chrisvoncsefalvay/vaers-outcomes huggingface dataset:
at least half of the dose was noted to have leaked out; Vaccine leaked down patient's arm; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (at least half of the dose was noted to have leaked out) and DEVICE CONNECTION ISSUE (Vaccine leaked down patient's arm) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced UNDERDOSE (at least half of the dose was noted to have leaked out) and DEVICE CONNECTION ISSUE (Vaccine leaked down patient's arm). At the time of the report, UNDERDOSE (at least half of the dose was noted to have leaked out) and DEVICE CONNECTION ISSUE (Vaccine leaked down patient's arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Call transferred by Moderna customer care representative with case number 00164162. Physician called to report that a staff member at their clinic reported today (12May2021) that while administering the second dose (lot number 037B21A) of the Moderna Covid 19 vaccine on 30Apr2021 to a patient (Name not provided), some of the vaccine leaked out and ran down their arm. Staff member confirmed that at least half of the dose was noted to have leaked out. Physician wouldn't share patient information other than the lot number, agent shared the case for physician to share with the patient to call back with contact information. Physician wanted to know is the patient should be re-vaccinated and if they are they still within the window to receive the second dose if needed. Physician gave consent for the safety team to follow-up and prefers email for future communication.
After 2 hours of the vaccine, ''my'' fever went up to 102.9 and it kept going up all day until it reached 104./ a fever of 102.3; After 2 weeks exactly of ''my'' 2nd dose, ''I'' feel very fatigue; No energy at all; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 01May2021 at 10:45 (at the age of 33-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. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 01May2021, after 2 hours of the vaccine, the patient experienced fever which went up to 102.9 and it kept going up all day until it reached 104. On an unknown date in May2021, after 2 weeks exactly of her second dose, the patient felt very fatigue, no energy at all, diarrhea and a fever of 102.3. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever went up to 102.9 and it kept going up all day until it reached 104. After 2 weeks exactly of her second dose, the patient felt very fatigue, no energy at all, diarrhea and a fever of 102.3 was unknown at the time of this report  No follow-up attempts are needed. No further information is expected.
Severe Headache - on and off for 4 days Chills - 2 days Body aches - 3 days Sore throat - 4 days Loss of feeling in left arm, numbness, tingling and moderate pain radiating into my armpit and down to my fingers with any movement - lasted 1 day  All were treated with acetaminophen, ibuprofen and excedrine migraine
Approximately 10 days after vaccination, I developed an itchy, red, swollen, hot  circle near the vaccination site. It resolved in 36 hours.
Pain up right side of head/ear.   Almost immediate Tinnitus!  Eustachian tube dysfunction.  BAD daily VERTIGO!  Ear aches, headaches/migraines, heart palpitations, sciatic nerve pain and arthritis worsen and TMJ jaw issues..  Effects still ongoing 18 months after vaccination!  Vertigo daily has affected my ability to live my life normally!
It was a severe rash, presented like a sun burn. When it first started it was on mu upper chest, then climber up my neck, there were spots coming up on my neck and ear area. There was heat around it just like a sun burn, it was hot to touch and itchy.  The Dr. gave me steroid ointment to help with it.  This lasted for a long time, it still feels different, there's little bumps there for about 2 weeks. It seem to stick around, now if I'm doing something it gets more red quicker but does not bother me.
Information has been received from a medical assistant concerning a patient who on 18-FEB-2010 was inadvertently vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD). No adverse effect was reported. At the time of the report, the outcome was unknown. Additional information has been requested.
Tylenol was take 1hr after vaccine on 5/8. On 5/9 @ approximately 11am severe fatigue unlike anything i ever felt, whole body muscle aches, 5in round swollen injection site along with swollen lymph nodes in underarm. Gland behind left ear swelled and throat felt tight. All symptoms listed above perused 48hrs the fatigue and muscle aches subsided. Under arm lymph nodes still swollen and painful and scratchy throat turned into laryngitis.
Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date; No adverse event; Administered the vaccine after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date).    No concomitant medication was reported by reporter.  Total 35 vials were affected. Vial was initially stored in refrigerator on 4-Jun-2022 and did not undergo temperature excursion. Manufactory code for the lot was MOD. Patient got half dose.  No treatment medication was reported by reporter.
Sunday night I had a dry throat, I was getting up and drinking a lot of water. I thought this may be due to allergy season. On Monday I started feeling achy, my sister also called to let us know that she had tested positive for COVID-19.  Although I had bad headache, I did not test for COVID-19 until the next morning. On Tuesday morning I used a home aCOVID-19 test that came back positive; I called and had a telehealth visit with my doctor. She prescribed the Paxlovid that I was able to start right away. The next day I started to feel better. I tested myself again the following Tuesday and I was negative.
Approximately 30 hours after vaccination developed fever of 102, chills and right arm became red, hot, painful and swollen.  Redness extended from axilla to elbow.  MD started patient on Augmentin 875mg po x 10 days.  Patient reported event on 10/18/12.  "Doing fine" at present.  Denies any respiratory signs or symptoms.  Not sure if latex allergy.  "Heard something about it years ago."  Reports can wear latex gloves and no allergy to kiwi or bananas.
SWOLLEN LEFT ARM, FEVER, FATIGUE, AND PAIN ON  RIGHT SIDE.
Hypertensive; felt dazed out; did not feel to answer/talk; Tachycardia; palpations; Fatigue; Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Hypertensive), FATIGUE (Fatigue), HEADACHE (Headache), FEELING ABNORMAL (felt dazed out; did not feel to answer/talk) and TACHYCARDIA (Tachycardia; palpations) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     It was reported that the patient took no medication and had no allergies.     On 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced HYPERTENSION (Hypertensive), FATIGUE (Fatigue), HEADACHE (Headache), FEELING ABNORMAL (felt dazed out; did not feel to answer/talk) and TACHYCARDIA (Tachycardia; palpations). At the time of the report, HYPERTENSION (Hypertensive), FATIGUE (Fatigue), HEADACHE (Headache), FEELING ABNORMAL (felt dazed out; did not feel to answer/talk) and TACHYCARDIA (Tachycardia; palpations) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Blood pressure systolic: 176 (High) 176, 160 (High) 160, 150 (High) 150 and 130 (High) gradually lowered to 130.     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.   Concomitant medication was not reported. Treatment medication was not reported.
NAUSEA MOMENTS AFTER RECEIVING VACCINE. AN HOUR LATER, STILL A LITTLE NAUSEOUS, BUT WAS FEELING BETTER. AROUND 3 HRS LATER LEGS AND ARMS STARTED ACHING. MY SHOULDERS, KNEES, HIP, AND WRIST STARTED BECOMING VERY TENDER. HEADACHES 5 HRS AFTER VACCINATION (MILD) AND UNTIL NEXT DAY. HEADACHE ON DAY 2 WAS MILD. BY DAY 3, ALL SYMPTOMS (ASIDE FROM PAIN AT THE SITE OF INJECTION) WERE GONE. TOOK TYLENOL, DRINK EXTRA WATER.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 27-OCT-2012 09:30, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient came in for HBO treatment.  Code team had to be called.  Found pt received vaccine day prior.  Unlikely to be related, but wanted to document
Approximately four hours after administration of Moderna vaccine the patient had a sudden syncopal event without warning.  He suffered a scalp contusion.  His equilibrium, hearing and vision were diminished for 7-10 days thereafter, gradually returning to normal.
DEVELOPED A FINE RAISED RASH LEFT NECK, BEHIND LEFT EAR AND LEFT SIDE OF FACE DAY 1;  DAY 2 AWOKE WITH ACUTE HEADACHE AT BASE OF SKULL AND PARESTHESIA TO LEFT SIDE OF FACE.   HEADACHE RESOLVED AFTER APPROX 1 HOUR, RASH RESOLVED WITHIN 1 WEEK, AND PARESTHESIA RESOLVED IN APPROX 3 WEEKS.  TREATED WITH BENADRYL, VALCYCLOVIR AND TYLENOL
This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 65-year-old female patient who received SHINGRIX (batch number G933B ? (GSK note: the reported lot number did not match with any GSK lot number), expiry date 22nd November 2020) for prophylaxis. On 1st August 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 1st August 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In August 2018, the patient experienced injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site warmth, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the right arm. The pharmacist stated that the patient came on the date of reporting and showed the area of the injection site was red and warm. When pharmacist checked the injection site, it looked like the vaccine was administered subcutaneously at a 45 degree angle instead of intramuscularly. This led to incorrect route of vaccine administration. No further details were provided.
PT STATED HAVING PAIN AND DIFFICULTY LIFTING ARM IN THE EVENING AFTER SHOT. NEXT DAY WAS SWOLLEN/RED/PAINFUL BUT NOT HOT. INFORMED PT TO TRY BENADRYL AND HYDROCORTISONE. ALSO SUGGESTED ICE/COMPRESSION AND ELEVATION. INFORMED PT TO SEEK MEDICAL ATTENTION IF GOT WORSE AFTER 24 HOURS. PT STOPPED INTO STORE THE NEXT DAY AND HAD GONE TO URGENT CARE WHERE SHE WAS EVALUATED BUT WAS TOLD TO DO NOTHING DIFFERENT THAN WHAT I HAD TOLD HER.
About 5-7 days after infection had upper right arm pain  and pain lifting arm above shoulder level.  Arms are sore when lifted, painful when lifted above shoulders or stretching to side.
pt w/ diffuse maculopapular rash noted on chest spreading to back and extremeties and face 20 hours post Hep A vaccination
Information has been received from a medical assistant concerning an infant who was vaccinated PO with an incomplete dose of ROTATEQ because the patient vomited during or after the administration of the vaccine.  It was unknown whether medical attention was sought.  The outcome was unknown.  There was no product quality complaint.
N17.0 - Acute kidney injury (AKI) with acute tubular necrosis (ATN) W19.XXXA - Fall, initial encounter N39.0 - UTI (urinary tract infection) R73.9 - Hyperglycemia
Family reports general malaise post treatment, followed by fever and chills 4/3/2021, and cardiac arrest 4/4/2021.
(I believe the shot was not given in the usual place in my upper arm; it was closer to  front  of  arm/shoulder than usual.)    By nightfall I experienced pain under my arm, in the armpit, as if there were a painful lump there, although there was no palpable lump. That pain continued to increase during the day. This morning, two days later, the pain under the arm was slightly diminished, but I noticed a 2-3" red rash (not itchy) on that same arm half way between where the shot had been given and my elbow. It was extremely painful to the touch.
RED, RASH, SWOLLEN, WARM TO TOUCH. TREATED WITH ANTIBIOTICS AND STEROIDS.
Pediatric dose (0.2 ml) of 5-11 serum administered to patient. Patient's mother  present and notified. No adverse event occurred.
Rash on arms, hips, thighs.  Started 1 day after injection.  Not treated - referred to dermo.
This spontaneous report as received from a pharmacist, refers to an unknown number of patients of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with doses of improperly stored PEDVAXHIB (the lot #, expiration date, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions: 0.3C for 26 days and -11C for 5 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sore arm; Was extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Was extremely tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (Was extremely tired). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Was extremely tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 antibody test: positive Positive.         The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No concomitant medication were reported No treatment medication were reported.
I began the Gardasil 3 dose vaccine series in June 2009, and my first tonic-clonic seizure occurred on 01 Mar 2010. I was hospitalized and began the start of 4+ years of testing to find out the cause of this adult onset seizure disorder. All test were inconclusive. I have been hospitalized three times, but have numerous seizures throughout the year. I take daily anti-epileptic medications. Cardiac disorders were ruled out as I had a loop recorder placed by a cardiolgist, that did not show any heart arrhythmias during my seizure activity. I just recently recalled receiving this vaccine a few months prior to my diagnosis. The first seizure was not witnessed, so it was not fully clear the diagnosis. However, all episodes present the same loss of consciousness, ridgid convulsions, tongue biting and prolactin levels 4x upper limit of normal and severe memory loss. I have lost normal cognitive functioning since 2009.
Patient was discharged after receiving vaccine. patient presented with symptomatic AS to the hospital. Family declined intervention. Received vaccine prior to discharge. His wife reported that he was sluggish/unresponsive in the evening that self-resolved. Declined ED evaluation. Currently only experiencing dizziness. Given severity of underlying cardiac disease, unclear if vaccine was cause of symptoms.
9/23/21 pt brought to ED with c/o fever, dysuria, fatigue, decreased oral intake; admitted with UTI; acute renal insufficiency; transferred to ICU due to respiratory failure; intubated; tested positive for COVID on 10/4/21; developed septic shock; acute renal failure and placed on dialysis; developed DVT left upper extremity; hypoxic; hospital stay complicated by A Fib and rapid ventricular response; sputum came back positive for MRSA; ABX given; pt continued to deteriorate; transitioned to comfort measures and passed away in the hospital
I had a scratchy throat on July 11th and then on the 12th I was feeling very bad and took a home test and it came out positive. I called my primary care office after testing positive. However they stated that I needed to be seen by a physician before being able to be given PAXLOVID. We talked about options and once she found out that I was on XARELTO I could not do that and then instead I was given the monoclonal antibodies. I did have a fever, low grade, terrible headache, and fatigue. I had no appetite, and I did start to vomit from Wednesday the 13th of July to the 15th of July. I was kept in bed for the whole day each day. Temperature got up to about 101 and on Friday the 15th I was able to receive the infusion. I am still having some symptoms such as coughing, and constantly trying to clear my throat. I did see my primary care doctor again and they stated that they did hear some wheezing so I did receive a steroid inhaler that doesn't help much. The general fatigue is unfortunately still lingering as well. I did retest myself and they came out negative twice.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic Pain" (unspecified if ongoing), notes: Other medical history: Chronic pain. The patient's concomitant medications were not reported. Past drug history included: Sulfa drugs, reaction(s): "Nausea with sulfa drugs", notes: Known allergies: Nausea with sulfa drugs. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective and covid-19 with paxlovid treatment from 27Dec2022 and 01Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial report received from a physician on 07 April 2011. A 47 year-old male patient who had no concurrent illnesses and no known allergies had received a first intramuscular left arm injection of MENACTRA (lot number U3517AA) on 05 April 2011, and 24 hours (reported also as next day) after vaccination had a temperature of 101.0 degrees Fahrenheit, tingling in the left arm, and swelling at the injection site. It was not reported whether the patient required medical evaluation or treatment. It was noted the patient had received a dose of MENOMUNE in the past with no reported adverse event. He also had no reported adverse events with any other prior vaccinations. Recovery status was reported as "not recovered". Documents held by sender: None.
Swelling, redness, itch 24 hrs later. Given Benadryl, ice.
Day after injection I got out of bed and was UNABLE to walk, nor could I crawl on my knees.  I belly crawled to the bathroom but was unable to get up on the toilet.  The symptoms improved over the course of the day but was not able to walk normally until the following day.  I experienced vomiting, headaches (still persist) brain fog (continues) and fatigue.
Covid positive on 5/11/22. Stuffy, runny nose, constant cough, fever On 5/12/22 began Paxlovid for 5 days Symptoms were gone by  5/14/22 Tested negative on 5/17/22
No adverse event; a baby was administered a adult dose of VAQTA; the vaccine was expired; This spontaneous report was received from a medical assistant (also reported as nurse) referring to a 1-year-old female patient. The patient's concomitant medication, drug reactions, allergies and medical history were unknown.     On 23-DEC-2020, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) 1ml, once, lot # S030588 with expiration date 20-OCT-2020 (route of administration was not reported) for prophylaxis (incorrect dosage administered, no adverse event and expired product administered). No additional adverse event (AE) was reported.