chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious, spontaneous report of "patient got a full dose of FLUMIST in each nare" and nasal stuffiness was received from a nurse practitioner concerning a female adult patient. Sometime between 24-Sep-2009 and 16-Oct-2009, the patient received two doses of FLUMIST at one time, one full dose given into each nostril. After receiving FLUMIST, the patient developed nasal stuffiness. The outcome of the events, "patient got a full dose of FLUMIST in each nare" and nasal stuffiness, was resolved.
This spontaneous report was received from a 57 year old female patient who reported for self. The patient has allergy to red dye and the patient's pertinent medical history was none. On 22-SEP-2015, the patient was vaccinated with ZOSTAVAX 19400 PFU (unknown dose, strength and lot#). Concomitant therapies included tramadol and FLEXERIL. On 23-SEP-2015, developed redness and warmth which was traveling down her arm after receiving ZOSTAVAX. The patient also reported that she also felt nauseous on 23-SEP-2015. No lab diagnostic studies were performed. The patient did not seek medical attention and no treatment was received in response to the events. The patient was not hospitalized. The outcome of the events was reported as not resolved. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: patient described weird taste, felt like tongue may be swelling, took benadryl, patient felt fine after that
painful rash at injection site initially small but enlarged now; Elongated oval hive; Feels feverish; A little lethargic; Injection site was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (A little lethargic), VACCINATION SITE PAIN (Injection site was a little sore), RASH (painful rash at injection site initially small but enlarged now), URTICARIA (Elongated oval hive) and PYREXIA (Feels feverish) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced LETHARGY (A little lethargic) and VACCINATION SITE PAIN (Injection site was a little sore). On 07-Mar-2021, the patient experienced RASH (painful rash at injection site initially small but enlarged now), URTICARIA (Elongated oval hive) and PYREXIA (Feels feverish). On 28-Feb-2021, VACCINATION SITE PAIN (Injection site was a little sore) had resolved. On 01-Mar-2021, LETHARGY (A little lethargic) had resolved. At the time of the report, RASH (painful rash at injection site initially small but enlarged now), URTICARIA (Elongated oval hive) and PYREXIA (Feels feverish) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No specific follow-up information recorded.
felt yucky for 2 to 3 days; had arm pain that lasted for 4 to 5 days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt yucky for 2 to 3 days) and PAIN IN EXTREMITY (had arm pain that lasted for 4 to 5 days) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     The patient had never been diagnosed or tested positive for COVID-19.  No other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Ovarian cancer stage IV (had the Ovarian peritoneal cancer for a while but it was diagnosed more recently in Feb-2022), Penicillin allergy, Allergy to antibiotic (Keflex allergy), Drug allergy (Sulfur allergy) and Allergy to chemicals (environmental sensitivity to different chemicals). Concomitant products included PACLITAXEL (TAXOL) and CARBOPLATIN for Ovarian cancer, COLECALCIFEROL (VITAMIN D3), IP-6, INOSITOL, ZINC PICOLINATE, MAGNESIUM L-THREONATE (MAGTEIN), MAGNESIUM TAURATE and MAGNESIUM GLYCINATE for an unknown indication.    On 30-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 30-Sep-2021, the patient experienced PAIN IN EXTREMITY (had arm pain that lasted for 4 to 5 days). On 01-Oct-2021, the patient experienced FEELING ABNORMAL (felt yucky for 2 to 3 days). In October 2021, FEELING ABNORMAL (felt yucky for 2 to 3 days) and PAIN IN EXTREMITY (had arm pain that lasted for 4 to 5 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight: lost 18 pounds (Low) had lost 18 pounds since the fall of 2021.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications also included high dosage probiotic and IP-6 inositol.  Treatment information was not reported for events that occurred after first dose vaccination.   This case was linked to MOD-2022-568683 (Patient Link).
During observation period, patient became unresponsive to verbal and non-verbal cues.  Patient had a briwf period of loss of consciousness less than 5 seconds in length.  Patient regained consciousness.  EMS called.  Patient observed for an extra 10 minutes.  Patient returned to homeostasis.  Patient left.
Red rash; Itching rash in my arm,; This spontaneous case was reported by a consumer and describes the occurrence of   in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      Treatment information was not provided.  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.
After each shot she started having palpitations; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (After each shot she started having palpitations) and DYSPNOEA (Shortness of breath) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LZ014) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to morphine), Shellfish allergy, Iodine allergy and Cardiomyopathy (Cardiomyopathy from a virus Start Date: A year before the COVID pandemic.  Stop Date: With exercise she only had palpitations when she is tired.).    On 15-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 PALPITATIONS (After each shot she started having palpitations) and DYSPNOEA (Shortness of breath). At the time of the report, PALPITATIONS (After each shot she started having palpitations) and DYSPNOEA (Shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) she had a EKG but it showed normal sinus with multiple contractions..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant product use was reported.  The patient received 1st dose on 15-Jan-2021, Lot number: 011LZ014 unsure if it was an H or an A. The patient reported that no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient reported that after each shot the patient started having palpitations, shortness of breath so the patient went to the Cardiologist, but they were not convinced it was the shot, the patient had an EKG, but it showed normal sinus with multiple contractions.  No treatment information was provided.   This case was linked to MOD-2022-503124, MOD-2022-503135 (Patient Link).
Skin was necrotizing; Infection; Swelling; Redness; Flucelvax an Pneumovax were both administered in the left arm; Information has been downloaded from Agency (US-SEQIRUS-202000959).  This spontaneous report was received from an other health professional and refers to a 86-year-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 18-OCT-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) lot # S025133 was confirmed as a valid lot number, expiation date was not provided, but upon internal validation, it was established as 15-SEP-2020, administered intramuscularly for prophylaxis (exact dose, dose # and anatomical location were not provided) and a dose of influenza virus sag 4v vaccine inactivated (mdck cell) (FLUCELVAX QUADRIVALENT) injection, lot # P100124435, administered intramuscularly(excact dose, dose #, anatomical location, expiration date and indication were not provided).  On the same date, the patient experienced infection, swelling, redness and skin necrosis. Both vaccine were administered in the left arm (product administration error). The outcome of the events was not provided.  The causality assessment between suspect vaccines and the events was not provided.  The Agency considered the event of skin necrosis to be medically significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); ommondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025133; expirationdate: 15-SEP-2020; 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 suggest a causal association with the device or device constituent; Sender Comments:Temporal relationship between Flucelvax administration and development of reported events is plausible. Alternative aetiology is provided by Pneumovax. Based on the available information, all events are assessed as possibly related to Flucelvax, which defaults to related causality per regulatory reporting purposes.
secondary to bat scratch, first rabies shot 5/16;second shot 5/19;erythema noted distal to inj;dx cellulitis;
Fridge was high at 46.13 no alarm, someone open frudge that caused alarm to go off; This spontaneous report was received from a Nurse referring to a 26 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.   On 02-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, and anatomical location were unknown) first dose with lot # R030456 and expiration date reported as July 2021, but upon internal validation established a 23-JUL-2021, via intramuscular route for prophylaxis.   There was a digital data logger involved, it was reported that the fridge was high at 46.13 °F degrees Fahrenheit  with no alarm, it seemed that someone opened the fridge and caused the alarm to go off. Additionally, it took 3 days to the Nurse to report the excursion, it was reported that the minimum temperature was 37.23 °F degrees Fahrenheit  and the maximum temperature was 47.65  °F degrees Fahrenheit  with an undefined duration in with alarm report, and the minimum temperature was 36.46 °F degrees Fahrenheit and the maximum temperature was 43.30  °F degrees Fahrenheit  with an undefined duration with the no alarm report . combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.;  devicelotnumber: R030456; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; operatorofdevice: Nurse; 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; Sender's Comments:  US-009507513-2009USA009583: US-009507513-2009USA009568: US-009507513-2009USA002514:
Patient presented 5 minutes after the vaccine was administered saying he thought it was difficult to swallow. He was given 12.5mg of oral liquid Benadryl and observed for 30 minutes. After 30 minutes, he said he thought his through was just full of phlegm from seasonal allergies and said he was feeling fine now.
1/15/2021 Took 2 Tylenol Extra Strength 500 mg about 1:00 pm to prevent injection site pain.  Chills began about 7:00 pm. Took 2 more Tylenol at 8:00 pm.  1/16/2021 Fever spike of 102.2 at 3:00 am. Took 2 Tylenol. 8:00 am headache and nausea and took 2  more Tylenol.  8:30 am fever down to 98.7.  9:30 took Nurtec ODT 75mg for severe headache.  Extreme fatigue.  Slept for several hours.  Headache subsiding.  2:00 pm fever back at 99.2   6:00 pm temperature back to 98.3   Went to bed at 8:00 pm with 2 Tylenol and body aches. 1/17/2021 feeling back to normal.  Patient was covid positive in July of 2020
No adverse effects reported.; an unspecified number of unspecified patients were administered doses of VARIVAX which were improperly stored.; Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent(manufacturer unknown).  On 01-SEP-2017, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were unknown, lot # M049127, expiration date:15-DEC-2018, lot # N010107, expiration date:28-MAR-2019) for prophylaxis(Incorrect product storage).   Administered vaccine experienced the temperature excursion of -14 celsius degree to -10 celsius degree (-14.2 celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint(PQC) was involved.    This is one of several reports from the same reporter.  All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful.  Follow up information has been received from an other reporter concerning a 12 month old patient. On 05-SEP-2017, the patient vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency and route were unknown, lot # N010107, expiration date:28-MAR-2019) for prophylaxis(Incorrect product storage).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1709USA002098:
Developed shingles two days after the booster dose. Saw Dr. for the shingles. Took a course of acyclovir. Had the shingles vaccine 1991 (Zostavax). Case not as bad as if he hadn't had the vaccine according to the patient. Moderna doses on: 01/28/2021, 02/25/2021, 10/28/2021 (.25ml)
SVT; Woke up about 1am with a rapid heart rate and pain in my chest/ heart rate was measured at 240bpm; Woke up about 1am with a rapid heart rate and pain in my chest; Trouble catching my breath; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EM9810), via an unspecified route of administration in right arm on 10Feb2021 11:30 AM (at the age of 34-years-old) as a single dose for COVID-19 immunisation at the hospital. Medical history included supraventricular tachycardia with unknown reasons of causing the rapid heart rate. The patient had no allergies. Concomitant medication included (other medications in two weeks) sertraline taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL8982), via an unspecified route of administration in right arm on 20Jan2021 12:00 PM (at the age of 34-years-old) for COVID-19 immunisation. No other vaccinations in 4 weeks. No COVID prior vaccination. Tested for COVID-19 post vaccination with negative result. On 11Feb2021 01:00, the patient experienced SVT (supraventricular tachycardia), woke up about 1 am with a rapid heart rate and pain in her chest/ heart rate was measured at 240bpm, trouble catching her breath. The patient stated that the night of 10Feb2021, she felt asleep symptom free. She woke up about 1am with a rapid heart rate and pain in her chest. She got out of bed to use the techniques to bring the heart rate down on her own. Unfortunately, she was unsuccessful. After almost 30 minutes she made her way to the ER due to pain in my chest, and trouble catching my breath due to me starting to become afraid of the rapid heart rate. Upon arriving my heart rate was measured at 240bpm. The SVT was resolved with Adenosine. She wanted to point out this was the first time waking to the rapid heart rate and the first time experiencing pain in her chest from it. She normally moving or doing some form of low impact activity when the SVT is triggered, like walking, dancing, She was unaware of how long she experienced the rapid heart rate before waking up. She was not sure if the vaccine contributed to the heart rate but thought it was safer to share. The adverse event was resulted in Emergency room visit. The adverse event was treated with adenosine. The patient underwent lab tests and procedures which included heart rate: 240bpm on 11Feb2021 and nasal swab COVID test: negative on 10Feb2021. The outcome of events was recovered on an unspecified date in 2021.  Follow-up (10Jun2021): Follow-up attempts are completed. No further information is expected.
21cm red, swollen from above elbow to upper forearm on the right arm. Motrin 800mg and Zyrtec 10mg prescribed. Also recommended to premedicate before next vaccine.
Pt's arm was very painful and couldn't move it from shoulder down. Sought medical attention on 10/23 and got Rx for prednisone.
Urticaria on right side and 3 hives on right scalp on same day of vaccine. Symptoms progressed over next 4 days resulting in anaphylaxis on 6/10 and requiring ER visit. Pt. took Benadryl on 6/6. Hives developed on 6/7 to left arm, increased on scalp and bilateral hands. Pt took Benadryl on 6/7 PM. Continued with more hives on 6/8 and added Zyrtec to Benadryl regimen. On 6/9 pt. took Prednisone 10mg. Awakened early on 6/10 with lip and facial swelling, hoarse, hives covering scalp/neck/left arm and reported to EUH ER. Given IV decadron/Benadryl/famotidine and IV fluids; required monitoring for 6 hrs. until discharged. Sent home with Zantac BID and Medrol Dose Pak. Hives and facial swelling returned on 6/12 and pt. started on high doses of prednisone with Benadryl/Zyrtec/Zantac.
lack of appetite; dizziness; energy ever since; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via regulatory authority (Reference number- US-SANOFI-00336223) and transmitted to Sanofi on 28-Oct-2020.  This case involves a 71 year old female patient who had lack of appetite (decreased appetite), dizziness (dizziness) and energy ever since (asthenia), while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications was not applicable.  On 20-Oct-2020, the patient received a 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ512AA, expiry date 30-Jun-2021) once (standard) via intramuscular route in the right deltoid for prophylactic vaccination.  On 20-Oct-2020, the patient developed a non-serious lack of appetite (decreased appetite), dizziness(dizziness) and energy ever since (asthenia) (same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.
The day after having the vaccine my arm was hurting, figured it was just a side effect, but the pain kept getting worse and then I started getting shooting pain into my shoulder. On 2/20 I called my doctor's office, they told me to ice it and take TYLENOL. That did not help I called them again on 2/26. She had me come in and looked at the arm, there was no swelling or redness, she said to use SALONPAS Patches and gave me a prescription for Gabapentin. The pain just kept getting worse I called Doctor back on 3/7 was told to increase the gabapentin. Still no relief so on 3/27 I called doctor again and she recommended I see a neurologist. On 4/4/18 I had an appointment with a neurologist. She did many tests and wanted me to see a Physical Therapist. Saw staff at Physical therapy on 4/11/18, she did some tests and gave me some exercises to do. She said I had an inflamed muscle from where the tetanus vaccine was given. I did the exercises and saw her again on 4/17/18. She gave me more exercises and also did some therapy on my arm. When I left there I was in the most severe pain ever, and it is still going on till this day. Very severe pain in the muscle of my arm with sharp stabbing pains from shoulder into the arm.
Pt recvd MMR vax 23JAN92 & the next morning pt devel a small area of induration @ inject site & a red sore throat & aching joints which lasted approx 3 days; tx w/Advil; no further details were provided;
Brochial plexus neuropathy R arm started 6 hrs after injection and now 3 weeks later, has pain, weakness in hand grip and resolved sensation.  Seeing neurology for nerve conditions studies.  Follow-up information received on 3/4/2003 states; "slight imporvement.  Still a lot of arm, wrist and hand pain and swelling". Follow up on 01/14/04: "Vaccine recipient did not recover from the adverse events that were reported for this vaccination.  Diagnosis: Brachail neuritis, still with numbness right hand and fingers, symptoms unchanged."