chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I immediately could 'taste' the shot in my mouth.  Then, tongue began to feel prickly, and then lips felt the same way.  Slight dizziness.  After 15 minutes, I left the pharmacy, could drive my car and felt only slight dizziness.  However, the tongue and lips continued to feel burning/prickly for the rest of the day.  I did not  report this to the pharmacy.  If the 2nd shot does this again, I will report it to them.
Expired vaccine administered beyond 12 hours expiration for punctured vial; Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) and PRODUCT STORAGE ERROR (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) and PRODUCT STORAGE ERROR (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) and PRODUCT STORAGE ERROR (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Pharmacist is called to report that 8 patients received expired doses of Moderna COVID-19 vaccine beyond 12 hour expiration for punctured vials.  Date the vial was initially stored in the refrigerator was 31AUG2021.  Date first punctured was on 05SEP2021 11AM Kept in Refrigerator.  Date of administration of vaccine was on 06SEP2021 4:30PM Room Temperature on 06SEP2021  then discarded the vial.  Total amount of time the vial was exposed to room temperature range 46° to 77° F.  From 06SEP2021 9:00AM and discarded vial after 4:30PM.   This case was linked to MOD-2021-311383 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up information included Updated Fax Contact details.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 10:21 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:56 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    50.85 for dose administered on 27-Feb-2021 and 50.93 for dose administered on 27-Mar-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion with temperature 35 degrees Fahrenheit from 11:00 AM to 02:00 PM and on 05:00 PM, 33 degrees Fahrenheit on 09:00 AM and 34 degrees Fahrenheit on 03: PM to 04:00 PM.  This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021. 20 vials were sent to clinic.  Batch number 019B21A underwent temperature excursion with temperature 35 degrees Fahrenheit at 9:00 to10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021. 20 vials were sent to clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a  traceable temperature monitor at every hour.  No treatment medications were reported.
Pfizer-BioNTech COVID-19 Vaccine EUA  Extreme level of defecation, not diarrhea - over 20 times in less than 24 hours.
Swollen lymph node on the left side of the neck. (Left shoulder injection site); This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient (non- pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6201) via an unspecified route of administration on 13Feb2021 (at the age of 30-year-old) as dose number unknown, single for COVID-19 immunisation at hospital. Medical history included known allergies to penicillin. No covid prior vaccination. Not tested for covid post vaccination. Concomitant medications were not reported. In Feb2021, the patient experienced swollen lymph node on the left side of the neck (Left shoulder injection site). The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
My arm is very painful after Shingrix vaccine.; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The patient stated that his/her arm was very painful after Shingrix vaccine. The patient asked what would help.
8 days after receiving the shot, my arm developed a large, red, hot lump at the injection site that was painful to the touch, and itched.
Pfizer Dose 1 2/1/21 (EL3302) Pfizer Dose 2 2/19/21 (EC9261) Pfizer Dose 3 10/26/21 (30145BA) COVID Positive 1/18/22  1/18/22: 80-year-old lady with history of dementia presented to the emergency room from Nursing Home with a history of agitation and aggressive behavior.  The patient was just recently admitted to that nursing home on January 7, 2022.  Apparently, she has been very angry, anxious, and agitated and was transferred to local facility for possible admission to behavioral health.  However, admission could not be processed, and she was sent to the emergency department where she was noted to be in atrial fibrillation.  The patient is demented and in poor health with some episode of aggressive behavior.  She was given antipsychotic in the emergency room and has become slightly obtunded.  Family member reports that the patient has been in multiple nursing homes because of agitation. In the emergency department, given a dose of metoprolol IV to control the heart rate and the CT of the chest was done that shows some possibility of interstitial edema in both lungs.  The chest x-ray was reported with no acute findings.  The CT head was noted to have no acute or suspicious intracranial findings.  The patient has a history of AFib and has been off her medication for several days, as she has not been cooperative.  Family member is requesting care coordination to be involved so that we can find a new placement for the patient.  2/17/22: Patient is a 80-year-old lady with history of dementia, HTN, AFib, depression presented to the emergency room from Nursing Home with a history of agitation and aggressive behavior. Patient was admitted for AFib RVR.  Cardiology was consulted.  Medication was recommended.  Ventricular rate has been well controlled. Will continue amiodarone and Eliquis.  During hospitalization patient had acute urinary retention requiring Foley, this is been removed and patient is voiding.  Patient also admitted for acute encephalopathy in the setting of dementia and agitated behavior.  Will continue current regimen.  Will discharge patient to long-term care.  Follow-up with PCP as needed.
This spontaneous report as received from a nurse practitioner via a company representative refers to a teenage female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with an unidentified Merck HPV vaccine GARDASIL or GARDASIL 9 (dose, route of administration, anatomical location, lot # and expiry date were not specified). On an unknown date, after the vaccination, the patient experienced vasovagal reaction. The outcome of the event and the causality assessment were not provided. Additional information is not expected as there was no consent for further contact.
08/20/05 ONSET OF NAUSEA, DIARHHEA, ABD. PAIN. PERISTED X 2 DAYS.CALLED MD ON 8/22. SEEN IN ED TO RULE OUT APPENDICITIS.  ABD. ULTRASOUND SHOWED SHOWED ENLARGED LYMPH NODES IN ABD. AND PELVIC REGION ACCORDING TO MOTHER.   MOTHER CALLED CLINIC ON 8/23 TO REPORT PT. STATUS AND TO ASK IF COULD BE RELTED TO MENACTRA. PT. STARTING TO FEEL BETTER TODAY. (8/23) WRITER CALLED MANUFACTURER MEDICAL TO INQUIRE AFTER NO INFO. FOUND ON PACKAGE INSERT RE: NODE ENLARGEMENT.  PT. TO CONTINUE TO FOLLOW UP WITH MD.
This spontaneous report as received from a nurse practitioner refers to a 44 years old female patient (who is also physician) with no medical history or drug reactions/allergies. The patient was vaccinated subcutaneously in the left arm with a 0.5 ml dose of VARIVAX (merck) on 05-OCT-2012. Lot number 0660AE (in validation) and exp. date 14-MAR-2014. No other co-suspects were reported. Concomitant medications included: SYNTHROID and another unspecified medication. On 17-OCT-2012 the patient developed a red golf ball size rash on the left arm at the injection site. On 18-OCT-2012 the patient had one vesicle at the same location of the red golf ball size rash. The patient sought medical attention by phone call and office visit. No laboratory tests were performed. Treatment included ice and TYLENOL. The outcome of red golf ball size rash on the left arm at the injection site and vesicle at the same location of the red golf ball size rash was reported as recovering/resolving. The relatedness for red golf ball size rash on the left arm at the injection site and vesicle at the same location of the red golf ball size rash was unknown for VARIVAX (Merck). Additional information has been requested.
This spontaneous report as received from a 22 year old female patient reporting on behalf of herself as part of a market research program. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. On an unknown date the patient got diseases after being vaccinated (details unspecified) (adverse event). The action taken with the therapy with PNEUMOVAX 23 was reported as unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with PNEUMOVAX 23 was unknown. Additional information is not expected as there was no consent.
Following booster shot:Swollen lymph nodes near site of injection; Painful lymph nodes near site of injection; Pain at injection site; Discomfort at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Sep2021 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 30Sep2021, following booster shot, the patient experienced swollen painful lymph nodes near site of injection, pain and discomfort at injection site. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen painful lymph nodes near site of injection, pain at injection site and discomfort at injection site was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mom states pt fine until about 10 days p/vax; began w/fever 102-103; had sz & was having some difficulty breathing on way to hosp; MD thought could be virus;
Multiple Myeloma Not Having Achieved Remission. Office visit within 6 weeks of receiving the COVID vaccine.
Moderna vaccine given out of the recommended age group.  No adverse reaction noted per mother.  Child had a sore arm.
On Jan 27, 20021, I fell and have a displaced fragment of the 5th metacarpal base.  About 34 hours after my shot, I started feeling discomfort from my fracture.  By 36 hours I had great discomfort and pain with some swelling.  More pain than with the original fracture /fall.  Talked with vaccine hotline at around 36 hours after shot.   They advised I talk with Doctor.  I did call doctor.  He advised elevation, two ibuprofen and on Tylenol every 4 to 6 hours.  I did that.  Now 48 hours out from shot, extreme pain gone; Have swelling and discomfort.  Only took two rounds of ibuprofen and Tylenol.
Information has been received from a 66 year old female consumer reporting herself with breast cancer and morphine allergy who on 21-MAR-2011 was vaccinated in her buttocks with a dose of PNEUMOVAX 23 (dose, route and lot number not provided) and with a dose of ZOSTAVAX (Merck) (MSD, dose, route and lot number not provided), in the left arm during the same office visit. Concomitant therapy also included letrozole. On 21-MAR-2011 the patient reported she experienced swelling, redness, warmth and tenderness at the site of injection 4 hours after administered PNEUMOVAX 23 in her buttocks. The area was about the size of a tennis ball. Patient sought unspecified medical attention. No laboratory diagnostics studies were performed. No treatment for the adverse event was given. At the time of the report, the patient was recovering. No further information is available.
Nausea, headaches , some migraines, fatigues, tummy weirdness, yuck feeling. Had to get nausea meds to work. And migraine meds.
Soreness and redness in arm has lasted 2 weeks 2nd shot   1st dose same thing but only 2-3 days.   Also, nerve irritation along the areas where patient had suffered with shingles in the past.
I had a headache that started on December 31st and has continued still to today. It is not terrible, but it has varied in strength. It has not been very responsive to over-the-counter pain medication. A couple of nights I had nausea and ended up throwing up 4 times in one night and twice on another night. The headache has felt like a pressure in my head and when it gets stronger, I can hear the blood rushing in my ears. I went to the doctor today and they indicated that it was most likely a migraine. I had a small hand full when I was 14 but they stopped when I got older. They never lasted as long as this one has. The doctor recommended that I monitor the headache and continue taking over the counter medications to treat.
Rash in mouth and throat and shortness of breath  on Thursday  3/11/21  around 7 p.m.. Called Covid line and spoke to a RN who recommended that I take Ibuprofen  and  not to take an antihistamine,  and  to contact my doctor in the morning.  Also to go to the ER if symptoms got worse I took Ibuprofen every 4 hours  over night and called  my  primary  care physician in the morning.  He sent me to the Urgent Care center since  the rash had persisted .  The Urgent Care  physician prescribed  Prednisone  and  Benadryl.  I  am taking antihistamines  and Ibuprofen  for relief of rash and  itching.  I will follow-up  doctor on Monday.
This case was reported by a physician and described the occurrence of an allergic reaction in a 45 year old male subject who received hepatitis B vaccine recombinant (Engerix-B). The subject smoked three cigarettes per day. Medical history included HIV positivity, contact dermatitis, bipolar disorder, "transgendering" and allergies to Soma, morphine, and novocaine. The subject's concurrent medications include Combivir and efavirenz (Sustiva) to treat HIV infection, clorazepate dipotassium (Tranxene) and fluxoetine hydrochloride (Prozac) to treat bipolar disorder, and conjugated estrogens (Premarin) and spironolactone (Aldactone) for "transgendering." On an unspecified date in 2001, the subject received the "hepatitis B vaccination series." The manufacturer for the hepatitis B vaccine was not provided. Approximately three years after the third dose of hepatitis B vaccine, on an unspecified date in October 2004, a hepatitis B surface antibody titer indicated that the subject was "non-immune." On 15 December 2004, the subject received a dose of Engerix-B as the 4th dose of hepatitis B vaccine. Approximately one day later, on 16 December 2004, the subject experienced swelling below the eyes, an itchy scalp and a rash on his arms. The subject was seen at a physician's office. The physician state that the subject, "had no lip swelling or dyspnea." The subject was diagnosed with "an allergic reaction to hepatitis B vaccine" and was treated with diphenhydramine hydrochloride (Benadryl). Immunization with Engerix-B was discontinued. The allergic reaction resolved on 17 December 2004. The reporting physician considered the allergic reaction to possibly be related to vaccination with Engerix-B.
Information has been received from a physician concerning an around 54 year old male patient with cardiovascular issues who about two weeks ago (approximately 18-NOV-2009) was vaccinated with the first 0.5 ml dose of PNEUMOVAX 23. Within 24 hours of receiving PNEUMOVAX 23, the patient developed a rash at the injection site. The patient called the office for medical attention. At the time of the report, the patient had recovered. Additional information has been requested.
depression; felt weird; Felt disoriented; could not walk without a cane; joint pain; A spontaneous report was received from a consumer concerning a 26-years-old, male patient who experienced joint pain, depression, could not walk without cane, "I felt disoriented" and "I felt weird".   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included topiramate, lithium, ziprasidone hydrochloride, escitalopram oxalate, lisdexamfetamine mesilate, clarithromycin, mometasone furoate, probiotic, vitamin D and multivitamin.  On 05 Mar 2021, approximately two days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 lot number 040A21A intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Mar 2021, the patient reported feeling weird, disoriented and having joint pain. Two days later he could not walk without a cane.   The patient reported being hospitalized for depression from unknown date until 11 Mar 2021.  Treatment for the event included gabapentin.  Action taken with mRNA-1273 in response to the events was not provided.  The events joint pain, depression, could not walk without cane, "I felt disoriented" and "I felt weird" were considered recovered on 14 Mar 2021.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Administered vaccine at 10:51 am, client to waiting area for 15 minutes at approximately 10:59 c/o dizziness, summoned by office staff, client transferred to wheelchair and move to private area, began c/o throat closing, 911 call made, Epinephrine  0.3 mg administered IM per Epipen at 11:05 byr RN per emergency standing order.  Client reports relief of symptoms 1-2 minutes after injection of epinephrine.  .Ambulance arrived at 11:08 approximately BP 156/110 P- 78.  Transported by EMS to Hospital ER by EMS.
soreness; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (soreness) and FATIGUE (tired). At the time of the report, PAIN (soreness) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       There was no concomitant list  Treatment was Not provided
Nausea, headache, neck and shoulder pain which developed 12-24 hours after vaccination. Patient was on vacation and was referred to emergency room.  Patient did not have a fever.
Wrong vaccine administered to patient under 18 years of age. Patient specifically requested Moderna,  looked "in her mid 20s", and had a child in the car per nurse giving the vaccine at our drive-through event. DOB was not verified prior to administration. Patient notified. Nurse re-educated that medication administration process includes verification of patient name and dob prior to administration. Nurse stated understanding. Patient not concerned and did not have any adverse reaction after vaccine. Plan to continue with Moderna series for 2nd dose.
Centralized chest pain. Not substernal, worse with palpation. Improved with nitro and aspirin. Nonradiating.