88. At 1434 Patient  transferred to cart stating some improvement in swallowing. VS HR76, O2sat 99% and BP 175/86. EMS here and transferred patient to Hospital. Husband to follow in car.
12 mins after vaccination, throat started to swell; resolved after 20 mins;  same reaction from Pfizer 1 & 2 but not as immediate Flu like symptoms which triggered autoimmune inflammation head to toe In bed very sick for 3 full days drifting in/out of sleep
48 hrs following vax pt devel mild gait ataxia; this progressed over the ensuing wks to profound ataxia leading to inability to walk; limb ataxia dev together w/dysarthria which progressed nearly complet bulbar paralysis;
Rash and redness approximately 3 x 5 inches in area of injection - COVID arm?
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 15Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 21Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Stage 2 kidney disease" (unspecified if ongoing), notes: Stage 2 kidney disease. Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jun2021; PRAVASTATIN, start date: 06Apr2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt spiked "high fever" at night on same day he received these vaccines.  Also had hives with the fever and c/o itching.  Zyrtec was given and pt resumed sleep.  Awoke at 0430 on 6/10/22 and hives were resolved.
swelling of face, eyes & neck p/4th dose given on 23JUN92; tx w/Pred, Tagamet & DPH;
VACCINE ADMINISTERED AROUND 10:30 AM 11/2/22. PATIENT STATES AROUND 8PM THAT NIGHT HE HAD EXTREME ITCHING AND NOTICED RED, RAISED RASH FROM CHIN DOWN. PATIENT STATES 11/3/22  RASH WAS DEVELOPING IN MORE AREAS AND EXTREME ITCHING. PATIENT REPORTS 11/4/22 IS CONSIDERABLY BETTER FOR ITCH BUT RASH REMAINS.
lump (swollen bump) underneath his jaw; noticed knot (swelling) on his forehead that traveled up to the side of his ear then up to the; tender from the eyebrow all the way down to his ear and jaw; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (lump (swollen bump) underneath his jaw), SKIN MASS (noticed knot (swelling) on his forehead that traveled up to the side of his ear then up to the) and TENDERNESS (tender from the eyebrow all the way down to his ear and jaw) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced SWELLING FACE (lump (swollen bump) underneath his jaw), SKIN MASS (noticed knot (swelling) on his forehead that traveled up to the side of his ear then up to the) and TENDERNESS (tender from the eyebrow all the way down to his ear and jaw). At the time of the report, SWELLING FACE (lump (swollen bump) underneath his jaw), SKIN MASS (noticed knot (swelling) on his forehead that traveled up to the side of his ear then up to the) and TENDERNESS (tender from the eyebrow all the way down to his ear and jaw) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include cholesterol medications.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable
I had a fever of 102 that lasted 36 hours. Then the fever broke.  I was left with Tinnitus in my ears. I went to my doctor about it.  They referred me to an ENT specialist.  My ENT said that I have slight hearing lost.  I have consent ringing in my ears.  He is unsure that if is inflamed.
a lot of pain all the way to my neck and shoulder blade; a lot of pain all the way to my neck and shoulder blade; sore arm; A spontaneous report was received from a consumer concerning a 36 year old female patient who received Moderna's COVID-19 vaccine and experienced a sore arm and a lot of pain all the way to my neck and shoulder blade.  The patient's medical history was not provided. No concomitant medications were reported.   On 16-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number 042L20A) intramuscularly for prophylaxis of COVID-19 infection.  Patient stated that at first she did not have any serious side effects just a sore arm. Upon call back on 18-Jan-2021 patient stated that the vaccine was given in the left arm, almost to her shoulder bone/upper arm. She had a lot of pain all the way to her neck and shoulder blade. Patient reported that she is taking ibuprofen 400mg.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events sore arm and a lot of pain all the way to my neck and shoulder blade is unknown.; Reporter's Comments: This case concerns a 36-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 042L20A), and who experienced the non-serious listed event of Arthralgia and the non-serious unlisted events of Pain in extremity and Neck pain.  Based on the current available information and temporal association between the use of the product and the onset of events after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 7/8/2022 IDIOPATHIC THROMBOCYTOPENIC PURPURA
This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients of unknown ages and genders. Pertinent Medical History and Drug Reactions/Allergies were not reported. On unknown dates, the patients were vaccinated with unspecified doses of improperly stored RECOMBIVAX HB (batch, lot # K010216, expiration date: 17-SEP-2016)(route not reported). Concomitant therapies were not reported. No adverse effect were reported. No further information was provided. This is one of four reports from the same source. Additional information has  been requested (correspondence containing a request for additional information is scheduled).