chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Off label use; Booster; shingles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 3 (Booster), Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Primary immunization series completed, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles". Therapeutic measures were taken as a result of herpes zoster.  Additional Information: Patient stated that I received the fourth dosis of your Covid vaccine a few days ago. Right now, I am on bed because I have developed shingles. I visited dermatologist, then she diagnosed the deseas. I am taking antivirals and cream. I have had a very uncomfortable time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a certified medical assistance regarding a 60 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On 11-APR-2016, the patient was inadvertently administered a dose of (Oka/Merck) VARIVAX lot # L013825, expiration date 21-APR-2017 instead of being administered an intended dose of ZOSTAVAX. No adverse event was reported. The outcome of the event was unknown. Additional information has been requested.
felt isolation; the side effects of previous vaccinations were painful/Vaccination site pain; This spontaneous case was reported by a non-health professional and describes the occurrence of SOCIAL PROBLEM (felt isolation) and VACCINATION SITE PAIN (the side effects of previous vaccinations were painful/Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. and fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOCIAL PROBLEM (felt isolation) and VACCINATION SITE PAIN (the side effects of previous vaccinations were painful/Vaccination site pain). At the time of the report, SOCIAL PROBLEM (felt isolation) and VACCINATION SITE PAIN (the side effects of previous vaccinations were painful/Vaccination site pain) outcome was unknown.            No concomitant medication was reported. No treatment information was reported.
I started to get a rash or hives about a week after the shot.  It had a small area where it was itchy and raised.  And has continued to be hot , itchy and hive like.
SEVERE VERTIGO; FATIGUE; MUSCLE ACHES; HEADACHE; SHORTNESS OF BREATH; This spontaneous report received from a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced shortness of breath. On 13-MAR-2021, the subject experienced severe vertigo. On 13-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced muscle aches. On 13-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath on 16-MAR-2021, and had not recovered from severe vertigo, fatigue, muscle aches, and headache. This report was non-serious.
Chills, fatigue. Soreness, and redness in the shoulder. Inflamed armpit.
Intense Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Intense Vertigo) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced VERTIGO (Intense Vertigo). On 05-Apr-2021, VERTIGO (Intense Vertigo) had resolved. Not Provided          No treatment medications are reported.   This case was linked to MOD-2021-106485 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: The follow up Source document received on 06-JUN-2021 contains No New Information
sore arm; bruise on the site of the injection; A spontaneous report was received from a healthcare professional concerning a 57-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, bruise on the site of the injection,  The patient's medical history was not provided. Concomitant medications reported were Aleve for knee pain occasionally, vitamins for drug use for unknown indication.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 006M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On Feb 2021, the patient experienced the event(s) sore arm. On an unknown date, the patient experienced the event(s) bruise on the site of the injection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, bruise on the site of the injection was unknown.; Sender's Comments:  MOD21-034490:patient 2
pt presented to ER w/hypotension, fever like sx p/vax;pt adm to area hosp for observation, sx abated w/time;
This spontaneous report was received from a nurse concerning an unspecified patient (demographics unknown). The patient's pertinent medical history and concurrent conditions were not provided. On 12-OCt-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose and route not provided) (Lot# reported as K021929; expiration date: 28-FEB-2016, which is an invalid lot number for PROQUAD (Merck). No adverse effects were reported. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (COVID 19), via an unspecified route of administration, administered in left arm on 02Mar2021 (Lot Number: EN6200) as dose 1, single, and then via an unspecified route of administration, administered in left arm on 02Mar2021 (Lot Number: EN6208) as dose 2, single, all at the age of 62-year-old for covid-19 immunization. No known allergies and no other medical history. Concomitant medications included serenoa repens (SAW PALMETTO) and minoxidil (ROGAINE, oral tablet) taken for an unspecified indication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. No other vaccine in four weeks. The patient received 1st and 2nd dose of bnt162b2 on the same date on 02Mar2021. The patient experienced following symptoms: cough, fatigue, congestion, muscle/body aches on 29Jun2021 and then he tested positive for covid on 04Jul2021. The patient underwent lab tests and procedures which included PCR (Nasal Swab): positive on 04Jul2021. Therapeutic measures were not taken as a result of tested positive for COVID with the following symptoms, cough, fatigue, congestion, muscle/body aches. The outcome of tested positive for COVID with the following symptoms, cough, fatigue, congestion, muscle/body aches was recovering.  No follow-up attempts are needed. No further information is expected.
received a dose from a vial that was expired/e vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired/e vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired/e vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired/e vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature) had resolved.        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 information was reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow-up information received contains no new information.
Cancer; This serious case was reported by a consumer via call center representative and described the occurrence of cancer in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In SEP-2021, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced cancer (Verbatim: Cancer) (serious criteria GSK medically significant). The outcome of the cancer was not reported.   It was unknown if the reporter considered the cancer to be related to Shingrix.     It was unknown if the company considered the cancer to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-MAY-2023 The patient reported that she received a dose of Shingrix and was diagnosed with cancer and was not able to get dose 2 yet.  The reporter had an appointment on 11th May 2023 to get Shingrix dose 2. The reporter did not wanted to provide any additional information.  The reporter did not consent to follow-up.
Nauseous; dizzy; This case was reported by a consumer via call center representative and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 2nd dose of Shingrix. On 3rd December 2019, 1 days after receiving Shingrix, the patient experienced nausea and dizziness. On an unknown date, the outcome of the nausea and dizziness were unknown.   It was unknown if the reporter considered the nausea and dizziness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. In the morning of reporting day, the patient was nauseous and dizzy. The patient asked if the events were related to the vaccine.
Sudden febrile seizure 12 days after immunization.  Blood culture/urine culture/CXR done - all normal.  Then developed urticarial rash a few days after febrile seizure.  Otherwise acting fine.
Fever, headache, body aches, joint pain, nausea, swollen glands in the neck, extreme fatigue, weakness.
patient shoulder began swelling. went to md and was told shot was administered too low and pt now has a hematoma with an infection
1/20  Developed pain redness swelling with increased warmth to the skin.  This has progressively worsened. Seen today.  Concerning for possible cellulitis.  Started on doxycycline.
Vaccine given after expiration date. Packing slip showed expiration date as 12/31/2069
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 1:03 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 1:03 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 59.51.  No concomitant medication was provided.  On 13-Feb-2021, Excursion time was 9 AM, temp was 32, total doses given for the day was 152, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vial was moved to clinic. Vaccine BUD date was 10-Mar-2021.  Vial was stored on cooler 2, on 13-Feb-2021, Excursion Temp at 9 AM: 32, 10 AM: 39, 11 AM: 42, 12 PM: 41, 1 PM: 40, 2 PM: 40, 3 PM: 40, 4 PM: 41.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Vials only punctured right before administration.  No treatment medication was provided.   This case was linked to MOD-2022-566976 (Patient Link).
This case was received from a health care professional on 09 June 2009. A female patient received an injection of FLUZONE SV '2005-'2006 USP (lot number U1846AA) on 17 October 2005. Within a few days of vaccination, she experienced "cardiac like symptoms". No additional information was reported. The reporter in this case also reported that the patient's brother experienced "similar symptoms" after receiving FLUZONE in 2005 (lot number U1753AA). This information is captured in case number 2009-02505.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from an other health care professional. This case is linked to cases 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298593, 2018SA298573, 2018SA297575, 2018SA298603, 2018SA298611, 2018SA298631, 2018SA298644, 2018SA298649, 2018SA298692, 2018SA298695, 2018SA298701 and 2018SA298649. This case involves a patient (age and gender not reported) who was vaccinated with dose of FLUZONE HIGH DOSE which was previously frozen, (lot U1995AB and Exp. Date 20 Jun 2018) via intramuscular route in the arm (either right or left) during the period 01 Oct 2018 to 08 Oct 2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. No any information about adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Dizziness after the Second Dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness after the Second Dose) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced DIZZINESS (Dizziness after the Second Dose). At the time of the report, DIZZINESS (Dizziness after the Second Dose) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
"Moderna Covid-19 EUA"  The day following the injection and presently there is a rash on my right shoulder in the area of the vaccination.  It  is approximately 3"X5" it feels warm and itches.  I have applied topical Benadryl with some relief  of the itching but the symptoms remain.  I have notified my Primary care Physician (not contact MD).  Awaiting a call back.
burning in her throat; This is a spontaneous report from a contactable nurse.  A 37-year-old female patient received bnt162b2, intramuscular from 16Dec2020 at 11:45 to at 0.3 mL, single for immunization ()COVID-19 vaccine). Medical history reported as "none".  There were no concomitant medications. On 16Dec2020 11:48, three minutes after receiving the vaccine, the patient experienced burning in her throat . It was further described as it felt like constant reflux in the bottom of her throat. The patient was monitored for about an hour and forty five minutes. The burning was not more or not less. She was swallowing fine. She was breathing fine. Her vital signs and "sats" (saturation) were stable. Outcome of event was unknown.
NO IMMEDIATE ADVERSE EVENTS PRESENT FOLLOWING IMMUNIZATION. RESIDENT WAS ALERT, RESPONSIVE, TALKATIVE, WITHOUT COMPLAINTS, AND ENGAGING IN NORMAL ACTIVITIES AFTER IMMUNIZATION, AS WELL AS THE FOLLOWING DAY. HE WAS FOUND IN BED THE SECOND MORNING AFTER VACCINATION (AT 6:25AM) WITHOUT VITAL SIGNS AND HAD EXPIRED PEACEFULLY IN HIS SLEEP. HE WAS A DNR, NO LIFE SUSTAINING MEASURES WERE PERFORMED.
I'd like to report an adverse reaction; pain down my right arm; tingling in my left hand; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I'd like to report an adverse reaction), PAIN IN EXTREMITY (pain down my right arm) and PARAESTHESIA (tingling in my left hand) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts (allergies to tree nuts), Fruit allergy (allergies to birch fruit), Vegetable allergy (allergies to vegetables), Depression and Anxiety. Concomitant products included LORAZEPAM for Anxiety, SERTRALINE for Depression.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain down my right arm) and PARAESTHESIA (tingling in my left hand). On an unknown date, the patient experienced VACCINATION COMPLICATION (I'd like to report an adverse reaction). At the time of the report, VACCINATION COMPLICATION (I'd like to report an adverse reaction), PAIN IN EXTREMITY (pain down my right arm) and PARAESTHESIA (tingling in my left hand) outcome was unknown.        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 treatment medications were reported.   This case was linked to MOD-2021-281440 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Followup received: Added reporter information .patient details, relevant history, concomitant medication, dose details of dose 1. new events.
While administering the vaccine (left deltoid), the needle tip came off of the plunger and unknown quantity of vaccine went into the patients arm. The pharmacist tried to reattach the needle tip to the plunger and re-inject however the amount of vaccine administered was still unknown. The patient was later administered another full dose of Moderna vaccine in her right arm per Moderna's recommendations.
Janssen COVID-19 Vaccine EUA  Approximately six hours after administration of the vaccine, patient experienced sever chills and dizziness. Unable to stop shaking, patient took temperature which registered at 95.4F and then 95.1F at 15 minutes. Patient donned flannel pants, thermal shirt, and oversized hooded sweatshirt and got in bed under flannel sheets, two doubled-over blankets, a bedspread, and quilt. A down-filled king-size pillow was placed on top of patient's torso and a space heater was turned on to highest setting. Patient reports heart seemed to be racing, but did not take BP. Unable to quell the chills, the patient continued to shake, developing very stiff shoulders, neck and back as a result. This continued until approximately 2 am. The next morning, patient's temperature was registering at 99.4F and pulse was 96, but patient did not report chills. General muscle aches and mild headache were noted. At time of this report, patient's temperature and pulse are normal (97.6F and 76 pulse).
SOA has a red/purplish bruise like rash. 9/13/13 woke up w/it. (L) arm sore up to shoulder.
Patient received Zostavax 11/5/2012.   He said it was given IM, form says it was given SQ.   Patient has a knot in his arm which he showed me on 6/1/19.
Patient (DOB 8/19/1975) received dose 1 of the Pfizer COVID vaccine (lot EW0182, exp 8/2021) at approximately 1320. Patient reported to EMT at 1530 that she felt lightheaded and sweaty. Patient moved unassisted to zero-gravity chair monitored by EMT. EMT alerted PHN while EMT 2 started the assessment. Vital signs: blood pressure 104/63, pulse 63, O2 97%. Allergy to erythromycin. Patient denied medications nor medical conditions. PHN offered patient Benadryl, patient declined. At 1540, patient was provided with a snack and water after patient reported only having a smoothie as she felt anxious in the morning prior to vaccine. At 1545, patient reported improvement in symptoms and sat up. Vital signs: blood pressure 117/82, pulse 76, O2 98%. PHN encouraged patient to stay for 30min since onset of symptoms, to follow up with provider, and when to call 911. At 1555, patient reported symptoms had resolved. Patient left walking without assistance at 1600.
6 discrete seizures 10/16/13 - 10/17/13; CT scan and MRI of brain at Med. Ctr. Started on KEPPRA 500mg BID and Neuro referral done for follow-up.