chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was a 30 day use by date expiry. The 30 day use by date was 07Nov2021/ When was the vaccine given? 09Nov2021; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It was a 30 day use by date expiry. The 30 day use by date was 07Nov2021/ When was the vaccine given? 09Nov2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (It was a 30 day use by date expiry. The 30 day use by date was 07Nov2021/ When was the vaccine given? 09Nov2021). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (It was a 30 day use by date expiry. The 30 day use by date was 07Nov2021/ When was the vaccine given? 09Nov2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant drug reported. No Treatment drug reported.   This case was linked to MOD-2021-386947 (Patient Link).; Sender's Comments: This case concerns a 59-year-old, male patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after booster dose of mRNA 1273 vaccine.  The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Projectile vomiting; patient has no memory of ever vomiting in past 15 years Significant double vision rendering patient unable to walk without assistance Trouble balancing when standing still and had a minor slip down some steps Slurred/incoherent speech Headache (less severe than other symptoms) Fatigue lingering 48 hours
No other adverse event; Expired product administered; This spontaneous report was received from a medical assistant concerning to a patient of an unknown age and gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.  On 10-DEC-2021, the patient was vaccinated with an expired dose of measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # S039311, expiry date 04 Dec 2021, 0.5 milligram (anatomical location, route of administration was not reported) for prophylaxis (expired product administered). No other adverse event reported.
pain at the shot site / cannot sleep at night because of the intense pain at the site; Sleeplessness; Cannot raise by hand than 45 degrees from the resting position; Hand has become weak and shakes uncontrollably; Hand has become weak and shakes uncontrollably; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2019, the patient received the 2nd dose of Shingrix. On 14th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, sleeplessness, mobility decreased, hands weakness of and tremor of hands. On an unknown date, the outcome of the injection site pain, sleeplessness, mobility decreased, hands weakness of and tremor of hands were unknown.   It was unknown if the reporter considered the injection site pain, sleeplessness, mobility decreased, hands weakness of and tremor of hands to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had pain at the shot site and cannot sleep at night because of the intense pain at the site. The patient cannot raise hand more than 45 degrees from the resting position. The patient hand had become weak and shakes uncontrollably. The patient asked if one of the side effects of the shot and can it be cured by some anti-dote treatment to the shot.
For both injections, I have, within an hour, a metalic taste that last, at least for the first dose, approimately 36 hours. The second dose, just today, has the same effect on my taste - matallic taste. Also, not too sure if connected, a runny nose. I know the matallic taste is both benign & rare, just thought it important to get the reaction on record.   Curious to know the cuase(s) of this adverse effect.   Also, feeling a bit under the weather after each shot.
chills, headache, fatigue, runny nose, feeling unwell, joint pain, muscle aches, tingling sensation all over body at time of injection
sore arm muscle, like someone had slugged me hard; uncomfortable sleeping; Discomfort lasted about 4 days; This non-serious 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 (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (chicken pox in 7th grade). Previously administered products included gamma globulin injection. Family history included shingles (aunt had shingles long before there was a vaccine).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm muscle, like someone had slugged me hard), discomfort (Verbatim: Discomfort lasted about 4 days) and sleep disturbance (Verbatim: uncomfortable sleeping). The outcome of the pain in arm and sleep disturbance were not reported and the outcome of the discomfort was resolved (duration 4 days).   It was unknown if the reporter considered the pain in arm, discomfort and sleep disturbance to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, discomfort and sleep disturbance to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-MAR-2023 The case  was received from the patient via interactive digital media. The patient said sorry as you got Shingles. The patient recommended to do get the 2-dose vaccine.  The patient got chicken pox and there was not a specific vaccine then he/she was given the generic gamma globulin injection. The patient stated that only reaction he/she had was a very sore arm muscle, like someone had slugged him/her hard.  The discomfort lasted about 4 days, but patient was glad to deal with that instead of the disease.  The patient stated that one of his/her colleagues had Shingles and she was out of work for quite a while affected her eyes (she was an artist) and she had nerve pain.  The patient stated that if you sleep on your side, get your vaccine in the arm you did not sleep on so you were not too uncomfortable sleeping. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR056753, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR056753:Same patient/same product
AN HOUR AFTER THE VACCINATION, THE PATIENT DEVELOPED SMALL BLISTERS ON HER NECK ON THE LEFT SIDE, SHE ALSO NOTICED THAT THEY HAD DEVELOPED ON HER LEFT SHOULDER AND DOWN HER BACK. THE BLISTERS GOT LARGER ON HER SHOULDER AND BACK THAN THE ONES ON HER NECK. THEY WERE FILLED WITH LIQUID. SHE RECEIVED THE VACCINE IN HER LEFT ARM. I ADVISED HER TO TAKE BENADRYL AND CALL THE DOCTOR OR GO TO ER IF SYMPTOMS PERSISTED OR GOT WORSE.
was vaccinated and still got them / suspected vaccination failure; still got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient was vaccinated and still got them. The reporter had it as a child and was very painful. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
at 5:00pm, call the pharmacy first. severe headache, nausea, more arm  pain than expected.  called doctor the next day, to let them know that she was still experiencing the symptoms. stayed home Tuesday and Wednesday. Yesterday felt lightheaded and couldn't eat much. Today  felt fine, a little nausea while eating breakfast so didn't finish eating. Having nausea today also and not able to finish any meals. On Tuesday, fibromyalgia flared up in right elbow. Had some fogginess.
MODERNA BOOSTER DOSE (0.25MLS) GIVEN TO PEDIATRIC PATIENT Father came with his twin sons to get Moderna booster for him and Pfizer pediatric 1st doses for his sons.  When it was time to administer shot by mistake I picked up the wrong syringe and gave Moderna Booster dose (0.25MLS) to 11yrs old Pediatric patient instead of Pfizer pediatric dose. I realized it after and informed the father about the mistake. We also inform his pediatric doctor. We are following up with parent and he seemed to be doing  well so far after 4hours of administration.
COVID-19 positive RT PCR assay test; I had my first shot of the Pfizer covid vaccine on 15Jan2021, I was diagnosed with covid on 26Jan; This is a spontaneous report from a contactable other hcp. A 58-year-old male patient started to receive bnt162b2 (BNT162B2, Solution for injection, Lot #: EL0142), via an unspecified route of administration from 15Jan2021 to 15Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing Caller says this was diagnosed 20 years ago, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing Caller says this was diagnosed 20 years ago. There were no concomitant medications. On 26Jan2021, the patient experienced i had my first shot of the pfizer covid vaccine on 15jan2021, i was diagnosed with covid on 26jan, On 28Jan2021, covid-19 positive rt pcr assay test. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jan2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.
Within 24 hrs of administration of flu vax, developed area 4 1/2 x 5 cm of swelling, redness & warmth of injection site. Resolved within 48 hours.
pt recvd vax;devel fever 103; fever subsequently resolved however devel irritability & was not eating or drinking;
PATIENT RECEIVED FLUAD VACCINE ON AUGUST 13TH IN THE EVENING. PATIENT RECEIVED FLUAD ON LEFT ARM AND PREVNAR 13 ON RIGHT ARM .  PATIENT HAD HIGH FEVER AT MIDNIGHT SAME DAY. HE FELT BETTER NEXT DAY. HIGH FEVER WAS ON AND OFF FOR NEXT 3 DAYS.  (FEVER RANGE# 102.5 TO 101 ) PATIENT'S LEFT ARM WERE FLUAD  INJECTION WAS GIVE WAS RED , SWOLLEN AND WARM TO TOUCH IT. PATIENT HAD MILD PAIN AND ITCHING AT INJECTION SITE.  PATIENT'S  PCP PRESCRIBED HIM AMOXIL AND BENADRY ON AUGUST 17 TH AT 8:04 PM AND HE HAS FOLLOW UP APPOINTMENT WITH PCP DR NEXT DAY.
HYPOTENSION 1/23/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
9/16/04: child complained of pain in throat, difficulty swallowing. "Belly ache" while at receptionist desk. Very anxious appearance. Drooling: holding throat. Vomited lunch particles after approximately 10 min. BP 80/42 HR 120 Given 2 mg Duodrin, 1.5 tbs Benadryl. Child flushed in face. BP 76/40 HR 116. Child feels better. Flushed face/ extremities. No cough complaint of pain in throat or belly ache. Sent home with instruction/ epi pen JR script/ Benadryl . Orapred. Gave Benadryl 4 hours later. Orapred x 2 days
Chills, joint aches, fever, headache, muscle pain, fatigue for 2 days following 2nd injection
pt woke with pain at injection site. red raised spot  dime-size appeared on day day and grew to silver dollar.  pt experiencing localized constant pain, stinging. with no relief as of  11/22/2021.
61year old male with a PMH sig for low back pain, hx MVA w/facial trauma, and 1.5ppd cig smoker. no documented PFTs or diagnosis of COPD, was vaccinated with pneumococcal vaccine 11/30/06 and was vaccinated again 1/10/08. On 1/11/08, patient called primary care nurse with complaints of red, swollen area of the arm in which he received the vaccine. Pt went to the DO and received diphenhydramine.
Extreme morning sickness and vomiting. Started on 08Mar, has continued persistently since; Extreme morning sickness and vomiting. Started on 08Mar, has continued persistently since; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6206, first dose) solution for injection intramuscular in the right arm on 03Mar2021 at 15:45 (at the age of 20-years-old) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medication included bupropion. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 08Mar2021 at 10:00, the patient experienced extreme morning sickness and vomiting. Started on 08Mar2021, has continued persistently since. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization in Mar2021 for 1 day. Lab test on 08Mar2021 included Nasal Swab SARS-COV-2 PCR was negative. Treatment for the events morning sickness and vomiting included IV fluids, prochlorperazine, diphenhydramine. The outcome of the events morning sickness and vomiting was not recovered.
a patient received a dose of MMR vaccine following a temperature excursion; no adverse effects were reported; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 09-OCT-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R031680, expiration date on 01-NOV-2020, for prophylaxis (strength, dosage, frequency and route were not provided), following a temperature excursion (product storage error). No adverse effects were reported.  It was explained that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), was in a temperature excursion of 47°F/9°C (72.4°F) for 8 hours and 50 minutes and highest temperature was above 47°F/9°C (70.2 °F) for 9 hours and 39 minutes. There was a previous temperature excursion and the total time and highest temperature was above 47°F/9°C (54.7F) for 1 hour and 50 minutes. There was not data logger.
rectal cancer s/p chemotherapy and radiation presenting with rectal pain and constipation.  On arrival, patient is mildly hypertensive but otherwise vitals are stable.  On exam, patient appears fatigued.  Immunocompromised Consulted ID regarding patient's immunocompromised state and new Covid diagnosis. They have recommended providing monoclonial antibodies, which have been ordered.
This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a 16-year-old male patient who received BEXSERO (batch number 158701, expiry date 30th September 2017). On 2nd November 2016, the patient received BEXSERO. On 2nd November 2016, less than a day after receiving BEXSERO, the patient experienced injection site redness, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site redness, injection site swelling and injection site pain were unknown. It was unknown if the reporter considered injection site redness, injection site swelling and pain to be related to BEXSERO. Additional details were provided as follows: The patient received a dose of BEXSERO and within 24 hours the patient experienced and injection site reaction, described as redness, swelling, and pain. The reporter has given the permission to contact again. This case has been linked with case US2016GSK165443, for the same patient for event experienced after receiving FLUARIX QIV.  This is one of the 5 cases reported by the same reporter.
rash/ Rash on chest, back, around hair line, injection site and behind ears; rash/ Rash on chest, back, around hair line, injection site and behind ears; hives; dizziness; numbness and tingling of tongue; numbness and tingling of tongue; This is a spontaneous report from a contact pharmacist.  An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 03Jan2021 as single dose for covid-19 immunization.  Medical history included known allergy to sulfa.  The patient's concomitant medications were not reported.  The patient experienced rash/ rash on chest, back, around hair line, injection site and behind ears on 03Jan2021 with outcome of not recovered; hives on 03Jan2021 with outcome of unknown; dizziness on 03Jan2021 with outcome of unknown; numbness and tingling of tongue on 03Jan2021 with outcome of not recovered.  No. Adverse event: Symptoms started 5 minutes after receiving vaccine: rash/hives, dizziness, numbness and tingling of tongue. Rash on chest, back, around hair line, injection site and behind ears. Patient was taken to ER as rash and tingling of tongue was persisting after taking diphenhydramine (BENADRYL), 50 mg and cetirizine (ZYRTEC)  10mg. An epinephrine (EPIPEN) was provided at discharge from the emergency department. Therapeutic measures were taken as a result of rash/ rash on chest, back, around hair line, injection site and behind ears and numbness and tingling of tongue as aforementioned; no treatment was provided for the other events.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
Bell's palsy symptoms developed a few days after the vaccine. Received the vaccine on 2/18, started having facial droop on the night of 2/23, was seen in the emergency department on 2/24 with left facial droop, had a stroke code activation, imaging was negative, was treated with valacyclovir and prednisone x7 days. Was seen on 3/5 by neurology for follow up. Then was seen 3/11 in the ED again for severe headache and facial pain behind the left ear related to the Bell's palsy. His Bell's palsy symptoms have somewhat improved since the original onset but have not resolved. He continues to have facial weakness, facial droop, auditory changes due to the Bell's palsy. He was most recently seen on 3/16 in primary care to follow up on his symptoms after being seen in the emergency department.   He did recently have COVID in October of last year. No other recent illness or vaccinations.
my body was sensitive to touch; my body was sensitive to touch, tender if you will; and the smell of my urine changed to an odd sweet/sour smell.; Initially it was common side effects (sore arm, chills, feverish); Initially it was common side effects (sore arm, chills, feverish); Initially it was common side effects (sore arm, chills, feverish); This is a spontaneous report from a contactable consumer (patient) reported for herself. A 33-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 24Feb2021 at 10:15 am (age at vaccination was 33 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history and known allergies. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 29Jan2021 at 12:00 pm (age at vaccination was 33 years) as dose 1, single for COVID-19 immunization. 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 has not been tested for COVID-19. On 27Feb2021 at 12:00 am, initially it was common side effects (sore arm, chills, feverish) but then the patient noticed a weird feeling in her entire body (day 3+ after vaccine) almost like her body was sensitive to touch, tender if you will and the smell of her urine changed to an odd sweet/sour smell. Her diet did not change and she stayed hydrated. No treatment was received for the adverse events. The outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Within 15 min. of vaccine,I had some brief mild shortness of breath,a stab of pain in the center of my left chest,I felt strange, had 3 stabs of pain in my right ear and 3 pressure type pains in my left ear.
no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 01-AUG-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA010266: US-009507513-2209USA010267: US-009507513-2209USA010268: US-009507513-2209USA010269: US-009507513-2209USA010270: US-009507513-2209USA010271: US-009507513-2209USA010272: US-009507513-2209USA010273: US-009507513-2209USA010274: US-009507513-2209USA010275:
Erythema and swelling in localized area of right arm day after administration. Secondary to PNEUMOVAX injection.
Patient's right arm became red and swollen 3.5 inches by 5 inches. Patient also reported fever of 102 F, body aches, chills, and upset stomach.
breast pain (both sides) lasted for about 4 days. pain level about 4-5 on a scale of 0-10.